Method and system for treating aneurysms

• US 10,390,836 B2
• Filed: 07/08/2016
• Issued: 08/27/2019
• Est. Priority Date: 04/06/2011
• Status: Expired due to Fees

• Current Assignee: Endologix
• Original Assignee: Endologix
• Inventors: Schreck, Stefan, Fox, Jason
• Primary Examiner(s): Dang, Anh T
• Application Number:
  US15/205,365
• Publication Number:
  US 20170007263A1
• Time in Patent Office: 1,145 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 comprising:

a first catheter and a second catheter each catheter having an 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 respective catheter,

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 respective endobag with the other end of the respective endobag pressurization piping in communication with an endobag pressurization tubing outside the respective catheter,

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

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

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

the manifold console further having a series of inlet ports including a first inlet port in communication with the two endobag pressurization tubing outlet ports, a second inlet port in communication with the two endoframe pressurization tubing outlet ports, and a third inlet port in communication with the two guidewire lumen pressurization outlet ports,

the manifold console being configured so that when the endobag pressurization and endoframe pressurization tubing ends from the first and the second catheters are connected to the corresponding manifold console outlet ports 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 the second catheter simultaneously.

2. The system of claim 1 wherein the first, second, and third inlet ports are configured in a 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 first and second catheter endobag pressurization, endoframe pressurization, and guidewire lumen pressurization tubings.

3. The system of claim 1, wherein the manifold console includes a fourth inlet port, which is also in communication with the endobag pressurization piping in the manifold console, where the fourth port is not located adjacent the first inlet port.

4. The system of claim 3, wherein the manifold console includes a fourth inlet port flow valve which when closed prevents flow between the endobag pressurization piping in the sequential manifold console and the fourth inlet port.

5. The system of claim 3, wherein the manifold console includes a third inlet port flow valve which when closed prevents flow between a guidewire lumen pressurization piping in the sequential manifold console and the third inlet port.

6. The system of claim 1, wherein the manifold console is configured to distribute pressure of a flowable polymer which is curable in situ that is supplied to through the first inlet port to facilitate concurrent filling of two endobags in situ through the endobag pressurization tubing.

7. The system of claim 6, wherein the flowable polymer has a density in the range from 0.1 gm/cc to 5 gm/cc when hardened.

8. The system of claim 6, wherein the filling pressure is in the range from 100 mm Hg to 330 mm Hg.

9. The system of claim 6, further comprising a polymer cure indicator so as to indicate to a user when the flowable polymer has reached a desired cure state.

10. A 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 the 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 a series of inlet ports that include a first inlet port that communicates with the two endobag pressurization tubing outlet ports, a second inlet port that communicates with the two endoframe pressurization tubing outlet ports, and a third inlet port that communicates with the two guidewire lumen pressurization outlet ports, the corresponding manifold console outlet ports being connectable to the corresponding pressurization tubing ends comprising corresponding endobag pressurization tubing, corresponding endoframe pressurization tubing and corresponding guidewire lumen pressurization tubing of the first and the 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.

11. The manifold console of claim 10 wherein the first, second, and third inlet ports are arranged to match a 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.

12. The manifold console of claim 10, wherein the sequential manifold console includes a fourth inlet port, which is also in communication with the endobag pressurization piping in the manifold console, where the fourth port is not located adjacent the first inlet port.

13. The manifold console as in claim 12, wherein the sequential manifold console includes a fourth inlet port flow valve which when closed prevents flow between the endobag pressurization piping in the sequential manifold console and the fourth inlet port.

14. The manifold console as in claim 10, wherein the sequential manifold console includes a third inlet port flow valve which when closed prevents flow between the guidewire lumen pressurization piping in the sequential manifold console and the third inlet port.

15. The manifold console of claim 10, wherein the manifold console is configured to retain balanced pressurization between the first and second catheters, the sequential configuration of first, second, and third ports.

16. The manifold console of claim 10, wherein the manifold console is configured to distribute pressure of a flowable polymer which is curable in situ that is supplied to through the first inlet port to facilitate concurrent filling of two endobags in situ through the endobag pressurization tubing.

17. The manifold console of claim 16, wherein the polymer comprises a polyurethane, a polyethylene glycol, or a collagen.

18. The manifold console of claim 16, wherein the flowable polymer has a density in the range from 0.1 gm/cc to 5 gm/cc when hardened.

19. The manifold console of claim 16, wherein the filling pressure is in the range from 100 mm Hg to 330 mm Hg.

20. The manifold console of claim 16, further comprising a polymer cure indicator so as to indicate to a user when the flowable polymer has reached a desired cure state.