Leaflet-restraining techniques

• US 10,195,030 B2
• Filed: 10/14/2015
• Issued: 02/05/2019
• Est. Priority Date: 10/14/2014
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation, Valtech Cardio Ltd (Edwards Lifesciences Corporation)
• Original Assignee: Valtech Cardio Ltd (Edwards Lifesciences Corporation)
• Inventors: Gross, Amir, Reich, Tal, Herman, Yaron, Iflah, Ehud, Brauon, Haim, Kutzik, Meir, Iamberger, Meni
• Primary Examiner(s): Tanner, Jocelin
• Application Number:
  US15/519,520
• Publication Number:
  US 20170245993A1
• Time in Patent Office: 1,210 Days
• CPC Class Codes: A61B 17/068 Surgical staplers , e.g. containing multiple staples or clampsstaplers containing only one staple A61B17/10; magazines or containers for staples A61B17/105; for performing anastomosis A61B17/115; staplers in general B25C5/00
• CPC Class Codes: A61B 2017/00292 mounted on or guided by flexible, e.g. catheter-like, means
• CPC Class Codes: A61B 2017/0647 having one single leg, e.g. tacks
• CPC Class Codes: A61B 2017/0649 Coils or spirals
• CPC Class Codes: A61F 2/2445 Annuloplasty rings in direct contact with the valve annulus
• CPC Class Codes: A61F 2/2451 Inserts in the coronary sinus for correcting the valve shape
• CPC Class Codes: A61F 2/2454 Means for preventing inversion of the valve leaflets, e.g. chordae tendineae prostheses
• CPC Class Codes: A61F 2/2457 Chordae tendineae prostheses
• CPC Class Codes: A61F 2/2466 Delivery devices therefor
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes

Abstract

Apparatus, comprising: (i) a catheter (64); (ii) an implant (100), comprising a flexible longitudinal member (102), and a linking member (104) that extends from a first linking site (106a) of the longitudinal member to a second linking site (106b) of the longitudinal member, the implant having: (a) a delivery state in which the longitudinal member is coaxial with the catheter, and at least a portion of the linking member is disposed alongside the longitudinal member, and (b) an implanted state in which a first distance between the first linking site and the second linking site, measured along the longitudinal member, is greater than a second distance between the first linking site and the second linking site, measured along the linking member; and (iii) a plurality of tissue anchors (46), slidable through the catheter and with respect to the longitudinal member. Other embodiments are also described.

Claims

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

a catheter, transluminally advanceable to the heart;

an implant, comprising

a flexible longitudinal member, and

a linking member that extends from a first linking site of the longitudinal member to a second linking site of the longitudinal member,

the implant having;

a delivery state in which (1) the implant is slidable through at least part of the catheter, (2) the longitudinal member is coaxial with the catheter, and (3) at least a portion of the linking member is disposed alongside the longitudinal member, and

an implanted state in which (1) a first distance between the first linking site and the second linking site, measured along the longitudinal member, is greater than a second distance between the first linking site and the second linking site, measured along the linking member, (2) the linking member has a mid-portion disposed between the first linking site and the second linking site, and (3) the mid-portion is not in contact with the longitudinal member; and

a plurality of tissue anchors, slidable through the catheter and with respect to the longitudinal member, each tissue anchor of the plurality of tissue anchors configured to anchor a respective portion of the longitudinal member to a respective location of tissue of the heart.

2. The apparatus according to claim 1, wherein in the implanted state, the mid-portion is disposed at least 10 mm from the longitudinal member.

3. The apparatus according to claim 1, wherein the at least a portion of the linking member includes the mid-portion of the linking member.

4. The apparatus according to claim 1, wherein the linking member is elastic.

5. The apparatus according to claim 1, wherein the longitudinal member comprises:

a first portion anchorable to atrial tissue of the heart by a first tissue anchor of the plurality of tissue anchors;

a second portion anchorable to ventricular tissue of the heart by a second tissue anchor of the plurality of tissue anchors;

a third portion including the first linking site, disposed between the first portion and the second portion, and placeable against a leaflet of the heart;

a fourth portion anchorable to atrial tissue of the heart by a third tissue anchor of the plurality of tissue anchors; and

a fifth portion including the second linking site, disposed between the second portion and the fourth portion, and placeable against the leaflet of the heart.

6. The apparatus according to claim 1, wherein the implant further comprises a resilient strand disposed within at least a portion of the longitudinal member, and configured to bias the longitudinal member toward assuming a particular shape.

7. The apparatus according to claim 6, wherein the resilient strand is aligned along the at least a portion of the longitudinal member.

8. The apparatus according to claim 6, wherein the at least a portion of the longitudinal member comprises the first linking site.

9. The apparatus according to claim 1, wherein in the delivery state, the at least a portion of the linking member that is disposed alongside the longitudinal member is disposed less than 1 mm from the linking member.

10. The apparatus according to claim 9, wherein in the delivery state, the at least a portion of the linking member that is disposed alongside the longitudinal member is in contact with the linking member.

11. The apparatus according to claim 1, wherein the second distance is adjustable by the linking member being slidable with respect to the longitudinal member at at least one of the linking sites.

12. The apparatus according to claim 11, wherein the implant further comprises a locking mechanism, and the second distance is fixable by locking the locking mechanism to the linking member.

13. The apparatus according to claim 12, wherein the locking mechanism comprises a ratcheting mechanism.

14. The apparatus according to claim 1, further comprising at least one anchor driver, slidable within the catheter and with respect to the longitudinal member, and configured to anchor the respective portions of the longitudinal member to the respective locations of the tissue using the tissue anchors.

15. The apparatus according to claim 14, wherein:

the flexible longitudinal member is a flexible tubular member, comprising a wall that defines a lumen,

the linking member extends from the first linking site outside of the tubular member to the second linking site,

the plurality of tissue anchors are slidable within the lumen of the tubular member,

the anchor driver is slidable within the lumen of the tubular member, and is configured to anchor the respective portions by driving the tissue anchors from the lumen, through the wall and into the respective locations of tissue.

16. The apparatus according to claim 15, wherein the wall comprises a lateral wall that circumscribes the lumen and a distal wall that defines a distal end of the lumen, and the apparatus is configured such that (1) at least one tissue anchor of the plurality of tissue anchors is drivable by the anchor driver through the distal wall, and (2) another at least one tissue anchor of the plurality of tissue anchors is drivable by the anchor driver through the lateral wall.

17. Apparatus for use with a heart of a subject, the apparatus comprising:

a catheter, transluminally advanceable to the heart;

an implant, comprising;

a flexible tubular member comprising a wall that defines a lumen, and

a linking member that extends, outside of the tubular member, from a first linking site of the tubular member to a second linking site of the tubular member,

the implant having;

a delivery state in which (1) the implant is slidable through at least part of the catheter, (2) the flexible tubular member is coaxial with the catheter, and (3) at least a portion of the linking member is disposed alongside the tubular member, and

an implanted state in which (1) a first distance between the first linking site and the second linking site, measured along the tubular member, is greater than a second distance between the first linking site and the second linking site, measured along the linking member, (2) the linking member has a mid-portion disposed outside of the tubular member between the first linking site and the second linking site, and (3) the mid-portion is not in contact with the wall of the tubular member for at least 0.5 cm of the linking member;

a plurality of tissue anchors, slidable within the lumen; and

at least one anchor driver, slidable within the catheter and within the lumen, and configured to drive the tissue anchors through the wall and into tissue of the heart.

18. The apparatus according to claim 17, wherein the at least a portion of the linking member includes the mid-portion of the linking member.

19. The apparatus according to claim 17, wherein the linking member is elastic.

20. The apparatus according to claim 17, wherein in the implanted state, the mid-portion is disposed at least 10 mm from the wall of the tubular member.

21. The apparatus according to claim 17, wherein the tubular member comprises:

a first portion anchorable to atrial tissue of the heart by a first tissue anchor of the plurality of tissue anchors;

a second portion anchorable to ventricular tissue of the heart by a second tissue anchor of the plurality of tissue anchors;

a third portion including the first linking site, disposed between the first portion and the second portion, and placeable against a leaflet of the heart;

a fourth portion anchorable to atrial tissue of the heart by a third tissue anchor of the plurality of tissue anchors; and

a fifth portion including the second linking site, disposed between the second portion and the fourth portion, and placeable against the leaflet of the heart.

22. The apparatus according to claim 17, wherein in the delivery state, the at least a portion of the linking member that is disposed alongside the tubular member is disposed less than 1 mm from the wall of the tubular member.

23. The apparatus according to claim 22, wherein in the delivery state, the at least a portion of the linking member that is disposed alongside the tubular member is in contact with the wall of the tubular member.

24. The apparatus according to claim 17, wherein the second distance is adjustable by the linking member being slidable through the wall at least one of the linking sites.

25. The apparatus according to claim 24, wherein the implant further comprises a locking mechanism, and the second distance is fixable by locking the locking mechanism to the linking member.

26. The apparatus according to claim 25, wherein the locking mechanism comprises a ratcheting mechanism.

27. The apparatus according to claim 24, wherein a proximal end of the linking member is slidable within the lumen.

28. The apparatus according to claim 17, wherein the wall comprises a lateral wall that circumscribes the lumen and a distal wall that defines a distal end of the lumen.

29. The apparatus according to claim 28, wherein the apparatus is configured such that at least one tissue anchor of the plurality of tissue anchors is drivable by the anchor driver through the distal wall, and another at least one tissue anchor of the plurality of tissue anchors is drivable by the anchor driver through the lateral wall.