TRANSAPICAL MITRAL VALVE REPAIR DEVICE

• US 20140114404A1
• Filed: 12/23/2013
• Published: 04/24/2014
• 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
• Granted Patent: US 8,852,213 B2
• Time in Patent Office: Days
• US Class Current: 623/2.11
• 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 comprising:

introducing into a ventricle of a heart proximate to a heart valve leaflet a suture having a distal portion and a proximal portion;

piercing the leaflet from a 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 suture disposed in a first configuration, and with the proximal portion of the suture remaining on the ventricular side of the leaflet; and

causing the distal portion of the suture to change from the first configuration to a second configuration, the second configuration being larger than the opening in the leaflet.

2. The method of claim 1, further comprising fixing the proximal portion of the suture to the heart.

3. The method of claim 1, wherein:

the distal portion of the suture is formed as a coil having a plurality of turns;

in the first configuration, the coil is straight; and

in the second configuration, the coil is a loop.

4. The method of claim 1, wherein:

the introducing includes introducing into the ventricle a needle having a distal portion and having the distal portion of the suture disposed about an exterior of the distal portion of the needle in the first configuration;

the piercing includes passing a distal tip of the needle through the leaflet;

the passing include passing the distal portion of the needle and the distal portion of the suture through the leaflet; and

the second configuration of the suture is a bulky knot.

5. The method of claim 1, wherein:

the introducing includes introducing into the ventricle a tubular pusher having a distal end and a needle slidably disposed in the pusher and having a distal portion with the distal portion of the suture wrapped around the distal portion of the needle in the first configuration, the distal portion of the needle and the distal portion of the suture extending from the distal end of the pusher;

the causing includes withdrawing the distal portion of the needle into the distal end of the pusher.

6. The method of claim 1, wherein the valve leaflet is a first leaflet of the heart valve and the suture is a first suture, further comprising:

introducing into the ventricle proximate to the heart valve a second suture having a distal portion and a proximal portion;

piercing a second leaflet of the heart valve from a ventricular side of the second leaflet to form an opening in the second leaflet;

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

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

joining the first suture and the second suture in the ventricle proximate to the heart valve.

7. The method of claim 1, wherein:

the suture includes a medial portion between the distal portion and the proximal portion; and

the passing includes the medial portion of the suture disposed in a first configuration remaining on the ventricular side of the leaflet, and

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

8. The method of claim 1, wherein the causing includes withdrawing proximally the proximal portion of the suture.

9. An apparatus comprising:

a tubular pusher having a distal end and an interior diameter;

a needle having a distal portion, the needle slidably disposed within the pusher with the distal portion of the needle extending from the distal end of the pusher;

a suture having a first section and a second section,

the first section having a first portion disposed in the pusher and a second portion including a coil formed of multiple turns about an exterior of the needle, the coil having a proximal end and a distal end, and further having an external diameter larger than the internal diameter of the pusher, the second portion having a first end at the distal end of the coil,

the second section having a second portion with a first end coupled to the first end of the second portion of the first section, extending proximally from the first end of the second portion of the first section through the interior of the coil to the proximal end of the coil, and including a loop forming segment extending distally from a first end of the loop forming segment at the proximal end of the coil along the outside of the coil to the distal end of the coil, and extending proximally through the interior of the coil to the proximal end of the coil at a second end of the loop forming segment, and having a first portion extending proximally from the second end of the loop forming segment into the pusher,

wherein the suture is configured for the coil to be formed into a loop by (1) withdrawing the needle proximally through the coil and the pusher to separate the coil from the needle, and (2) withdrawing the first portion of the second section relative to the distal end of the pusher to draw the second end of the loop forming segment of the second portion of the second section proximally from the proximal end of the coil to draw the proximal end of the coil and the distal end of the coil towards each other.

10. The apparatus of claim 9, wherein the coil is a first coil, the loop is a first loop, and

the second portion of the second section includes a second coil formed of multiple turns about the exterior of the needle proximal to the first coil and having a proximal end and a distal end, the second portion of the second section extending proximally from the first end of the second portion through the interior of the second coil to the proximal end of the second coil, the first end of the loop forming segment of the second portion of the second section extending from the distal end of the second coil,

the second portion of the first section having a loop forming segment extending from a first end of the loop forming segment proximally from the proximal end of the first coil along the outside of the second coil to the proximal end of the second coil and extending distally through the interior of the second coil to the distal end of the second coil at a second end of the loop forming segment of the second portion of the first section, the first portion of the first section extending proximally from the second end of the loop forming segment of the second portion of the first section into the pusher,

wherein the suture is configured for the second coil to be formed into a second loop by (1) withdrawing the needle proximally through the second coil and the pusher to separate the second coil from the needle, and (2) withdrawing the first portion of the first section relative to the distal end of the pusher to draw the second end of the loop forming segment of the second portion of the first section proximally from the distal end of the second coil to draw the proximal end of the second coil and the distal end of the second coil towards each other.

11. The apparatus of claim 9, wherein:

the needle has an interior lumen and the distal portion of the needle has a slot communicating with the lumen;

the first portion of the first section of the suture and the first portion of the second section of the suture extend through the lumen of the needle;

the slot extends through the coil; and

the second portion of the second section of the suture extends through the interior of the coil within the lumen and extends through the slot from the lumen to the exterior of the coil.

12. The apparatus of claim 10, wherein:

the needle has an interior lumen and the distal portion of the needle has a slot communicating with the lumen;

the first portion of the first section of the suture and the first portion of the second section of the suture extend through the lumen of the needle;

the slot extends through the first coil and the second coil;

the second portion of the second section of the suture extends through the interior of the first coil within the lumen and extends through the slot from the lumen to the exterior of the first coil; and

the second portion of the first section of the suture extends through the interior of the second coil within the lumen and extends through the slot from the lumen to the exterior of the second coil.

13. The apparatus of claim 9, wherein the distal end of the pusher has an external diameter and the loop has a dimension larger than the external diameter of the pusher.

14. The apparatus of claim 9, further comprising an outer tube surrounding at least a portion of the pusher, the outer tube having a distal end with an external diameter greater than an external diameter of the pusher, the distal end of the outer tube being spaced proximally from the distal end of the pusher.

15. The apparatus of claim 14, wherein the outer tube includes an expandable balloon, the distal end of the outer tube defined by the expandable balloon.

16. The apparatus of claim 9, further comprising a device operably coupled to a proximal portion of the needle, the device configured to withdraw the needle proximally relative to the distal end of the pusher.

17. An apparatus, comprising:

a suture having a first section and a second section,

the first section having a first portion and a second portion, the second portion of the first section including a coil formed of multiple turns, the coil having a first end and a second end, the second portion of the first section having a first end at the second end of the coil, the first portion of the first section extending away from the first end of the coil,

the second section having a second portion with a first end coupled to the first end of the second portion of the first section, extending from the first end of the second portion of the first section through the interior of the coil to the first end of the coil, and including a loop forming segment extending from a first end of the loop forming segment at the first end of the coil along the outside of the coil to the second end of the coil, and extending through the interior of the coil to the first end of the coil at a second end of the loop forming segment, and having a first portion extending away from the second end of the loop forming segment,

the loop forming segment holding the coil in a looped configuration with the first end of the coil adjacent the second end of the coil.

18. The apparatus of claim 17, wherein the coil is a first coil, the loop forming segment is a first loop forming segment, and

the second portion of the second section includes a second coil formed of multiple turns, the second coil having a first end and a second end, the second portion of the second section extending from the first end of the second portion of the second section through the interior of the second coil to the first end of the second coil,

the second portion of the first section having a second loop forming segment extending from a first end of the second loop forming segment at the first end of the first coil along the outside of the second coil to the first end of the second coil, and extending through the interior of the second coil to the second end of the second coil at a second end of the second loop forming segment, the first portion of the first section extending away from the second end of the second loop forming segment,

the second loop farming segment holding the second coil in a looped configuration with the first end of the second coil adjacent to the second end of the second coil.

19. The apparatus of claim 17, wherein the coil includes between 20 and 200 turns.

20. The apparatus of claim 18, wherein the first coil includes between 20 and 200 turns and the second coil includes between 20 and 200 turns

21-28. -28. (canceled)