Stent graft delivery system
A system for treating an aneurysm comprises an elongate flexible shaft and an expandable member. An expandable scaffold is disposed over the expandable member and may be expanded from a collapsed configuration to an expanded configuration. A double-walled filling structure is disposed over the scaffold and has an outer wall and an inner wall. The filling structure is adapted to be filled with a hardenable fluid filing medium so that the outer wall conforms to an inside surface of the aneurysm and the inner wall forms a substantially tubular lumen to provide a path for blood flow. In the expanded configuration the scaffold engages the inner wall of the filling structure. A tether is releasably coupled with the filling structure and the flexible shaft thereby constraining axial movement of the structures relative to each other.
1. A system for treating an aneurysm in a blood vessel, the system comprising:
an elongate flexible shaft having a proximal region and a distal region;
a first double-walled filling structure disposed over the distal region of the elongate flexible shaft, the first double-walled filling structure having an outer wall and an inner wall, wherein the first double-walled filling structure is adapted to be filled with a hardenable fluid filling medium so that the outer wall conforms to an inside surface of the aneurysm and the inner wall forms a first substantially tubular lumen to provide a path for blood flow across the aneurysm;
at least a first expandable scaffold disposed at least partly within the first double-walled filling structure, the first expandable scaffold radially expandable within at least a portion of the first substantially tubular lumen of the first double-walled filling structure;
a balloon fillable with a fluid;
a pressure monitor device configured to monitor pressure during filling of the first double-walled filing structure, the pressure monitor device configured to measure a pressure transmitted through the balloon and along a fluid line to the pressure monitor device;
a filling device configured to facilitate flow of the hardenable fluid filling medium into the first double-walled filling structure via a fill tube coupling the filling device to the first double-walled filling structure and configured to facilitate filling of the first double-walled filling structure based at least in part on measurements from the pressure monitor device, the filling device including a handle that is squeezable to discharge the hardenable fluid filling medium from a reservoir into the fill tube; and
a locking mechanism that is configured to physically lock the handle to prevent actuation of the handle when the pressure exceeds a predetermined value.
2. The system of claim 1 wherein the pressure monitor device comprises a pressure measurement device in communication with an interior space of the first double-walled filling structure.
3. The system of claim 2 wherein the pressure monitor device comprises a pressure gage or pressure transducer.
4. The system of claim 2 wherein the filling device is configured such that filling is based on a pressure measurement of an interior space of the first double-walled filling structure.
5. The system of claim 1 wherein the pressure monitor device is configured to measure a pressure in between the first double-walled filling structure and the inside surface of the aneurysm.
6. The system of claim 1 wherein the balloon is positionable between the first double-walled filling structure and the inside surface of the aneurysm.
7. The system of claim 1 wherein the filling device is configured such that filling is based on a pressure measurement between the first double-walled filling structure and the inside surface of the aneurysm.
8. The system of claim 1 wherein the pressure monitor device comprises a first pressure measurement device in communication with an interior space of the first double-walled filling structure that is configured to obtain a first pressure measurement of the interior space during filling and wherein the balloon is positionable between the first double-walled filling structure and the inside surface of the aneurysm and wherein the pressure monitor device is configured to obtain a second pressure measurement of the pressure transmitted through the balloon when the balloon is positioned between the first double-walled filling structure and the inside surface of the aneurysm during filling of the first double-walled filling structure.
9. The system of claim 8 wherein the filling device is configured such that filling of the first double-walled filling structure is based on a composite pressure based on the first and second pressure measurements.
10. The system of claim 1 wherein the pressure monitor device comprises a pressure gage or pressure transducer.
11. The system of claim 10 wherein the filling device is configured such that filling of the first double-walled filling structure is based on a pressure measurement of an interior space of the first double-walled filling structure relative a preset pressure level.
12. The system of claim 1 wherein the filling device is configured such that filling of the first double-walled filling structure is based on a functional fill pressure determined from a prefill volume or pressure.
13. The system of claim 1 wherein the pressure monitor device includes a pressure relief valve to eliminate or reduce spikes in pressure during filling of the first double-walled filling structure.
14. The system of claim 1 wherein the pressure monitor device includes an electronic pressure transducer and the filling device includes a low pass filter to reduce or eliminate pressure spikes during filling of the first double-walled filling structure.
15. The system of claim 1 wherein the filling device is configured such that filling of the first double-walled filling structure is based on an average pressure measurement over a period of time so as to reduce or eliminate pressure spikes during filling.
16. The system of claim 1 wherein the filling device comprises a graphical display of pressure measurements to facilitate filling of the first double-walled filling structure.
17. The system of claim 1 wherein the pressure monitor device includes an internal flexible membrane so as to compress or absorb pressure spikes during filling of the first double-walled filling structure.
18. The system of claim 1 further comprising:
a second elongate flexible shaft having a proximal region and a distal region;
a second double-walled filling structure disposed over the distal region of the second elongate flexible shaft, the second double-walled filling structure having an outer wall and an inner wall, wherein the second double-walled filling structure is adapted to be filled with an additional hardenable fluid filling medium so that the outer wall conforms to an inside surface of the aneurysm and the inner wall forms a substantially tubular lumen to provide a path for blood flow across the aneurysm;
a second expandable scaffold disposed at least partly within the second double-walled filling structure, the second expandable scaffold radially expandable within at least a portion of the substantially tubular lumen of the second double-walled filling structure; and
a second pressure monitor device configured to monitor pressure during filling of the second double-walled filling structure;
wherein the filling device is further configured to facilitate flow of the additional hardenable fluid filling medium into the second double-walled filling structure via a second fill tube coupling the filling device to the second double-walled filling structure and is further configured to facilitate concurrent filling of the first and second double-walled filling structures based at least in part on measurements from the pressure monitor device and the second pressure monitor device.
19. The system of claim 1 , wherein the fill tube includes a distal portion with a plurality of side ports so as to facilitate breakage of hardened filling medium along where the hardenable fluid filling medium exits the fill tube to allow retraction of the fill tube after filling of the first double-walled filling structure and at least partial hardening of the hardenable fluid filling medium.
20. The system of claim 1 , wherein the fill tube includes a distal portion with a distal opening and a tapered tip to facilitate breakage of any hardened plug of the hardenable fluid filling medium formed along the distal opening of the fill tube after at least partial hardening of the hardenable fluid filling medium to allow removal of the fill tube.
21. The system of claim 1 ,
wherein a rack having teeth is coupled with the handle; and
wherein the locking mechanism is configured such that a plunger is moved to engage one of the teeth on the rack when the pressure exceeds the predetermined value.
22. The system of claim 1 ,
wherein the balloon extends around an entire circumference of the first double-walled filling structure.
23. The system of claim 1 ,
wherein at least a portion of the balloon is surrounded by the first expandable scaffold, and the balloon is expandable to radially expand the first expandable scaffold.