IMPLANTATION OF FLEXIBLE IMPLANT

• US 20170196691A1
• Filed: 02/28/2017
• Published: 07/13/2017
• Est. Priority Date: 12/26/2013
• Status: Active Application

• Current Assignee: Valtech Cardio Ltd (Edwards Lifesciences Corporation)
• Original Assignee: Valtech Cardio Ltd (Edwards Lifesciences Corporation)
• Inventors: ZIPORY, Yuval, HAMMER, Tal
• Granted Patent: US 10,265,170 B2
• Time in Patent Office: Days
• 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, anchoring a first section of the sleeve by deploying a first tissue anchor through the first section and into a first portion of annulus tissue, and anchoring a second section of the sleeve by deploying a second tissue anchor through the second section and into a second portion of annulus tissue. A longitudinal portion of the tubular side wall is disposed between the first and second tissue anchors and has first and second lateral parts. The first lateral part is closer to the annulus than the second lateral part is to the annulus, and the second lateral part is opposite the first lateral part and has a larger degree of tension than a degree of tension of the first lateral part.

Claims

1-74. -74. (canceled)

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

introducing the annuloplasty structure into a heart atrium, the annuloplasty structure having a sleeve with an elongated tubular side wall;

anchoring a first section of the sleeve by deploying a first tissue anchor through the first section of the sleeve and into a first portion of the annulus tissue; and

anchoring a second section of the sleeve by deploying a second tissue anchor through the second section of the sleeve and into a second portion of the annulus tissue, such that;

a longitudinal portion of the tubular side wall is disposed between the first tissue anchor and the second tissue anchor, and has a first lateral part and a second lateral part opposite the first lateral part, the first lateral part being closer to the annulus than the second lateral part is to the annulus, and

the second lateral part of the longitudinal portion has a degree of tension that is larger than a degree of tension of the first lateral part of the longitudinal portion.

76. The method according to claim 75, wherein deploying the second tissue anchor comprises deploying the second tissue anchor such that the first tissue anchor and the second tissue anchor:

(a) are deployed consecutively; and

(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.

77. The method according to claim 75, wherein deploying the second tissue anchor comprises deploying the second tissue anchor substantially parallel with respect to the first tissue anchor.

78. The method according to claim 75, wherein deploying the second tissue anchor comprises deploying the second tissue anchor between 0 and 45 degrees with respect to the first tissue anchor.

79. The method according to claim 75, wherein deploying the first tissue anchor comprises deploying the first tissue anchor from a distal end of a deployment manipulator through the first section 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 first section of the sleeve at a point at which the first tissue anchor penetrates the first section of the sleeve.

80. The method according to claim 75, wherein deploying the second tissue anchor comprises deploying the second tissue anchor from a distal end of a deployment manipulator through the second section 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 second section of the sleeve at a point at which the second tissue anchor penetrates the second section of the sleeve.

81. The method according to claim 75, 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 the sleeve.

82. The method according to claim 75, 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.

83. The method according to claim 75, 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 first section of the sleeve between the distal end of the channel and the first portion of the annulus tissue.

84. The method according to claim 83, wherein deploying the first tissue anchor comprises deploying the first tissue anchor into a planar surface of the valve annulus at the first portion of the annulus tissue, and 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.

85. The method according to claim 75, 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 second section of the sleeve between the distal end of the channel and the second portion of the annulus tissue.

86. The method according to claim 85, wherein deploying the second tissue anchor comprises deploying the second tissue anchor into a planar surface of the valve annulus at the first portion of the annulus tissue, and 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.

87. The method according to claim 75, further comprising, in conjunction with the anchoring the second section of the sleeve, forming the longitudinal portion of the tubular side wall into a shape having a concavity.

88. The method according to claim 87, wherein forming the longitudinal portion into the shape having the concavity comprises creating a gap between (1) the first lateral part, and (2) the annulus tissue, the gap having a longest distance between 0.2 and 7.5 mm.

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

introducing the annuloplasty structure into a heart atrium, the annuloplasty structure having a sleeve with an elongated tubular side wall;

anchoring a first section of the sleeve by deploying a first tissue anchor through the first section of the sleeve and into a first portion of the annulus tissue;

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

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

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

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

anchoring the longitudinal portion of the tubular side wall to the annulus by deploying a second tissue anchor through a second section of the sleeve and into a second portion of the annulus tissue,

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

90. The method according to claim 89, 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 the sleeve.

91. The method according to claim 89, wherein positioning the longitudinal portion alongside the valve annulus comprises creating a gap between (1) the first lateral part, and (2) the annulus tissue, the gap having a longest distance between 0.2 and 7.5 mm.

92. The method according to claim 89, 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.

93. The method according to claim 92, wherein deploying the second tissue anchor comprises deploying the second tissue anchor substantially parallel with respect to the first tissue anchor.

94. 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 tip;

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

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

(a) the first and second tissue anchors are disposed with no intervening anchors therebetween;

(b) the first and second tissue anchors extend in a substantially same direction; and

.

(c) a longitudinal portion of the tubular side wall is disposed between the first tissue anchor and the second tissue anchor, and has a first lateral part and a second lateral part opposite the first lateral part, the first lateral part being closer to the first and second tissue anchors than the second lateral part is to the first and second tissue anchors,

wherein the second lateral part of the longitudinal portion has a degree of tension that is larger than a degree of tension of the first lateral part of the longitudinal portion.

95. The apparatus according to claim 94, wherein the second tissue anchor is disposed between 0 and 20 degrees with respect to the first tissue anchor.