Apparatus and methods for renal stenting

• US 8,702,744 B2
• Filed: 05/09/2005
• Issued: 04/22/2014
• Est. Priority Date: 05/09/2005
• Status: Expired due to Fees

• Current Assignee: Nexeon MedSystems, Inc.
• Original Assignee: Nexeon MedSystems, Inc.
• Inventors: Bates, Mark C.
• Primary Examiner(s): Erezo, Darwin
• Assistant Examiner(s): STRANSKY, KATRINA MARIE
• Application Number:
  US11/125,448
• Publication Number:
  US 20060253186A1
• Time in Patent Office: 3,270 Days
• Field of Search: 604/101.01, 604/103.07, 604/509, 604/35, 604/96.01, 604/101.3, 604/101.05, 604/529, 604/103.1, 606/200, 606191-198, 623/1.11, 623/1.12, 623/23.65, 623/23.7, 623/1.23, 600/424
• US Class Current: 606/192
• 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. A balloon catheter comprising:

a catheter having proximal and distal ends, including a dilatation balloon disposed on the distal end and coupled to an inflation port at the proximal end by an inflation lumen,

the catheter comprising an array of discrete dissimilarly shaped radio-opaque markers permanently affixed at the distal end, each of the markers in the array disposed equidistant from the distal end and aligned about a predetermined circumference of the catheter to facilitate determination of placement and angularity of the catheter relative to an ostium, the array of radio-opaque markers having an elliptical pattern when the catheter is fluoroscopically imaged at a first angle oblique to a longitudinal axis of the catheter, and a linear pattern when the catheter is fluoroscopically imaged at a second angle in alignment with the longitudinal axis of the catheter.

2. The balloon catheter of claim 1 further comprising a guide wire lumen.

3. The balloon catheter of claim 1 further comprising a stent configured to be deployed at the ostium.

4. The balloon catheter of claim 1 wherein the array of dissimilarly shaped radio-opaque markers is configured to facilitate longitudinal positioning of the stent relative to the ostium.

5. The balloon catheter of claim 3 further comprising an occlusion element disposed at the distal end of the catheter.

6. The balloon catheter of claim 5 wherein the occlusion element comprises a balloon, the balloon comprises a compliant material, and a proximal portion of the balloon is more rigid than a distal portion of the balloon.

7. The balloon catheter of claim 6 wherein the balloon has an asymmetric shape when deployed.

8. The balloon catheter of claim 5 further comprising an aperture in a lateral wall of the catheter that communicates with a guide wire lumen, the aperture disposed between the dilatation balloon and the occlusion element.

9. The balloon catheter of claim 6 further comprising a reinforcing matrix embedded within the proximal portion of the balloon.

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

11. The balloon catheter of claim 10 wherein the protective structure comprises an expandable mesh or plurality of longitudinally extending struts.

12. The balloon catheter of claim 1 wherein the balloon catheter is configured to be delivered through a guide catheter having an articulable distal region and a control knob for articulating the distal region.

23. The balloon catheter of claim 1, wherein the array of dissimilarly shaped radio-opaque markers is configured to facilitate rotational positioning of the catheter relative to the ostium.

24. The balloon catheter of claim 1, wherein the array provides a narrower elliptical pattern when the catheter is fluoroscopically imaged at a third angle.

13. Apparatus for treating a renal vessel in the vicinity of a renal ostium, the apparatus comprising:

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

the catheter comprising an array of discrete dissimilarly shaped radio-opaque marker segments permanently affixed at the distal end, each of the marker segments in the array disposed equidistant from the distal end and aligned about a predetermined circumference of the catheter to facilitate determination of placement and angularity of the catheter relative to the renal ostium, the array of marker segments having an elliptical pattern when the catheter is fluoroscopically imaged at a first angle oblique to a longitudinal axis of the catheter, and a linear pattern when the catheter is fluoroscopically imaged at a second angle in alignment with the longitudinal axis of the catheter.

14. The apparatus of claim 13, further comprising a selectively inflatable occlusion element disposed at a distance of between 0.2 cm and 2.5 cm from the balloon such that the occlusion element and balloon may be deployed simultaneously in a renal artery without interfering with each other.

15. The apparatus of claim 14 wherein the catheter further comprises an aperture in a lateral wall that communicates with the guide wire lumen, the aperture disposed between the balloon and the occlusion element, and the occlusion element is configured to occlude a guide wire lumen when deployed.

16. The apparatus of claim 13 wherein the array of radio-opaque marker segments is configured to facilitate longitudinal positioning of the catheter relative to the renal ostium.

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

18. The apparatus of claim 17 wherein the occlusion element has an asymmetric shape when deployed in a renal artery.

19. The apparatus of claim 17 further comprising a reinforcing matrix embedded within the proximal portion of the occlusion element.

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

21. The apparatus of claim 20 wherein the protective structure comprises an expandable mesh or plurality of longitudinally extending struts.

22. The apparatus of claim 13 further comprising a guide catheter having an articulable distal region and a control knob for articulating the distal region.

25. The apparatus of claim 13, wherein the array of radio-opaque marker segments is configured to facilitate rotational positioning of the catheter relative to the renal ostium.

26. The apparatus of claim 13, wherein the array of radio-opaque marker segments is configured to provide a narrower elliptical pattern when the catheter is fluoroscopically imaged at a third angle.