Less-invasive devices and methods for treatment of cardiac valves

• US 6,564,805 B2
• Filed: 07/18/2002
• Issued: 05/20/2003
• Est. Priority Date: 02/22/1993
• Status: Expired due to Fees

• Current Assignee: Edwards Lifesciences LLC (Edwards Lifesciences Corporation)
• Original Assignee: Heartport, Inc. (Johnson & Johnson)
• Inventors: Garrison, Michi E., Donlon, Brian S., Stevens, John H., Daniel, S. Christopher
• Primary Examiner(s): Isabella, David J.
• Application Number:
  US10/198,513
• Publication Number:
  US 20020183839A1
• Time in Patent Office: 306 Days
• Field of Search: 128/898, 623/2.11, 623/2.36, 623/66, 623/904, 606/7, 606/151, 606/153, 606/205, 606/206, 600/101, 604/49, 604/4.5, 604/280, 604/174, 604/175
• 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 17/0293 with ring member to support retractor elements
• 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 17/122 Clamps or clips , e.g. for the umbilical cord for the vas deferens A61F6/206
• CPC Class Codes: A61B 17/29 Forceps for use in minimally invasive surgery
• CPC Class Codes: A61B 17/2909 Handles
• CPC Class Codes: A61B 17/3421 Cannulas
• 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 2017/00053 Mapping
• 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 2017/00575 for closure at remote site, e.g. closing atrial septum defects
• CPC Class Codes: A61B 2017/00867 shape memory effect
• CPC Class Codes: A61B 2017/00907 for light
• CPC Class Codes: A61B 2017/00946 malleable
• CPC Class Codes: A61B 2017/0237 for heart surgery
• 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 2017/0496 : for tensioning sutures
• CPC Class Codes: A61B 2017/2912 : transmission of forces to actuating rod or piston
• CPC Class Codes: A61B 2017/2926 : Details of heads or jaws
• 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 2017/3492 : 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 2018/00982 : combined with or comprising means for visual or photographic inspections inside the body, e.g. endoscopes
• CPC Class Codes: A61B 2090/061 : for measuring dimensions, e.g. length
• 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 2/2442 : Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
• CPC Class Codes: A61F 2/2445 : Annuloplasty rings in direct contact with the valve annulus
• CPC Class Codes: A61F 2/2448 : D-shaped rings
• CPC Class Codes: A61F 2/2466 : Delivery devices therefor
• 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: 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 1/3621 : Extra-corporeal blood circuits single-needle circuits A61M1/30
• CPC Class Codes: A61M 2025/028 : having a mainly rigid support structure
• CPC Class Codes: A61M 2039/027 : having a particular valve, seal or septum
• 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 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

Devices and methods are provided for less-invasive surgical treatment of cardiac valves whereby the need for a gross thoracotomy or median sternotomy is eliminated. In one aspect of the invention, a delivery system for a cardiac valve prosthesis such as an annuloplasty ring or prosthetic valve includes an elongated handle configured to extend into the heart through an intercostal space from outside of the chest cavity, and a prosthesis holder attached to the handle for releasably holding a prosthesis. The prosthesis holder is attached to the handle in such a way that the holder, prosthesis and handle have a profile with a height smaller than the width of an intercostal space when the adjacent ribs are unretracted, preferably less than about 30 mm. In a further aspect, the invention provides a method for repairing or replacing a heart valve which includes the steps of introducing a prosthesis through an intercostal space and through a penetration in a wall of the heart, and securing the prosthesis to an interior wall of the heart, wherein each step is carried out without cutting, removing, or significantly retracting the ribs or sternum.

Claims

1. A method of repairing a heart valve in a patient'"'"'s heart, the heart being disposed within a chest cavity defined by a plurality of ribs attached to a sternum, each rib being separated from an adjacent rib by an intercostal space having an intercostal width when the ribs are in an unretracted position, the method comprising:

establishing cardiopulmonary bypass;

arresting the patient'"'"'s heart;

forming a percutaneous penetration into the chest cavity through an intercostal space;

forming a cardiac penetration into the heart through an outer wall of the heart;

positioning an annuloplasty device through the percutaneous penetration and the cardiac penetration into the heart; and

securing the annuloplasty device to an internal wall of the heart around the heart valve;

wherein each of the above steps are performed with the ribs and sternum intact and substantially unretracted.