US2021093473A1PendingUtilityA1

System and methods for endovascular aneurysm treatment

69
Assignee: NELLIX INCPriority: Jul 7, 2005Filed: Dec 11, 2020Published: Apr 1, 2021
Est. expiryJul 7, 2025(expired)· nominal 20-yr term from priority
A61F 2220/0058A61F 2/958A61B 17/12118A61F 2/06A61F 2250/0003A61B 17/12195A61M 2025/0002A61F 2230/005A61F 2/90A61B 17/12136A61F 2002/077A61F 2220/005A61F 2002/067A61F 2/95A61B 2017/1205A61F 2/82A61F 2230/0034A61F 2002/065A61F 2/07
69
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Claims

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

exact text as granted — not AI-modified
What is claimed is: 
     
         1 . A method for treating an aneurysm in a patient, the method comprising:
 positioning a double-walled filling structure across the aneurysm, the double-walled filling structure comprising an inner wall and an outer wall;   filling the double-walled filling structure with a filling medium so that the outer wall conforms to an inside of the aneurysm and the inner wall forms a generally tubular lumen to provide for blood flow across the aneurysm;   monitoring a first pressure at an interior of the double-walled filling structure during and/or after filling of the double-walled filling structure; and   monitoring a second pressure between an outer surface of the double-walled filling structure and a wall of the aneurism during and/or after filling of the double-walled filling structure.   
     
     
         2 . The method of  claim 1 , wherein the blood flow directly contacts a surface of the inner wall, and the double-walled filling structure substantially fills the aneurysm when filled with the filling medium. 
     
     
         3 . The method of  claim 1 , further comprising:
 supporting the tubular lumen with a support structure during and/or after filling the double-walled filling structure with the filling medium.   
     
     
         4 . The method of  claim 1 , wherein the first pressure comprises a filling pressure of the filling medium during filling of the double-walled filling structure. 
     
     
         5 . The method of  claim 4 , further comprising:
 determining a pressure differential between the first pressure and the second pressure.   
     
     
         6 . The method of  claim 5 , further comprising:
 determining an end point of filling of the double-walled filling structure with the filling medium based on the pressure differential.   
     
     
         7 . The method of  claim 4 , further comprising:
 controlling a flow rate of the filling medium during filling of the double-walled filling structure based on the filling pressure.   
     
     
         8 . The method of  claim 1 , further comprising:
 controlling filling of the double-walled filling structure based on the first and second pressure.   
     
     
         9 . The method of  claim 1 , further comprising:
 positioning a pressure monitoring catheter, guidewire or pressure sensing member placed at an aneurysm site between the double-walled filling structure and a wall of the aneurysm.   
     
     
         10 . The method of  claim 1 , further comprising:
 controlling filling of the double-walled filling structure based on the first pressure.   
     
     
         11 . The method of  claim 10 , wherein controlling filling is performed automatically with a metered pump coupled with a computerized control system. 
     
     
         12 . The method of  claim 1 , further comprising:
 determining an end point of filling of the double-walled filling structure based on the first pressure.   
     
     
         13 . The method of  claim 12 , 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. 
     
     
         14 . The method of  claim 13 , 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. 
     
     
         15 . 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. 
     
     
         16 . 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. 
     
     
         17 . A system for treating an aneurysm comprising:
 a double-walled filling structure positionable across an aneurysm, the double-walled filling structure comprising an inner wall and an outer wall, wherein the inner wall and the outer wall are configured such that when the double-walled filling structure is filled with a filling medium, the outer wall conforms to an inside of the aneurysm and the inner wall forms a generally tubular lumen to provide for blood flow across the aneurysm; and   a pressure monitoring system having first and second pressure sensors, wherein the first pressure sensor is in fluid communication with an interior of the double-walled filling structure, and the second pressure sensor is disposed on an outer surface of the double-walled filling structure.   
     
     
         18 . The system of  claim 17 , further comprising:
 an expandable support member disposed within the double-walled filling structure so as to support the generally tubular lumen during and/or after filling of the double-walled filling structure.   
     
     
         19 . The system of  claim 17 , wherein the first pressure sensor is disposed between the inner wall and the outer wall. 
     
     
         20 . The system of  claim 17 , further comprising:
 a tube configured to deliver the filling medium into the double-walled filling structure, wherein the tube is coupled to a controller communicatively coupled with an output of at least one of the first and second pressure sensors, the controller configured to control one or both of a flow rate and a filling pressure based on the output from at least one of the first and second pressure sensors.

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