Self-expanding stent with enhanced delivery precision and stent delivery system

• US 6,695,862 B2
• Filed: 07/31/2001
• Issued: 02/24/2004
• Est. Priority Date: 05/17/1999
• Status: Expired due to Term

• Current Assignee: Advanced Cardiovascular Systems Incorporated
• Original Assignee: Advanced Cardiovascular Systems Incorporated
• Inventors: Harrison, William James, Cox, Daniel L., Schultz, Michael D., Fitz, Matthew J., Ventura, Joseph A.
• Primary Examiner(s): McDermott, Corrine
• Assistant Examiner(s): Pellegrino, Brian E
• Application Number:
  US09/919,083
• Publication Number:
  US 20020052642A1
• Time in Patent Office: 938 Days
• Field of Search: 606/191, 606/194, 606/198, 606/108, 606/192, 623/1.11, 604/103.1, 604/529, 604/523-526, 604/103.09
• US Class Current: 606/191
• CPC Class Codes: A61F 2/91 made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes
• CPC Class Codes: A61F 2/915 with bands having a meander structure, adjacent bands being connected to each other
• CPC Class Codes: A61F 2/95 Instruments specially adapted for placement or removal of stents or stent-grafts
• CPC Class Codes: A61F 2/9517 handle assemblies therefor
• CPC Class Codes: A61F 2002/91516 the meander having a change in frequency along the band
• CPC Class Codes: A61F 2002/91533 characterised by the phase between adjacent bands
• CPC Class Codes: A61F 2002/91575 connected peak to trough
• CPC Class Codes: A61F 2230/0013 Horseshoe-shaped, e.g. crescent-shaped, C-shaped, U-shaped

Abstract

The invention is directed to a self-expanding stent for implantation into a body lumen, such as an artery. The stent consists of a plurality of radially expandable cylindrical elements generally aligned on a common longitudinal stent axis and interconnected by a plurality of interconnecting members placed on the stent in a collinear arrangement such as to create at least one continuous spine which extends along the length of the stent. The invention is also directed to a stent delivery system for implantation of a stent in a vessel which includes an outer tubular member having a restraining sheath and an inner tubular member having a distal end which has a compressed stent mounted thereto. The proximal end of the inner tubular member is connected to a housing assembly which prevents the inner tubular member from moving when the outer tubular member is retracted to deploy the stent. The proximal end of the outer tubular member is attached to a pull-back handle which is slidably mounted on the base of the housing assembly. When the pull-back handle is retracted, the restraining sheath is retracted to deploy the sheath, while the inner tubular member remains stationary.

Claims

1. A stent delivery system comprising:

a delivery catheter having an inner tubular member having a region for mounting a compressed stent thereon with a tip assembly including a tip component having a tapered shape which facilitates the insertion and delivery of the delivery catheter in a patient'"'"'s body vessel attached to the mounting region and an outer tubular member having a restraining sheath overlying a portion of said inner tubular member, the outer tubular member and restraining sheath being adapted for axial movement with respect to said inner tubular member, the tip component being made from a polymeric material compounded with a radiopaque substance and including a wire coil molded into the polymeric material; and

a housing assembly having a pull-back handle slidably mounted on a base, said inner tubular member having a proximal end attached to said base and said outer tubular member having a proximal end attached to said pull-back handle wherein movement of said pull-back handle proximally retracts said restraining sheath proximally from the compressed stent on the inner tubular member, while the inner tubular member remains stationary.

2. The stent delivery system of claim 1, wherein said inner tubular member includes a guide wire lumen extending from the proximal end of the inner tubular member to the distal end of the inner tubular member.

3. The stent delivery system of claim 2, further including means for evacuating air from the delivery catheter.

4. The stent delivery system of claim 1, wherein the tip component is made from poly-ether-block amide.

5. The stent delivery system of claim 4, wherein the tip component is made from poly-ether-block amide which contains BaSO4.

6. The stent delivery system of claim 1, wherein the wire coil is molded into urethane material.

7. A stent delivery system comprising:

a delivery catheter including an inner tubular member having a lumen for receiving a guide wire and a region for mounting a compressed stent thereon and an outer tubular member adapted for axial movement with respect to the inner tubular member which includes a restraining sheath overlying at least a portion of the inner tubular member, an annular space being formed between the outer tubular member and the inner tubular member; and

a housing assembly having a pull-back handle slidably mounted on a base, the inner tubular member having a proximal end attached to the base and the outer tubular member having a proximal end attached to the pull-back handle, wherein movement of the pull-back handle proximally retracts the restraining sheath proximally from the compressed stent on the inner tubular member while the inner tubular member remains stationary, the inner tubular member including an opening in fluid communication with the annular space and the guide wire lumen, the guide wire lumen having fluid receiving opening adapted to receive a fluid that flows through the opening of the inner tubular member into the annular space and through a distal end of the restraining sheath to evacuate air from the delivery catheter.

8. The stent delivery system of claim 7, further including a tip assembly attached to the inner tubular member and having a tip component with a tapered shape which facilitates the insertion and delivery of the delivery catheter in a patient'"'"'s body vessel, the tip component being made from poly-ether-block amide.

9. The stent delivery system of claim 7, further including a tip assembly attached to the inner member and having a tip component with a tapered shape which facilitates the insertion and delivery of the delivery catheter in a patient'"'"'s body vessel, the tip component being made from a polymeric material compounded with a radiopaque substance.

10. The stent delivery system of claim 9, wherein the tip component is made from poly-ether-block amide compounded with BaSO4.

11. The stent delivery system of claim 7, wherein the one end of the inner tubular member is attached to a fitting which is connected to the housing assembly and provides an inlet to the guide wire lumen.

12. A stent delivery system comprising:

a delivery catheter having an inner tubular member having a region for mounting a compressed stent thereon with a tip assembly attached to the mounting region and an outer tubular member coaxially disposed over the inner tubular member to form an annular space between the outer tubular member and the inner tubular member, the outer tubular member being adapted for axial movement with respect to said inner tubular member, a guide wire lumen extending from a proximal end to a distal end of the inner tubular member;

a housing assembly having a pull-back handle slidably mounted on a base, said inner tubular member having a proximal end attached to the base and the outer tubular member having a proximal end attached to the pull-back handle wherein movement of the pull-back handle proximally retracts the outer tubular member proximally from the compressed stent on the inner tubular member, while the inner tubular member remains stationary; and

means for evacuating air from the delivery catheter including a fluid receiving opening located at the proximal end of the inner tubular member and an opening formed in the inner tubular member which is in fluid communication with the annular space and the guide wire lumen, wherein a fluid can be introduced into the fluid receiving opening of the inner tubular member which will flow through the opening in the inner tubular member into the annular space and through a distal end of the outer tubular member and a distal opening formed on the tip assembly.

13. A stent delivery catheter comprising:

an inner tubular member having a lumen for receiving a guide wire and a region for mounting a compressed stent thereon;

a tip assembly including a tip component having a tapered shape which facilitates the insertion and delivery of the delivery catheter in a patient'"'"'s body vessel attached distally to the mounting region, the tip component being made from a polymeric material compounded with a radiopaque substance and including a wire coil molded into the polymeric material;

an outer tubular member adapted for axial movement with respect to the inner tubular member and including a restraining sheath overlying the stent mounting region formed on the inner tubular member; and

means for moving the outer tubular member relative to the inner member while maintaining the inner tubular member in a stationary position.

14. The stent delivery system of claim 13, wherein the tip component is made from poly-ether-block amide.

15. The stent delivery system of claim 13, wherein the tip component is made from poly-ether-block amide which contains BaSO4.

16. The stent delivery system of claim 13, wherein the wire coil is molded into urethane material.