Apparatus, system, and method for applying and adjusting a tensioning element to a hollow body organ

• US 20090043153A1
• Filed: 10/03/2008
• Published: 02/12/2009
• Est. Priority Date: 03/09/2006
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Zollinger, Christopher J., Adzich, W. Vaso
• Granted Patent: US 7,871,368 B2
• Time in Patent Office: Days
• US Class Current: 600/37
• 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 17/0487 Suture clamps, clips or locks, e.g. for replacing suture knots; Instruments for applying or removing suture clamps, clips or locks suture anchors A61B17/0401; wound clamps or clips A61B17/08; ligaturing clamps or clips A61B17/122
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61B 2017/00734 battery operated
• CPC Class Codes: A61B 2017/0404 Buttons
• CPC Class Codes: A61B 2017/0459 Multiple holes in the anchor through which the suture extends and locking the suture when tension is applied
• CPC Class Codes: A61B 2017/0464 for soft tissue
• CPC Class Codes: A61B 2017/048 for reducing heart wall tension, e.g. sutures with a pad on each extremity
• CPC Class Codes: A61B 2017/0496 for tensioning sutures
• CPC Class Codes: A61B 2017/06171 helically or spirally coiled
• CPC Class Codes: A61B 2090/378 using ultrasound
• CPC Class Codes: A61F 2/2457 Chordae tendineae prostheses
• CPC Class Codes: A61F 2/2487 Devices within the heart chamber, e.g. splints
• CPC Class Codes: A61F 2002/30546 for adjusting elasticity, flexibility, spring rate or mechanical tension
• CPC Class Codes: A61F 2250/0012 for adjusting elasticity, flexibility, spring rate or mechanical tension

Abstract

An adjustable support pad for adjustably holding a tensioning line used to apply tension to a body organ. The adjustable support pad can include a locking mechanism for preventing slidable movement of the tensioning element in one or both directions. The locking mechanism may include spring-loaded locks, rotatable cam-like structures, and/or rotatable spool structures. The adjustable support pad may be formed from rigid, semi-rigid, and/or flexible materials, and may be formed to conform to the outer surface of a body organ. The adjustable support pad can be configured to adjustably hold one or more separate tensioning lines, and to provide for independent adjustment of one or more tensioning lines or groups thereof.

Claims

1. A replacement chordae tendinae assembly, comprising:

a tensioning line having a first end portion and a second end portion, wherein the first end is configured for attachment to a valve leaflet; and

an adjustable support pad configured for attachment to a heart wall, the adjustable support pad comprising a first surface configured to be placed against and secured to the heart wall, the adjustable support pad configured to receive the tensioning line therethrough and including a locking mechanism configured to slidingly receive the tensioning line in a first direction with respect to the adjustable support pad, and to prevent the tensioning line from sliding in a second direction with respect to the adjustable support pad, wherein the first direction is opposite to the second direction.

2. The assembly of claim 1, wherein the adjustable support pad is configured for attachment to an external surface of the heart wall.

3. The assembly of claim 1, wherein the adjustable support pad comprises a plurality of suture openings therethrough, wherein the plurality of suture openings are positioned at or adjacent a perimeter of the adjustable support pad.

4. The assembly of claim 1, wherein the locking mechanism has an unlocked configuration wherein the tensioning line can slidingly move in the first direction, and a locked configuration wherein the tensioning line is prevented from moving in the second direction.

5. The assembly of claim 4, wherein the locking mechanism in the unlocked configuration allows movement of the tensioning line in the second direction.

6. The assembly of claim 4, wherein the locking mechanism in the locked configuration prevents movement of the tensioning line in the first direction.

7. The assembly of claim 1, wherein the tensioning line comprises a shock absorbing component.

8. The assembly of claim 7, wherein the shock absorbing component comprises a spring configured to mimic the characteristics of one or more papillary muscles.

9. The assembly of claim 1, wherein the adjustable support pad comprises a pre-formed pad hole configured to receive the tensioning line therethrough.

10. The assembly of claim 1, wherein the adjustable support pad comprises a generally compressible and solid material configured to receive a suturing needle and suturing line therethrough.

11. A method of replacing a chordae tendon in a heart, comprising:

securing a first portion of a replacement chordae tendon to a heart valve leaflet;

securing an adjustable support pad to an exterior surface of a heart wall of the heart;

passing the replacement chordae tendon through the heart wall;

adjusting tension in the replacement chordae tendon from outside the heart wall by proximally or distally moving a second portion of the replacement chordae tendon; and

securing the second portion of the replacement chordae tendon to the support pad.

12. The method of claim 11, further comprising:

monitoring the performance of the heart while concurrently adjusting tension in the replacement chordae tendon.

13. The method of claim 12, wherein monitoring the performance of the heart comprises monitoring the performance of the heart using an imaging system.

14. The method of claim 11, wherein securing the support pad to the exterior surface of the heart wall of the heart comprises securing the support pad adjacent the apex of the heart.

15. The method of claim 11, wherein securing the first portion of the replacement chordae tendon to the heart valve leaflet occurs prior to securing the second portion of the replacement chordae tendon to the support pad.

16. The method of claim 11, wherein adjusting tension in the replacement chordae tendon from outside the heart wall comprises adjusting tension while the heart is beating.

17. An apparatus for replacing a chordae tendon, the apparatus comprising:

a tensioning line;

an adjustable support pad comprising a first surface configured to be secured to a heart wall, the adjustable support pad further comprising an adjustable tensioning element configured to move with respect to the adjustable support pad, the adjustable support pad configured to receive and movably hold a portion of the tensioning line via movement of the adjustable tensioning element; and

a controller for controlling movement of the adjustable tensioning element.

18. The apparatus of claim 17, wherein the controller comprises a motor.

19. The apparatus of claim 18, wherein the motor is positioned on or in the adjustable support pad.

20. The apparatus of claim 17, wherein the adjustable tensioning element is configured for rotational movement.