Endovascular delivery system having textile component for implant restraint and delivery

• US 8,920,481 B2
• Filed: 04/20/2009
• Issued: 12/30/2014
• Est. Priority Date: 04/20/2009
• Status: Active Grant

• Current Assignee: Medtronic Vascular, Inc. (Medtronic Plc)
• Original Assignee: Medtronic Vascular, Inc. (Medtronic Plc)
• Inventors: Stiger, Mark
• Primary Examiner(s): MCEVOY, THOMAS M
• Application Number:
  US12/426,431
• Publication Number:
  US 20100268328A1
• Time in Patent Office: 2,080 Days
• Field of Search: 623/1.11, 623/1.12, 606/108, 604/104, 604/107
• US Class Current: 623/1.11
• CPC Class Codes: A61F 2/07 Stent-grafts
• CPC Class Codes: A61F 2/95 Instruments specially adapted for placement or removal of 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

Abstract

A stent-graft delivery system is disclosed having an outer tubular shaft or sheath with a relatively stiff proximal segment and a distal segment formed from a tubular textile component. The proximal segment being formed from a polymeric tubing and having a distal end attached to a proximal end of the tubular textile component. During tracking of the delivery system through the vasculature, a self-expanding stent-graft is constrained by and within the tubular textile component in a compressed delivery configuration. Upon positioning at a treatment site, such as an aneurysm, retraction of the outer tubular shaft proximally slides the tubular textile component over the stent-graft to expose and deploy the stent-graft. The tubular textile component may be made from strands of one or more biocompatible materials that have been formed into a textile by weaving, braiding, knitting, crocheting, felting or a combination thereof.

Claims

1. A stent-graft delivery system comprising:

an outer tubular shaft having a proximal shaft segment attached to a distal shaft segment having a tubular textile component consisting of a fabric or cloth for flexibility, a distal end of the proximal shaft segment being attached to a proximal end of the tubular textile component by an attachment mechanism, wherein the proximal shaft segment is of a polymeric tubing that has a substantially greater resistance to bending than the tubular textile component and wherein the tubular textile component is non-compliant;

an inner shaft that extends through an entire length of the outer tubular shaft;

a distal tip component attached to the inner shaft,

wherein a hub component is attached to a distal segment of the tubular textile component to provide radial support thereto, the hub component having an inner diameter that is sized to receive a proximal end of the distal tip component, and

wherein the hub component includes a polymeric inner support tube and a polymeric outer support tube between which the distal segment of the tubular textile component is disposed; and

a self-expanding stent-graft positioned around a distal portion of the inner shaft and constrained by the tubular textile component in a compressed delivery configuration, wherein retraction of the outer tubular shaft proximally slides the tubular textile component over the stent-graft to expose and deploy the stent-graft.

2. The delivery system of claim 1, wherein the attachment mechanism is an adhesive.

3. The delivery system of claim 2, wherein the tubular textile component is made from a woven fabric of strands of a biocompatible polymeric material.

4. The delivery system of claim 2, wherein a circumference of the proximal end of the tubular textile component includes regularly spaced perforations that receive the adhesive for attaching the tubular textile component to the proximal shaft segment distal end.

5. The delivery system of claim 1, wherein a circumference of the distal end of the tubular textile component includes regularly spaced perforations that receive an adhesive for attaching the tubular textile component between the inner and outer support tubes of the hub component.

6. The delivery system of claim 1, further comprising:

a tubular middle member disposed within the outer tubular shaft and having a distal end proximate an end of the stent-graft held within the tubular textile component, wherein the outer tubular shaft is longitudinally slidable relative to the middle member, the inner shaft and the distal tip component to deploy the stent-graft.

7. The delivery system of claim 6, wherein the middle member acts as a proximal stop to prevent proximal migration of the stent-graft with the tubular textile component during retraction of the outer tubular shaft.

8. A stent-graft delivery system comprising:

an outer tubular shaft having a proximal shaft segment and a distal shaft segment having a tubular textile component consisting of a fabric or cloth, a distal end of the proximal shaft segment being thermally bonded to a proximal end of the tubular textile component, wherein the proximal shaft segment is of a polymeric tubing that has a substantially greater resistance to bending than the tubular textile component and the outer tubular shaft having a substantially constant outer diameter from a proximal end to a distal end thereof;

an inner shaft that extends through an entire length of the outer tubular shaft;

a distal tip component attached to the inner shaft,

wherein a hub component is attached to a distal segment of the tubular textile component to provide radial support thereto, the hub component having an inner diameter that is sized to receive a proximal end of the distal tip component, and

wherein the hub component includes a polymeric inner support tube and a polymeric outer support tube between which the distal segment of the tubular textile component is disposed; and

a self-expanding stent-graft positioned around a distal portion of the inner shaft and constrained by the tubular textile component in a compressed delivery configuration, wherein retraction of the outer tubular shaft proximally slides the tubular textile component over the stent-graft to expose and deploy the stent-graft.

9. The delivery system of claim 8, wherein the tubular textile component is made from a woven fabric of strands of a biocompatible polymeric material.

10. The delivery system of claim 8, wherein a bonding sleeve surrounds a portion of the tubular textile component proximal end which overlaps the proximal shaft segment distal end and a circumference of the proximal end of the tubular textile component includes regularly spaced perforations that allow the bonding sleeve and the proximal shaft segment distal end to join therethrough when thermally bonded.

11. The delivery system of claim 8, further comprising:

a tubular middle member coaxially disposed between the outer tubular shaft and the inner shaft and having a distal end proximate an end of the stent-graft held within the tubular textile component, wherein the middle member acts as a proximal stop to prevent proximal migration of the stent-graft with the tubular textile component during retraction of the outer tubular shaft.

12. The delivery system of claim 8, wherein a circumference of the distal end of the tubular textile component includes regularly spaced perforations that allow the inner support tube to join with the outer support tube therethrough when thermally bonded.