Devices and methods for intracardiac procedures

• US 6,283,127 B1
• Filed: 09/25/1998
• Issued: 09/04/2001
• 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., Stevens, John L., Gifford, Hanson S. III, Sterman, Wesley D.
• Primary Examiner(s): Isabella, David J.
• Application Number:
  US09/161,190
• Time in Patent Office: 1,075 Days
• Field of Search: 128/898, 604/4, 604/5, 604/49, 604/51-53, 604/96-103, 604/113, 606/192, 606/194, 606/7, 606/8, 623/2.11, 600/101
• US Class Current: 128/898
• 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 method of closed-chest surgical intervention within an internal cavity of a patient'"'"'s heart or great vessel, the method comprising:

establishing cardiopulmonary bypass;

arresting the patient'"'"'s heart;

viewing an internal portion of the patient'"'"'s chest through a scope extending through a percutaneous intercostal penetration in the patient'"'"'s chest;

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

introducing an interventional tool through a percutaneous intercostal penetration and through the internal penetration to perform a surgical procedure within the internal cavity under visualization by means of said scope.

2. The method of claim 1 wherein the patient'"'"'s heart is arrested by occluding the patient'"'"'s aorta between the patient'"'"'s coronary arteries and the patient'"'"'s brachiocephalic artery with an expandable member on a distal end of an endovascular catheter, and perfusing the patient'"'"'s myocardium with cardioplegic fluid.

3. The method of claim 1 wherein the interventional tool is introduced through a cannula positioned in a percutaneous intercostal penetration.

4. The method of claim 1 wherein the surgical procedure comprises surgically treating a heart valve.

5. The method of claim 4 further comprising the step of removing at least a portion of the heart valve by means of a cutting tool introduced through a percutaneous intercostal penetration-and through the internal penetration.

6. The method of claim 4 further comprising the step of introducing a replacement valve through a percutaneous intercostal penetration and through the internal penetration into the internal cavity.

7. The method of claim 6 further comprising fastening the replacement valve within the internal cavity by means of an instrument introduced through a percutaneous intercostal penetration and through the internal penetration.

8. The method of claim 6 wherein the replacement valve is introduced through a cannula positioned in a percutaneous intercostal penetration.

9. The method of claim 4 wherein a percutaneous intercostal penetration is created in a right lateral portion of the patient'"'"'s chest.

10. The method of claim 9 wherein the internal penetration is made in a wall of the patient'"'"'s left atrium.

11. The method of claim 10 wherein the heart valve comprises a mitral valve.

12. The method of claim 10 wherein the heart valve comprises an aortic valve.

13. A method of closed-chest replacement of a heart valve in a patient'"'"'s heart, the method comprising:

establishing cardiopulmonary bypass;

arresting the patient'"'"'s heart;

viewing the patient'"'"'s heart through a scope extending through a percutaneous intercostal penetration in the patient'"'"'S chest;

forming an internal penetration through a wall of the patient'"'"'s heart using a cutting tool introduced through a percutaneous intercostal penetration in the patient'"'"'s chest;

positioning a replacement valve through a percutaneous intercostal penetration in the patient'"'"'s chest and through the internal penetration into a chamber of the heart; and

securing the replacement valve in a valve position in the heart.

14. The method of claim 13 wherein the patient'"'"'s heart is arrested by occluding the patient'"'"'s aorta between the patient'"'"'s coronary arteries and the patient'"'"'s brachiocephalic artery with an expandable member on a distal end of an endovascular catheter, and perfusing the patient'"'"'s myocardium with cardioplegic fluid.

15. The method of claim 13 wherein the heart valve comprises a mitral valve, the valve position comprising a mitral valve position.

16. The method of claim 15 wherein the chamber comprises a left atrium of the patient'"'"'s heart.

17. The method of claim 13 wherein the percutaneous intercostal penetration is disposed in a right lateral portion of the patient'"'"'s chest.

18. The method of claim 13 further comprising the step of removing at least a portion of the patient'"'"'s heart valve using a cutting tool introduced through a percutaneous intercostal penetration and through the internal penetration.

19. The method of claim 13 further comprising sizing the patient'"'"'s heart valve by means of a sizing instrument introduced through a percutaneous intercostal penetration and through the internal penetration.