Endovascular aneurysm treatment device and method

• US 20020026210A1
• Filed: 08/10/2001
• Published: 02/28/2002
• Est. Priority Date: 08/11/2000
• Status: Active Grant

• Current Assignee: Hesham M. Abdel-Gawwad
• Original Assignee: University of Louisville Research Foundation
• Inventors: Abdel-Gawwad, Hesham M.
• Granted Patent: US 6,855,154 B2
• Time in Patent Office: Days
• US Class Current: 606/194
• CPC Class Codes: A61B 17/12022 Occluding by internal devices, e.g. balloons or releasable wires plugging an opening in the wall of an organ A61B17/0057; occluders for the cervical canal A61F6/146; vas deferens occluders A61F6/20
• CPC Class Codes: A61B 17/12113 within an aneurysm
• CPC Class Codes: A61B 17/12136 Balloons
• CPC Class Codes: A61B 17/12172 having a pre-set deployed three-dimensional shape methods of manufacturing A61B2017/00526
• CPC Class Codes: A61B 17/122 Clamps or clips , e.g. for the umbilical cord for the vas deferens A61F6/206
• CPC Class Codes: A61B 2017/1205 Introduction devices
• CPC Class Codes: A61B 2017/22051 with an inflatable part, e.g. balloon, for positioning, blocking, or immobilisation A61B2017/22048, A61B2017/3486 take precedence
• CPC Class Codes: A61M 2025/0037 characterized by lumina being arranged side-by-side
• CPC Class Codes: A61M 2025/0063 having means, e.g. stylets, mandrils, rods or wires to reinforce or adjust temporarily the stiffness, column strength or pushability of catheters which are already inserted into the human body
• CPC Class Codes: A61M 2025/0076 Unidirectional valves
• CPC Class Codes: A61M 2025/0078 for fluid inflow from the body into the catheter lumen
• CPC Class Codes: A61M 2025/0681 Systems with catheter and outer tubing, e.g. sheath, sleeve or guide tube
• CPC Class Codes: A61M 2025/1079 having radio-opaque markers in the region of the balloon
• CPC Class Codes: A61M 25/003 characterized by features relating to least one lumen located at the distal part of the catheter, e.g. filters, plugs or valves catheter tips A61M25/0067
• CPC Class Codes: A61M 25/007 Side holes, e.g. their profiles or arrangements; Provisions to keep side holes unblocked
• CPC Class Codes: A61M 25/0074 Dynamic characteristics of the catheter tip, e.g. openable, closable, expandable or deformable
• CPC Class Codes: A61M 25/0082 Catheter tip comprising a tool
• CPC Class Codes: A61M 25/0147 with movable mechanical means, e.g. pull wires
• CPC Class Codes: A61M 25/10 Balloon catheters A61M25/0125 takes precedence; embolectomy A61B17/22032; retractors A61B17/02; inflatable balloons for placing stents or stent-grafts A61F2/958 ; stomach balloons for treatment of obesity A61F5/0003; oesophagal tubes A61J15/00

Abstract

An self-expanding frame is mounted on the distal end of a shaft. The frame is sized and configured so that it can be inserted into the cavity of an aneurysm. Suction is applied to the interior of the aneurysm through the shaft or through another catheter, and the wall of the aneurysm is collapsed onto the exterior surface of the frame. The frame is then collapsed upon further suction being applied to the interior of the aneurysm, which collapses the aneurysm wall with it. The frame folds down on itself, carrying with it the aneurysm wall. The frame is detachable from the shaft and can be left in the collapsed aneurysm.

Claims

1. A system useful for treating an aneurysm in a blood vessel of a mammalian patient, the aneurysm having a neck, a wall, and a cavity, comprising:

an elongated catheter having a proximal end, a distal end, and including at least one lumen extending therethrough;

a telescoping stretching rod positioned in the catheter;

at least one steering pull wire extending distally through the catheter and attached adjacent to the distal end of the catheter;

an inflatable member positioned adjacent the catheter distal end;

a one-way valve positioned adjacent the catheter distal end and in fluid communication with the at least one lumen, the one-way valve oriented to permit fluid flow into the catheter lumen;

an expandable clip releasably attached to the catheter distal end, the expandable clip having an unbiased, expanded condition and a biased, collapsed condition;

wherein when the expandable clip is positioned inside the cavity of an aneurysm and expands, when the inflatable member is inflated to substantially seal the neck of the aneurysm from the blood vessel, and when suction is applied through the catheter lumen and through the one-way valve, the aneurysm wall at least partially collapses on the expanded clip.

2. A system in accordance with claim 1, further comprising:

a flexible spring positioned adjacent the catheter distal end, the spring including a distal end, at least one steering pull wire attached to the catheter adjacent to the spring distal end.

3. A system useful for treating an aneurysm in a blood vessel of a mammalian patient, the aneurysm having a neck, a wall, and a cavity, comprising:

an elongated shaft having a proximal end, a distal end, a longitudinal direction defined between the proximal end and the distal end, and including at least one lumen extending therethrough;

a self-expanding frame positioned at the distal end of the shaft, the frame including a plurality of self-expanding sections and at least one joint, each of the plurality of self-expanding sections having an unbiased, expanded condition and a biased, collapsed condition, each of the plurality of self-expanding sections being foldable about one of the at least one joint when in a biased, collapsed condition.

4. A system in accordance with claim 3, wherein the frame includes a closed distal end, and further comprising:

a stiffening rod extending through the shaft lumen, the stiffening rod being longitudinally movable in the lumen.

5. A system in accordance with claim 3, wherein the frame sections are detachable from the elongated shaft.

6. A system in accordance with claim 3, wherein the frame sections are radially collapsible.

7. A system in accordance with claim 3, further comprising:

a stiffening rod extending through the shaft lumen, the stiffening rod being longitudinally movable in the lumen.

8. A catheter useful for accessing a vascular location adjacent to an aneurysm, comprising:

a hollow shaft including a proximal end, a distal end, a longitudinal direction defined between the proximal end and the distal end, a port in a distal portion of the shaft, and including at least one lumen extending therethrough;

an inflatable member mounted on the shaft adjacent to the shaft distal end, the inflatable member in fluid communication with the shaft at least one lumen, the inflatable member including a proximal end, a distal end, and a wall between the proximal end and the distal end which extends to the shaft so that the shaft port is directly exposed to the exterior of the balloon, the wall delimiting a central working channel.

9. A catheter in accordance with claim 8, further comprising:

a longitudinally movable steering wire extending along the shaft; and

a deflectable tube mounted at the shaft port, the steering wire attached to the deflectable tube so that when the steering wire is pulled proximally, the deflectable tube deflects laterally.

10. A catheter in accordance with claim 8, further comprising:

a suction port on a distal portion of the shaft directly exposed to the exterior of the balloon; and

a suction lumen extending through the shaft from the shaft proximal end to the suction port.

11. A catheter in accordance with claim 8, further comprising:

at least one radiopaque marker mounted immediately adjacent to the central working channel.

13. A method in accordance with claim 12, further comprising verifying complete occlusion of the neck by injection of contrast agent through multiple side holes just proximal to the balloon and simultaneously applied suction through the one-way valve at the distal end of the catheter until no inflow of the contrast is demonstrated together with deformation of the aneurysm with suction, indicating that the aneurysm neck is completely closed.

14. A method in accordance with claim 13, further comprising continuing suction with the aneurysm neck completely closed to almost completely collapse the aneurysm by creating a vacuum within the aneurysm.

15. A method in accordance with claim 12, further comprising measuring transverse and longitudinal dimensions of the aneurysm.

16. A method in accordance with claim 13, further comprising maintaining vacuum within the aneurysm with continuous suction and adhering the aneurysm wall to sides of the clip.

17. A method in accordance with claim 16, further comprising repeating the pulling step until successive segments fold and complete collapse of the aneurysm is be achieved.

18. A method in accordance with claim 12, further comprising perform a road-mapping arteriogram with measurement of the three dimensional size of the aneurysm and its neck.

19. A method in accordance with claim 12, further comprising accessing the aneurysm neck using a steerable catheter.

20. A method in accordance with claim 19, further comprising locking the distal end of the catheter in a position perpendicular to the center of the neck transverse axis.

21. A method in accordance with claim 12, further comprising inflating a balloon mounted on the distal end of a catheter with a diluted contrast to the previously measured size of the neck.

22. A method in accordance with claim 12, further comprising:

pulling a stretching bar to telescope a very distal segment of the stretching bar into the next proximal segment of the stretching bar.

12. A method of treating an aneurysm in a patient comprising the steps of:

advancing a compressed clip through the distal end of a catheter and into the aneurysm;

expanding portions of the clip inside the aneurysm;

folding a distal segment of the clip on itself together with the adjacent wall of the aneurysm as it becomes dislodged from the stretching bar.