Treatment of incompetent vessels

• US 10,363,043 B2
• Filed: 04/27/2015
• Issued: 07/30/2019
• Est. Priority Date: 05/01/2014
• Status: Active Grant

• Current Assignee: ArtVentive Medical Group Inc
• Original Assignee: ArtVentive Medical Group Inc
• Inventors: Rudakov, Leon
• Primary Examiner(s): Shi, Katherine M
• Assistant Examiner(s): Mannan, Mikail A
• Application Number:
  US14/697,547
• Publication Number:
  US 20150313602A1
• Time in Patent Office: 1,555 Days
• CPC Class Codes: A61B 17/12031 complete occlusion
• CPC Class Codes: A61B 17/12104 in an air passage
• CPC Class Codes: A61B 17/12109 in a blood vessel
• CPC Class Codes: A61B 17/12145 having a pre-set deployed three-dimensional shape methods of manufacturing A61B2017/00526
• CPC Class Codes: A61B 17/1215 comprising additional materials, e.g. thrombogenic, having filaments, having fibers, being coated
• CPC Class Codes: A61B 2017/00004 (bio)absorbable, (bio)resorbable, resorptive for implantable prostheses A61F2210/0004
• CPC Class Codes: A61B 2017/00597 Implements comprising a membrane
• CPC Class Codes: A61B 2017/1205 Introduction devices
• CPC Class Codes: A61B 2017/12127 Double occlusion, e.g. for creating blood-free anastomosis site
• CPC Class Codes: A61B 2017/3413 guided by ultrasound
• CPC Class Codes: A61B 2017/4233 Operations on Fallopian tubes, e.g. sterilization A61B2017/1125 takes precedence

Abstract

An implant device can include a frame and a cover member for delivery to and occlusion of a target body vessel. The frame can include proximal and distal members, coupled by a link member structure, and can expand from a collapsed configuration to an expanded configuration. In the collapsed configuration, a first plane passes through the proximal member and a second plane passes through the distal member, and the link member extends substantially parallel relative to a longitudinal axis of the device. In moving to the expanded configuration, the first and second planes each move angularly, relative to the longitudinal axis, from the collapsed configuration by between about 10 degrees and about 170 degrees, and the link member foreshortens along the longitudinal axis to bias the proximal member toward the distal member.

Claims

1. An expandable device for delivery to a target location in a body vessel, comprising:

a frame comprising a proximal loop, a distal loop, and first and second U-shaped link members, the first U-shaped link member having a first radius of curvature and the second U-shaped link member having a second radius of curvature, wherein the first and second radii of curvature have a common bend axis, the first U-shaped link member having a first proximal end obliquely coupled to the proximal loop at a first proximal location, the second U-shaped link member having a second proximal end obliquely coupled to the proximal loop at a second proximal location, the second proximal location being spaced apart from the first proximal location, and a second end coupled to the distal loop, the first U-shaped link member further having a first distal end obliquely coupled to the distal loop at a first distal location, the second U-shaped link member having a second distal end obliquely coupled to the distal loop at a second distal location, the second distal location being spaced apart from the first distal location, the proximal and distal loops being at opposite ends of a longitudinal axis, wherein in an expanded configuration, the first and second U-shaped link members (i) are symmetrical with each other about a first plane passing through the longitudinal axis and (ii) are each symmetrical about a second plane that is oriented perpendicular to the first plane;

wherein the frame is expandable from (1) a collapsed configuration in which the first and second U-shaped link members are generally straight and extend substantially parallel relative to the longitudinal axis, to (2) an expanded configuration, in moving to which (a) the first and second planes each rotate angularly, relative to the longitudinal axis, from the collapsed configuration by between about 10 degrees and about 170 degrees, and (b) the first and second radii of curvature decrease to cause the first and second U-shaped link members to foreshorten along the longitudinal axis to bias the proximal loop toward the distal loop; and

a cover member coupled to the frame.

2. The device of claim 1, wherein at least one of the proximal or distal loops comprises an annular shape.

3. The device of claim 2, wherein, in the collapsed configuration, the annular shape is positioned in an oblong, deflected state.

4. The device of claim 2, wherein the annular shape has an expanded diameter of between about 5 mm and about 15 mm.

5. The device of claim 1, wherein, in the collapsed configuration, the proximal and distal loops are positioned substantially parallel relative to the longitudinal axis.

6. The device of claim 1, wherein, when moving to the expanded configuration, at least one dimension of the proximal loop expands within the first plane and at least one dimension of the distal loop expands within the second plane.

7. The device of claim 1, wherein, in the collapsed configuration, the first and second planes each are oriented at angles of between about 10°

and about 50°

relative to the longitudinal axis.

8. The device of claim 1, wherein, in the expanded configuration, the first and second planes each are oriented at angles of between about 70°

and about 110°

relative to the longitudinal axis.

9. The device of claim 1, wherein the device foreshortens by over 40% when expanding from the collapsed configuration to the expanded configuration.

10. A combination of the expandable device of claim 1 and a delivery system for delivering the expandable device to a target vessel, the system comprising:

a handle portion;

a tubular shaft comprising a proximal end, coupled to the handle portion, and a distal end, comprising a lumen;

a delivery component slidably disposed within the lumen and configured to advance the expandable device within the lumen for delivery to the target vessel;

an actuation component coupled to the handle portion and the delivery component for selectively advancing or retracting the delivery component relative to the shaft; and

a release member coupled to the delivery component, the release member being movable between an engaged position in which the release member engages the proximal and distal loops, and a disengaged position, in which the proximal and distal loops are disengaged from the delivery component.

11. The combination of claim 10, wherein the release member comprises an elongate wire extending through a lumen of the delivery component, and the delivery component comprises first and second slots, and wherein in the engaged position, the release member engages the proximal loop through the first slot and the distal loop through the second slot, the release member being proximally retractable to sequentially release the distal loop and then the proximal loop from the delivery component.

12. An expandable device for delivery to a target location in a body vessel, comprising:

a frame comprising a proximal loop, a distal loop, and first and second U-shaped link members, the first U-shaped link member having a first radius of curvature and the second U-shaped link member having a second radius of curvature, wherein the first and second radii of curvature have a common bend axis, the first U-shaped link member being coupled at its ends to the proximal and distal loops, the second U-shaped link member being coupled at its ends to the proximal and distal loops, wherein the frame is expandable from (1) a collapsed configuration in which the first and second U-shaped link members are generally straight and straightened to extend substantially parallel relative to a longitudinal axis of the device, to (2) an expanded configuration, in moving to which (a) the proximal and distal loops each rotate angularly, relative to the longitudinal axis, from the collapsed configuration by between about 10 degrees and about 170 degrees, and (b) the first and second radii of curvature decrease to cause the first and second U-shaped link members to foreshorten along the longitudinal axis to bias the proximal loop toward the distal loop; and

a cover member coupled to the frame.

13. The device of claim 12, wherein the first U-shaped link member has a first proximal end obliquely coupled to the proximal loop at a first proximal location, the second U-shaped link member has a second proximal end obliquely coupled to the proximal loop at a second proximal location, the second proximal location being spaced apart from the first proximal location, and a second end coupled to the distal loop, the first U-shaped link member further having a first distal end obliquely coupled to the distal loop at a first distal location, the second U-shaped link member having a second distal end obliquely coupled to the distal loop at a second distal location, the second distal location being spaced apart from the first distal location, the proximal and distal loops being at opposite ends of the longitudinal axis, and wherein in an expanded configuration, the first and second U-shaped link members (i) are symmetrical with each other about a first plane passing through the longitudinal axis and (ii) are each symmetrical about a second plane that is oriented perpendicular to the first plane.

14. The device of claim 12, wherein at least one of the proximal or distal loops comprises an annular shape.

15. The device of claim 14, wherein, in the collapsed configuration, the annular shape is positioned in an oblong, deflected state.

16. The device of claim 14, wherein the annular shape has an expanded diameter of between about 5 mm and about 15 mm.

17. The device of claim 12, wherein, in the collapsed configuration, the proximal and distal loops are positioned substantially parallel relative to the longitudinal axis.

18. The device of claim 12, wherein, when moving to the expanded configuration, at least one dimension of the proximal loop expands within the first plane and at least one dimension of the distal loop expands within the second plane.

19. The device of claim 12, wherein, in the collapsed configuration, the first and second planes each are oriented at angles of between about 10°

and about 50°

relative to the longitudinal axis.

20. The device of claim 12, wherein, in the expanded configuration, the first and second planes each are oriented at angles of between about 70°

and about 110°

relative to the longitudinal axis.

21. The device of claim 12, wherein the device foreshortens by over 40% when expanding from the collapsed configuration to the expanded configuration.