Implantation of flexible implant

• US 9,610,162 B2
• Filed: 12/26/2013
• Issued: 04/04/2017
• Est. Priority Date: 12/26/2013
• Status: Active Grant

• Current Assignee: Valtech Cardio Ltd (Edwards Lifesciences Corporation)
• Original Assignee: Valtech Cardio Ltd (Edwards Lifesciences Corporation)
• Inventors: Zipory, Yuval, Hammer, Tal
• Primary Examiner(s): GHERBI, SUZETTE JAIME J
• Application Number:
  US14/141,228
• Publication Number:
  US 20150182336A1
• Time in Patent Office: 1,195 Days
• Field of Search: 623 236- 238, 623 211
• 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: A61B 2090/306 using optical fibres
• CPC Class Codes: A61B 2090/309 using white LEDs
• CPC Class Codes: A61B 90/30 Devices for illuminating a surgical field, the devices having an interrelation with other surgical devices or with a surgical procedure
• 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 2220/0008 Fixation appliances for connecting prostheses to the body
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes

Abstract

A method is provided, including introducing into a heart atrium, an annuloplasty structure having a sleeve with an elongated tubular side wall and at least one distal end wall having a surface substantially transverse to a lateral surface of the tubular side wall. A first tissue anchor is deployed through the surface of the end wall of the sleeve and into a first portion of annulus tissue. A second tissue anchor is deployed through a portion of the tubular side wall and into a second portion of annulus tissue, such that the first tissue anchor and the second tissue anchor are both deployed consecutively, to extend in a substantially same direction and into a common, substantially planar surface of a valve annulus, the common, substantially planar surface including the first and second portions of the annulus tissue. Other applications are also described.

Claims

1. A method of deploying a flexible annuloplasty structure at annulus tissue of a valve annulus, the method comprising:

introducing into a heart atrium, the annuloplasty structure having a sleeve with an elongated tubular side wall and at least one distal end wall having a surface substantially transverse to a lateral surface of the tubular side wall;

deploying a first tissue anchor through the surface of the distal end wall of the sleeve and into a first portion of the annulus tissue; and

deploying a second tissue anchor through a section of the tubular side wall and into a second portion of the annulus tissue, such that the first tissue anchor and the second tissue anchor;

(a) are deployed consecutively;

(b) extend in a substantially same direction and into a common, substantially planar surface of the valve annulus, the common, substantially planar surface including the first and second portions of the annulus tissue; and

(c) are disposed in a manner in which a portion of the tubular side wall that is between the first and second tissue anchors assumes a shape in which;

the portion of the tubular side wall defines a first part of the lateral surface of the tubular side wall and a second part of the lateral surface of the tubular side wall opposite the first part, and

the second part of the lateral surface of the tubular side wall has a degree of tension that is larger than a degree of tension of the first part of the lateral surface of the tubular side wall.

2. The method according to claim 1, wherein deploying the second tissue anchor through the section of the tubular side wall comprises deploying the second tissue anchor substantially parallel with respect to the first tissue anchor.

3. The method according to claim 1, wherein deploying the second tissue anchor through the section of the tubular side wall comprises deploying the second tissue anchor between 0 and 45 degrees with respect to the first tissue anchor.

4. The method according to claim 1, wherein deploying the second tissue anchor through the section of the tubular side wall, comprises deploying the second tissue anchor between 0 and 20 degrees with respect to the first tissue anchor.

5. The method according to claim 1, wherein deploying the first tissue anchor comprises deploying the first tissue anchor from a distal end of a deployment manipulator through the surface of the distal end wall of the sleeve into the first portion of the annulus tissue, while the distal end of the deployment manipulator is positioned such that a central longitudinal axis through the distal end of the deployment manipulator forms an angle of between 20 and 90 degrees with the distal end wall of the sleeve at a point at which the first tissue anchor penetrates the distal end wall.

6. The method according to claim 1, wherein deploying the second tissue anchor comprises deploying the second tissue anchor from a distal end of a deployment manipulator through the section of the tubular side wall of the sleeve into the second portion of the annulus tissue, while the distal end of the deployment manipulator is positioned such that a central longitudinal axis through the distal end of the deployment manipulator forms an angle of between 20 and 90 degrees with the section of the tubular side wall of the sleeve at a point at which the second tissue anchor penetrates the section of the tubular side wall.

7. The method according to claim 1, wherein deploying the first tissue anchor comprises deploying the first tissue anchor through a channel disposed within a lumen of the sleeve, the channel having a distal end defining an opening through with the first tissue anchor passes, and wherein deploying the first tissue anchor comprises sandwiching the surface of the distal end wall of the sleeve between the distal end of the channel and the first portion of the annulus tissue.

8. The method according to claim 7, wherein sandwiching comprises positioning the distal end of the channel in a manner in which the distal end of the channel is aligned substantially parallel to the planar surface.

9. The method according to claim 1, wherein deploying the second tissue anchor comprises deploying the second tissue anchor through a channel disposed within a lumen of the sleeve, the channel having a distal end defining an opening through with the second tissue anchor passes, and wherein deploying the second tissue anchor comprises sandwiching the section of the tubular side wall of the sleeve between the distal end of the channel and the second portion of the annulus tissue.

10. The method according to claim 9, wherein sandwiching comprises positioning the distal end of the channel in a manner in which the distal end of the channel is aligned substantially parallel to the planar surface.

11. The method according to claim 1, further comprising forming the portion of the tubular side wall between the first and second tissue anchors into the shape.

12. The method according to claim 11, wherein forming the portion of the tubular side wall into the shape comprises forming the portion of the tubular side wall into the shape prior to the deploying of the second tissue anchor by flexing the portion of the tubular side wall.

13. The method according to claim 11, wherein forming the portion of the tubular side wall into the shape comprises forming the portion of the tubular side wall into the shape responsively to the deploying of the second tissue anchor.

14. The method according to claim 11, wherein the annuloplasty structure includes a stiffener configured to bias the annuloplasty structure into the shape.

15. The method according to claim 11, wherein forming the portion of the tubular side wall into the shape comprises forming the portion of the tubular side wall into a shape having a concavity.

16. The method according to claim 15, wherein forming the portion of the tubular side wall into the shape having the concavity comprises creating a gap between (1) the portion of the tubular side wall at the first part of the lateral surface of the tubular side wall, and (2) the annulus tissue, the gap having a longest distance between 0.2 and 7.5 mm.

17. The method according to claim 1, wherein deploying the first tissue anchor and deploying the second tissue anchor comprises deploying the first and second tissue anchors from within a lumen of a channel disposed within a lumen of the sleeve while at least a proximal portion of the sleeve is surrounded by a catheter.

18. A method of repairing a cardiac valve, the method comprising:

introducing into a heart atrium at annulus tissue of a valve annulus, a flexible annuloplasty structure having a sleeve with an elongated tubular side wall and at least one distal end wall having a surface substantially transverse to a lateral surface of the tubular side wall;

anchoring the distal end wall of the sleeve to the valve annulus on an atrial surface of the valve by deploying a first tissue anchor through the surface of the distal end wall of the sleeve and into a first portion of the annulus tissue;

while the distal end wall is anchored, positioning alongside the valve annulus a portion of the tubular side wall that is proximal to the distal end wall in a manner in which the portion of the tubular side wall assumes a shape in which;

a first part of the lateral surface of the tubular side wall is positioned close to the annulus tissue,

a second part of the lateral surface of the tubular side wall is disposed opposite the first part of the lateral surface of the tubular side wall and away from the annulus tissue, and

the second part of the lateral surface of the tubular side wall has a degree of tension that is larger than a degree of tension of the first part of the lateral surface of the tubular side wall; and

anchoring the portion of the tubular side wall to the annulus by deploying through a section of the tubular side wall and into a second portion of the annulus tissue, a second tissue anchor consecutively to the first tissue anchor, the second tissue anchor extending in a substantially same direction as the first tissue anchor, the portion of the tubular side wall being between the first and second tissue anchors,

wherein the first and second tissue anchors are disposed in a manner in which the portion of the tubular side wall assumes the shape.

19. The method according to claim 18, wherein the first part of the lateral surface of the tubular side wall is ruffled and is disposed adjacent the annulus tissue.

20. The method according to claim 18, wherein positioning comprises forming the portion of the tubular side wall into a shape having a concavity.

21. The method according to claim 20, wherein forming the portion of the tubular side wall into the shape having the concavity comprises creating a gap between (1) the portion of the tubular side wall at the first part of the lateral surface of the tubular side wall, and (2) the annulus tissue, the gap having a longest distance between 0.2 and 7.5 mm.

22. The method according to claim 18, wherein deploying the first tissue anchor and deploying the second tissue anchor comprises deploying the first and second tissue anchors into a common, substantially planar surface of the valve annulus, the common, substantially planar surface including the first and second portions of the annulus tissue.

23. The method according to claim 22, wherein deploying the second tissue anchor comprises deploying the second tissue anchor substantially parallel with respect to the first tissue anchor.

26. The method according to claim 18, further comprising, subsequently to the anchoring the portion of the tubular side wall, continuing to position the annuloplasty structure about a circumference of the atrial surface of the valve while periodically anchoring additional locations of the tubular side wall of the sleeve to the atrial surface of the valve.

24. Apparatus for repairing a cardiac valve, the apparatus comprising:

a flexible annuloplasty structure having a sleeve with an elongated tubular side wall and at least one distal end wall having a surface substantially transverse to a lateral surface of the tubular side wall;

a first tissue anchor passing through the distal end wall of the sleeve; and

a second tissue anchor passing through a section of the tubular side wall, the first and second tissue anchors;

(a) being disposed consecutively;

(b) extending in a substantially same direction; and

(c) being disposed in a manner in which a portion of the tubular side wall that is between the first and second tissue anchors assumes a shape in which;

the portion of the tubular side wall defines a first part of the lateral surface of the tubular side wall and a second part of the lateral surface of the tubular side wall opposite the first part, and

the second part of the lateral surface of the tubular side wall has a degree of tension that is larger than a degree of tension of the first part of the lateral surface of the tubular side wall.

25. The apparatus according to claim 24, wherein the second tissue anchor is disposed between 0 and 20 degrees with respect to the first tissue anchor.