Method and system for treating aneurysms

• US 10,349,946 B2
• Filed: 05/20/2015
• Issued: 07/16/2019
• Est. Priority Date: 04/06/2011
• Status: Active Grant

• Current Assignee: Endologix
• Original Assignee: Endologix
• Inventors: Herbowy, Steve, Dueri, Jean-Pierre, Fox, William Jason
• Primary Examiner(s): Dang, Anh T
• Application Number:
  US14/717,938
• Publication Number:
  US 20150250989A1
• Time in Patent Office: 1,518 Days
• CPC Class Codes: A61B 17/12036 partial occlusion
• CPC Class Codes: A61B 17/12118 for positioning in conjunction with a stent
• CPC Class Codes: A61B 17/12136 Balloons
• CPC Class Codes: A61B 17/12186 liquid materials adapted to be injected
• CPC Class Codes: A61B 2017/00659 located only on one side of the opening
• CPC Class Codes: A61B 2017/1205 Introduction devices
• CPC Class Codes: A61B 6/481 involving the use of contrast agents
• CPC Class Codes: A61B 6/504 for diagnosis of blood vessels, e.g. by angiography
• CPC Class Codes: A61F 2/07 Stent-grafts
• CPC Class Codes: A61F 2/90 characterised by a net-like or mesh-like structure
• CPC Class Codes: A61F 2002/075 the stent being loosely attached to the graft material, e.g. by stitching
• CPC Class Codes: A61F 2002/077 having means to fill the space between stent-graft and aneurysm wall, e.g. a sleeve
• CPC Class Codes: A61F 2230/0034 D-shaped
• CPC Class Codes: A61M 25/09 Guide wires
• CPC Class Codes: A61M 25/1018 Balloon inflating or inflation-control devices
• CPC Class Codes: A61M 25/104 used for angioplasty

Abstract

Methods for treatment of aneurysms using a sequential manifold console to deploy multiple filling structures are provided herein. In one aspect, aneurysms are treated by simultaneously filling two double-walled filling structure using a sequential manifold console to guide a user in the steps to be followed in the procedure and to reliably achieve a consistent and durable aneurysmal treatment using a curable medium. The structures may be delivered over balloon deployment mechanisms in order to shape and open tubular lumens therethrough. Pairs of filling structures delivered to the aneurysm from different access openings of a patient can be simultaneously prepared and pressurized from a single treatment console when treating abdominal aortic aneurysms using the described systems and methods.

Claims

1. A system for treating an aneurysm, said system comprising:

an elongate flexible inner shaft having a proximal region and a distal region, wherein the inner shaft further comprises a single guidewire lumen extending therethrough;

a distally tapered nosecone disposed at the distal region of the inner shaft, the nosecone comprising a single through lumen in fluid communication with the guidewire lumen, wherein the single through lumen extends along a longitudinal axis of the nosecone from a proximal opening to a distal opening of the nosecone;

a guidewire disposed within the inner shaft and extending through the single through lumen of the nosecone; and

a contrast media for injecting into the single guidewire lumen and the single through lumen of the nosecone, wherein the single guidewire lumen of the inner shaft is sized to allow a flow of the contrast media sufficient for performing angiography while the guidewire is disposed therein,

wherein the distal opening of the nosecone is configured to remain open upon removal of the guidewire,

wherein the nosecone further comprises one or more open side ports in fluid communication with the single through lumen before and during injection of the contrast media, the one or more side ports disposed between the proximal and distal openings of the single through lumen such that contrast media injected into the single guidewire lumen flows through the one or more side ports,

wherein the single through lumen of the nosecone comprises a narrowed distal region having a diameter smaller than a diameter of the single through lumen proximal of the narrowed distal region, the single through lumen being sized to simultaneously receive the guidewire and the flow of contrast media, and wherein the narrowed distal region fittingly receives the guidewire so as to inhibit the flow of the contrast media through the narrowed distal region so as to direct the flow of contrast media out the one or more side ports of the nosecone.

2. The system of claim 1 wherein the one or more side ports comprise a plurality of pairs of side ports, the pairs of side ports arranged in a helical pattern along a longitudinal axis of the nosecone.

3. The system of claim 2, wherein a pair of side ports of the plurality of pairs of side ports comprises two side ports adjacent to one another along the longitudinal axis of the nosecone.

4. The system of claim 1, wherein the one or more side ports comprise a plurality of side ports, a majority of which are substantially perpendicular to the single through lumen of the nosecone.

5. The system of claim 1, wherein the one or more side ports comprise a series of side ports disposed along the nosecone at regular intervals along a helical pattern.

6. The system of claim 1, further comprising:

an elongate flexible outer sheath slidably disposed over the inner shaft, wherein a distal end of the outer sheath releasably couples with the nosecone at an interface, and the distal end of the outer sheath releasably couples with a proximal portion of the nosecone and a portion of a proximal region of the nosecone is isodiametric with the outer shaft adjacent the interface.

7. The system of claim 6, further comprising:

a first double-walled filling structure disposed over the distal region of the inner shaft, the filling structure having an outer wall and an inner wall, wherein the filling structure is adapted to be filled with a hardenable fluid filing medium so that the outer wall conforms to an inside surface of the aneurysm and the inner wall forms a first generally tubular lumen to provide a path for blood flow; and

at least a first expandable endoframe disposed within the filling structure, the first endoframe radially expandable within at least a portion of the tubular lumen of the filling structure, wherein the outer sheath is slidably disposed over the filling structure, endoframe and inner shaft;

a filling tube having a lumen fluidly coupled with and adapted to fill the filling structure with the filling medium; and

an inflation device fluidly coupled with the filling structure.

8. The system of claim 1, further comprising:

an expandable member disposed on a distal region of the inner shaft; and

a support endoframe disposed over the expandable member; and

an endograft disposed over the support endoframe.