Devices and methods for intracardiac procedures

• US 5,718,725 A
• Filed: 06/05/1995
• Issued: 02/17/1998
• 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: Garrison, Michi E., Gifford, Hanson S. III, Stevens, John H., Sterman, Wesley D.
• Primary Examiner(s): ISABELLA, DAVID J
• Application Number:
  US08/463,814
• Time in Patent Office: 988 Days
• Field of Search: 604/4, 604/28, 604/96, 604/206, 604/205, 604/16, 623/2, 623/3, 623/66
• US Class Current: 623/2.11
• 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 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 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 2039/0282 : with implanted tubes connected to the port
• 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 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

The invention provides devices and methods for performing less-invasive surgical procedures within an organ or vessel. In an exemplary embodiment, the invention provides a method of closed-chest surgical intervention within an internal cavity of a patient'"'"'s heart or great vessel. According to the method, the patient'"'"'s heart is arrested and cardiopulmonary bypass is established. A scope extending through a percutaneous intercostal penetration in the patient'"'"'s chest is used to view an internal portion of the patient'"'"'s chest. An internal penetration is formed in a wall of the heart or great vessel using cutting means introduced through a percutaneous penetration in an intercostal space in the patient'"'"'s chest. An interventional tool is then introduced, usually through a cannula positioned in a percutaneous intercostal penetration. The interventional tool is inserted through the internal penetration in the heart or great vessel to perform a surgical procedure within the internal cavity under visualization by means of the scope. In a preferred embodiment, a cutting tool is introduced into the patient'"'"'s left atrium from a right portion of the patient'"'"'s chest to remove the patient'"'"'s mitral valve. A replacement valve is then introduced through an intercostal space in the right portion of the chest and through the internal penetration in the heart, and the replacement valve is attached in the mitral valve position.

Claims

1. A system for performing an interventional procedure in a heart within a patient'"'"'s chest, the chest being defined by a plurality of ribs and a sternum, the system comprising:

a device for inducing cardioplegic arrest from outside the patient'"'"'s chest;

a blood circulation device for maintaining circulation of oxygenated blood in the patient'"'"'s arterial system downstream of the heart; and

an interventional device positionable through a percutaneous penetration between two adjacent ribs and through a penetration in a wall of the heart for performing a surgical intervention within the heart, the interventional device being configured for manipulation entirely from outside the chest, the intervensional device also including a replacement valve, a valve delivery device, and an elongate handle, the replacement valve being configured to be positioned into the chest through a percutaneous penetration between two adjacent ribs, the valve delivery device being couplable to the replacement valve and configured for positioning the replacement valve between the ribs and into the heart, the elongated handle having distal and proximal ends, the distal end having a coupling configured to releasably hold the replacement valve, the coupling being pivotable relative to the handle.

2. The system of claim 1 wherein the replacement valve has an outer diameter and is configured to pass through a percutaneous penetration having a width smaller than the outer diameter.

3. The system of claim 1 wherein the valve delivery device has a handle defining a longitudinal axis, and wherein the replacement valve has a sewing ring for attachment to the heart, the sewing ring having a central axis, the valve delivery device being configured to position the valve through the percutaneous penetration with the central axis generally parallel to the longitudinal axis.

4. The system of claim 1 wherein the replacement valve is attached to a holder which is couplable to the valve delivery device.

5. The system of claim 4 wherein the holder and valve together have a first profile smaller than the percutaneous penetration.

6. The system of claim 5 wherein the holder and valve together have a second profile larger than the percutaneous penetration.

7. The system of claim 1 wherein the delivery device further comprises an actuator actuable from the proximal end for pivoting the coupling.

8. The system of claim 1 wherein the device for inducing cardioplegic arrest comprises an occlusion device for occluding the ascending aorta between the coronary arteries and the brachiocephalic artery.

9. The system of claim 8 wherein the occlusion device comprises an endoaortic catheter having proximal and distal ends, and an occluding member near the distal end configured to occlude the ascending aorta with the proximal end extending transluminally out of the chest through a peripheral artery.

10. The system of claim 9 further comprising a fluid delivery device for delivering cardioplegic fluid to the myocardium from outside the chest.

11. The system of claim 10 wherein the endoaortic catheter has a port near the distal end and an inner lumen extending from the proximal end to the port, the fluid delivery device being in communication with the inner lumen.

12. The system of claim 1 wherein the blood circulation device comprises a cardiopulmonary bypass system including a venous cannula positionable in a peripheral vein for withdrawing blood therefrom, an oxygenator for oxygenating the blood, and an arterial cannula positionable in a peripheral artery for returning the blood thereto.