PERCUTANEOUS TISSUE ANCHOR TECHNIQUES

• US 20190321049A1
• Filed: 05/30/2019
• Published: 10/24/2019
• 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
• Granted Patent: US 11,344,310 B2
• Time in Patent Office: 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

An example anchor-manipulation tool includes (i) at a distal portion of the tool, an anchor-engaging element and an actuator, (ii) at an extracorporeal proximal portion of the tool, a controller, and (iii) a flexible longitudinal member extending between the proximal portion and the distal portion. The distal portion of the tool can be transluminally advanced to an anchor that is intracorporeally implanted in a subject. Subsequently, the anchor-engaging element can be engaged with an eyelet defined by a head of the anchor. Subsequently, the controller can be used to transition the tool into an articulatably-coupled state in which: (i) the eyelet at least in part inhibits movement of the anchor-engaging element away from the anchor, and (ii) the distal portion of the anchor-manipulation tool is deflectable with respect to the anchor. Subsequently, the anchor can be de-anchored by using the anchor-manipulation tool to apply a de-anchoring force to the eyelet.

Claims

1. A method, comprising:

transluminally advancing a distal portion of an anchor-manipulation tool to an anchor that is intracorporeally implanted in a subject, a tissue-coupling element of the anchor being anchored within tissue of the subject, and the anchor-manipulation tool including;

at the distal portion, an anchor-engaging element and an actuator, the actuator configured to actuate the anchor-engaging element,

at an extracorporeal proximal portion of the anchor-manipulation tool, a controller, and

a flexible longitudinal member extending between the proximal portion and the distal portion;

subsequently, engaging the anchor-engaging element with an eyelet defined by a head of the anchor;

subsequently, using the controller to transition the tool into an articulatably-coupled state in which;

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

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

subsequently, de-anchoring the anchor by removing the tissue-coupling element from the tissue by using the anchor-manipulation tool to apply a de-anchoring force to the eyelet.

2. The method according to claim 1, wherein de-anchoring the anchor comprises de-anchoring the anchor while the tool is in the articulatably-coupled state.

3. The method according to claim 1, further comprising, prior to de-anchoring the anchor, using the controller to transition the tool into a rigidly-coupled state in which the distal portion of the anchor-manipulation tool is inhibited from deflecting with respect to the tissue anchor.

4. The method according to claim 3, wherein using the controller to transition the tool into the rigidly-coupled state comprises using the controller to transition the tool from the articulatably-coupled state into the rigidly-coupled state.

5. The method according to claim 3, wherein de-anchoring the anchor comprises de-anchoring the anchor while the tool is in the rigidly-coupled state.

6. The method according to claim 3, wherein de-anchoring the anchor comprises de-anchoring the anchor while the tool is in the articulatably-coupled state.

7. The method according to claim 3, wherein:

the actuator is a housing that defines a compartment, and

using the controller to transition the tool into the rigidly-coupled state comprises using the controller to transition the tool into the rigidly-coupled state by sliding the eyelet into the compartment.

8. The method according to claim 7, wherein sliding the eyelet into the compartment comprises sliding the eyelet into the compartment such that a central longitudinal axis of the anchor becomes axially aligned with the distal portion of the tool.

9. The method according to claim 7, wherein:

the eyelet is dimensioned to fit snugly within the compartment, and

using the controller to transition the tool into the rigidly-coupled state by sliding the eyelet into the compartment comprises using the controller to transition the tool into the rigidly-coupled state by sliding the eyelet snugly into the compartment.

10. The method according to claim 7, wherein:

the housing includes one or more protrusions that protrude radially inward into the compartment, and

using the controller to transition the tool into the rigidly-coupled state by sliding the eyelet into the compartment comprises using the controller to transition the tool into the rigidly-coupled state by sliding the eyelet into the compartment such that the eyelet becomes disposed in a circumferential space between the one or more protrusions.

11. The method according to claim 10, wherein using the anchor-manipulation tool to apply the de-anchoring force to the eyelet comprises pressing the one or more protrusions against the eyelet by rotating the housing with respect to the anchor.

12. The method according to claim 7, wherein:

the eyelet has an arch portion that has a generally parabolic shape, and

sliding the eyelet into the compartment comprises sliding, into the compartment, the arch portion that has the generally parabolic shape.

13. The method according to claim 7, wherein:

the eyelet has an arch portion that has a height and a width, the height being at least 50% greater than the width, and

sliding the eyelet into the compartment comprises sliding, into the compartment, the arch portion that has the height that is at least 50% greater than the width.

14. The method according to claim 7, wherein:

the eyelet has an arch portion that is defined by a bar that has a thickness of between 0.25 mm and 0.4 mm, and

sliding the eyelet into the compartment comprises sliding, into the compartment, the arch portion that is defined by the bar that has the thickness of between 0.25 mm and 0.4 mm.

15. The method according to claim 1, wherein the tissue-coupling element is helical, and de-anchoring the anchor comprises unscrewing the tissue-coupling element from the tissue by using the anchor-manipulation tool to apply a de-anchoring rotational force to the eyelet.

16. The method according to claim 1, wherein:

the articulatably-coupled state is an articulatably-coupled state in which the distal portion of the anchor-manipulation tool is rotatable with respect to the anchor, and

using the controller to control the actuator to transition the tool into the articulatably-coupled state comprises using the controller to control the actuator to transition the tool into the articulatably-coupled state in which the distal portion of the anchor-manipulation tool is rotatable with respect to the anchor.

17. The method according to claim 1, wherein:

the articulatably-coupled state is an articulatably-coupled state in which the distal portion of the anchor-manipulation tool is deflectable in at least 1 steradian with respect to the tissue anchor, and

using the controller to control the actuator to transition the tool into the articulatably-coupled state comprises using the controller to control the actuator to transition the tool into the articulatably-coupled state in which the distal portion of the anchor-manipulation tool is deflectable in at least 1 steradian with respect to the tissue anchor.

18. The method according to claim 17, wherein:

the articulatably-coupled state is an articulatably-coupled state in which the distal portion of the anchor-manipulation tool is deflectable in at least 3 steradians with respect to the tissue anchor, and

using the controller to control the actuator to transition the tool into the articulatably-coupled state comprises using the controller to control the actuator to transition the tool into the articulatably-coupled state in which the distal portion of the anchor-manipulation tool is deflectable in at least 3 steradians with respect to the tissue anchor.

19. The method according to claim 18, wherein:

the articulatably-coupled state is an articulatably-coupled state in which the distal portion of the anchor-manipulation tool is deflectable in at least 7 steradians with respect to the tissue anchor, and

using the controller to control the actuator to transition the tool into the articulatably-coupled state comprises using the controller to control the actuator to transition the tool into the articulatably-coupled state in which the distal portion of the anchor-manipulation tool is deflectable in at least 7 steradians with respect to the tissue anchor.

20. The method according to claim 1, wherein:

an implant includes a sleeve that defines a lumen and a proximal opening that provides access to the lumen,

the anchor that is intracorporeally implanted in the subject is anchoring the implant to the tissue, with;

the eyelet disposed within the lumen, and

the tissue-engaging element extending through the sleeve and into the tissue within which the tissue-engaging element is anchored,

transluminally advancing the distal portion of the anchor-manipulation tool to the anchor comprises transluminally advancing the distal portion of the anchor-manipulation tool through the opening and into the lumen, and

engaging the anchor-engaging element with the eyelet comprises engaging the anchor-engaging element with the eyelet within the lumen.

21. The method according to claim 20, wherein:

the anchor is a target anchor of a plurality of anchors, each of the anchors anchoring a respective longitudinal site of the sleeve to the tissue, with;

the eyelet of each of the anchors disposed within the lumen, and

the tissue-engaging element of each of the anchors extending through the sleeve and into the tissue within which the tissue-engaging element is anchored,

a proximal one of the anchors is disposed between the target anchor and the opening, and

transluminally advancing the distal portion of the anchor-manipulation tool to the anchor comprises transluminally advancing the distal portion of the anchor-manipulation tool through the opening, into the lumen, past the proximal one of the anchors, and to the target anchor.

22. The method according to claim 1, further comprising implanting the anchor in the subject by driving the tissue-coupling element into the tissue.

23. The method according to claim 22, wherein implanting the anchor in the subject comprises implanting the anchor in the subject using the anchor-manipulation tool.