Apparatus and methods for renal stenting

• US 20060253186A1
• Filed: 05/09/2005
• Published: 11/09/2006
• Est. Priority Date: 05/09/2005
• Status: Active Grant

• Current Assignee: Nexeon MedSystems, Inc.
• Original Assignee: Paragon Intellectual Properties, LLC
• Inventors: Bates, Mark C.
• Granted Patent: US 8,702,744 B2
• Time in Patent Office: Days
• US Class Current: 623/1.110
• CPC Class Codes: A61F 2/013 Distal protection devices, i.e. devices placed distally in combination with another endovascular procedure, e.g. angioplasty or stenting
• CPC Class Codes: A61F 2/95 Instruments specially adapted for placement or removal of stents or stent-grafts
• CPC Class Codes: A61F 2002/018 made from tubes or sheets of material, e.g. by etching or laser-cutting
• CPC Class Codes: A61F 2230/0006 circular
• CPC Class Codes: A61F 2230/008 paraboloidal

Abstract

The present invention provides and apparatus and methods for emboli removal and stenting within the renal arteries having a catheter system having a distal occlusion element, a stent deployment section, and an emboli removal lumen. The occlusion element is disposed at a predetermined distance from the stent deployment section specific for use in the renal artery, and is constructed to reduce the potential for perforation or jailing during stent deployment. The apparatus further includes an array of radio-opaque markers disposed on the stent delivery catheter to facilitate accurate stent deployment within a renal artery.

Claims

1. Apparatus for renal stenting comprising:

a guide catheter having proximal and distal ends, a lumen extending therebetween, and a suction port in fluid communication with the lumen;

a stent delivery catheter having proximal and distal ends, a stent deployment balloon disposed on distal end and coupled to an inflation port at the proximal end by an inflation lumen, and a stent disposed on the stent deployment balloon; and

an occlusion element disposed at a predetermined distance from the stent deployment balloon,

wherein the occlusion element and stent deployment balloon are configured to be deployed simultaneously in a renal artery without interfering with each other, and blood disposed proximal to the occlusion element may be aspirated through the lumen and suction port of the guide catheter.

2. The apparatus of claim 1 wherein the occlusion element is mounted on the stent delivery catheter and the stent delivery catheter further comprises a guide wire lumen.

3. The apparatus of claim 1 wherein the occlusion element is disposed on an elongated tube having proximal and distal ends, separate from the stent delivery catheter.

4. The apparatus of claim 3 wherein the stent delivery catheter further comprises a lumen that enables the stent delivery catheter to be advanced over the elongated tube.

5. The apparatus of claim 1 wherein the stent delivery catheter further comprises an array of dis-similiarly shaped radio-opaque markers disposed about a circumference of the catheter to facilitate positioning of the stent delivery catheter.

6. The apparatus of claim 1 wherein the occlusion element comprises a balloon.

7. The apparatus of claim 6 wherein the balloon comprises a compliant material, and a proximal portion of the balloon is more rigid than a distal portion of the balloon.

8. The apparatus of claim 7 wherein the balloon has an asymmetric shape when deployed in a renal artery.

9. The apparatus of claim 6 wherein the stent delivery catheter further comprises a guide wire lumen and an aperture in a lateral wall of the stent delivery catheter that communicates with the guide wire lumen, the aperture disposed between the stent deployment balloon and the occlusion element,

wherein the occlusion element is mounted on the stent delivery catheter and configured to occlude the guide wire lumen when deployed.

10. The apparatus of claim 7 further comprising a reinforcing matrix embedded within the proximal portion of the balloon.

11. The apparatus of claim 6 further comprising a protective structure disposed to overlie the proximal portion of the balloon when deployed.

12. The apparatus of claim 11 wherein the protective structure comprises an expandable mesh or plurality of longitudinally extending struts.

13. The apparatus of claim 1 wherein the guide catheter further comprises an articulable distal region and a control knob for articulating the distal region.

14. Apparatus for renal stenting comprising:

a guide catheter having proximal and distal ends, a lumen extending therebetween, and a suction port in fluid communication with the lumen;

a stent delivery catheter having proximal and distal ends, a stent deployment balloon disposed on distal end and coupled to an inflation port at the proximal end by an inflation lumen, and a stent disposed on the stent deployment balloon; and

a selectively inflatable occlusion balloon disposed at a predetermined distance from the stent deployment balloon such that the occlusion balloon and stent deployment balloon may be deployed simultaneously in a renal artery without interfering with each other,

wherein the guide catheter is configured so that blood disposed proximal to the occlusion balloon may be aspirated via the lumen and suction port to remove emboli released during deployment of the stent.

15. The apparatus of claim 14 wherein the occlusion balloon is mounted on the stent delivery catheter and the stent delivery catheter further comprises a guide wire lumen.

16. The apparatus of claim 15 wherein the stent delivery catheter further comprises an aperture in a lateral wall that communicates with the guide wire lumen, the aperture disposed between the stent deployment balloon and the occlusion element, and the occlusion element is configured to occlude the guide wire lumen when deployed.

17. The apparatus of claim 14 wherein the occlusion balloon is disposed on an elongated tube having proximal and distal ends, separate from the stent delivery catheter.

18. The apparatus of claim 14 wherein the stent delivery catheter further comprises an array of dis-similiarly shaped radio-opaque markers disposed about a circumference of the catheter to facilitate positioning of the stent delivery catheter.

19. The apparatus of claim 14 wherein the occlusion balloon comprises a compliant material, and a proximal portion of the balloon is more rigid than a distal portion of the balloon.

20. The apparatus of claim 19 wherein the occlusion balloon has an asymmetric shape when deployed in a renal artery.

21. The apparatus of claim 19 further comprising a reinforcing matrix embedded within the proximal portion of the occlusion balloon.

22. The apparatus of claim 14 further comprising a protective structure disposed to overlie a proximal portion of the occlusion balloon when deployed.

23. The apparatus of claim 22 wherein the protective structure comprises an expandable mesh or plurality of longitudinally extending struts.

24. The apparatus of claim 14 wherein the guide catheter further comprises an articulable distal region and a control knob for articulating the distal region.