Devce with tensioners

• US 10,076,430 B2
• Filed: 10/12/2016
• Issued: 09/18/2018
• Est. Priority Date: 10/19/2015
• Status: Active Grant

• Current Assignee: Cook Medical Technologies, LLC (Cook Group Incorporated)
• Original Assignee: Cook Medical Technologies, LLC (Cook Group Incorporated)
• Inventors: Klausen, Kasper
• Primary Examiner(s): GHERBI, SUZETTE JAIME J
• Application Number:
  US15/291,384
• Publication Number:
  US 20170105855A1
• Time in Patent Office: 706 Days
• Field of Search: 623 115- 148
• CPC Class Codes: A61F 2/013 Distal protection devices, i.e. devices placed distally in combination with another endovascular procedure, e.g. angioplasty or stenting
• CPC Class Codes: A61F 2/89 the wire-like elements comprising two or more adjacent rings flexibly connected by separate members
• CPC Class Codes: A61F 2/90 characterised by a net-like or mesh-like structure
• CPC Class Codes: A61F 2/95 Instruments specially adapted for placement or removal of stents or stent-grafts
• CPC Class Codes: A61F 2/966 with relative longitudinal movement between outer sleeve and prosthesis, e.g. using a push rod
• CPC Class Codes: A61F 2002/016 made from wire-like elements
• CPC Class Codes: A61F 2210/0076 multilayered, e.g. laminated structures
• CPC Class Codes: A61F 2230/0021 square
• CPC Class Codes: A61F 2230/0069 cylindrical
• CPC Class Codes: A61F 2230/0073 Quadric-shaped
• CPC Class Codes: A61F 2240/001 Designing or manufacturing processes
• CPC Class Codes: A61F 2250/0018 differing in elasticity, stiffness or compressibility
• CPC Class Codes: A61F 2250/0048 differing in mechanical expandability, e.g. in mechanical, self- or balloon expandability

Abstract

This disclosure provides for a medical device to be implanted in the vasculature and a method for treatment in the vasculature. The device has an outer layer of a first material and an inner layer of a second material attached to the outer layer. The inner layer further has a plurality of elastomeric tensioners. If the device experiences relaxation, resulting in a decreased radial force against the vessel wall, the elastomeric tensioners may provide a contraction force to the inner layer and the outer layer, resulting in a maintained radial force on the vessel wall.

Claims

1. A medical device for treatment in a body vessel having a vessel wall, the device having a longitudinal axis and comprising:

an outer layer comprising a first material and a plurality of outer cells arranged in outer circumferential rows, each outer cell having an outer perimeter comprising a first outer cell edge attached to a second outer cell edge at a distal outer cell end, defining a distal outer angle, and a third outer cell edge attached to a fourth outer cell edge at a proximal outer cell end, defining a proximal outer angle, the distal outer angle being distal the proximal outer angle along the longitudinal axis;

an inner layer comprising a second material being elastomeric and a plurality of inner cells arranged in inner circumferential rows, the outer and inner layers defining a tubular body having a proximal end extending to a distal end and a lumen formed therethrough, the tubular body being movable between a collapsed state for delivery and an expanded state for treatment in the body vessel, each inner cell having an inner perimeter comprising a first inner cell edge attached to a second inner cell edge at a distal inner cell end defining a distal inner angle in the expanded state, and a third inner cell edge attached to a fourth inner cell edge at a proximal inner cell end defining a proximal inner angle in the expanded state, the distal inner angle being distal the proximal inner angle along the longitudinal axis, wherein at least one outer perimeter is attached to at least one inner perimeter; and

a plurality of tensioners having an extended length and a contracted length and comprising the second material, each inner cell having one tensioner being attached to the proximal inner cell end and extending distally to the distal inner cell end to apply a contraction force on the one inner cell.

2. The device of claim 1 wherein in each tensioner moves from the extended length to the contracted length to maintain a radial force on the vessel wall.

3. The device of claim 1 wherein the outer and inner perimeters are rhombic.

4. The device of claim 1 wherein the second and third outer cell edges form a first outer cell apex and the first and fourth outer cell edges form a second outer cell apex, and the second and third inner cell edges form a first inner cell apex and the first and fourth inner cell edges form a second inner cell apex.

5. The device of claim 4 wherein the first and second outer cell apices and the first and second inner cell apices are arcuate.

6. The device of claim 1 wherein the tensioner forms a first angle with the first inner cell edge and a second angle with the second inner cell edge, the sum of the first and second angles being about the same as the distal inner angle.

7. The device of claim 6 wherein the first and second angles are between about 25 to about 50 degrees in the expanded state.

8. The device of claim 1 wherein the inner layer, outer layer, and tensioners are a co-extrusion.

9. The device of claim 1 wherein the first material is a high mechanical strength material.

10. The device of claim 9 wherein the high mechanical strength material comprises at least one material selected from the group consisting of a polyurethane;

a polyester;

a polyanhydride;

polylactide;

poly-L-lactic acid;

poly-L/D-latic acid; and

a co-polymer of poly lactic-co-glycolic acid and polycaprolactone.

11. The device of claim 1 wherein the elastomeric material comprises polycaprolactone ranging from about 10 percent to about 100 percent of the elastomeric material.

12. The device of claim 1 wherein the first and second materials are biodegradable.

13. The device of claim 1 further comprising a plurality of filter struts attached to the inner layer.

14. The device of claim 13 wherein each filter strut comprises a proximal segment attached to the distal end and extending distally to a distal segment wherein all distal segments are attached to each other.

15. The device of claim 1 wherein the first outer and inner cell apices are each about 80 degrees to about 130 degrees in the expanded state and the second outer and inner cell apices are each about 80 degrees to about 130 degrees in the expanded state.