Self-expanding stent and stent delivery system for treatment of vascular stenosis

• US 20050049668A1
• Filed: 08/29/2003
• Published: 03/03/2005
• Est. Priority Date: 08/29/2003
• Status: Abandoned Application

• Current Assignee: Codman & Shurtleff Incorporated (Johnson & Johnson)
• Original Assignee: Codman & Shurtleff Incorporated (Johnson & Johnson)
• Inventors: Mitelberg, Vladimir, Jones, Donald K.
• Application Number:
  US10/651,569
• Publication Number:
  US 20050049668A1
• 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 2/82 Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents stent-grafts for tubular structures of the body other than blood vessels A61F2/04; stent-grafts for blood vessels A61F2/07; instruments specially adapted for placement or removal of stents or stent-grafts A61F2/95; for closing wounds, or holding wounds closed A61B17/04 - A61B17/115; dilators A61M29/00
• CPC Class Codes: A61F 2/848 having means for fixation to the vessel wall, e.g. barbs
• 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 2/966 with relative longitudinal movement between outer sleeve and prosthesis, e.g. using a push rod
• CPC Class Codes: A61F 2002/018 made from tubes or sheets of material, e.g. by etching or laser-cutting
• CPC Class Codes: A61F 2002/9505 having retaining means other than an outer sleeve, e.g. male-female connector between stent and instrument
• CPC Class Codes: A61F 2002/9511 the retaining means being filaments or wires
• 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 angioplasty and during 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 and an inflation lumen, said elongated catheter having 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 slidably disposed within the delivery lumen of said elongated catheter, said elongated core member including a proximal cylindrical member disposed about said elongated core member, and a distal cylindrical member disposed about said elongated core member and positioned distally of said proximal cylindrical member and being spaced apart from said proximal cylindrical member to define a gap having a predetermined length; and

,

a self-expanding stent comprised of a small diameter skeletal tubular member having a thin wall, said wall of said skeletal tubular member including a plurality of cells which are formed by a plurality of interconnected strut members, and a cylindrical anchor member placed on one of said plurality of strut members, said cylindrical anchor member having a length less than the length of the gap between the proximal cylindrical member and the distal cylindrical member, and said self-expanding stent being mounted on one of said cylindrical members such that said cylindrical anchor member is interlocked within said gap and between said proximal cylindrical member and said distal cylindrical member to thereby retain said stent on said elongated core member.

2. A self-expanding stent and stent delivery system as defined in claim 1, wherein said elongated core member takes the form of a wire.

3. A self-expanding stent and stent delivery system as defined in claim 2, wherein said skeletal tubular member includes threads formed on one of said plurality of strut members, and wherein said cylindrical anchor member takes the form of a helically wound coil, formed of radiopaque material, wound onto said threads.

4. A self-expanding stent and stent delivery system as defined in claim 2, wherein said self-expanding stent includes eight cylindrical anchor members, each cylindrical anchor member taking the form of a helically wound coil, formed of radiopaque material, wound onto threads which are formed on each one of said eight cylindrical anchor members.

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

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

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

,

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

6. A self-expanding stent and stent delivery system as defined in claim 5, 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 balloon catheter includes an inflation lumen communicating with said expandable balloon.

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

9. A self-expanding stent and stent delivery system as defined in claim 8, wherein said self-expanding stent is comprised of a small diameter skeletal tubular member having a thin wall, said wall of said skeletal tubular member including a plurality of cells which are formed by a plurality of interconnected strut members, and a cylindrical anchor member disposed about one of said plurality of strut members.

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

providing a balloon catheter comprised of an elongated catheter having a delivery lumen, said elongated catheter having a distal section and an expandable balloon mounted on the distal section of said catheter, an elongated core member disposed within the delivery lumen of said catheter, said elongated core member including a stop member extending radially outward from said elongated core member, and a self-expanding stent mounted on said elongated core member and engaging said stop member so that said self-expanding stent can be moved through said delivery lumen when said elongated core member is moved through said delivery lumen,

inserting the balloon catheter into a vessel of a patient;

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

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

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

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

,

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

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

providing a balloon catheter comprised of an elongated catheter having a delivery lumen, said elongated catheter having a distal section and an expandable balloon mounted on the distal section of said elongated catheter, an elongated core wire including a stop member extending radially outward from said elongated core wire, and a self-expanding stent comprised of a small diameter skeletal tubular member having a thin wall, said wall of said skeletal tubular member including a plurality of cells which are formed by a plurality of interconnected strut members, said self-expanding stent being mounted on said elongated core wire and engaging said stop member so that said self-expanding stent can be moved through said delivery lumen when said elongated core wire is moved through said delivery lumen;

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

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

inserting the self-expanding stent mounted on the 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;

expanding the balloon;

contracting 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 elongated core wire; and

,

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

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

providing a guidewire, a balloon catheter comprised of an elongated catheter having a delivery lumen and an inflation lumen, said elongated catheter having 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 proximal cylindrical member disposed about said elongated core member, and a distal cylindrical member disposed about said elongated core member and positioned distally of said proximal cylindrical member and being spaced apart from said proximal cylindrical member to define a gap having a predetermined length, and a self-expanding stent comprised of a small diameter skeletal tubular member having a thin wall, said wall of said skeletal tubular member including a plurality of cells which are formed by a plurality of interconnected strut members, a cylindrical anchor member being placed on one of said plurality of strut members, said cylindrical anchor member having a length less than the length of the gap between the proximal cylindrical member and the distal cylindrical member, and said self-expanding stent being mounted on one of said cylindrical members such that said cylindrical anchor member is interlocked within said gap and between said proximal cylindrical member and said distal cylindrical member to thereby retain said stent on said elongated core member;

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

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

removing the guidewire;

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

injecting a fluid into the inflation lumen of the 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 cylindrical anchor member from the gap to thereby release the self-expanding stent from the elongated core member; and

,

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