SYSTEM AND METHODS FOR ENDOVASCULAR ANEURYSM TREATMENT

• US 20150142093A1
• Filed: 11/10/2014
• Published: 05/21/2015
• Est. Priority Date: 07/07/2005
• Status: Active Grant

• Current Assignee: Endologix
• Original Assignee: Nellix, Inc.
• Inventors: EVANS, MICHAEL A., LEE, AMY, HERBOWY, STEVEN L., WANTANABE, GWENDOLYN A.
• Granted Patent: US 9,737,425 B2
• Time in Patent Office: Days
• US Class Current: 623/1.11
• CPC Class Codes: A61B 17/12118 for positioning in conjunction with a stent
• CPC Class Codes: A61B 17/12136 Balloons
• CPC Class Codes: A61B 17/12195 comprising a curable material
• CPC Class Codes: A61B 2017/1205 Introduction devices
• CPC Class Codes: A61F 2/06 Blood vessels
• CPC Class Codes: A61F 2/07 Stent-grafts
• CPC Class Codes: A61F 2/82 Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents stent-grafts for tubular structures of the body other than blood vessels A61F2/04; stent-grafts for blood vessels A61F2/07; instruments specially adapted for placement or removal of stents or stent-grafts A61F2/95; for closing wounds, or holding wounds closed A61B17/04 - A61B17/115; dilators A61M29/00
• CPC Class Codes: A61F 2/90 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 2/958 Inflatable balloons for placing stents or stent-grafts
• CPC Class Codes: A61F 2002/065 Y-shaped blood vessels
• CPC Class Codes: A61F 2002/067 modular
• 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 2220/005 using adhesives
• CPC Class Codes: A61F 2220/0058 soldered or brazed or welded
• CPC Class Codes: A61F 2230/0034 D-shaped
• CPC Class Codes: A61F 2230/005 Rosette-shaped, e.g. star-shaped
• CPC Class Codes: A61F 2250/0003 having an inflatable pocket filled with fluid, e.g. liquid or gas
• CPC Class Codes: A61M 2025/0002 with a pressure sensor at the distal end

Abstract

Embodiments provide methods and systems for treating aneurysms using filling structures filled with a curable medium. An embodiment of a method comprises positioning at least one double-walled filling structure across the aneurysm and filling the structure(s) with a filling medium so that an outer wall conforms to the inside of the aneurysm and an inner wall forms a generally tubular lumen to provide for blood flow. The lumen is supported with a balloon or other expandable device while and/or after filling. The pressure within the structure and/or in the space between an external wall of the structure and the aneurysm wall is monitored and a flow of the medium into the structure is controlled responsive to the pressure. The pressure can also be used to determine a filling endpoint. The medium is hardened while the lumen remains supported by the balloon. The balloon is then removed after the medium hardens.

Claims

1. A method for treating an aneurysm in a patient, the method comprising:

positioning at least one double-walled filling structure across the aneurysm;

filling the at least one filling structure with a fluid filling medium so that an outer wall conforms to the inside of the aneurysm and an inner wall forms a generally tubular lumen to provide for blood flow, wherein the blood flow directly contacts a surface of the inner wall, and wherein the at least one filling structure substantially fills the aneurysm when filled with the fluid filling medium;

supporting the tubular lumen with a support structure during filling and/or after the filling of the at least one double-walled filling structure;

monitoring a filling pressure during filling of the at least one filling structure;

controlling filling of the filling medium into the filling structure in response to the monitored pressure based on a threshold pressure relative a blood pressure of the patient, wherein the threshold pressure is in the range of about 100 to 140% of the patient'"'"'s blood pressure;

supporting the tubular lumen while the filling medium hardens within the at least one double-walled filling structure; and

removing the support structure from the at least one double-walled filling structure after the filling medium has hardened, at least in part.

2. The method of claim 1, further comprising:

determining an end point of filling the at least one filling structure with the filling medium in response to a pressure increase of the monitored filling pressure.

3. The method of claim 1, wherein controlling filling comprises controlling a flow rate of the filling medium into the filling structure.

4. The method of claim 1, wherein controlling filling comprises decreasing or stopping flow of the filling medium when the monitored filling pressure exceeds the threshold pressure.

5. The method of claim 1, wherein the threshold pressure is determined based on any of a maximum systolic pressure, a maximum diastolic pressure, a maximum time averaged pressure, or any combination thereof.

6. The method of claim 1, wherein the threshold pressure is further determined based on a dimensional, mechanical and/or morphological characteristic of the aneurysm.

7. The method of claim 6, wherein the dimensional characteristic includes any of an aneurysmal wall thickness, a size of the aneurysm, a shape of the aneurysm, or any combination thereof.

8. The method of claim 1, wherein filling with the filling medium is controlled so that the monitored filling pressure stays below a pre-determined pressure increase rate.

9. The method of claim 1, further comprising:

monitoring a volume of medium injected into the filling structure; and

controlling a flow rate of the filling medium responsive to the monitored volume.

10. The method of claim 1, wherein monitoring of the filling pressure comprises monitoring of a delivery pressure of the filling medium.

11. The method of claim 1, wherein monitoring of the filling pressure comprises monitoring of a composite pressure, the composite pressure comprising any combination of a delivery pressure of the filling medium, a pressure within an internal space of the filling structure, and a pressure between an external wall of the filling structure and an inner wall of the aneurysm.

12. The method of claim 1, wherein the filling pressure is monitored using any of a gage, a pressure sensor positioned in or on the filling structure, or a filling member coupled to the filling structure.

13. The method of claim 12, wherein the pressure sensor is disposed on a catheter or a guide wire.

14. The method of claim 1, wherein a flow of the filling medium is stopped by means of a valve coupled to the filling structure or an associated filling tube coupled thereto.

15. The method of claim 14, wherein the valve is a control valve, a pressure sensitive valve, or an electronic valve.

16. The method of claim 14, wherein controlling filling comprises decreasing or stopping flow of the filling medium by sending a signal to the valve based on the monitored filling pressure.

17. The method of claim 1, wherein the support structure comprises an expandable stent.

18. The method of claim 17, wherein the expandable stent has sufficient radial strength to withstand a circumferential pressure from the at least one filling structure when filled at the threshold pressure.

19. The method of claim 1, wherein the support structure comprises an inflatable support balloon.

20. The method of claim 19, wherein the threshold pressure is further determined based on an inflation pressure of the inflatable support balloon.

21. The method of claim 19, further comprising:

controlling the inflation pressure so that the inflatable support balloon is inflated at an inflation pressure greater than the monitored filling pressure during filling.

22. The method of claim 21, wherein the filling pressure is in a range from 100 mm Hg to 1000 mm Hg and the inflation pressure is in a range from 101 mm Hg to 5000 mm Hg.

23. The method of claim 1, wherein the at least one double-walled filling structure is a first double-walled filling structure, the method further comprising:

positioning a second double-walled filling structure across the aneurysm generally adjacent to and parallel with the first double-walled filling structure;

filling the second filling structure with the fluid filling medium so that an outer wall conforms to the inside of the aneurysm and an inner wall forms a generally tubular lumen to provide for blood flow, wherein the blood flow directly contacts a surface of the inner wall, such that the first and second filling structures, in combination, substantially fill the aneurysm when filled with the fluid filling medium;

supporting the tubular lumen of the second filling structure with a support structure during filling and/or after the filling of the second filling structure;

monitoring a filling pressure of the second filling structure during filling of the second filling structure;

controlling filling of the filling medium into the second filling structure in response to the monitored filling pressure of the second filling structure based on a threshold pressure relative a blood pressure of the patient, wherein the threshold pressure is in the range of about 100 to 140% of the patient'"'"'s blood pressure;

supporting the tubular lumen of the second filling structure while the filling medium hardens, at least in part, within the second filling structure; and

removing the support structure from the second filling structure after the filling medium has hardened, at least in part.

24. The method of claim 23, wherein the first and second filling structures are filled concurrently, at least in part, or sequentially within the aneurysm.

25. The method of claim 24, wherein threshold pressure is adjusted for at least one of the first and second filling structures based on the filling pressure of the other of the first and second filling structures when the first and second filling structures are filled concurrently.