Multiple anchor delivery tool

• US 8,523,881 B2
• Filed: 07/26/2010
• Issued: 09/03/2013
• Est. Priority Date: 07/26/2010
• 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): McDermott, Corrine M
• Assistant Examiner(s): Lynch, Robert A
• Application Number:
  US12/843,412
• Publication Number:
  US 20120022557A1
• Time in Patent Office: 1,135 Days
• Field of Search: 606/139, 606/142, 606/143, 606/213, 606/305, 606/308, 411/16, 411/347, 411/349, 411/402, 411/407
• US Class Current: 606/139
• 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 2017/0649 Coils or spirals
• CPC Class Codes: A61F 2/2445 Annuloplasty rings in direct contact with the valve annulus

Abstract

An anchor deployment tool includes a flexible outer tube, within which is positioned a flexible inner shaft, and a rotating deployment element coupled to a distal end of the shaft. The tool is configured to provide an anchor storage area, which initially stores a plurality of tissue anchors, such that the inner shaft passes through channels of the anchors along entire longitudinal lengths of the anchors, and the anchors are within the outer tube. The rotating deployment element is configured to directly engage the anchors in the anchor storage area one at a time, advance each of the anchors while engaged in a distal direction, and deploy each of the anchors through the distal tube end and into tissue of a subject. Other embodiments are also described.

Claims

1. Apparatus comprising:

a plurality of tissue anchors; and

an anchor deployment tool, which comprises;

a flexible outer tube, which has a distal tube end, and which defines (a) an anchor storage area in which the plurality of tissue anchors are stored before deployment thereof, and (b) a flexible distal anchor manipulation area between the anchor storage area and the distal tube end, the anchor manipulation area having a length of at least 3 cm;

a rotating deployment element, which is positioned within the flexible outer tube, and which is configured to;

pass through one or more of the anchors without engaging the anchors when the rotating deployment element is withdrawn in a proximal direction within the outer tube,

directly engage the anchors in the anchor storage area, a single one at a time, when the rotating deployment element is advanced in the distal direction against the one of the anchors,

advance each of the anchors, while thus directly engaged, in a distal direction, and

deploy each of the anchors through the distal tube end and into tissue of a subject by screwing the anchor 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.

2. The apparatus according to claim 1, wherein the rotating deployment element comprises a locking mechanism that is configured to selectively assume (a) a locked state, in which the locking mechanism, even upon withdrawal of the rotating deployment element in the proximal direction, prevents disengagement of the rotating deployment element from one of the anchors which the rotating deployment element engages, and (b) an unlocked state, in which the locking mechanism does not prevent disengagement of the rotating deployment element from the anchor upon the withdrawal of the rotating deployment element in the proximal direction.

3. The apparatus according to claim 1, wherein the distal anchor manipulation area comprises steering functionality.

4. The apparatus according to claim 1, wherein the length of the anchor storage area is at least 5 cm.

5. The apparatus according to claim 1, wherein the anchor storage area is configured to provide a plurality of anchor storage locations, wherein the anchors are initially stored in respective ones of at least a portion of the anchor storage locations, and wherein, when the rotating deployment element advances a distal-most one of the anchors out of the anchor storage area in the distal direction, the anchors remaining in the anchor storage area remain in their respective initial anchor storage locations.

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

7. The apparatus according to claim 1, wherein the anchor deployment tool further comprises an anchor restraining mechanism in a vicinity of a distal end of the anchor storage area, which mechanism is configured to temporarily restrain at least a distal-most one of the anchors currently stored in the anchor storage area from advancing in the distal direction.

8. The apparatus according to claim 1, further comprising an annuloplasty ring, which comprises a sleeve having a lumen, wherein the anchor deployment tool is configured to be removably positioned within the lumen of the sleeve, and, while so positioned, to deploy the anchors from the distal tube end through a wall of the sleeve into the tissue.

9. A method comprising:

providing a plurality of tissue anchors;

providing an anchor deployment tool, which includes (i) a flexible outer tube, which has a distal tube end, and which defines (a) an anchor storage area in which the plurality of tissue anchors are stored before deployment thereof, and (b) a flexible distal anchor manipulation area between the anchor storage area and the distal tube end, the anchor manipulation area having a length of at least 3 cm, and (ii) a rotating deployment element, which is positioned within the flexible outer tube;

withdrawing the rotating deployment element in a proximal direction within the outer tube, such that the rotating deployment element passes through one or more of the anchors without engaging the anchors; and

using the rotating deployment element, (a) directly engaging the anchors in the anchor storage area, a single one at a time, when the rotating deployment element is advanced in the distal direction against the one of the anchors, (b) advancing each of the anchors, while thus directly engaged, in a distal direction, such that only the single anchor being advanced at the time by the rotating deployment element is within the distal anchor manipulation area, and (c) deploying each of the anchors through the distal tube end and into tissue of a subject by screwing the anchor into the tissue.

10. The method according to claim 9,

wherein the rotating deployment element includes a locking mechanism that is configured to selectively to assume a locked state, in which the locking mechanism, even upon withdrawal of the rotating deployment element in the proximal direction, prevents disengagement of the rotating deployment element from the anchor,

wherein the method further comprises causing the locking mechanism to assume the locked state, and

wherein withdrawing the anchor comprises withdrawing the anchor in the proximal direction while the rotating deployment element is in the locked state.

11. Apparatus comprising:

a plurality of tissue anchors; and

an anchor deployment tool, which (a) defines an anchor storage area in which the plurality of tissue anchors are stored before deployment thereof, and (b) comprises;

a flexible outer tube, which has a distal tube end; and

a rotating deployment element, which is positioned within the flexible outer tube, and which is configured to;

pass through one or more of the anchors without engaging the anchors when the rotating deployment element is withdrawn in a proximal direction within the outer tube,

directly engage the anchors in the anchor storage area, a single one at a time, when the rotating deployment element is advanced in the distal direction against the one of the anchors,

advance each of the anchors, while thus directly engaged, in a distal direction, and

deploy each of the anchors through the distal tube end and into tissue of a subject by rotating only the anchor directly engaged by the rotating deployment element, without rotating the anchors stored in the anchor storage area.

12. The apparatus according to claim 11, wherein the anchor storage area is configured to provide a plurality of anchor storage locations, wherein the anchors are initially stored in respective ones of at least a portion of the anchor storage locations, and wherein, when the rotating deployment element advances a distal-most one of the anchors out of the anchor storage area in the distal direction, the anchors remaining in the anchor storage area remain in their respective initial anchor storage locations.

13. The apparatus according to claim 11, wherein the plurality of anchors comprises at least 6 anchors.

14. The apparatus according to claim 11, wherein the anchor deployment tool further comprises an anchor restraining mechanism in a vicinity of a distal end of the anchor storage area, which mechanism is configured to temporarily restrain at least a distal-most one of the anchors currently stored in the anchor storage area from advancing in the distal direction.

15. Apparatus comprising:

a plurality of tissue anchors, which are shaped so as to define respective channels along entire longitudinal lengths of the anchors; and

an anchor deployment tool, which (a) defines an anchor storage area and (b) comprises;

a flexible outer tube, which has a distal tube end;

a flexible inner shaft, which is positioned within the flexible outer tube; and

a rotating deployment element, which is positioned within the flexible outer tube and is coupled to a distal shaft end of the flexible inner shaft, and which is configured to;

directly engage the anchors in the anchor storage area, a single one at a time,

advance each of the anchors, while thus directly engaged, in a distal direction, and

deploy each of the anchors through the distal tube end and into tissue of a subject by screwing the anchor into the tissue,

wherein the plurality of tissue anchors are stored in the anchor storage area before deployment thereof, such that the flexible inner shaft passes through the channels of the stored anchors without engaging the stored anchors, and the stored anchors are within the flexible outer tube.

16. The apparatus according to claim 15, wherein the rotating deployment element directly engages the anchors in the anchor storage area, a single one at a time.

17. The apparatus according to claim 16, wherein the rotating deployment element advances each of the anchors, while thus directly engaged, in the distal direction.

18. The apparatus according to claim 17, wherein the rotating deployment element deploys each of the anchors through the distal end and into the tissue of the subject by screwing the anchor into the tissue.

19. The apparatus according to claim 15, wherein the rotating deployment element is configured to pass through one or more of the anchors without engaging the anchors when the rotating deployment element is withdrawn in a proximal direction within the outer tube, and to directly engage one of the anchors when the rotating deployment element is advanced in the distal direction against the one of the anchors.

20. The apparatus according to claim 15, wherein the anchor storage area is configured to provide a plurality of anchor storage locations, wherein the anchors are initially stored in respective ones of at least a portion of the anchor storage locations, and wherein, when the rotating deployment element advances a distal-most one of the anchors out of the anchor storage area in the distal direction, the anchors remaining in the anchor storage area remain in their respective initial anchor storage locations.

21. The apparatus according to claim 15, wherein the plurality of anchors comprises at least 6 anchors.

22. The apparatus according to claim 15, wherein the anchor deployment tool further comprises an anchor restraining mechanism in a vicinity of a distal end of the anchor storage area, which mechanism is configured to temporarily restrain at least a distal-most one of the anchors currently stored in the anchor storage area from advancing in the distal direction.

23. A method comprising:

providing a plurality of tissue anchors;

providing an anchor deployment tool, which (a) defines an anchor storage area in which the plurality of tissue anchors are stored before deployment thereof, and (b) includes (i) a flexible outer tube, which has a distal tube end, and (ii) a rotating deployment element, which is positioned within the flexible outer tube;

withdrawing the rotating deployment element in a proximal direction within the outer tube, such that the rotating deployment element passes through one or more of the anchors without engaging the anchors; and

using the rotating deployment element, (a) directly engaging the anchors in the anchor storage area, a single one at a time, when the rotating deployment element is advanced in the distal direction against the one of the anchors, (b) advancing each of the anchors, while thus directly engaged, in a distal direction, and (c) deploying each of the anchors through the distal tube end and into tissue of a subject by rotating only the anchor directly engaged by the rotating deployment element, without rotating the anchors stored in the anchor storage area.

24. A method comprising:

providing a plurality of tissue anchors, which are shaped so as to define respective channels along entire longitudinal lengths of the anchors;

providing an anchor deployment tool, which (a) defines an anchor storage area and (b) includes (i) a flexible outer tube, which has a distal tube end, (ii) a flexible inner shaft, which is positioned within the flexible outer tube, and (iii) a rotating deployment element, which is positioned within the flexible outer tube and is coupled to a distal shaft end of the flexible inner shaft; and

using the rotating deployment element, (a) directly engaging the anchors in the anchor storage area, a single one at a time, (b) advancing each of the anchors, while thus directly engaged, in a distal direction, and (c) deploying each of the anchors through the distal tube end and into tissue of a subject by screwing the anchor into the tissue,

wherein the plurality of tissue anchors are stored in the anchor storage area before deployment thereof, such that the flexible inner shaft passes through the channels of the stored anchors without engaging the stored anchors, and the stored anchors are within the flexible outer tube.