Systems and methods for supporting or occluding a physiological opening or cavity

• US 8,388,650 B2
• Filed: 09/04/2009
• Issued: 03/05/2013
• Est. Priority Date: 09/05/2008
• Status: Active Grant

• Current Assignee: Pulsar Vascular, Inc. (Johnson & Johnson)
• Original Assignee: Pulsar Vascular, Inc. (Johnson & Johnson)
• Inventors: Gerberding, Brent C., Abrams, Robert M., Clarke, Gilbert
• Primary Examiner(s): McDermott, Corrine M
• Assistant Examiner(s): ORKIN, ALEXANDER J
• Application Number:
  US12/554,850
• Publication Number:
  US 20100094335A1
• Time in Patent Office: 1,278 Days
• Field of Search: 606/200, 606/157, 606/158, 606/108, 606/198
• US Class Current: 606/213
• CPC Class Codes: A61B 17/12022 Occluding by internal devices, e.g. balloons or releasable wires plugging an opening in the wall of an organ A61B17/0057; occluders for the cervical canal A61F6/146; vas deferens occluders A61F6/20
• CPC Class Codes: A61B 17/12036 partial occlusion
• CPC Class Codes: A61B 17/12113 within an aneurysm
• CPC Class Codes: A61B 17/12118 for positioning in conjunction with a stent
• CPC Class Codes: A61B 17/12172 having a pre-set deployed three-dimensional shape methods of manufacturing A61B2017/00526
• CPC Class Codes: A61B 17/12177 comprising additional materials, e.g. thrombogenic, having filaments, having fibers or being coated
• CPC Class Codes: A61B 2017/00526 Methods of manufacturing
• CPC Class Codes: A61B 2017/00778 Operations on blood vessels A61B2017/22097, A61B2017/320741 take precedence
• CPC Class Codes: A61B 2017/00867 shape memory effect for prostheses A61F2210/0014
• CPC Class Codes: A61B 2017/00893 pharmaceutically effective
• CPC Class Codes: A61B 2017/00898 expandable upon contact with fluid
• CPC Class Codes: A61B 2017/1205 Introduction devices
• CPC Class Codes: A61B 2017/12054 Details concerning the detachment of the occluding device from the introduction device
• CPC Class Codes: A61F 2/06 Blood vessels
• CPC Class Codes: A61F 2/86 Stents in a form characterised by the wire-like elements; Stents in the form 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 2240/001 Designing or manufacturing processes

Abstract

Implantable devices for placement at a cavity or opening such as an aneurysm are disclosed. The implantable devices, in a deployed condition, have a generally inverted U-shaped profile with a curved or angled framework support structure sized and configured for placement in proximity to tissue surrounding the opening and anchoring legs extending proximally from the framework structure sized and configured to contact the wall of a neighboring lumen at opposed locations. Occlusive and semi-occlusive membranes may be associated with the framework support structure and deployed over the opening to provide exclusion of the opening and flow diversion. Proximal anchoring segments providing additional lumen wall surface area contact for the implantable device following deployment may be incorporated.

Claims

1. An implantable device for placement at an opening of a physiological cavity and adjustable from a generally small diameter delivery condition to a deployed condition in which it assumes a larger diameter configuration, wherein the implantable device, in the deployed condition, comprises a substantially inverted U-shaped framework structure curving angularly away from a central longitudinal axis with at least two anchoring legs extending directly from the U-shaped framework structure, wherein the framework structure has at least one lateral area sized and configured to be positioned in proximity to the opening of the physiological cavity, and the at least two anchoring legs extend from the U-shaped framework structure generally opposite one another and along substantially parallel, opposed planes in the deployed condition, and further wherein the anchoring legs are sized and configured to contact tissue surface areas generally opposite one another on a neighboring lumen.

2. The implantable device of claim 1, wherein the U-shaped framework structure has two lateral areas aligned on a longitudinal centerline, each lateral area being sized and configured to be positioned in proximity to the opening.

3. The implantable device of claim 2, wherein the U-shaped framework structure is curved along its longitudinal centerline.

4. The implantable device of claim 3, wherein the U-shaped framework structure is curved concavely along its longitudinal centerline.

5. The implantable device of claim 1, wherein the U-shaped framework structure has a perimeter structure with two lateral areas aligned on a longitudinal centerline of the framework structure and side walls tapering away from the central longitudinal axis substantially symmetrically in both directions from the longitudinal centerline.

6. The implantable device of claim 1, wherein the U-shaped framework structure has tapered, curved side walls.

7. The implantable device of claim 1, wherein the U-shaped framework structure and anchoring legs are integrally formed.

8. The implantable device of claim 1, wherein the U-shaped framework structure incorporates a shaped, curved three-dimensional portion.

9. The implantable device of claim 1, wherein the U-shaped framework structure is constructed from a material selected from the group consisting of:

stainless steels, biocompatible shape change alloys, super-elastic metallic materials, biocompatible flexible polymeric materials, composite materials and combinations thereof.

10. The implantable device of claim 1, wherein the perimeter of the anchoring legs have a generally triangular configuration, terminating in a proximal apex.

11. The implantable device of claim 1, wherein the anchoring legs comprise a combination of different geometrical structures.

12. The implantable device of claim 1, wherein the anchoring legs incorporate at least one curved flexure segment.

13. The implantable device of claim 1, wherein the anchoring legs are constructed from a material selected from the group consisting of:

stainless steels, biocompatible shape change alloys, super-elastic metallic materials, biocompatible flexible polymeric materials, composite materials and combinations thereof.

14. The implantable device of claim 1, additionally comprising proximal anchoring segments extending from each anchoring leg and out of the plane of the anchoring legs.

15. The implantable device of claim 14, wherein the proximal anchoring segments have terminal portions arranged substantially opposite one another.

16. The implantable device of claim 14, wherein the proximal anchoring segments have terminal portions arranged in different axial and circumferential locations than the terminal portions of the anchoring legs.

17. The implantable device of claim 1, wherein at least one radiopaque marker is associated with the framework structure and at least one radiopaque marker is associated with at least one of the anchoring legs, and the radiopaque marker(s) associated with the framework structure and at least one of the anchoring legs are distinctive.

18. An implantable device for placement at the opening of a physiological cavity and adjustable from a generally small diameter delivery condition to a deployed condition in which it assumes a larger diameter configuration, wherein the implantable device, in the deployed condition, comprises (a) a framework support structure curving angularly away from a central longitudinal axis and having at least one lateral area sized and configured for positioning in proximity to tissue near the opening of the cavity, (b) at least two anchoring legs that, in a deployed condition, extend directly from the framework support structure and are arranged substantially opposite one another and along substantially parallel, opposed planes, wherein the opposed planes are generally parallel with the longitudinal axis, and wherein the at least two anchoring legs are configured to contact the walls of a neighboring vessel along opposed anchoring surface areas, and (c) at least two proximal anchoring extensions that, in a deployed condition, are sized and configured to contact walls of the neighboring vessel at surface areas proximal to the anchoring surface areas and at circumferential vessel wall locations different from the anchoring surface areas.

19. An implantable device for placement at the opening of a physiological cavity and configured to vary between a delivery condition and a deployed condition, wherein the implantable device, in the deployed condition, defines a framework support structure extending angularly away from a central longitudinal axis and at least two anchoring legs extending directly away from the framework support structure and generally opposite one another along substantially parallel, opposed planes, wherein the opposed planes are generally parallel with the longitudinal axis, and wherein the framework support structure has at least one lateral area having a widest dimension and further wherein a distance between the at least two anchoring legs, in the deployed condition, is less than the widest dimension of the framework support structure lateral area.

20. An implantable device assembly for placement at an opening or cavity in a target tissue, the implantable device comprising an elongated, flexible delivery catheter, at least one elongated, flexible delivery mechanism axially movable with respect to the catheter, and an implantable device associated with a distal end of the delivery mechanism and positioned in a distal end of the delivery catheter, wherein the implantable device is transformable between a delivery arrangement and a deployed arrangement in which the implantable device assumes a larger diameter configuration outside the catheter, and further wherein the implantable device, in the deployed arrangement, comprises a generally U-shaped support structure curving laterally away from a central longitudinal axis and at least two anchoring legs extending directly from the U-shaped support structure substantially opposite one another and along substantially parallel, opposed planes.

21. An implantable device configured for placement at an opening of a physiological cavity, the implantable device comprising:

a substantially inverted U-shaped framework structure curving angularly away from a central longitudinal axis, wherein the framework structure has at least one lateral area sized and configured to be positioned in proximity to the opening of the physiological cavity; and

two anchoring legs extending directly from the U-shaped framework structure and generally opposite one another, wherein the anchoring legs are sized and configured to contact tissue surface areas generally opposite one another on a neighboring lumen,

wherein a perimeter of the each anchoring leg defines a generally triangular configuration and terminates in a proximal apex.