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

• US 9,615,831 B2
• Filed: 02/10/2015
• Issued: 04/11/2017
• 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, Abrams, Robert M., Clarke, Gilbert
• Primary Examiner(s): ORKIN, ALEXANDER J
• Application Number:
  US14/618,969
• Publication Number:
  US 20150216687A1
• Time in Patent Office: 791 Days
• 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. A method of deploying an implantable device in proximity to the neck of an aneurysm of a human patient, the method comprising:

navigating the implantable device to a location in proximity to the neck of the aneurysm in a low profile delivery arrangement;

initiating deployment of the implantable device at the location in proximity to the neck of the aneurysm by advancing a distal portion of the implantable device incorporating lateral portions of a framework support structure and allowing the lateral portions to assume a larger diameter, deployed arrangement;

positioning of the lateral portions of the framework support structure in close proximity to the neck of the aneurysm;

continuing to deploy the implantable device by fully deploying the framework support structure in proximity to the neck of the aneurysm,

wherein, in the fully deployed arrangement, the framework support structure positioned across the neck of the aneurysm has an inverted U-shape configured to arch over lumina of adjacent branch vessels, and wherein the inverted U-shaped framework support structure is configured to span unobtrusively over the lumina and without impeding flow in the vascular flow path; and

completing deployment of the implantable device by deploying at least two proximal anchoring legs that, in the deployed arrangement, extend directly from the U-shaped framework support structure and into a neighboring vessel such that they are arranged substantially opposite one another and contact the walls of the neighboring vessel along opposed surface areas.

2. The method of claim 1 wherein navigating the implantable device to a location in proximity to the neck of an aneurysm in a low profile delivery arrangement comprises transluminally delivering the implantable device in the delivery arrangement within a delivery catheter.

3. The method of claim 2 wherein the lateral portions of the framework support structure comprise lateral corners, and wherein, in the delivery arrangement, the lateral corners of the framework structure are positioned distally, and further wherein allowing the lateral portions to assume a larger diameter, deployed arrangement comprises expanding the lateral corners laterally toward their fully deployed arrangement.

4. The method of claim 2 wherein initiating deployment of the implantable device comprises actively pushing the implantable device out of the delivery catheter and actively withdrawing the delivery catheter.

5. The method of claim 1 wherein the lateral portions of the framework support structure comprise lateral corners, and wherein positioning of the lateral portions of the framework support structure in close proximity to the neck of the aneurysm comprises positioning at least the lateral corners in contact with tissue adjacent the neck of the aneurysm.

6. The method of claim 1 wherein completing deployment of the implantable device by deploying at least two proximal anchoring legs comprises deploying anchoring legs integrally formed with the U-shaped framework support structure.

7. The method of claim 1 wherein completing deployment of the implantable device by deploying at least two proximal anchoring legs comprises deploying anchoring legs that, in the deployed arrangement, each define a perimeter having a generally triangular configuration terminating in a proximal apex.

8. The method of claim 1 wherein the framework support structure further comprises a closure membrane, and wherein positioning of the lateral portions of the framework support structure in close proximity to the neck of the aneurysm comprises positioning the framework support structure and associate closure membrane across the neck of the aneurysm and in contact with tissue surrounding the neck.

9. The method of claim 1 wherein the implantable device further comprises one or more radiopaque markers, and wherein the implantable device is accurately navigated, positioned, and deployed using the one or more radiopaque markers.

10. A method of deploying an implantable device in proximity to the neck of an aneurysm of a human patient, the method comprising:

navigating the implantable device to a location in proximity to the neck of the aneurysm in a small diameter delivery configuration;

initiating deployment of the implantable device at the location in proximity to the neck of the aneurysm by

advancing a distal portion of the implantable device incorporating a framework support structure and allowing the framework support structure to assume a larger diameter, deployed configuration; and

positioning at least a portion of the framework support structure in proximity to the neck of the aneurysm,

wherein, when the framework support structure is in the larger diameter deployed configuration, the framework support structure has an inverted U-shape curving angularly away from a central longitudinal axis and configured to arch over lumina of adjacent branch vessels, and

wherein the inverted U-shaped framework support structure is configured to span over the lumina and without inhibiting blood flow in the vascular flow path;

continuing deployment of the implantable device by deploying at least two anchoring legs that, in the deployed configuration, extend directly from the U-shaped framework support structure and into a neighboring vessel such that they are arranged substantially opposite one another and contact the walls of the neighboring vessel along opposed anchoring surface areas; and

completing deployment of the implantable device by deploying at least two proximal anchoring extensions that, in the deployed configuration, 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.

11. The method of claim 10 wherein the U-shaped framework support structure comprises two lateral areas aligned on a longitudinal centerline, and wherein each lateral area is sized and shaped to be positioned in contact with tissue proximate the neck of the aneurysm.

12. The method of claim 10 wherein the U-shaped framework support structure has tapered, curved side walls.

13. The method of claim 10 wherein continuing deployment of the implantable device by deploying at least two anchoring legs comprises deploying at least two anchoring legs integrally formed with the U-shaped framework support structure.