Deployment system for intraluminal devices

• US 6,899,727 B2
• Filed: 01/22/2001
• Issued: 05/31/2005
• Est. Priority Date: 01/22/2001
• Status: Active Grant

• Current Assignee: W. L. Gore & Associates (W.L. Gore & Associates)
• Original Assignee: Gore Enterprise Holdings Incorporated
• Inventors: Armstrong, Joseph P., Cully, Edward H., Vonesh, Michael J., Ulm, Mark J., Shaw, Edward E.
• Primary Examiner(s): McDermott, Corrine
• Assistant Examiner(s): Sweet, Thomas
• Application Number:
  US09/767,314
• Publication Number:
  US 20040073286A1
• Time in Patent Office: 1,590 Days
• Field of Search: 623/1.12, 623/1.11, 606/108
• US Class Current: 623/1.12
• CPC Class Codes: A61F 2/86 Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
• CPC Class Codes: A61F 2/95 Instruments specially adapted for placement or removal of stents or stent-grafts
• CPC Class Codes: A61F 2/9522 Means for mounting a stent or stent-graft onto or into a placement instrument
• CPC Class Codes: A61F 2/958 Inflatable balloons for placing stents or stent-grafts
• CPC Class Codes: A61F 2/97 the outer sleeve being splittable
• CPC Class Codes: A61F 2002/9511 the retaining means being filaments or wires
• CPC Class Codes: A61F 2002/9583 Means for holding the stent on the balloon, e.g. using protrusions, adhesives or an outer sleeve
• CPC Class Codes: A61F 2250/0071 breakable or frangible

Abstract

A constraining sheath for use around an endoprosthesis (e.g., a stent device, with or without a graft covering), which may be a balloon expandable endoprosthesis but more preferably is a self-expanding prosthesis. The endoprosthesis is coaxially enclosed within the constraining sheath, which is an outer, disruptable, preferably implantable tubular sheath, preferably made of ePTFE. The constraining sheath and endoprosthesis are preferably mounted together as an assembly on an angioplasty balloon for delivery. Deployment of the endoprosthesis entails inflating the angioplasty balloon to a pressure sufficient to disrupt or break the constraining sheath in a prescribed fashion, thereby allowing a self-expanding endoprosthesis to spontaneously deploy. The constraining sheath of ePTFE may be attached to the endoprosthesis and implanted along with the device, or alternatively attached to the balloon catheter shaft and removed with the balloon catheter.

Claims

1. An endoprosthesis assembly comprising:

an endoprosthesis having an outer surface and capable of being diametrically expanded from a smaller diameter to a larger diameter; and

a generally tubular constraining sheath provided coaxially around the endoprosthesis at the smaller diameter of the endoprosthesis and attached to the outer surface of the endoprosthesis, said constraining sheath being provided with means for disruption initiated by application of a distending force to the constraining sheath.

2. An endoprosthesis assembly according to claim 1 wherein the distending force results from inflation of a catheter balloon.

3. An endoprosthesis assembly according to claim 1 wherein the means for disruption comprises perforations.

4. An endoprosthesis assembly according to claim 3 wherein the perforations are oriented in at least one substantially straight line substantially parallel to a longitudinal axis of the generally tubular constraining sheath.

5. An endoprosthesis assembly according to claim 1 wherein the sheath comprises porous expanded polytetrafluoroethylene.

6. An endoprosthesis assembly according to claim 5 wherein the porous expanded polytetrafluoroethylene comprises porous expanded polytetrafluoroethylene film.

7. An endoprosthesis assembly according to claim 1 wherein the constraining sheath is implantable.

8. An endoprosthesis assembly according to claim 1 wherein said endoprosthesis comprises a stent provided with a distensible stent covering.

9. An endoprosthesis assembly according to claim 1 wherein the constraining sheath contains a therapeutic agent releasable following deployment.

10. An endoprosthesis assembly according to claim 1 wherein the constraining sheath contains a radiopaque marker.

18. An endoprosthesis assembly according to claim 1 wherein the constraining sheath is implantable.

19. An endoprosthesis assembly according to claim 1 wherein said endoprosthesis comprises a stent provided with a distensible stent covering.

20. An endoprosthests assembly according to claim 1 wherein the constraining sheath contains a radiopaque marker.

11. A constraining sheath comprising a tubular form, for use coaxially around an endoprosthesis having a first, smaller circumference intended to allow insertion into a body conduit having a luminal surface and a second, larger circumference to which it may be deployed within the body conduit to contact the luminal surface of the body conduit, said constraining sheath fitted coaxially around the endoprosthesis at the first, smaller circumference and attached to an outer surface of the endoprosthesis, said constraining sheath having means for disruption initiated by application of a distending force to the constraining sheath, wherein disruption of the constraining sheath results in deployment of the endoprosthesis to the second, larger circumference.

12. A constraining sheath according to claim 11 wherein the distending force results from inflation of the catheter balloon.

13. A constraining sheath according to claim 11 wherein the means for disruption comprises perforations.

14. A constraining sheath according to claim 13 wherein the perforations are oriented in at least one substantially straight line substantially parallel to a longitudinal axis of the generally tubular constraining sheath.

15. A constraining sheath according to claim 11 wherein the sheath comprises porous expanded polytetrafluoroethylene.

16. A constraining sheath according to claim 15 wherein the porous expanded polytetrafluoroethylene comprises porous expanded polytetrafluoroethylene film.

17. A constraining sheath according to claim 11 wherein the constraining sheath contains a therapeutic agent releasable following deployment.