Devices and methods for intracardiac procedures

• US 6,899,704 B2
• Filed: 07/10/2001
• Issued: 05/31/2005
• Est. Priority Date: 12/03/1992
• Status: Expired due to Fees

• 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., Peters, William S., Sterman, Wesley D.
• Primary Examiner(s): Isabella, David J.
• Application Number:
  US09/902,523
• Publication Number:
  US 20030145865A1
• Time in Patent Office: 1,421 Days
• Field of Search: 606/10, 606/34, 606/1, 606/7, 606/46, 606/108, 606/142, 606/151, 606/158, 606/213, 606/215, 600201-208, 604/2, 604/4.01, 604/96.01, 604/93.01, 604171-174, 604/164, 604/508, 604/509, 604/264, 604/823, 604/532, 607/1, 623/66, 128/898, 128/897
• US Class Current: 606/1
• 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 2017/0243 : 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 2017/2943 : 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 2017/3427 : 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 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 2/2496 : Devices for determining the dimensions of the prosthetic valve to be implanted, e.g. templates, sizers
• CPC Class Codes: A61M 1/3623 : Means for actively controlling temperature of blood
• CPC Class Codes: A61M 1/3664 : for preparing cardioplegia solutions
• CPC Class Codes: A61M 2025/0003 : having an additional lumen transmitting fluid pressure to the outside for measurement
• 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 2039/027 : having a particular valve, seal or septum septum A61M2039/0036
• 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

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 closed-chest surgical intervention witbin a patient'"'"'s heart or great vessel, the system comprising:

means for forming a percutaneous penetration in an intercostal space in the patient'"'"'s chest;

a visualization scope configured to pass through an intercostal space in the patient'"'"'s chest for viewing an internal chest cavity;

means for arresting the patient'"'"'s heart from a location outside of the chest cavity;

a cardiopulmonary bypass system, including means for delivering oxygenated blood to the patient'"'"'s arterial system;

cutting means positionable through a percutaneous intercostal penetration into the chest cavity for forming an internal penetration in a wall of the patient'"'"'s heart or great vessel; and

means for securing a replacement valve at a valve location within the patient'"'"'s heart, the means being positionable through a percutaneous intercostal penetration and through the internal penetration.

2. The system of claim 1 wherein the means for arresting the heart comprises an endovascular catheter having expandable means for occluding the patient'"'"'s ascending aorta between the patient'"'"'s coronary arteries and the patient'"'"'s brachiocephalic artery, and an internal lumen for delivering cardioplegic fluid into the ascending aorta upstream of the expandable means.

3. The system of claim 1 further comprising a cannula positionable in a percutaneous intercostal penetration, the cannula having a lumen therein through which the replacement valve may be introduced into the internal chest cavity.

4. The system of claim 1, wherein the replacement valve comprises an annular portion for attachment to a valve annulus in the heart, the annular portion having an outer diameter, wherein the lumen in the cannula has a cross-sectional height at least equal to the outer diameter, and a cross-sectional width less than the width of the intercostal space.

5. The system of claim 1 further comprising cutting means positionable through a percutaneous intercostal penetration and through the internal penetration for removing at least a portion of the patient'"'"'s heart valve.

6. The system of claim 1 further comprising means positionable through a percutaneous intercostal penetration and through the internal penetration for sizing a valve annulus of the patient'"'"'s heart valve.

7. The system of claim 6 wherein the sizing means comprises an elongated shaft and sizing means at a distal end of the shaft, wherein the shaft and sizing means may be introduced through a percutaneous intercostal penetration and through the internal penetration to position the sizing means near the valve annulus.

8. The system of claim 1 further comprising means for introducing the replacement valve into the patient'"'"'s heart, the introducing means comprising an elongated shaft having means at a distal end thereof for releasably holding the replacement valve.

9. The system of claim 8 wherein the introducing means further comprises means actuated from a proximal end of the shaft for pivoting the replacement valve relative to the shaft from a first position for introduction through a percutaneous intercostal penetration to a second position for attachment at the valve location.

10. The system of claim 1 wherein the means for securing the replacement valve comprises means positionable through a percutaneous intercostal penetration for suturing the replacement valve to a valve annulus at the valve location.

11. The system of claim 10 further comprising organizing means for maintaining sutures in spaced-apart positions outside of the chest cavity after the sutures have been applied to the valve annulus.

12. The system of claim 11 wherein the organizing means is fixed to a proximal end of a cannula disposed in a percutaneous intercostal penetration, the cannula having a lumen through which the replacement valve may be introduced into the chest cavity.

13. The of claim 11 further comprising means on the organizing means for maintaining tension on ends of the sutures to facilitate advancing the replacement valve along the sutures into the patient'"'"'s heart.

14. The system of claim 1 further comprising retraction means positionable through an intercostal space in the patient'"'"'s chest for opening the internal penetration in the wall of the heart or great vessel.

15. The system of claim 1 wherein the interventional means is configured to reach the interior of the heart or great vessel from a percutaneous penetration in a right lateral portion of the patient'"'"'s chest.

16. The system of claim 15 wherein the interventional means is at least about 20 cm in length.

17. A system for surgical intervention within a patient'"'"'s heart or great vessel, the system comprising:

means for forming a percutaneous penetration in an intercostal space in the patient'"'"'s chest;

cutting means positionable through a percutaneous intercostal penetration into the chest cavity for forming an internal penetration in a wall of the patient'"'"'s heart or great vessel; and

means for securing a replacement valve at a valve location within the patient'"'"'s heart, the means being positionable through a percutaneous intercostal penetration and through the internal penetration.