Method and system for treating aneurysms

• US 9,415,195 B2
• Filed: 04/06/2012
• Issued: 08/16/2016
• Est. Priority Date: 04/06/2011
• Status: Active Grant

• Current Assignee: Endologix
• Original Assignee: Engologix Incorporated
• Inventors: Schreck, Stefan, Fox, Jason
• Primary Examiner(s): Severson, Ryan J
• Assistant Examiner(s): DANG, ANH TIEU
• Application Number:
  US13/441,762
• Publication Number:
  US 20120259406A1
• Time in Patent Office: 1,593 Days
• Field of Search: 606191-200, 623/1.11, 623/1.12, 623/1.25, 604/96.01, 604/97.03, 604/100.01, 604/100.02, 60410101-10105
• US Class Current: 1/1
• 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 comprising:

a first catheter and a second catheter each catheter having an endobag, the endobag comprising a double-walled filling structure with an aneurysm conforming outer wall and a blood transit lumen creating an inner wall surrounding an endoframe releasably coupled to the catheter and covered in an unexpanded configuration by a retractable sheath,

wherein each of the first and second catheters includes an endobag pressurization piping having one end releasably coupled to the respective endobag and an inner lumen in communication with the inside of the respective endobag with the other end of the respective endobag pressurization piping extending within the sheath and in communication with an endobag pressurization tubing outside the respective catheter,

wherein each of the first and second catheters comprises balloon on which the respective endoframe is mounted so as to expand the endoframe when inflated, wherein each balloon is in communication with an endoframe pressurization tubing outside of the respective catheter; and

wherein each of the first and second catheters comprises a guidewire lumen, each guidewire lumen being in communication with a guidewire lumen pressurization tubing extending outside of the respective catheter;

a sequential manifold console having two endobag pressurization tubing outlet ports, two endoframe pressurization tubing outlet ports, and two guidewire lumen pressurization outlet ports wherein the two endobag pressurization tubing outlet ports are connectable to the corresponding ends of the endobag pressurization tubing of the endobags of the first and second catheters, wherein the two endoframe pressurization tubing outlet ports are connectable to the corresponding ends of the endoframe pressurization tubing of the first and second catheters, and wherein the two guidewire lumen pressurization outlet ports are connectable to the corresponding ends of the guidewire lumen pressurization tubing of the first and second catheters;

the manifold console further having sequential inlet ports, wherein a first inlet port communicates with said two endobag pressurization tubing outlet ports, wherein a second inlet port communicates with said two endoframe pressurization tubing outlet ports, and wherein a third inlet port communicates with said two guidewire lumen pressurization outlet ports, wherein when said endobag pressurization and endoframe pressurization tubing ends from said first and said second catheters are connected to said corresponding manifold console outlet ports, such that pressurization of the first inlet port equally pressurizes corresponding endobag pressurization tubing to both the first and second catheters simultaneously and pressurization of the second inlet port equally pressurizes corresponding endoframe pressurization tubing to both the first catheter and said second catheter simultaneously;

wherein the first, second, and third inlet ports are configured in a side by side sequential configuration to provide operator guidance and to retain balanced pressurization between the first and second catheters, where the sequential configuration of first, second, and third ports is arranged to match a desired sequence of an operator'"'"'s steps of pressure application to said first and second catheter endobag pressurization, endoframe pressurization, and guidewire lumen pressurization tubings, and

wherein said sequential manifold console includes a polymer cured indicator comprising a colored surface facing a light transmissive section of an endobag pressurization piping of the sequential manifold along a polymer flow path of said piping between said first inlet port and said two endobag pressurization tubing outlet ports, such that a color of said colored surface can be seen by the operator through said light transmissive section of said piping when said piping is empty or is pressurized to contain uncured polymer and that said color of said colored surface is at least partially obstructed by a change in light.

2. The system for treating an aneurysm as in claim 1, wherein said sequential manifold console includes a fourth inlet port, which is also in communication with said endobag pressurization piping in said manifold console, where said fourth port is not located adjacent said first inlet port.

3. The system for treating an aneurysm as in claim 2, wherein said sequential manifold console includes a fourth inlet port flow valve which when closed prevents flow between said endobag pressurization piping in said sequential manifold console and said fourth inlet port.

4. The system for treating an aneurysm as in claim 2, wherein said sequential manifold console includes a third inlet port flow valve which when closed prevents flow between a guidewire lumen pressurization piping in said sequential manifold console and said third inlet port.

5. A sequential manifold console comprising:

two endobag pressurization tubing outlet ports;

two endoframe pressurization tubing outlet ports; and

two guidewire lumen pressurization outlet ports, wherein at least one of said two ports are connectable to an end of corresponding pressurization tubing outside of each of a first catheter and a second catheter;

the manifold console further having sequential inlet ports, wherein a first inlet port communicates with said two endobag pressurization tubing outlet ports, wherein a second inlet port communicates with said two endoframe pressurization tubing outlet ports, and wherein a third inlet port communicates with said two guidewire lumen pressurization outlet ports, wherein said corresponding manifold console outlet ports are connectable to said corresponding pressurization tubing ends comprising corresponding endobag pressurization tubing, corresponding endoframe pressurization tubing and corresponding guidewire lumen pressurization tubing of said first and said second catheters,

wherein the manifold console is configured such that pressurization of the first inlet port equally pressurizes the corresponding endobag pressurization tubing to both the first catheter and the second catheter simultaneously and pressurization of the second inlet port equally pressurizes the corresponding endoframe pressurization tubing to both the first catheter and the second catheter simultaneously;

wherein the first, second, and third inlet ports are configured in a side by side sequential configuration to provide operator guidance and to retain balanced pressurization between the first and second catheters, where the sequential configuration of first, second, and third ports is arranged to match a desired sequence of an operator'"'"'s steps of pressure application to the connectable first and second catheter endobag pressurization, endoframe pressurization, and guidewire lumen pressurization tubing, and

wherein said sequential manifold console includes a polymer cured indicator comprising a colored surface facing a light transmissive section of an endobag pressurization piping of the sequential manifold console along a polymer flow path of said piping between said first inlet port and said two endobag pressurization tubing outlet ports, such that a color of said colored surface can be seen through said light transmissive section of said piping when said piping is empty or is pressurized to contain uncured polymer and that said color of said colored surface is at least partially obstructed by a change in light transmissivity of the polymer as it cures thereby providing a visual confirmation by the obstruction of viewing of the colored surface to the operator of the state of cure of the polymer.

6. The sequential manifold console as in claim 5, wherein said sequential manifold console includes a fourth inlet port, which is also in communication with said endobag pressurization piping in said manifold console, where said fourth port is not located adjacent said first inlet port.

7. The sequential manifold console as in claim 6, wherein said sequential manifold console includes a fourth inlet port flow valve which when closed prevents flow between said endobag pressurization piping in said sequential manifold console and said fourth inlet port.

8. The sequential manifold console as in claim 5, wherein said sequential manifold console includes a third inlet port flow valve which when closed prevents flow between said guidewire lumen pressurization piping in said sequential manifold console and said third inlet port.