Systems and methods for endovascular aneurysm treatment
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.
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 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 across the aneurysm, 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 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 with the filling medium; and
monitoring aneurysm repair by monitoring at least a first pressure measured at the interior of the at least one filling structure with a pressure monitoring system during filling and/or after filling of the at least one filling structure; and
wherein monitoring aneurysm repair further comprises monitoring a second pressure between an outer surface of the at least one filling structure and a wall of the aneurysm with the pressure monitoring system during filling and/or after filling of the at least one filling structure.
2. The method of claim 1 , wherein the first pressure comprises a filling pressure of the filling medium during filling of the at least one filling structure.
3. The method of claim 2 , further comprising:
determining an increase of the pressure differential between the first pressure and the second pressure, with the pressure monitoring system.
4. The method of claim 3 , further comprising:
determining an end point of filling of the at least one filling structure with the filling medium based on the pressure increase of the monitored filling pressure.
5. The method of claim 2 , further comprising:
controlling a flow rate of the filling medium during filling of the at least one filling structure based on the monitored filling pressure.
6. The method of claim 1 , further comprising:
controlling filling of the at least one filling structure based on the first and second monitored pressure.
7. The method of claim 1 , wherein the second pressure comprises a pressure between an outer surface of the at least one filling structure and a wall of the aneurysm.
8. The method of claim 1 , further comprising:
positioning a pressure monitoring catheter, guidewire or pressure sensing member placed at an aneurysm site between the filling structure and a wall of theaneurysm.
9. The method of claim 1 , further comprising:
controlling filling of the at least one filling structure based on the first pressure.
10. The method of claim 9 , wherein controlling filling is performed automatically with a metered pump coupled with a computerized control system.
11. The method of claim 1 , further comprising:
determining an end point of filling of the at least one filling structure based on the first pressure.
12. The method of claim 11 , wherein the end point of filling is determined in response to the first pressure reaching a selected threshold pressure corresponding to an increased likelihood of dissection of the aneurysm.
13. The method of claim 12 , wherein the selected threshold pressure is determined based on a size and shape of the particular aneurysm, a patient blood pressure, a wall thickness of the aneurysm, and/or a dimensional, mechanical or morphological characteristic of the aneurysm.
14. The method of claim 1 , wherein the filling medium comprises any of: a curable two-part material, a polymer, an epoxy, and a liquid of stable form.
15. The method of claim 1 , wherein the filling medium comprises a curable medium comprising any of: a liquid, a gel, a foam, and a slurry.
16. A system for treating an aneurysm comprising:
at least one double-walled filling structure that is implantable across the aneurysm, the double-walled filling structure having an inner wall and an outer wall that are conformable so that when filled with a filling medium, the outer wall conforms to an inside of the aneurysm and the inner wall conforms forms a generally tubular lumen to provide for blood flow across the aneurysm;
an expandable support member disposed within the at least one double-walled filling structure so as to support the generally tubular lumen during filling and/or after filling of the at least one double-walled filling structure; and
a pressure monitoring system having one or more pressure sensors in fluid communication with an interior of the at least one double-walled filling structure and one or more pressure sensors disposed between an exterior of the at least one double-walled filling structure and inside surface of the aneurysm.
17. The system of claim 16 , further comprising:
a tube configured to deliver the filling medium into the at least one double-walled filling structure, wherein the tube is coupled to a controller communicatively coupled with an output of the one or more pressure sensors, the controller configured to control one or both of a flow rate and a filling pressure based on the output from the one or more pressure sensors.