Expandable medical device delivery system and method

• US 7,344,514 B2
• Filed: 08/17/2004
• Issued: 03/18/2008
• Est. Priority Date: 05/20/1999
• Status: Expired due to Fees

• Current Assignee: Innovational Holdings, LLC
• Original Assignee: Innovational Holdings, LLC
• Inventors: Shanley, John F.
• Primary Examiner(s): MENDEZ, MANUEL A
• Application Number:
  US10/920,856
• Publication Number:
  US 20050015135A1
• Time in Patent Office: 1,309 Days
• Field of Search: 604/96.01, 604/101.01, 604192-194, 60410102-1015, 60410201-10203, 604/915, 604/916, 604/917, 604/918, 604/919, 604/920, 604/921, 604/93.01, 604/164.01, 60416402-16409, 60410301-10314, 604/191, 623/7.7, 623 711- 774
• US Class Current: 604/96.01
• CPC Class Codes: A61F 2/856 Single tubular stent with a side portal passage
• CPC Class Codes: A61F 2/954 for placing stents or stent-grafts in a bifurcation
• CPC Class Codes: A61F 2/958 Inflatable balloons for placing stents or stent-grafts
• CPC Class Codes: A61M 2025/1056 having guide wire lumens outside the main shaft, i.e. the guide wire lumen is within or on the surface of the balloon

Abstract

A delivery system and method are provided for accurately locating, orienting, and implanting expandable tissue supporting devices at a lumen junction or bifurcation in a body lumen. For example, the system may be used to deliver a tissue supporting device to a bifurcated artery such that, on expansion, the tissue supporting device provides side ports of a specific size and geometry to accommodate bifurcations in the artery. The delivery system is capable of accurately orienting these side ports both radially and longitudinally with respect to branch lumen openings of the artery. The delivery system achieves orientation by utilizing a guide member which is positioned to extend from the side port feature of the tissue supporting device. The guide member is tracked along a guidewire which extends into the branch lumen, ultimately orienting the side port of the tissue supporting device properly at the branch lumen opening. After expansion of the tissue supporting device, the guide member-drops out of the enlarged side port and is withdrawn.

Claims

1. A method for delivering an expandable medical device to a vessel lumen, the method comprising:

providing an expandable medical device on a balloon catheter with the expandable medical device having a distal end and a proximal end, with respect to a physician;

delivering the expandable medical device to the vessel lumen;

expanding the distal end of the expandable medical device by inflating the balloon catheter with a first pressure; and

expanding the proximal end of the expandable medical device by inflating the balloon catheter with a second pressure higher than the first pressure.

2. The method of claim 1, wherein the vessel lumen is a bifurcated vessel lumen.

3. The method of claim 2, further comprising the steps of inserting a guidewire into a branch vessel of the bifurcated vessel, and removing the guidewire from the branch vessel after the expansion of the distal end of the expandable medical device and before the expansion of the proximal end of the expandable medical device.

4. The method of claim 1, further comprising removing a guidewire from the vessel after the expansion of the distal end of the expandable medical device and before the expansion of the proximal end of the expandable medical device.

5. The method of claim 1, wherein the expandable medical device distal end is configured to expand at the first pressure and the expandable medical device distal end is configured to expand at the second pressure by varying the structure of the expandable medical device struts.

6. The method of claim 1, wherein the expandable medical device is formed with a plurality of struts interconnected by ductile hinges, and wherein the ductile hinge shape differs between the distal and proximal ends of the device.

7. The method of claim 1, wherein the expandable medical device is expandable to a device having a plurality of struts, a plurality of spaces between the struts, and a side hole for accommodating a bifurcation which is larger than the spaces between the struts.

8. The method of claim 7, wherein the distal end which expands first is located distally of the side hole and the proximal end which expands second is located proximally of the side hole.

9. A system for placing an expandable medical device in a bifurcated body lumen, the system comprising:

a balloon catheter having a balloon and a catheter shaft; and

an expandable medical device mounted on the balloon, the expandable medical device having an expandable structure, a distal end, and a proximal end with respect to a physician, wherein the distal end is configured to expand at a first pressure and the second end is configured to expand at a second pressure higher than the first pressure.

10. The system of claim 9, wherein the expandable medical device is formed with a plurality of struts interconnected by ductile hinges, and wherein the ductile hinge shape differs between the distal and proximal ends of the device.

11. The system of claim 10, wherein the ductile hinges in the distal end have widths smaller than the ductile hinges in the proximal end.

12. The system of claim 9, wherein the expandable medical device is expandable to form a lumen supporting device having a plurality of struts, a plurality of spaces between the struts, and a side hole for accommodating a bifurcation which is larger than the spaces between the struts.