Short sleeve stent delivery catheter and methods

• US 7,387,639 B2
• Filed: 05/18/2001
• Issued: 06/17/2008
• Est. Priority Date: 06/04/1999
• Status: Expired due to Fees

• Current Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Original Assignee: Advanced Stent Technologies Inc. (Boston Scientific Corporation)
• Inventors: Williams, Eric, Vardi, Gil M., Sagastegui, Javier, Davidson, Charles, Bourang, Henry, Fariabi, Sepehr, Patel, Udayan G.
• Primary Examiner(s): Thaler; Michael
• Application Number:
  US09/860,744
• Publication Number:
  US 20020173835A1
• Time in Patent Office: 2,587 Days
• Field of Search: 623/1.11, 623/1.23, 623/1.35, 606/108, 128/898
• US Class Current: 623/1.11
• 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

Abstract

A stent delivery catheter comprises a catheter body having a proximal end, a distal end, and a guidewire lumen extending from the distal end to at least part way between the proximal end and the distal end. A balloon is disposed over the catheter body near the distal end, and a stent is positioned over the balloon. The stent has a proximal end, a distal end, and a side opening between the proximal end and the distal end. A side sheath is coupled to the catheter body and has a proximal end, a distal end, and a guidewire lumen extending between the proximal end and the distal end. The proximal end of the side sheath is located between the proximal end of the catheter body and the balloon, and the side sheath exits out of the side opening of the stent.

Claims

1. A method for placing a stent having a side hole into a main vessel such that the side hole is aligned with an ostium of a branch vessel that extends from the main vessel, the method comprising:

providing a delivery catheter that comprises a catheter body having a proximal end, a distal end, and a guidewire lumen extending from the distal end to at least part way between the proximal end and the distal end;

a balloon disposed over the catheter body near the distal end;

a stent positioned over the balloon, the stent having a proximal end, a distal end, and a side opening between the proximal end and the distal end; and

a side sheath coupled to the catheter body, the side sheath having a proximal end, a distal end, and a guidewire lumen extending between the proximal end and the distal end, wherein the proximal end of the side sheath is located between the proximal end of the catheter body and the balloon, and wherein the side sheath exits out of the side opening of the stent;

introducing a first guiding apparatus into the main vessel until a distal end of the first guiding apparatus passes into only one vessel;

advancing the catheter over only the first guiding apparatus such that the first guiding apparatus passes through at least a portion of the delivery catheter, until the catheter is in the region of the ostium;

advancing a second guiding apparatus through at least a portion of the delivery catheter so as to provide a guiding apparatus in each vessel;

advancing the catheter over the first guiding apparatus and the second guiding apparatus until the side sheath is within the branch vessel and the side opening of the stent is aligned with an ostium of the branch vessel; and

inflating the balloon to deploy the stent.

2. A method as in claim 1, further comprising introducing a secondary main vessel guidewire into the main vessel such that a distal end of the secondary main vessel guidewire passes beyond the ostium of the branch vessel prior to inserting the catheter over the first guiding apparatus, and withdrawing the secondary main vessel guidewire prior to inflation of the balloon.

3. A method as in claim 2, further comprising advancing the catheter over the first guiding apparatus and the second guiding apparatus after the secondary main vessel guidewire has been withdrawn.

4. A method as in claim 2, wherein the catheter body is constructed of a relatively stiff material, and further comprising torquing the proximal end of the catheter body to rotate the catheter body and thereby overcome a wire cross between the first guiding apparatus and the secondary main vessel guidewire.

5. A method as in claim 1, further comprising deflating the balloon and withdrawing the catheter from the main vessel and the branch vessel.

6. The method of claim 1, wherein said first guiding apparatus and said second guiding apparatus are each a guidewire.

7. The method of claim 6, wherein said first guiding apparatus is a branch vessel guidewire.

8. The method of claim 6, wherein said second guiding apparatus is a main vessel guidewire.

9. The method of claim 8, further comprising inserting the main vessel guidewire into the catheter body guidewire lumen prior to the step of advancing the catheter over only the first guiding apparatus, and maintaining a fixed axial position of the main vessel guidewire relative to the catheter body guidewire lumen during the step of advancing the catheter over only the first guiding apparatus.

10. A method as in claim 9, wherein the primary main vessel guidewire distally extends about 1 to about 3 cm from the catheter body while the catheter is being advanced over the first guiding apparatus.

11. A method as in claim 9, wherein the catheter is advanced over the first guiding apparatus until the balloon exits a guiding catheter.

12. A method as in claim 9, wherein the catheter body guidewire lumen terminates in a side port within the catheter body at a location within about 1 cm to about 150 cm of the distal end, and further comprising routing the primary main vessel guidewire through the guidewire lumen in the catheter body until exiting through the side port.

13. A method as in claim 1, wherein the catheter body includes at least one marker and the side sheath includes at least one marker, and further comprising observing separation of the markers to indicate that the catheter body has passed beyond the ostium and the side sheath extends into the branch vessel using angiographic imaging.

14. A method for placing a stent having a side hole into a main vessel such that the side hole is aligned with an ostium of a branch vessel that extends from the main vessel, the method comprising:

providing a delivery catheter that comprises a catheter body having a proximal end, a distal end, and a guidewire lumen extending from the distal end to at least part way between the proximal end and the distal end;

a balloon disposed over the catheter body near the distal end;

a stent positioned over the balloon, the stent having a proximal end, a distal end, and a side opening between the proximal end and the distal end; and

a side sheath coupled to the catheter body, the side sheath having a proximal end, a distal end, and a guidewire lumen extending between the proximal end and the distal end, wherein the proximal end of the side sheath is located between the proximal end of the catheter body and the balloon, and wherein the side sheath exits out of the side opening of the stent;

introducing a main vessel guidewire into the main vessel until a distal end of the main vessel guidewire passes beyond the branch vessel;

introducing a branch vessel guidewire into the main vessel until a distal end of the branch vessel guidewire passes into the branch vessel;

advancing the catheter over the branch vessel guidewire and the main vessel guidewire such that the main vessel guidewire passes through the guidewire lumen of the catheter body and the branch vessel guidewire passes through the side sheath;

advancing the catheter over the main vessel guidewire and the branch vessel guidewire until the side sheath is within the branch vessel and the side opening of the stent is aligned with an ostium of the branch vessel; and

inflating the balloon to deploy the stent.

15. A method as in claim 14, further comprising introducing a secondary main vessel guidewire into the main vessel such that a distal end of the secondary main vessel guidewire passes beyond the ostium of the branch vessel prior to inserting the catheter over the branch vessel guidewire, and withdrawing the secondary main vessel guidewire prior to inflation of the balloon.

16. A method as in claim 15, further comprising further advancing the catheter over the branch vessel guidewire and the primary main vessel guidewire after the secondary main vessel guidewire has been withdrawn.

17. A method as in claim 15, wherein the catheter body is constructed of a relatively stiff material, and further comprising torquing the proximal end of the catheter body to rotate the catheter body and thereby overcome a wire cross between the branch vessel guidewire and the secondary main vessel guidewire.

18. A method as in claim 14, further comprising deflating the balloon and withdrawing the catheter from the main vessel and the branch vessel.

19. A method as in claim 14, wherein the catheter body includes at least one marker and the side sheath includes at least one marker, and further comprising observing separation of the markers to indicate that the catheter body has passed beyond the ostium and the side sheath extends into the branch vessel using angiographic imaging.

20. A method as in claim 14, wherein the primary main vessel guidewire is preloaded in the side sheath and distally extends about 1 to about 3 cm from the catheter body while the catheter is being advanced over the branch vessel guidewire.

21. A method as in claim 14, wherein the catheter is advanced over the branch vessel guidewire until the balloon exits a guiding catheter.

22. A method as in claim 14, wherein the catheter body guidewire lumen terminates in a side port within the catheter body at a location within about 1 cm to about 150 cm of the distal end, and further comprising routing the main vessel guidewire through the guidewire lumen in the catheter body until exiting through the side port.