Transapical mitral valve repair method

• US 10,285,686 B2
• Filed: 09/05/2014
• Issued: 05/14/2019
• Est. Priority Date: 06/27/2011
• Status: Active Grant

• Current Assignee: University of Maryland Baltimore County (University of Maryland)
• Original Assignee: University of Maryland Baltimore County (University of Maryland)
• Inventors: Gammie, James, Patel, Rahul, Ghoreishi, Mehrdad
• Primary Examiner(s): Templeton, Christopher L
• Application Number:
  US14/478,325
• Publication Number:
  US 20150032127A1
• Time in Patent Office: 1,712 Days
• Field of Search: 606139, 606148, 606144, 606232, 623 1311, 623 1314
• CPC Class Codes: A61B 17/0401 Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors A61B17/0642 takes precedence; fixation devices for tendons or ligaments A61F2/0811
• CPC Class Codes: A61B 17/0469 Suturing instruments for use in minimally invasive surgery, e.g. endoscopic surgery
• CPC Class Codes: A61B 17/0485 Devices or means, e.g. loops, for capturing the suture thread and threading it through an opening of a suturing instrument or needle eyelet
• CPC Class Codes: A61B 17/06066 Needles, e.g. needle tip configurations making needles B21G1/00
• CPC Class Codes: A61B 17/06166 Sutures suture materials A61L17/00; manufacture of artificial threads D01D; treatment of threads D06M
• CPC Class Codes: A61B 17/062 Needle manipulators
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61B 2017/00783 Valvuloplasty
• CPC Class Codes: A61B 2017/0404 Buttons
• CPC Class Codes: A61B 2017/0406 Pledgets
• CPC Class Codes: A61B 2017/0409 Instruments for applying suture anchors for applying suture clamps, clips or locks A61B2017/0488
• CPC Class Codes: A61B 2017/0417 T-fasteners
• CPC Class Codes: A61B 2017/0464 for soft tissue
• 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 2017/06171 helically or spirally coiled for needles A61B2017/06076
• CPC Class Codes: A61F 2/2457 Chordae tendineae prostheses
• CPC Class Codes: A61F 2/2466 Delivery devices therefor

Abstract

Methods and devices for repairing a cardiac valve. A minimally invasive procedure includes creating an access in the apex region of the heart through which one or more instruments may be inserted. The device can implant artificial heart valve chordae tendineae into cardiac valve leaflet tissues to restore proper leaflet function and prevent reperfusion. The device punctures the apex of the heart and travels through the ventricle. The tip of the device rests on the defective valve and punctures the valve leaflet. A suture or a suture/guide wire combination is inserted, securing the top of the leaflet to the apex of the heart. A resilient element or shock absorber mechanism adjacent to the outside of the apex of the heart minimizes the linear travel of the device in response to the beating of the heart or opening/closing of the valve.

Claims

1. A method of repairing a prolapsed leaflet of a valve of a heart comprising:

introducing into a ventricle of the heart a distal portion of a delivery system having a distal tip and carrying an artificial chordae having a distal portion and a proximal portion;

disposing the distal tip of the delivery system in contact with a ventricular side of the leaflet;

while maintaining the entire distal portion of the delivery system on the ventricular side of the leaflet, extending from the distal tip of the delivery system a needle having a distal portion carrying the distal portion of the artificial chordae to pierce a prolapsed segment of the leaflet from the ventricular side of the leaflet to an atrial side of the leaflet to form an opening in the leaflet;

passing through the opening, from the ventricular side to the atrial side, the distal portion of the artificial chordae disposed in a first configuration, and with the proximal portion of the artificial chordae remaining on the ventricular side of the leaflet;

causing the distal portion of the artificial chordae to change from the first configuration to a second configuration, the second configuration being larger than the opening in the leaflet;

securing the artificial chordae to an apex region of the heart to reduce prolapse of the leaflet;

the artificial chordae includes a medial portion between the distal portion of the artificial chordae and the proximal portion of the artificial chordae; and

the passing through the opening includes the medial portion of the artificial chordae disposed in a first configuration remaining on the ventricular side of the leaflet, and

further comprising causing the medial portion of the artificial chordae to change from the first configuration of the artificial chordae to a second configuration of the artificial chordae, the second configuration of the artificial chordae being larger than the opening in the leaflet, a portion of the leaflet being disposed between the medial portion of the artificial chordae in the second configuration of the artificial chordae and the distal portion of the artificial chordae in the second configuration of the artificial chordae.

2. A method of repairing a prolapsed leaflet of a valve of a heart comprising:

introducing into a ventricle of the heart a distal portion of a delivery system having a distal tip and carrying an artificial chordae having a distal portion and a proximal portion;

disposing the distal tip of the delivery system in contact with a ventricular side of the leaflet;

while maintaining the entire distal portion of the delivery system on the ventricular side of the leaflet, extending from the distal tip of the delivery system a needle having a distal portion carrying the distal portion of the artificial chordae to pierce a prolapsed segment of the leaflet from the ventricular side of the leaflet to an atrial side of the leaflet to form an opening in the leaflet;

passing through the opening, from the ventricular side to the atrial side, the distal portion of the artificial chordae disposed in a first configuration, and with the proximal portion of the artificial chordae remaining on the ventricular side of the leaflet;

causing the distal portion of the artificial chordae to change from the first configuration to a second configuration, the second configuration being larger than the opening in the leaflet;

securing the artificial chordae to an apex region of the heart to reduce prolapse of the leaflet;

evaluating regurgitation of the valve while the heart is beating; and

lengthening or shortening a distance between the leaflet and the apex region of the heart until regurgitation of the heart valve is reduced.