Annuloplasty ring with intra-ring anchoring

• US 9,592,122 B2
• Filed: 04/01/2014
• Issued: 03/14/2017
• Est. Priority Date: 05/07/2009
• Status: Active Grant

• Current Assignee: Valtech Cardio Ltd (Edwards Lifesciences Corporation)
• Original Assignee: Valtech Cardio Ltd (Edwards Lifesciences Corporation)
• Inventors: Zipory, Yuval, Cabiri, Oz, Gross, Yossi
• Primary Examiner(s): MCEVOY, THOMAS M
• Application Number:
  US14/242,151
• Publication Number:
  US 20140343668A1
• Time in Patent Office: 1,078 Days
• US Class Current: 1/1
• CPC Class Codes: A61B 17/00234 for minimally invasive surgery A61B17/0218, A61B17/0469, A61B17/12013, A61B17/1285, A61B17/29, A61B17/320016 take precedence
• CPC Class Codes: A61B 17/064 Surgical staples, i.e. penetrating the tissue
• 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 2017/00243 cardiac
• 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 2/2442 Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
• CPC Class Codes: A61F 2/2445 Annuloplasty rings in direct contact with the valve annulus
• 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 is provided that includes an annuloplasty system for use on a subject. The system includes an annuloplasty ring, which includes a sleeve having a lumen, and at least one anchor, shaped so as to define a coupling head and a tissue coupling element, which tissue coupling element is shaped so as to define a longitudinal axis, and is configured to penetrate cardiac tissue of the subject in a direction parallel to the longitudinal axis. The system further includes an anchor deployment manipulator, configured to be removably positioned within the lumen of the sleeve, and, while so positioned, to deploy the tissue coupling element from a distal end of the deployment manipulator through a wall of the sleeve into the cardiac tissue in the direction parallel to the longitudinal axis of the tissue coupling element and parallel to a central longitudinal axis through the distal end of the deployment manipulator.

Claims

1. Apparatus comprising an annuloplasty system for use on a subject, which comprises:

an annuloplasty ring, which comprises a sleeve having a wall defining a lumen that extends longitudinally along a length of the sleeve;

an elongated contracting member, which (a) comprises an element selected from the group consisting of;

a wire, a ribbon, a rope, a band, and a suture, and (b) extends along at least a portion of the sleeve and is coupled at a location along the contracting member to the sleeve, wherein the elongated contracting member is arranged to contract the annuloplasty ring by pulling on the sleeve;

a steerable tube, which is configured to provide steering functionality;

at least one anchor, which is shaped so as to define a tissue coupling element; and

an anchor deployment manipulator, which (a) is removably positioned within the lumen of the sleeve, (b) is configured, while positioned in the lumen, to deploy the tissue coupling element through the wall of the sleeve into cardiac tissue of the subject, and (c) comprises (i) an outer anchor driver tube, and (ii) an anchor driver, which is at least partially positioned within the outer anchor driver tube and comprises an elongated, flexible shaft,

wherein the outer anchor driver tube is at least partially positioned within the steerable tube, such that a portion of the sleeve is radially between the outer anchor driver tube and the steerable tube, and

wherein the annuloplasty system is arranged such that the anchor driver is configured to introduce the at least one anchor into the lumen of the sleeve while the sleeve is at least partially positioned within the steerable tube and while the outer anchor driver tube is positioned in the sleeve.

2. The apparatus according to claim 1, wherein the anchor deployment manipulator is configured to deploy the tissue coupling element while the outer anchor driver tube is at least partially positioned within the steerable tube, such that the portion of the sleeve is radially between the outer anchor driver tube and the steerable tube.

3. The apparatus according to claim 1, wherein the annuloplasty system further comprises a sheath, which removably surrounds at least a portion of the sleeve, the steerable tube, and the anchor deployment manipulator.

4. The apparatus according to claim 1, wherein the annuloplasty system further comprises a contracting mechanism, which is coupled to (a) the contracting member at a location along the contracting member and (b) the sleeve.

5. The apparatus according to claim 4, wherein the contracting mechanism comprises a locking mechanism.

6. The apparatus according to claim 4,

wherein the lumen of the sleeve has an opening at a proximal end of the sleeve,

wherein the steerable tube passes through the opening, and

wherein the contracting mechanism is positioned in a vicinity of a distal end of the sleeve.

7. The apparatus according to claim 1, wherein the steerable tube comprises one or more steering wires, which are arranged such that pulling and releasing of the steering wires cause deflection of a distal tip of the steerable tube, thereby providing the steering functionality.

8. The apparatus according to claim 1, wherein the steering functionality is configured to position an area near a distal end of the anchor deployment manipulator with six degrees of freedom.

9. The apparatus according to claim 1,

wherein the annuloplasty system comprises a plurality of anchors, which are shaped so as to define respective tissue coupling elements, and

wherein the anchor driver is configured to introduce the anchors into the lumen of the sleeve one-at-a-time while the sleeve is at least partially positioned within the steerable tube and the outer anchor driver tube is partially positioned within the sleeve.

10. The apparatus according to claim 9, wherein the anchor deployment manipulator is configured to hold a single one of the plurality anchors at any given time.

11. Apparatus comprising an annuloplasty system for use on a subject, which comprises:

an annuloplasty ring, which comprises a sleeve having a wall defining a lumen that extends longitudinally along a length of the sleeve;

an elongated contracting member, which (a) comprises an element selected from the group consisting of;

a wire, a ribbon, a rope, a band, and a suture, and (b) extends along at least a portion of the sleeve and is coupled at a location along the contracting member to the sleeve, wherein the elongated contracting member is arranged to contract the annuloplasty ring by pulling on the sleeve;

a steerable tube, which is configured to provide steering functionality;

at least one anchor, which is shaped so as to define a tissue coupling element; and

an anchor deployment manipulator, which (a) is removably positioned within the lumen of the sleeve, (b) is configured, while positioned in the lumen, to deploy the tissue coupling element through the wall of the sleeve into cardiac tissue of the subject, and (c) comprises (i) an outer anchor driver tube, and (ii) an anchor driver, which is at least partially positioned within the outer anchor driver tube and comprises an elongated, flexible shaft,

wherein the outer anchor driver tube is at least partially positioned within the steerable tube, such that a portion of the sleeve is radially between the outer anchor driver tube and the steerable tube, and

wherein the annuloplasty system is arranged such that the anchor driver is configured to introduce the at least one anchor into the outer anchor driver tube and the lumen of the sleeve while the sleeve is at least partially positioned within the steerable tube.

12. A method comprising:

providing an annuloplasty system, which includes (a) an annuloplasty ring, which comprises a sleeve having a wall defining a lumen that extends longitudinally along a length of the sleeve, (b) an elongated contracting member, which (i) includes an element selected from the group consisting of;

a wire, a ribbon, a rope, a band, and a suture, and (ii) extends along at least a portion of the sleeve and is coupled at a location along the contracting member to the sleeve, (c) a steerable tube, which is configured to provide steering functionality, (d) at least one anchor, which is shaped so as to define a tissue coupling element, and (e) an anchor deployment manipulator, which includes (i) an outer anchor driver tube, and (ii) an anchor driver, which is at least partially positioned within the outer anchor driver tube and includes an elongated, flexible shaft;

placing, into an atrium of a subject in a vicinity of an annulus of an atrioventricular valve, the sleeve;

steering the anchor deployment manipulator using the steerable tube, while the outer anchor driver tube is at least partially positioned within the steerable tube, and a portion of the sleeve is radially between the outer anchor driver tube and the steerable tube;

introducing, using the anchor driver, the at least one anchor into the lumen of the sleeve while the sleeve is at least partially positioned within the steerable tube;

deploying the tissue coupling element from the anchor deployment manipulator through the wall of the sleeve into cardiac tissue of the subject, while the anchor deployment manipulator is positioned in the lumen of the sleeve; and

contracting the annuloplasty ring by pulling on the sleeve with the elongated contracting member.

13. The method according to claim 12, wherein deploying the tissue coupling element comprises deploying the tissue coupling element from the anchor deployment manipulator while the outer anchor driver tube is at least partially positioned within the steerable tube, such that the portion of the sleeve is radially between the outer anchor driver tube and the steerable tube.

14. The method according to claim 12, wherein placing the at least a portion of the sleeve into the atrium comprises advancing the sleeve, the steerable tube, and the anchor deployment manipulator through a sheath.

15. The method according to claim 12, wherein contracting the annuloplasty ring comprises actuating a contracting mechanism of the annuloplasty system to pull on the portion of the sleeve with the elongated contracting member, and wherein the contracting mechanism is coupled to (a) the contracting member at a location along the contracting member and (b) the sleeve.

16. The method according to claim 15, wherein the contracting mechanism includes a housing.

17. The method according to claim 15, wherein the contracting mechanism includes a locking mechanism.

18. The method according to claim 15,

wherein the lumen of the sleeve has an opening at a proximal end of the sleeve,

wherein the steerable tube passes through the opening, and

wherein the contracting mechanism is positioned in a vicinity of a distal end of the sleeve.

19. The method according to claim 12, wherein the steerable tube includes one or more steering wires, and wherein steering the anchor deployment manipulator comprises pulling and releasing the steering wires to deflect a distal tip of the steerable tube.

20. The method according to claim 12, wherein steering the anchor deployment manipulator comprises positioning an area near a distal end of the anchor deployment manipulator with six degrees of freedom.

21. The method according to claim 12,

wherein the annuloplasty system comprises a plurality of anchors, which are shaped so as to define respective tissue coupling elements, and

wherein introducing, using the anchor driver, the at least one anchor into the lumen of the sleeve comprises introducing, using the anchor driver, the anchors into the lumen of the sleeve one-at-a-time while the sleeve is at least partially positioned within the steerable tube and the outer anchor driver tube is partially positioned within the sleeve.

22. The method according to claim 21, wherein introducing, using the anchor driver, the anchors into the lumen of the sleeve one-at-a-time comprises:

introducing, using the anchor driver, a first one of the plurality of anchors into the lumen of the sleeve while the sleeve is at least partially positioned within the steerable tube;

thereafter, withdrawing the anchor driver from a body of the subject while the sleeve is at least partially positioned within the steerable tube;

thereafter, providing the anchor driver with a second one of the plurality of anchors, while the anchor driver is outside the body of the subject; and

thereafter, reintroducing the anchor driver into the body of the subject and into the outer anchor driver tube while the sleeve is at least partially positioned within the steerable tube.