Percutaneous stent-graft and method for delivery thereof

• US 5,591,226 A
• Filed: 01/23/1995
• Issued: 01/07/1997
• Est. Priority Date: 01/23/1995
• Status: Expired due to Term

• Current Assignee: ADVANCED RESEARCH & TECHNOLOGY INSTITUTE, Boston Scientific Scimed (Boston Scientific Corporation), Johns Hopkins University
• Original Assignee: Indiana University Foundation, Johns Hopkins University, Schneider Electric SE
• Inventors: Johnson, Wade M., Trerotola, Scott O.
• Primary Examiner(s): Milano, Michael J.
• Application Number:
  US08/377,069
• Time in Patent Office: 715 Days
• Field of Search: 623/1, 623/12, 606/108, 606/191, 606/195, 606/198, 604/96, 604/103, 604/104
• US Class Current: 623/1.12
• CPC Class Codes: A61B 17/11 for performing anastomosis; Buttons for anastomosis
• CPC Class Codes: A61B 2017/1107 for blood vessels
• CPC Class Codes: A61F 2/064 with special features to facilitate anastomotic coupling anastomosis of natural blood vessels A61B17/11
• CPC Class Codes: A61F 2/07 Stent-grafts
• CPC Class Codes: A61F 2/848 having means for fixation to the vessel wall, e.g. barbs
• CPC Class Codes: A61F 2/90 characterised by a net-like or mesh-like structure
• CPC Class Codes: A61F 2002/072 Encapsulated stents, e.g. wire or whole stent embedded in lining
• CPC Class Codes: A61F 2002/075 the stent being loosely attached to the graft material, e.g. by stitching
• CPC Class Codes: A61F 2002/8486 provided on at least one of the ends
• CPC Class Codes: A61F 2210/0076 multilayered, e.g. laminated structures
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2220/0075 sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
• CPC Class Codes: A61M 1/3655 Arterio-venous shunts or fistulae
• CPC Class Codes: A61M 39/0247 Semi-permanent or permanent transcutaneous or percutaneous access sites to the inside of the body peritoneal dialysis catheters A61M1/285; tracheostomy devices A61M16/0465; measuring pressure within the body A61B5/03; colostomy devices A61F5/445; gastrotomy feeding tubes A61J15/0015; means for fixing a feeding tube outside of the body A61J15/0053

Abstract

A percutaneous stent-graft is disclosed for restoring blood flow between vessels. The stent-graft has a body implantable device and first and second peel-away retaining elements. Also disclosed are methods for deploying a stent-graft.

Claims

1. An apparatus comprising:

a body implantable self-expanding stent comprising a flexible tube of open weave construction having a first end and a second end, the ends being compressible into radially compressed states, the flexible tube having an elastic layer arranged along at least a portion of its length; and

first and second removable retaining elements secured to the flexible tube proximate the first and second ends, respectively, for maintaining the first and second ends of the self-expanding stent in radially compressed states until removed, wherein each retaining element is a peel-away sheath adapted for insertion into vascular access means, said peel-away sheath comprising a tubular material attached to at least two leaves, the leaves upon an application of force being adapted to tear the tubular material thereby separating the sheath into removable pieces allowing the stent to self-expand.

2. The apparatus of claim 1 wherein the leaves comprise handles to facilitate the application of the force.

3. The apparatus of claim 1 wherein the flexible tube is constructed of helical, braided strands of biocompatible material.

4. The device of claim 3 wherein the biocompatible material is selected from the group consisting of stainless steel, Elgiloy, Nitinol, and combinations thereof.

5. The device of claim 3 wherein the biocompatible material is a plastic.

6. The apparatus of claim 1 wherein the elastic layer at least partially embeds the flexible tube.

7. The apparatus of claim 1 wherein the elastic layer comprises a semi-permeable biostable material selected from the group consisting of polytetrafluoroethylene, polyester, polyurethane, and silicone.

8. The apparatus of claim 1 and further, including at least one gripping means disposed along at least a portion of the length of the flexible tube between the first and second removable retaining elements for protecting the flexible tube member.

9. The apparatus of claim 8 and further, wherein said gripping means comprises a peel-away sheath.

10. The apparatus of claim 9 and further, including a cap member for selective placement over one of the first and second ends of the flexible tube to inhibit the flow of fluid therethrough.

11. A system for delivering a percutaneous stent-graft, the system comprising:

a) a body implantable self-expanding stent comprising a flexible tube member of open weave construction having a first end and a second end, the ends being compressible into radially compressed states, the flexible tube having an elastic layer disposed along at least a portion of its length;

b) first and second removable retaining elements secured to the flexible tube proximate the first and second ends, respectively, for maintaining the first and second ends of the self-expanding stent in radially compressed states wherein the retaining elements comprise peel-away sheaths adapted for insertion into vascular access means; and

c) first and second vascular access means adapted to receive the first and second removable retaining elements, respectively, wherein the first and second vascular access means comprise peel-away sheaths.

12. The system of claim 11 wherein the peel-away sheaths comprise a tubular material attached to at least two leaves, the leaves upon an application of force being adapted to tear the tubular material thereby separating the sheath into removable pieces.

13. The system of claim 12 wherein the leaves comprise handles to facilitate the application of the force.

14. The apparatus of claim 11 and further, including at least one gripping means disposed along at least a portion of the length of the flexible tube member between the first and second removable retaining elements for protecting the flexible tube member.

15. The apparatus of claim 14 and further, wherein said gripping means comprises a peel-away sheath.

16. The apparatus of claim 15 and further, including a cap member for selective placement over one of the first and second ends of the flexible tube member to inhibit the flow of fluid therethrough.

17. A system for delivering a percutaneous stent-graft, comprising:

a) a body implantable self-expanding stent comprising a flexible tube member of open weave construction having a first end and a second end, the ends being compressible into radially compressed states, the flexible tube having an elastic layer disposed along at least a portion of its length;

b) first and second removable retaining elements secured to the flexible tube proximate the first and second ends, respectively, for maintaining the first and second ends of the self-expanding stent in radially compressed states, wherein the retaining elements comprise peel-away sheaths adapted for insertion into vascular access means;

c) at least one gripping means disposed along at least a portion of the length of the flexible tube member between the first and second removable retaining elements for protecting the flexible tube member.