Self-expanding stent and stent delivery system with distal protection

• US 20050049669A1
• Filed: 08/29/2003
• Published: 03/03/2005
• Est. Priority Date: 08/29/2003
• Status: Abandoned Application

• Current Assignee: Cordis Neurovascular, Inc. (Johnson & Johnson)
• Original Assignee: Cordis Neurovascular, Inc. (Johnson & Johnson)
• Inventors: Mitelberg, Vladimir, Jones, Donald K.
• Application Number:
  US10/651,605
• Publication Number:
  US 20050049669A1
• Time in Patent Office: Days
• US Class Current: 623/1.120
• 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 2/958 Inflatable balloons for placing 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 2002/9665 with additional retaining means
• CPC Class Codes: A61F 2230/0008 elliptical or oval
• CPC Class Codes: A61F 2230/0067 conical

Abstract

A self-expanding stent and stent delivery system are provided for treating vascular diseases such as partially occluded blood vessels within the brain. The self-expanding stent is preferably mounted on an elongated core wire including proximal, intermediate and distal cylindrical members disposed about the core wire. The proximal, intermediate, and distal cylindrical members are spaced apart such that first and second gaps are formed. The stent, which includes anchor members, is mounted on the intermediate cylindrical member such that the anchor members interlock within the gaps between the cylindrical members. The self-expanding stent and elongated core wire are disposed within a delivery lumen of a balloon catheter such that the balloon catheter compresses and constrains the stent about the intermediate cylindrical member to thereby interlock the stent onto the core wire. The elongated core wire further includes an expandable capture basket attached to the distal end of the elongated core wire in order to capture embolic debris released during the angioplasty of the blood vessel and the deployment of the self-expanding stent.

Claims

1. A self-expanding stent and stent delivery system comprising:

a balloon catheter comprised of an elongated catheter having a delivery lumen, proximal and distal sections, and an expandable balloon mounted on the distal section of said elongated catheter;

an elongated core member including a stop member extending radially outward from said elongated core member and having proximal and distal ends, said elongated core member slidably disposed within the delivery lumen of said elongated catheter;

a self-expanding stent mounted on said elongated core member and engaging said stop member so that said self-expanding stent may be moved through said delivery lumen when said elongated core member is moved through said delivery lumen; and

,

an expandable capture basket attached to the distal end of said elongated core member, said expandable capture basket serving the purpose of trapping embolic debris which may be dislodged from a diseased blood vessel during angioplasty of the blood vessel.

2. A self-expanding stent and stent delivery system as defined in claim 1, wherein said expandable capture basket is comprised of a self-expanding metallic frame and a mesh body.

3. A self-expanding stent and stent delivery system as defined in claim 2, wherein said expandable capture basket includes proximal and distal ends, said self-expanding stent includes proximal and distal ends, and said self-expanding stent is mounted on said elongated core member proximal of said expandable capture basket such that the proximal end of said capture basket is spaced apart from the distal end of said stent.

4. A self-expanding stent and stent delivery system as defined in claim 3, wherein the distance between the proximal end of said expandable capture basket and the distal end of said self-expanding stent is in a range of about one millimeter to two centimeters.

5. A self-expanding stent and stent delivery system as defined in claim 3, wherein the distance between the proximal end of said expandable capture basket and the distal end of said self-expanding stent is in a range of about five millimeters to fifteen millimeters.

6. A self-expanding stent and stent delivery system as defined in claim 3 wherein said elongated core member takes the form of a wire.

7. A self-expanding stent and stent delivery system as defined in claim 6, wherein said stop member takes the form of a cylindrical coil disposed about said elongated core member.

8. A self expanding stent and stent delivery system comprising:

a balloon catheter comprised of an elongated catheter having a delivery lumen, proximal and distal sections, and an expandable balloon mounted on the distal section of said elongated catheter;

an elongated core member having proximal and distal ends, said elongated core member slidably disposed within the delivery lumen of said elongated catheter;

a self-expanding stent mounted on said elongated core member; and

,

a self-expanding capture basket attached to the distal end of said elongated core member and spaced apart from said self-expanding stent, said self-expanding capture basket serving the purpose of trapping embolic debris which may be dislodged from a diseased blood vessel during angioplasty of the blood vessel.

9. A self-expanding stent and stent delivery system as defined in claim 8, wherein said self-expanding capture basket is comprised of a self-expanding wire frame and a mesh body.

10. A self-expanding stent and stent delivery system as defined in claim 9, wherein said elongated core member includes a stop member extending radially outward from said elongated core member, and said self-expanding stent engages with said stop member to thereby allow said self-expanding stent to be moved proximally and distally through said delivery lumen of said elongated catheter when said elongated core member is moved proximally and distally through said delivery lumen of said elongated catheter.

11. A self-expanding stent and stent delivery system comprising:

a deployment catheter having a lumen;

an elongated core member having proximal and distal ends, said elongated core member slidably disposed within the lumen of said deployment catheter;

a self-expanding stent mounted on said elongated core member such that said self-expanding stent is engaged with said elongated core member; and

,

a self-expanding capture basket attached to the distal end of said core member, said self-expanding capture basket serving the purpose of trapping embolic debris which may be dislodged from a diseased blood vessel during placement of the self-expanding stent.

12. A self-expanding stent and stent delivery system as defined in claim 11, wherein said elongated core member takes the form of a wire.

13. A self-expanding stent and stent delivery system as defined in claim 12, wherein said self-expanding capture basket is comprised of a self-expanding metallic frame and a mesh body.

14. A self-expanding stent and stent delivery system as defined in claim 13, wherein said elongated core member includes a stop member extending radially outward from said core member, said stop member aiding in engaging said self-expanding stent to said elongated core member.

15. A self-expanding stent and stent delivery system comprising:

a deployment catheter having a lumen;

an elongated core member having proximal and distal ends, said elongated core member slidably disposed within the lumen of said deployment catheter;

a self-expanding stent mounted on said elongated core member such that said self-expanding stent is engaged with said elongated core member; and

,

an expandable capture basket attached to the distal end of said elongated core member, said expandable capture basket being spaced apart from said self-expanding stent, and said expandable capture basket serving the purpose of trapping embolic debris which may be dislodged from a diseased blood vessel during placement of the self-expanding stent within the diseased blood vessel.

16. A self-expanding stent and stent delivery system as defined in claim 15, wherein the distance between said expandable capture basket and said self-expanding stent is in a range of about one millimeter to two centimeters.

17. A self-expanding stent and stent delivery system as defined in claim 15, wherein the distance between the said expandable capture basket and said self-expanding stent is in a range of about five millimeters to fifteen millimeters.

18. A self-expanding stent and stent delivery system as defined in claim 15, wherein said expandable capture basket is comprised of a self-expanding metallic frame and a mesh body.

19. A self-expanding stent and stent delivery system as defined in claim 18, wherein said elongated core member includes a stop member extending radially outward from said elongated core member, said stop member serving the purpose of engaging said self-expanding stent to said elongated core member.

20. A method of treating a stenosis comprising the steps of:

providing a balloon catheter comprised of an elongated catheter having a delivery lumen, a distal section, and an expandable balloon mounted on the distal section of said elongated catheter, an elongated core member having a distal end, a self-expanding capture basket attached to the distal end of said elongated core member, and a self-expanding stent mounted on said elongated core member and engaging said elongated core member so that said self-expanding stent may be moved through said delivery lumen when said elongated core member is moved through said delivery lumen;

inserting said balloon catheter into a vessel of a patient;

advancing said balloon catheter until the balloon catheter is positioned across a stenosis within the vessel;

inserting said self-expanding stent mounted on said elongated core member into the delivery lumen of said elongated catheter and advancing the self-expanding stent and elongated core member distally through the delivery lumen until the self-expanding stent is aligned approximate the stenosis;

expanding said balloon;

withdrawing said elongated catheter proximally to thereby allow the self-expanding capture basket and self-expanding stent to expand within the vessel;

disengaging the self-expanding stent from the elongated core member; and

,

withdrawing said balloon catheter and elongated core member from the vessel of the patient.

21. A method of treating a stenosis comprising the steps of:

providing a balloon catheter comprised of an elongated catheter having a delivery lumen, a distal section, and an expandable balloon mounted on the distal section of said elongated catheter, an elongated core wire having a distal end, a self-expanding capture basket attached to the distal end of said core wire, and a self-expanding stent mounted on said core wire and engaging said core wire so that said self-expanding stent may be moved through said delivery lumen when said core wire is moved through said delivery lumen;

inserting said balloon catheter into a blood vessel of a patient;

advancing said balloon catheter until the balloon catheter is positioned across a stenosis within the blood vessel;

inserting said self-expanding stent mounted on said elongated core wire into the delivery lumen of the elongated catheter and advancing the self-expanding stent and elongated core wire distally through the delivery lumen until the self-expanding stent is aligned with the stenosis and said capture basket has exited the delivery lumen and expanded within the blood vessel;

expanding said balloon;

contracting said balloon;

withdrawing the elongated catheter proximally to thereby allow the self-expanding stent to expand within the blood vessel;

disengaging the self-expanding stent from the core wire; and

,

withdrawing the balloon catheter and the core wire from the blood vessel of the patient.

22. A method of treating a stenosis comprising the steps of:

providing a balloon catheter comprised of an elongated catheter having a delivery lumen and an inflation lumen, said elongated catheter further including a distal section and an inflatable balloon mounted on the distal section of said elongated catheter and communicating with the inflation lumen, an elongated core member including a stop member extending radially outward from said elongated core member, a distal end, an expandable capture basket attached to the distal end of said elongated core member, and a self-expanding stent mounted on said elongated core member engaging said stop member so that said self-expanding stent may be moved through said lumen when said elongated core member is moved through said lumen;

inserting said balloon catheter into a blood vessel of a patient over a guidewire;

advancing said guidewire and said balloon catheter until the balloon catheter is positioned across a stenosis within the blood vessel;

removing said guidewire;

inserting said self-expanding stent mounted on said elongated core member into the delivery lumen of the elongated catheter;

advancing the self-expanding stent and elongated core member distally through the delivery lumen until the self-expanding stent is aligned approximate the stenosis and the capture basket has exited the delivery lumen and expanded within the blood vessel;

injecting a fluid into the inflation lumen of said elongated catheter to thereby inflate the balloon;

removing the fluid from within the inflation lumen to thereby deflate the balloon;

withdrawing the elongated catheter proximally to thereby allow the self-expanding stent to expand within the blood vessel;

disengaging the self-expanding stent from the core member;

retracting the elongated core member so that the capture basket collapses within the delivery lumen; and

,

withdrawing the balloon catheter and the core member from the blood vessel of the patient.

23. A method of treating a stenosis comprising the steps of:

providing a deployment catheter having a lumen, an elongated core member having a distal end, a self-expanding capture basket attached to the distal end of said core member, and a self-expanding stent mounted on said elongated core member and engaging said elongated core member so that said self-expanding stent may be moved through said lumen when said elongated core member is moved through said lumen;

inserting said deployment catheter into a vessel of a patient;

advancing said deployment catheter until the deployment catheter is positioned across a stenosis within the vessel;

inserting said self-expanding stent mounted on said elongated core member into the lumen of said deployment catheter and advancing the self-expanding stent and elongated core member distally through the lumen until the self-expanding stent is aligned with the stenosis;

withdrawing said deployment catheter proximally to thereby allow the self-expanding capture basket and self-expanding stent to expand within the vessel;

disengaging the self-expanding stent from the elongated core member; and

,

withdrawing said deployment catheter and elongated core member from the vessel of the patient.

24. A method of treating a stenosis comprising the steps of:

providing a deployment catheter having a lumen, an elongated core wire having a distal end, a self-expanding capture basket attached to the distal end of said core wire, and a self-expanding stent mounted on said core wire and engaging the core wire so that said self-expanding stent may be moved through the lumen of the deployment catheter when the core wire is moved through said lumen;

inserting said deployment catheter into a blood vessel of a patient;

advancing said deployment catheter until the deployment catheter is positioned across a stenosis within the blood vessel;

inserting said self-expanding stent mounted on the elongated core wire into the lumen of the deployment catheter;

advancing the self-expanding stent and elongated core wire distally through the lumen until the self-expanding stent is aligned approximate the stenosis and the capture basket has exited the lumen and expanded within the blood vessel;

withdrawing the deployment catheter proximally to thereby allow the self-expanding stent to expand within the blood vessel;

disengaging the self-expanding stent from the core wire; and

,

withdrawing the deployment catheter and the core wire from the blood vessel of the patient.

25. A method of treating a stenosis comprising the steps of:

providing a deployment catheter having a lumen, an elongated core member having a stop member extending radially outward from said elongated core member and a distal end, a self-expanding capture basket attached to the distal end of the core member, and a self-expanding stent mounted on said elongated core member and engaging said stop member so that said self-expanding stent may be moved through said lumen when said elongated core member is moved through said lumen;

inserting said deployment catheter into a blood vessel of a patient over a guidewire;

advancing said guidewire and said deployment catheter until the deployment catheter is positioned across a stenosis within the blood vessel;

removing said guidewire;

inserting said self-expanding stent mounted on said elongated core member into the lumen of the deployment catheter and advancing the self-expanding stent and elongated core member distally through the lumen until the self-expanding stent is aligned approximate the stenosis and the capture basket has exited the lumen and expanded within the blood vessel;

withdrawing the deployment catheter proximally to thereby allow the self-expanding stent to expand within the blood vessel;

disengaging the self-expanding stent from the core member;

retracting the elongated core member until the capture basket has collapsed into the lumen of the deployment catheter; and

,

withdrawing the deployment catheter and the elongated core member from the blood vessel of the patient.