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

• US 20070213582A1
• Filed: 03/09/2006
• Published: 09/13/2007
• Est. Priority Date: 03/09/2006
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Adzich, W., Zollinger, Christopher
• Granted Patent: US 7,431,692 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 for needles A61B2017/06076
• 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. :

An apparatus for applying tension to a body structure, the apparatus comprising;

a tensioning line; and

an adjustable support pad, the adjustable support pad 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 apparatus 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.

3. :

The apparatus of claim 2, wherein the locking mechanism in the unlocked configuration allows movement of the tensioning line in the second direction.

4. :

The apparatus of claim 2, wherein the locking mechanism in the locked configuration prevents movement of the tensioning line in the first direction.

5. :

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

6. :

The apparatus of claim 5, wherein the shock absorbing component comprises a spring configured to mimic the characteristics of one or more papillary muscles.

7. :

The apparatus of claim 1, wherein the locking mechanism comprises a spool configured to receive the tensioning line, and the first direction is a first longitudinal direction, and wherein the spool can be rotated by a user in a first rotating direction to slidingly advance the tensioning line in the first longitudinal direction with respect to the adjustable support pad.

8. :

The apparatus of claim 7, wherein the second direction is a second longitudinal direction, and wherein the spool comprises a locking mechanism configured to prevent rotation of the spool in a second rotational direction, thereby preventing movement of the tensioning line in the second longitudinal direction.

9. :

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

10. :

The apparatus 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 applying tension to a body organ, comprising;

applying a first portion of a tensioning line to a first portion of the body organ;

applying an adjustable support pad to a second portion of the body organ, the adjustable support pad 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;

slidingly securing a second portion of the tensioning line to the adjustable support pad; and

adjusting tension in the tensioning line by slidably moving the tensioning line in a first direction with respect to the adjustable support pad.

12. :

The method of claim 11, wherein the adjustable support pad comprises compressible material, and further comprising;

creating a hole in the compressible material using a suturing needle; and

passing the tensioning line through the compressible material using a suturing needle.

13. :

The method of claim 11, 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, and the method further comprises;

changing the locking mechanism from the unlocked configuration to the locked configuration.

14. :

The method of claim 11, wherein the locking mechanism comprises a spool configured to receive the tensioning line, and adjusting tension in the tensioning line comprises rotating the spool in a first rotational direction.

15. :

The method of claim 11, wherein applying the adjustable support pad to the second portion of the body organ comprises applying the adjustable support pad to an outside surface of the body organ.

16. :

A method of replacing chordae tendineae in a heart, comprising;

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

securing a first adjustable support pad to the heart, wherein the first adjustable support pad includes a locking mechanism configured to slidingly receive the first replacement chordae tendon in a first direction with respect to the first adjustable support pad, and to prevent the first replacement chordae tendon line from sliding in a second direction with respect to the first adjustable support pad, wherein the first direction is opposite to the second direction;

slidingly securing a second portion of the first replacement chordae tendon to the first adjustable support pad; and

adjusting tension in the first replacement chordae tendon by slidingly moving the first replacement chordae tendon in a first direction with respect to the adjustable support pad.

17. :

The method of claim 16, wherein the adjustable support pad comprises compressible material, and further comprising;

creating a hole in the compressible material using a suturing needle; and

passing the first replacement chordae tendon through the compressible material using the suturing needle.

18. :

The method of claim 16, comprising;

monitoring the function of the heart valve while the heart is beating.

19. :

The method of claim 18, wherein adjusting the tension in the first replacement chordae tendon concurrently with monitoring the function of the heart valve.

20. :

The method of claim 18, wherein monitoring the function of the heart valve comprises monitoring via echocardiography.

21. :

An apparatus for applying tension to a body organ, the apparatus comprising;

a tensioning line;

an adjustable support pad 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.

22. :

The apparatus of claim 21, wherein the controller comprises a motor.

23. :

The apparatus of claim 22, wherein the motor is positioned on or in the adjustable support pad.

24. :

The apparatus of claim 21, wherein the controller comprises an elongated adjustment element, the elongated adjustment element comprising a distal end and a proximal end, wherein the distal end is secured to the adjustable support pad.

25. :

The apparatus of claim 24, wherein the distal end of the elongated adjustment element is releasably secured to the adjust support pad.

26. :

The apparatus of claim 21, wherein the adjustable tensioning element is configured for rotational movement.