PROSTHESIS DEPLOYMENT SYSTEM FOR VASCULAR REPAIR

• US 20120123511A1
• Filed: 11/17/2010
• Published: 05/17/2012
• Est. Priority Date: 11/17/2010
• Status: Active Grant

• Current Assignee: Cook Medical Incorporated (Cook Group Incorporated)
• Original Assignee: Cook Critical Care, Inc.
• Inventors: BROWN, ELIZABETH M.
• Granted Patent: US 9,675,487 B2
• Time in Patent Office: Days
• US Class Current: 623/1.11
• 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 2/95 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 2/97 the outer sleeve being splittable
• CPC Class Codes: A61F 2002/9665 with additional retaining means

Abstract

A deployment system for vascular repair of a transected body vessel is provided. The system can include a prosthesis, an inner sheath, and an outer sheath. The inner sheath can be configured to selectively retain a first portion of the prosthesis in the compressed configuration, leaving a remaining portion of the prosthesis uncovered by the inner sheath. The outer sheath can be configured to retain the remaining portion of prosthesis in the compressed configuration and the first portion of the prosthesis within the inner sheath. The outer sheath is removable from the prosthesis to allow an expansion of the remaining portion of the prosthesis to the expanded configuration at a first opening in the transected vessel. The inner sheath is removable from the prosthesis first portion to allow an independent expansion of the first portion to the expanded configuration at a second opening in the transected vessel.

Claims

1. A deployment system for repair of a body vessel comprising:

a prosthesis having a proximal end and a distal end, and being radially movable between a compressed configuration and an expanded configuration;

an inner sheath configured to selectively retain a first portion of the prosthesis in the compressed configuration, leaving a remaining portion of the prosthesis uncovered by the splittable sheath;

an outer sheath having a lumen extending therethrough configured to receive the prosthesis in the compressed configuration, the outer sheath having a delivery position and a deployed position, where, in the delivery position, the outer sheath retains the remaining portion of prosthesis in the compressed configuration and the first portion of the prosthesis with the inner sheath, and, in the deployed position, the outer sheath is removed from the prosthesis to allow an expansion of the remaining portion of the prosthesis to the expanded configuration,

where the inner sheath is removable from the first portion of the prosthesis to allow an expansion of the first portion of the prosthesis to the expanded configuration, independent to the expansion of the remaining portion.

2. The system of claim 1, where the prosthesis comprises a tubular graft and one or more self-expanding stent structures attached to the tubular graft.

3. The system of claim 1, further comprising a proximal handle coupled to the outer sheath, and operable to provide relative movement between the outer sheath and the inner sheath.

4. The system of claim 1, where the outer sheath is axially movable relative to the prosthesis between the delivery and deployed positions.

5. The system of claim 1, where the outer sheath has a tapered distal end to facilitate insertion into an end opening of a body vessel.

6. The system of claim 1, where the outer sheath further comprises a splittable region configured to longitudinally split from the delivery position to the deployed position.

7. The system of claim 1, further comprising an inner shaft disposed within the outer sheath.

8. The system of claim 7, where the inner shaft comprises an enlarged portion configured to contact the proximal end of the prosthesis in response to axial movement of the outer sheath relative to the enlarged portion.

9. The system of claim 1, where the inner sheath is configured to split, the inner sheath comprising a proximal end and a distal end, and a handle portion attached to a proximal portion of the inner sheath, the handle portion configured to facilitate formation of a split in the inner sheath for removal from the first portion of the prosthesis after deployment within said body vessel.

10. The system of claim 9, where the handle portion comprises a length sized to extend beyond the distal end of the inner sheath.

11. The system of claim 9, where the handle portion is configured to axially split the inner sheath.

12. A method of delivering a prosthesis for intraoperative repair of a transected body vessel, comprising:

providing a deployment system including a prosthesis having a proximal end and a distal end, and being radially movable between a compressed configuration and an expanded configuration, an inner sheath configured to selectively retain a first portion of the prosthesis in the compressed configuration, leaving a remaining portion of the prosthesis uncovered by the inner sheath, an outer sheath having a lumen extending therethrough configured to receive the prosthesis in the compressed configuration, the outer sheath retaining the remaining portion of prosthesis in the compressed configuration and the first portion of the prosthesis with the inner sheath;

inserting a distal end of the outer sheath of the deployment system into a first end opening of said transected body vessel, and positioning the system so that a length of the remaining portion of the prosthesis is within a first vessel portion;

removing the outer sheath from the prosthesis to allow an expansion of the remaining portion of the prosthesis to the expanded configuration so that the remaining portion of prosthesis engages along a vessel wall of the first vessel portion;

inserting a length of the first portion of the prosthesis with the inner sheath into a second end opening of said transected body vessel; and

removing the inner sheath from the first portion of the prosthesis to allow an expansion of the first portion of the prosthesis to the expanded configuration so that the first portion engages along a vessel wall of a second vessel portion, and the prosthesis provides a fluid conduit between the first and second vessel portions of the transected body vessel.

13. The method of claim 12, where the removing the outer sheath step comprises axially moving the outer sheath relative to the prosthesis.

14. The method of claim 13, further comprising providing a blocker disposed within the lumen of the outer sheath proximal to the prosthesis, where, in response to axially moving the outer sheath relative to the blocker, the blocker contacts the proximal end of the prosthesis.

15. The method of claim 12, where the outer sheath is splittable, and the removing the outer sheath step further comprises splitting the outer sheath.

16. The method of claim 12, where the inner sheath is a splittable sheath, and the removing the inner sheath step further comprises splitting the inner sheath.

17. A deployment system for vascular repair of a transected body vessel having two vessel end openings, comprising:

a self-expanding prosthesis having a proximal end and a distal end, and being radially movable between a compressed configuration and an expanded configuration;

an inner sheath disposed around only an inner sheath portion of the prosthesis to leave a remaining portion of the prosthesis uncovered by the inner sheath, where the inner sheath is configured to selectively retain said inner sheath portion of the prosthesis in the compressed configuration; and

an outer sheath disposed around the prosthesis to retain the remaining portion of the prosthesis in the compressed configuration and to surround the inner sheath with the inner sheath portion of the prosthesis in the compressed configuration,

where a distal portion of the outer sheath is sized to fit within a first of the vessel end openings, and the outer sheath is removable from the prosthesis to allow a first expansion of the remaining portion of the prosthesis to the expanded configuration at the first of the vessel end openings of said transected body vessel,

where at least a portion of the inner sheath is sized to fit within a second of the vessel end openings, and the inner sheath is removable from the inner sheath portion of the prosthesis to allow a second expansion, independent to the first expansion, of the inner sheath portion to the expanded configuration at the second of the vessel end openings of said transected body vessel.

18. The system of claim 17, where the outer sheath is configured to be removed from the prosthesis in a first direction toward an intermediate portion of the prosthesis away from the prosthesis.

19. The system of claim 18, where the inner sheath is configured to be removed from the inner sheath portion of the prosthesis in a second direction, opposite the first direction, toward the intermediate portion of the prosthesis, whereby radial expansion of the intermediate portion of the prosthesis is subsequent to radial expansion of the proximal and distal ends of the prosthesis.

20. The system of claim 19, where the outer sheath is slidably removed from the prosthesis in the proximal direction to allow radial expansion of the distal end of the prosthesis, and the inner sheath is a splittable sheath capable of being longitudinally split in a manner to allow radial expansion of the proximal end of the prosthesis.