Apparatus and method for deployment of an endoluminal device

• US 20030163189A1
• Filed: 02/22/2002
• Published: 08/28/2003
• Est. Priority Date: 02/22/2002
• Status: Active Grant

• Current Assignee: Lifeshield Sciences LLC (Acacia Research Corporation)
• Original Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Inventors: Thompson, Richard, Johnson, Wade
• Granted Patent: US 7,004,964 B2
• Time in Patent Office: Days
• US Class Current: 623/1.11
• CPC Class Codes: A61F 2/958 Inflatable balloons for placing stents or stent-grafts

Abstract

An introducer deploys an endoluminal device in a distal location from a proximal location. The introducer comprises a retrograde portion, an anterograde portion axially moveable relative to the retrograde portion, a shaft having a distal tip and an anterograde sheath attached to the distal tip, and an inflatable balloon mounted radially outside the retrograde portion for anchoring the device during deployment from its proximal end to its distal end. The retrograde portion may comprise bilumen tubing having an external wall, an internal wall that defines a central lumen radially inward of the internal wall, and an annular lumen in fluid communication with the balloon defined between the external wall and the internal wall.

Claims

1. An introducer for deployment of an endoluminal device in a distal location from a proximal location, the introducer comprising:

a retrograde portion;

an anterograde portion, axially moveable relative to the retrograde portion, comprising a distal tip and an anterograde sheath attached proximally to the distal tip;

a shaft attached to the distal tip and extending concentrically through a central lumen defined by the anterograde portion and retrograde portion;

an endoluminal device mounted concentrically over the shaft in the central lumen and having a distal end contained by the anterograde portion and a proximal end contained by the retrograde portion; and

an inflatable balloon mounted radially outside the retrograde portion.

2. The introducer of claim 1, wherein the retrograde portion comprises bitumen tubing having an external wall, an internal wall that defines the central lumen radially inward of the internal wall, and an annular lumen defined between the external wall and the internal wall, the annular lumen in fluid communication with the balloon, the balloon located radially outward of the external wall at or near a distal end of the retrograde portion.

3. The introducer of claim 1, wherein the endoluminal device has a length and the balloon has a length that is less than the endoluminal device length.

4. The introducer of claim 1, wherein the retrograde sheath and the anterograde portion axially abut one another.

5. The introducer of claim 1, wherein the retrograde portion extends over a longer portion of the endoluminal device than the anterograde sheath.

6. The introducer of claim 1, wherein the anterograde sheath extends over a longer portion of the endoluminal device than the retrograde portion.

7. The introducer of claim 1, wherein the anterograde sheath and the retrograde portion extend over essentially equal lengths of the endoluminal device.

8. The introducer of claim 1, wherein the shaft comprises one or more radiopaque markers.

9. The introducer of claim 1 further comprising at least a first radiopaque marker that marks the proximal end of the device.

10. The introducer of claim 9 further comprising a second radiopaque marker that marks the distal end of the device.

11. The introducer of claim 1, wherein the endoluminal device comprises a stent, graft, or a combination thereof.

12. The introducer of claim 1, wherein the endoluminal device comprises a vena cava filter.

13. The introducer of claim 1, wherein the endoluminal device comprises a stent-graft for repair of an abdominal aortic aneurysm.

14. The introducer of claim 1, wherein the endoluminal device is self-expanding.

15. The introducer of claim 1, wherein the endoluminal device is adapted for deployment in a location having a sensitive area located distally of the deployment location, the anterograde portion having a length sufficiently short to prevent intrusion of the anterograde portion into the sensitive area.

16. An introducer for deployment of a self-expanding endoluminal device in a distal location from a proximal location, the introducer comprising:

a retrograde portion having a distal end and comprising coaxial bitumen tubing having an external wall, an internal wall, a balloon located radially outward of the external wall at or near the retrograde portion distal end for anchoring the endoluminal device during deployment of the device from the device proximal end to the device distal end, a retrograde central lumen defined radially inward of the internal wall, and an annular lumen defined between the external wall and the internal wall, the annular lumen in fluid communication with the balloon;

an anterograde portion comprising a distal tip, an anterograde sheath attached proximally to the distal tip, and an anterograde central lumen defined radially inward of the anterograde sheath;

an endoluminal device mounted concentrically over the shaft in the retrograde and anterograde central lumens, the device distal end contained by the anterograde portion and the device proximal end contained by the retrograde portion, the retrograde portion having a length sufficient to be engaged by the balloon against the lumen wall; and

a shaft attached to the distal tip and extending concentrically through the anterograde and retrograde central lumens, the shaft comprising at least a first radiopaque marker that marks the proximal end of the endoluminal device and adapted for moving the anterograde portion relative to the retrograde portion.

17. A method for deployment of an endoluminal device in a distal location in a body lumen from a proximal location, the method comprising the steps of:

(a) inserting an introducer into the body lumen having a lumen wall, the introducer comprising a retrograde portion, an anterograde portion comprising a distal tip and an anterograde sheath attached proximally to the distal tip, a shaft attached to the distal tip and extending concentrically through a central lumen defined by the anterograde portion and retrograde portion, an endoluminal device mounted concentrically over the shaft in the central lumen and having a distal end contained by the anterograde portion and a proximal end contained by the retrograde portion, and an inflatable balloon mounted radially outside the retrograde portion for anchoring the endoluminal device during deployment of the device;

(b) aligning the proximal end of the device in a deployment location;

(c) retracting the retrograde portion to allow a proximal portion including the proximal end of the endoluminal device to deploy;

(d) advancing the retrograde portion so that the balloon is aligned axially within the proximal portion of the device;

(e) inflating the balloon to compress the proximal portion of the endoluminal device against the lumen wall; and

(f) extending the shaft to distally advance the anterograde sheath to deploy a remaining portion of the endoluminal device.

18. The method of claim 17, wherein the introducer shaft comprises at least one radiopaque marker marking the proximal end of the device and in which step (b) comprises determining the alignment of the proximal end in the deployment location using fluoroscopy to visualize the radiopaque marker.

19. The method of claim 17, further comprising the steps of:

(g) deflating the balloon; and

(h) removing the introducer from the body lumen.

20. The method of claim 19, further comprising, prior to step (h), using the balloon to model the endoluminal device against the body lumen.

21. The method of claim 17, wherein the endoluminal device is adapted for deployment in a location having a sensitive area located distally of the deployment location, the method comprising in step (f) advancing the shaft a distance insufficient for the anterograde portion to intrude into the sensitive area.

22. The method of claim 21, wherein the endoluminal device comprises a stent, graft, or combination thereof for deployment in an aorta, and the sensitive area comprises a heart.