Percutaneous tissue anchor techniques

• US 10,376,266 B2
• Filed: 10/23/2013
• Issued: 08/13/2019
• Est. Priority Date: 10/23/2012
• Status: Active Grant

• Current Assignee: Valtech Cardio Ltd (Edwards Lifesciences Corporation)
• Original Assignee: Valtech Cardio Ltd (Edwards Lifesciences Corporation)
• Inventors: Herman, Yaron, Zipory, Yuval, Starobinsky, Slava, Reich, Tal, Iflah, Ehud, Koifman, Alexei
• Primary Examiner(s): McEvoy, Thomas M
• Application Number:
  US14/437,062
• Publication Number:
  US 20150272586A1
• Time in Patent Office: 2,120 Days
• 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 17/12009 Implements for ligaturing other than by clamps or clips, e.g. using a loop with a slip knot
• CPC Class Codes: A61B 2017/00477 Coupling A61B2017/0046 takes precedence
• CPC Class Codes: A61B 2017/00681 Aspects not otherwise provided for
• CPC Class Codes: A61B 2017/0409 Instruments for applying suture anchors for applying suture clamps, clips or locks A61B2017/0488
• CPC Class Codes: A61B 2017/0411 Instruments for removing suture anchors for removing suture clamps, clips or locks A61B2017/049
• CPC Class Codes: A61B 2017/0441 the shaft being a rigid coil or spiral
• CPC Class Codes: A61B 2017/0464 for soft tissue
• CPC Class Codes: A61B 2017/0496 for tensioning sutures
• CPC Class Codes: A61B 2017/2937 with flexible part
• CPC Class Codes: A61F 2/2445 Annuloplasty rings in direct contact with the valve annulus

Abstract

A first element (91) includes a first arm (92) and a second arm coupled thereto and having a concavity (103) facing the first arm and defining a space (96). In an open state, a tissue anchor portion (46) moves into the space through a gap between distal portions (94) of the first and second arms. In the closed state, the anchor portion is not movable through the gap. A second element (82) is movable with respect to the first element, such that, while the portion (46) of the anchor (40) is within the space, and the first element is in the closed state, in a first position of the second element, the portion of the anchor is movable within the space, and in a second position of the second element, the second element applies torque to the anchor by rotating the second element. Other embodiments are also described.

Claims

1. Apparatus for use with a tissue of a subject, the apparatus comprising:

a tissue anchor, comprising (i) an engaging head that defines an eyelet, and (ii) a helical tissue-coupling element, the tissue anchor being transluminally deliverable to the tissue, and reversibly anchorable to the tissue by the tissue-coupling element being screwed into the tissue by rotation of the engaging head; and

an anchor-manipulation tool having a distal portion deliverable to the tissue via a body lumen of the subject, the anchor-manipulation tool comprising;

at the distal portion of the tool, an anchor-engaging element and an anchor-engaging-element actuator,

at a proximal portion of the tool, a controller configured to control the anchor-engaging-element actuator, and

a flexible longitudinal member extending between the proximal portion and the distal portion, such that when the distal portion is delivered to the tissue via the body lumen, the longitudinal member is disposed within the body lumen,

the apparatus having at least two states, comprising;

an uncoupled state in which the anchor-engaging element is not in contact with the tissue anchor, and

an articulatably-coupled state in which;

the eyelet at least in part inhibits movement of the anchor-engaging element away from the tissue anchor, and

the distal portion of the anchor-manipulation tool is deflectable with respect to the tissue anchor,

wherein, while the distal portion of the tool is at the tissue, and the longitudinal member is disposed within the body lumen;

the anchor-engaging-element actuator being configured to facilitate transition of the apparatus from the uncoupled state to the articulatably-coupled state, and

the anchor-manipulation tool, in at least one of the at least two states, being configured to unscrew the tissue anchor from the tissue by rotating the tissue anchor by applying a de-anchoring rotational force to the eyelet.

2. The apparatus according to claim 1, wherein in the articulatably-coupled state, the distal portion of the anchor-manipulation tool is rotatable with respect to the tissue anchor.

3. The apparatus according to claim 2, wherein in the articulatably-coupled state, the distal portion of the anchor-manipulation tool is deflectable in at least 1 steradian with respect to the tissue anchor.

4. The apparatus according to claim 1, wherein the at least two states further comprise a rigidly-coupled state in which the distal portion of the anchor-manipulation tool is inhibited from deflecting with respect to the tissue anchor.

5. The apparatus according to claim 4, wherein the anchor-manipulation tool is configured to unscrew the tissue anchor while the apparatus is in the rigidly-coupled state.

6. The apparatus according to claim 4, wherein the anchor-engaging-element actuator is configured to transition the apparatus from the articulatably-coupled state to the rigidly-coupled state.

7. The apparatus according to claim 6, wherein the actuator is a housing that defines a compartment, and the anchor-engaging-element actuator is configured to transition the apparatus from the articulatably-coupled state to the rigidly-coupled state by sliding the eyelet into the compartment.

8. The apparatus according to claim 7, wherein the eyelet has an arch portion that has a generally parabolic shape.

9. The apparatus according to claim 7, wherein the housing comprises one or more protrusions that protrude radially inward into the compartment.

10. The apparatus according to claim 9, wherein the apparatus is configured such that, while in the rigidly-coupled state, rotation of the housing with respect to the anchor presses the protrusions against the eyelet.

11. The apparatus according to claim 9, wherein the housing is configured to receive the eyelet at a continuum of rotational positions with respect to the housing.

12. The apparatus according to claim 7, wherein the eyelet is dimensioned to fit snugly within the compartment.

13. The apparatus according to claim 1, wherein in the articulatably-coupled state, the distal portion of the anchor-manipulation tool is deflectable in at least 1 steradian with respect to the tissue anchor.

14. The apparatus according to claim 13, wherein in the articulatably-coupled state, the distal portion of the anchor-manipulation tool is deflectable in at least 3 steradians with respect to the tissue anchor.

15. The apparatus according to claim 14, wherein in the articulatably-coupled state, the distal portion of the anchor-manipulation tool is deflectable in at least 7 steradians with respect to the tissue anchor.

16. Apparatus for use with a tissue of a subject, the apparatus comprising:

a tissue anchor, comprising (i) an engaging head that defines an eyelet, and (ii) a helical tissue-coupling element, the tissue anchor being transluminally deliverable to the tissue, and reversibly anchorable to the tissue by the tissue-coupling element being screwed into the tissue by rotation of the engaging head; and

an anchor-manipulation tool having a distal portion transluminally deliverable to the tissue, the anchor-manipulation tool comprising;

at the distal portion of the tool, an anchor-engaging element and an anchor-engaging-element actuator, and

at a proximal portion of the tool, a controller configured to control the anchor-engaging-element actuator,

the apparatus having a plurality of states, comprising;

an uncoupled state in which the anchor-engaging element is not in contact with the tissue anchor, and

an articulatably-coupled state in which;

the eyelet at least in part inhibits movement of the anchor-engaging element away from the tissue anchor,

the distal portion of the anchor-manipulation tool is deflectable with respect to the tissue anchor, and

a rigidly-coupled state in which the distal portion of the anchor-manipulation tool is inhibited from deflecting with respect to the tissue anchor, wherein;

the anchor-engaging-element actuator is configured to facilitate transition of the apparatus from the uncoupled state to the articulatably-coupled state,

the anchor-engaging-element actuator is a housing that defines a compartment, and the anchor-engaging-element actuator is configured to transition the apparatus from the articulatably-coupled state to the rigidly-coupled state by sliding the eyelet into the compartment, and

the anchor-manipulation tool, in at least one of the states, being configured to unscrew the tissue anchor from the tissue.

17. The apparatus according to claim 16, wherein the housing comprises one or more protrusions that protrude radially inward into the compartment.

18. The apparatus according to claim 17, wherein the apparatus is configured such that, while in the rigidly-coupled state, rotation of the housing with respect to the anchor presses the protrusions against the eyelet.

19. The apparatus according to claim 17, wherein the housing is configured to receive the eyelet at a continuum of rotational positions with respect to the housing.

20. The apparatus according to claim 16, wherein the eyelet has an arch portion that has a height and a width, the height being at least 50% greater than the width.

21. The apparatus according to claim 16, wherein in the articulatably-coupled state, the distal portion of the anchor-manipulation tool is rotatable with respect to the tissue anchor.

22. An apparatus comprising:

a tissue anchor, comprising (i) an engaging head, and (ii) a helical tissue-coupling element, the tissue anchor being transluminally deliverable to the tissue, and reversibly anchorable to the tissue by the tissue-coupling element being screwed into the tissue by rotation of the engaging head; and

an anchor-manipulation tool having a distal portion transluminally deliverable to the tissue, the anchor-manipulation tool comprising;

at the distal portion of the tool, an anchor-engaging-element actuator, and

at a proximal portion of the tool, a controller configured to control the anchor-engaging-element actuator,

the apparatus transitionable between a plurality of states, the plurality of states comprising;

an uncoupled state in which the anchor-manipulation tool is not in contact with the tissue anchor, and

an articulatably-coupled state in which the engaging head at least in part inhibits movement of the anchor-manipulation tool away from the tissue anchor, and

a rigidly-coupled state in which the distal portion of the anchor-manipulation tool is inhibited from deflecting with respect to the tissue anchor,

wherein;

the anchor-engaging-element actuator is configured to facilitate transition of the apparatus from the uncoupled state to the articulatably-coupled state,

the anchor-engaging-element actuator is a housing that defines a compartment, and the anchor-engaging-element actuator is configured to transition the apparatus from the articulatably-coupled state to the rigidly-coupled state by sliding the engaging head into the compartment, and

the anchor-manipulation tool, in at least one of the states, being configured to unscrew the tissue anchor from the tissue while at least a portion of the anchor-manipulation tool is positioned inside a blood vessel.