Multiple anchor delivery tool

• US 9,937,042 B2
• Filed: 08/27/2015
• Issued: 04/10/2018
• 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: Cabiri, Oz, Gross, Amir, Hammer, Tal, Reich, Tal, Iflah, Ehud
• Primary Examiner(s): LYNCH, ROBERT A
• Application Number:
  US14/837,783
• Publication Number:
  US 20160008132A1
• Time in Patent Office: 957 Days
• 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

An anchor deployment tool is provided that includes a flexible tube, which defines an anchor storage area in which tissue anchors are stored before deployment, and a distal anchor manipulation area that has a length of at least 3 cm. The tool also includes a rotating deployment element, which is positioned within the flexible tube, and is configured to, while the distal anchor manipulation area is disposed within a lumen defined by a wall of a sleeve, (i) directly engage the anchors in the anchor storage area a single one at a time, (ii) advance each of the anchors, while thus directly engaged, in a distal direction into the anchor manipulation area, and (iii) anchor the sleeve to tissue of a subject by deploying each of the tissue anchors through a distal end of the flexible tube, through the wall of the sleeve, and into the tissue.

Claims

1. Apparatus comprising:

an implantable sleeve having a wall that is shaped to define a lumen;

a plurality of tissue anchors; and

an anchor deployment tool, which comprises;

(a) a flexible tube, which has a distal tube end, and which defines;

(i) an anchor storage area in which the plurality of tissue anchors are stored before deployment thereof, and

(ii) a distal anchor manipulation area, which (A) is disposed between the anchor storage area and the distal tube end, (B) has a length of at least 3 cm, and (C) is removably positionable within the lumen of the sleeve; and

(b) a rotating deployment element, which is positioned within the flexible tube, and is configured to, while the distal anchor manipulation area is disposed within the lumen of the sleeve;

(i) directly engage the tissue anchors in the anchor storage area a single one at a time,

(ii) advance each of the tissue anchors, while thus directly engaged, in a distal direction into the anchor manipulation area, and

(iii) anchor the sleeve to tissue of a subject by deploying each of the tissue anchors through the distal tube end, through the wall of the sleeve, and into the tissue,

wherein the anchor deployment tool is configured such that only the single anchor being advanced at the time by the rotating deployment element is within the distal anchor manipulation area that is disposed within the lumen of the sleeve.

2. The apparatus according to claim 1, wherein the distal anchor manipulation area is flexible.

3. The apparatus according to claim 1, wherein the anchor deployment tool comprises one or more steering wires, which are arranged such that pulling and releasing of the steering wires cause deflection of the distal tube end, thereby providing steering functionality to the distal anchor manipulation area.

4. The apparatus according to claim 1, wherein the rotating deployment element is configured to assume a state in which the rotating deployment element is passable through one or more of the tissue anchors without engaging the tissue anchors.

5. The apparatus according to claim 4, wherein the rotating deployment element is configured to assume the state when withdrawn in a proximal direction within the tube.

6. The apparatus according to claim 4, wherein the state is a radially-compressed state, and wherein the rotating deployment element is configured to assume a radially-expanded state when engaging each of the tissue anchors.

7. The apparatus according to claim 1, wherein the anchor deployment tool is configured to deploy each of the tissue anchors into the tissue in a direction parallel to a central longitudinal axis of the tube through the distal tube end, and parallel to a central longitudinal axis of the tissue anchor.

8. The apparatus according to claim 1, wherein the rotating deployment element is configured to unscrew an already-deployed tissue anchor from the tissue, withdraw the tissue anchor in a proximal direction, and subsequently redeploy the tissue anchor into the tissue.

9. The apparatus according to claim 1, comprising an annuloplasty ring, which comprises the implantable sleeve.

10. The apparatus according to claim 1, wherein the rotating deployment element is configured to deploy each of the tissue anchors through the distal tube end and into the tissue by rotating only the tissue anchor directly engaged by the rotating deployment element, without rotating the tissue anchors stored in the anchor storage area.

11. The apparatus according to claim 1, wherein the length of the distal anchor manipulation area is at least 5 cm.

12. The apparatus according to claim 1, wherein the plurality of tissue anchors comprises at least 6 tissue anchors.

13. Apparatus comprising:

an implantable sleeve having a wall that is shaped to define a lumen;

a plurality of tissue anchors; and

an anchor deployment tool, which comprises;

(a) a flexible tube, which has a distal tube end, and which defines;

(i) an anchor storage area in which the plurality of tissue anchors are stored before deployment thereof, and

(ii) a distal anchor manipulation area, which (A) is disposed between the anchor storage area and the distal tube end, (B) has a length of at least 3 cm, and (C) is removably positionable within the lumen of the sleeve; and

(b) a deployment element, which is positioned within the flexible tube, and is configured to, while the distal anchor manipulation area is disposed within the lumen of the sleeve;

(i) directly engage the tissue anchors in the anchor storage area a single one at a time,

(ii) advance each of the tissue anchors, while thus directly engaged, in a distal direction into the anchor manipulation area, and

(iii) anchor the sleeve to tissue of a subject by deploying each of the tissue anchors through the distal tube end, through the wall of the sleeve, and into the tissue,

wherein the anchor deployment tool is configured such that only the single anchor being advanced at the time by the deployment element is within the distal anchor manipulation area that is disposed within the lumen of the sleeve.

14. The apparatus according to claim 13, wherein the distal anchor manipulation area is flexible.

15. The apparatus according to claim 13, wherein the anchor deployment tool comprises one or more steering wires, which are arranged such that pulling and releasing of the steering wires cause deflection of the distal tube end, thereby providing steering functionality to the distal anchor manipulation area.

16. The apparatus according to claim 13, wherein the deployment element is configured to assume a state in which the deployment element is passable through one or more of the tissue anchors without engaging the tissue anchors.

17. The apparatus according to claim 16, wherein the deployment element is configured to assume the state when withdrawn in a proximal direction within the tube.

18. The apparatus according to claim 13, wherein the anchor deployment tool is configured to deploy each of the tissue anchors into the tissue in a direction parallel to a central longitudinal axis of the tube through the distal tube end, and parallel to a central longitudinal axis of the tissue anchor.

19. The apparatus according to claim 13, comprising an annuloplasty ring, which comprises the implantable sleeve.

20. A method comprising:

providing an anchor deployment tool, which includes (a) a flexible tube, which has a distal tube end, and which defines (i) an anchor storage area and (ii) a distal anchor manipulation area, which (A) is disposed between the anchor storage area and the distal tube end, and (B) has a length of at least 3 cm, and (b) a rotating deployment element;

providing a plurality of tissue anchors, which are initially stored within the anchor storage area; and

while the rotating deployment element is positioned within the flexible tube and the distal anchor manipulation area is removably disposed within a lumen defined by a wall of a sleeve, using the rotating deployment element to (i) directly engage the tissue anchors in the anchor storage area a single one at a time, (ii) advance each of the tissue anchors, while thus directly engaged, in a distal direction into the anchor manipulation area, such that only the single anchor being advanced at the time by the rotating deployment element is within the distal anchor manipulation area that is disposed within the lumen of the sleeve, and (iii) anchor the sleeve to tissue of a subject by deploying each of the tissue anchors through the distal tube end, through the wall of the sleeve, and into the tissue.