Methods and systems for performing thoracoscopic coronary bypass and other procedures

• US 6,027,476 A
• Filed: 09/19/1997
• Issued: 02/22/2000
• Est. Priority Date: 12/03/1992
• Status: Expired due to Term

• Current Assignee: Edwards Lifesciences LLC (Edwards Lifesciences Corporation)
• Original Assignee: Heartport, Inc. (Johnson & Johnson)
• Inventors: Machold, Timothy R., Stevens, John H., Sterman, Wesley D., Siegel, Lawrence C., Curtis, Patricia E.
• Primary Examiner(s): Isabella, David J.
• Application Number:
  US08/933,634
• Time in Patent Office: 886 Days
• Field of Search: 604/96, 604/97, 604/98, 604/99, 604/100, 604/101, 604/51-53, 604/4, 606/192, 606/193, 606/194, 606/195, 600/18, 128/898
• 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 17/0057 Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect sutures A61B17/04; closing rectum or urethra near body surface A61F2/0009
• 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 17/064 Surgical staples, i.e. penetrating the tissue
• CPC Class Codes: A61B 17/068 Surgical staplers , e.g. containing multiple staples or clampsstaplers containing only one staple A61B17/10; magazines or containers for staples A61B17/105; for performing anastomosis A61B17/115; staplers in general B25C5/00
• CPC Class Codes: A61B 17/12013 for use in minimally invasive surgery, e.g. endoscopic surgery
• CPC Class Codes: A61B 17/122 Clamps or clips , e.g. for the umbilical cord for the vas deferens A61F6/206
• CPC Class Codes: A61B 17/1227 Spring clips
• CPC Class Codes: A61B 17/1285 for minimally invasive surgery
• CPC Class Codes: A61B 17/29 Forceps for use in minimally invasive surgery
• CPC Class Codes: A61B 17/2909 Handles
• CPC Class Codes: A61B 17/30 Surgical pincettes without pivotal connectionsfor holding suture needles or materials A61B17/0483; wound clamps A61B17/08 ; hand-held gripping tools without pivotal connections in general B25B9/02
• CPC Class Codes: A61B 17/3403 Needle locating or guiding means guides for suture needles A61B17/0482; guiding or tracking by nuclear magnetic resonance G01R33/285
• CPC Class Codes: A61B 18/1442 Probes having pivoting end effectors, e.g. forceps
• 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 2017/00637 : for sealing trocar wounds through abdominal wall
• CPC Class Codes: A61B 2017/00663 : the implement being a suture
• CPC Class Codes: A61B 2017/0225 : flexible, e.g. fabrics, meshes, or membranes
• CPC Class Codes: A61B 2017/0237 : for heart surgery endoscopic heart surgery A61B2017/00243; endoscopic access devices, i.e. trocars, A61B17/34
• CPC Class Codes: A61B 2017/0243 : for immobilizing local areas of the heart, e.g. while it beats trocars attached to inner organs or inner body tissue A61B2017/3488
• 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 J-shaped suture needles A61B2017/0608
• 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 2017/2912 : transmission of forces to actuating rod or piston
• CPC Class Codes: A61B 2017/2927 : the angular position of the head being adjustable with respect to the shaft
• CPC Class Codes: A61B 2017/2932 : Transmission of forces to jaw members
• 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 2017/308 : with suction cups
• CPC Class Codes: A61B 2017/3405 : using mechanical guide means
• CPC Class Codes: A61B 2017/3427 : for intercostal space
• 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 90/36 : Image-producing devices or illumination devices not otherwise provided for
• 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: A61F 2007/0001 : Body part
• CPC Class Codes: A61F 2007/0054 : with a closed fluid circuit, e.g. hot water
• CPC Class Codes: A61F 2007/101 : for cooling organs in the body before or during surgery
• CPC Class Codes: A61F 7/10 : Cooling bags, e.g. ice-bags
• CPC Class Codes: A61M 2025/0003 : having an additional lumen transmitting fluid pressure to the outside for measurement
• CPC Class Codes: A61M 2025/0031 : characterized by lumina for withdrawing or delivering, i.e. used for extracorporeal circuit treatment
• CPC Class Codes: A61M 2025/028 : having a mainly rigid support structure
• CPC Class Codes: A61M 2025/1052 : for temporarily occluding a vessel for isolating a sector
• CPC Class Codes: A61M 2039/0279 : for introducing medical instruments into the body, e.g. endoscope, surgical tools
• CPC Class Codes: A61M 2202/047 : cardioplegic
• 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 2210/127 : Aorta
• CPC Class Codes: A61M 2230/005 : Parameter used as control input for the apparatus
• CPC Class Codes: A61M 25/0023 : by the form of the lumen, e.g. cross-section, variable diameter
• 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 25/1011 : Multiple 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

A method for closed-chest cardiac surgical intervention relies on viewing the cardiac region through a thoracoscope or other viewing scope and endovascularly partitioning the patient'"'"'s arterial system at a location within the ascending aorta. The cardiopulmonary bypass and cardioplegia can be induced, and a variety of surgical procedures performed on the stopped heart using percutaneously introduced tools. The method of the present invention will be particularly suitable for forming coronary artery bypass grafts, where an arterial blood source is created using least invasive surgical techniques, and the arterial source is connected to a target location within a coronary artery while the patient is under cardiopulmonary bypass and cardioplegia.

Claims

1. A system for facilitating a surgical procedure on or around a patient'"'"'s heart comprising:

a device positionable in the patient'"'"'s chest wall for forming a viewing passage through the patient'"'"'s chest wall for viewing the interior of the patient'"'"'s chest cavity with the patient'"'"'s sternum at least partially intact;

an aortic occlusion device for internally occluding the patient'"'"'s ascending aorta at a location between the patient'"'"'s coronary arteries and the brachiocephalic artery;

a cardiopulmonary bypass system, including an arterial return lumen to direct oxygenated blood into the patient'"'"'s arterial system downstream from the occluded ascending aorta;

a delivery lumen for delivering cardioplegic fluid to the heart; and

surgical tools which can be manipulated from outside the chest cavity for operating on and around the heart.

2. The system of claim 1, wherein the aortic occlusion device is an elongated aortic catheter having proximal and distal ends and an expandable member on a distal portion thereof, the catheter being adapted to be advanced through the patient'"'"'s aorta until the expandable member on the distal portion is disposed at a location between the ostia of the coronary arteries and the brachiocephalic artery and the expandable member being shaped and dimensioned so that, upon the expansion thereof within the patient'"'"'s ascending aorta, the aortic passageway therethrough is occluded.

3. The system of claim 1, wherein the cardiopulmonary bypass system includes a venous drainage lumen to withdraw blood from the patient'"'"'s venous system, and an oxygenator to oxygenate the withdrawn blood which is directed into the patient'"'"'s arterial system downstream of the occluded ascending aorta.

4. The system of claim 1, further comprising at least one trocar sheath which can be disposed within a relatively small opening in the patient'"'"'s chest to define an introducing path for at least one device selected from the aortic occlusion device and the surgical tools.

14. The system of claim 1 wherein the aortic occlusion device is positionable through the chest wall and into the aorta through an arteriotomy in a wall thereof.

15. The system of claim 14 further comprising an access device positionable in the chest wall for forming an access passage therein with the sternum at least partially intact, the aortic occlusion device being positionable through the access passage.

5. A system for performing a coronary artery bypass graft procedure comprising:

device positionable between the patient'"'"'s ribs with the sternum at least partially intact for forming a viewing passage through the patient'"'"'s chest wall to observe a procedure within a patient'"'"'s chest cavity;

an aortic occlusion device to internally occlude the patient'"'"'s ascending aorta at a location between the patient'"'"'s coronary arteries and the brachiocephalic trunk;

a cardiopulmonary bypass system including a venous drainage lumen to withdraw blood from the patient'"'"'s venous system, an oxygenator to oxygenate the withdrawn blood and an arterial return lumen to direct the oxygenated blood into the patient'"'"'s arterial system downstream of the occluded ascending aorta;

a delivery lumen to deliver cardioplegic fluid to the patient'"'"'s heart;

a first cutting tool which can be inserted into the chest cavity through a small opening in the patient'"'"'s chest, to transect an artery under observation through the viewing passage to provide a free upstream arterial end within the chest cavity;

a second cutting tool which can be inserted into the chest cavity through a relatively small opening in the patient'"'"'s chest, to form an incision in a coronary artery downstream from a blockage therein under observation through the viewing passage; and

an anastomosis instrument which can be inserted into the chest cavity through an opening in the patient'"'"'s chest, for securing the free upstream end of the transected artery to the coronary artery about the incision therein under observation through the viewing passage.

6. The system of claim 5, wherein the delivery lumen is within a catheter for introducing cardioplegic material into at least one of the patient'"'"'s coronary blood vessels.

7. The system of claim 5, further comprising at least one trocar sheath which can be disposed within a relatively small opening in the patient'"'"'s chest to define an introducing path for at least one device selected from the aortic occlusion device and the surgical tools.

8. A system as in claim 5, wherein the delivery lumen is within a coronary sinus catheter which permits retrograde delivery of cardioplegic fluid to the heart.

9. A system as in claim 5, further comprising a pulmonary venting catheter which can vent fluid from the pulmonary trunk and decompress the left ventricle.

10. A system as in claim 5, further comprising an aortic root vent lumen to vent the left ventricle.

12. A system as in claim 5 wherein the aortic occlusion device comprises an aortic occlusion catheter positionable within the aorta having an expandable member at its distal end configured to occlude the ascending aorta between the coronary ostia and the brachiocephalic artery.

13. A system as in claim 12 wherein the aortic occlusion catheter is configured to extend into the ascending aorta with a proximal extremity thereof extending to a femoral artery.

11. A system for performing a coronary artery bypass graft procedure in a patient including:

an aortic occlusion catheter having a distal end, a proximal end and an expandable member at the distal end configured to occlude the ascending aorta between the coronary ostia and the brachiocephalic artery, the aortic occlusion catheter being adapted to be positioned into the ascending aorta with the sternum at least partially intact, the aortic occlusion catheter having a configuration selected from the group consisting of a peripheral access configuration adapted for introduction into a peripheral artery and a direct access configuration adapted for placement through the chest wall and through an aortic arteriotomy;

a first cutting tool which can be inserted into the patient'"'"'s chest cavity through a small opening in the patient'"'"'s chest to create an arterial blood source within the patient'"'"'s chest cavity by severing an artery and providing a free, upstream end of the artery within the chest cavity under observation through a viewing passage between the patient'"'"'s ribs;

a second cutting tool which can be inserted into the patient'"'"'s chest cavity through a small opening in the patient'"'"'s chest to form an incision in a coronary artery downstream from a blockage therein under observation through a viewing passage between the patient'"'"'s ribs; and

means which can be inserted into the patient'"'"'s chest cavity through a small opening in the patient'"'"'s chest for securing the free, upstream end of the severed artery to the coronary artery about the incision therein under observation through a viewing passage between the patient'"'"'s ribs.

16. A system for surgical intervention on a patient'"'"'s heart, comprising:

a first access device adapted to be positioned in the patient'"'"'s chest wall with the patient'"'"'s sternum at least partially intact for forming a first passage into the chest cavity;

an aortic occlusion device adapted to be positioned into the aorta through an arteriotomy in a wall thereof for internally occluding the patient'"'"'s ascending aorta at a location between the patient'"'"'s coronary arteries and the brachiocephalic artery, the aortic occlusion device being positionable into the chest cavity through the first passage;

an arterial return lumen to direct oxygenated blood into the patient'"'"'s arterial system downstream from the occluded ascending aorta;

a delivery lumen for delivering cardioplegic fluid to the heart.

17. The system of claim 16 further comprising:

a second access device adapted to be positioned in the chest wall with the sternum at least partially intact to form a second passage into the chest cavity, the second passage being configured to receive surgical tools for performing surgery on the heart; and

a surgical tool positionable through the second passage for performing a surgical procedure on the heart.