Stent Graft Delivery System for Accurate Deployment

• US 20080082154A1
• Filed: 09/28/2007
• Published: 04/03/2008
• Est. Priority Date: 09/28/2006
• Status: Abandoned Application

• Current Assignee: Vascular Innovations Inc (B. Braun Holding GmbH & Co. KG)
• Original Assignee: Cook Incorporated (Cook Group Incorporated)
• Inventors: Llort, Francisco Moisef, Tseng, David
• Application Number:
  US11/864,071
• Publication Number:
  US 20080082154A1
• Time in Patent Office: Days
• US Class Current: 623/1.11
• CPC Class Codes: A61F 2/07 Stent-grafts
• CPC Class Codes: A61F 2/89 the wire-like elements comprising two or more adjacent rings flexibly connected by separate members
• CPC Class Codes: A61F 2/90 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 2/9517 handle assemblies therefor
• CPC Class Codes: A61F 2002/075 the stent being loosely attached to the graft material, e.g. by stitching
• CPC Class Codes: A61F 2002/9511 the retaining means being filaments or wires
• CPC Class Codes: A61F 2002/9665 with additional retaining means

Abstract

A delivery system for deploying a stent graft at a lesion site is provided. The delivery system comprises a wire lumen and a support stent slidably positioned about the wire lumen. The support stent is expandable from a compressed delivery configuration to an expanded configuration. An inner sheath is retractably positioned about the support stent with the support stent in the delivery configuration. An anchor stent is slidably positioned about the inner sheath. A tubular graft proximal end is coupled to the anchor stent and deployable with the anchor stent from a compressed delivery configuration to a deployed configuration. An outer sheath is retractably positioned about the anchor stent and the graft in the compressed delivery configuration.

Claims

1. A delivery system for deploying a stent graft in a body vessel, comprising:

a wire lumen;

a support stent slidably positioned about the wire lumen and having a proximal end and a distal end, the support stent expandable from a compressed delivery configuration to an expanded configuration;

an inner sheath retractably positioned about the support stent with the support stent in the delivery configuration;

an anchor stent slidably positioned about the inner sheath and having a proximal end and a distal end, the anchor stent deployable from a compressed delivery configuration to a deployed configuration,

a tubular graft having a proximal end and a distal end, the graft proximal end coupled to the anchor stent and deployable with the anchor stent from a compressed delivery configuration to a deployed configuration; and

an outer sheath retractably positioned about the anchor stent and the graft in the compressed delivery configuration.

2. The delivery system of claim 1 further comprising a support member positioned about the wire lumen, the support member having a proximal end and a distal end, where the proximal end of the support member contacts the distal end of the support stent in the delivery configuration.

3. The delivery system of claim 2 where the support member is configured to substantially maintain a position of the support stent in the body vessel as the inner sheath is retracted from about the support stent.

4. The delivery system of claim 1 further comprising an actuator operatively coupled to the anchor stent, the actuator configured to retract the outer sheath and deploy the anchor stent, and retract the inner sheath and deploy the support stent.

5. The delivery system of claim 4 further comprising:

a housing;

an outer sheath retraction tube coupled to the outer sheath slideably positioned within the housing and movable in a distal direction to retract the outer sheath and deploy the anchor stent;

a first locking element configured to lock the outer sheath retraction tube in a locked position and limit movement of the outer sheath retraction tube within the housing;

an inner sheath retraction tube slidably positioned about the outer sheath retraction tube and coupling the inner sheath to the first locking element; and

a second locking element configured to lock the inner sheath retraction tube in a locked position and limit movement of the inner sheath retraction tube relative to the outer sheath retraction tube;

where the first locking element is movable relative to the outer sheath in a distal direction to retract the inner sheath and deploy the support stent.

10. A delivery system for deploying a stent graft in a body vessel, comprising:

a wire lumen slidably positionable about a guide wire;

a support stent having a proximal end and a distal end slidably positioned about the wire lumen and expandable from a compressed delivery configuration to an expanded configuration;

an inner sheath retractably positioned about the support stent with the support stent in the compressed delivery configuration;

an anchor stent having a proximal end and a distal end slidably positioned about the inner sheath and deployable from a compressed delivery configuration to a deployed configuration;

an outer sheath retractably positioned about the anchor stent with the anchor stent in the insertion configuration; and

a handle operatively coupled to each of the inner sheath and the outer sheath.

11. The delivery system of claim 10 where the handle comprises:

a housing;

an outer sheath retraction tube coupled to the outer sheath and slideably positioned within the housing and movable in a distal direction to retract the outer sheath and deploy the anchor stent;

a first locking element configured to lock the outer sheath retraction tube in a locked position and limit movement of the outer sheath retraction tube within the housing;

an inner sheath retraction tube slidably positioned about the outer sheath retraction tube and coupling the inner sheath to the first locking element; and

a second locking element configured to lock the inner sheath retraction tube in a locked position and limit movement of the inner sheath retraction tube relative to the outer sheath retraction tube;

where the first locking element is movable relative to the outer sheath in a distal direction to retract the inner sheath and deploy the support stent.

12. The delivery system of claim 11 where each of the outer sheath retraction tube and the inner sheath retraction tube has an anti-rotational cross-sectional area.

13. The delivery system of claim 10 where the handle comprises:

a housing defining an axis and a track along at least a portion of the axis, the track including a plurality of locking grooves;

a locking element positioned about the housing and operatively coupled to the outer sheath, where, in a locked position the locking element is positioned within a first locking groove of the plurality of locking grooves to limit movement of the outer sheath and, where, in an unlocked position the first locking element is slidably movable with respect to the housing in a distal direction along the track to retract the outer sheath;

a second locking element positioned about the housing and operatively coupled to the anchor stent, where, in a locked position the second locking element positioned within a second locking groove of the plurality of locking grooves to limit movement of the anchor stent and, where, in an unlocked position the second locking element is slidably movable with respect to the housing in the distal direction along the track to deploy the anchor stent; and

a third locking element positioned about the housing and operatively coupled to the inner sheath, where, in a locked position the third locking element is positioned within a third locking groove of the plurality of locking grooves to limit movement of the inner sheath and, where, in an unlocked position the third locking element is slidably movable with respect to the housing in the distal direction along the track to retract the inner sheath and deploy the support stent.

14. The delivery system of claim 10 where the handle comprises:

a housing defining a track along at least a portion of a length of the housing;

a retraction element operatively coupled to the outer sheath, the retraction element rotatable with respect to the housing between a locked position and an unlocked position, where in the unlocked position the retraction element is slidably movable with respect to the housing in a distal direction between an initial position and a first stop position to retract the outer sheath and between the first stop position and a second stop position to retract the inner sheath.

15. The delivery system of claim 14 further comprising a first connector coupling the retraction element to the outer sheath, the first connector slidably positioned within the track.

16. The delivery system of claim 15 further comprising a second connector coupled to the inner sheath, the second connector at least partially positioned within the track and configured to interfere with the first connector as the retraction element is moved from the first stop position to the second stop position.

17. The delivery system of claim 11 where the handle comprises:

a housing defining a chamber along at least a portion of a length of the housing, at least a portion of the outer sheath and at least a portion of the inner sheath movable within the chamber;

a button coupled to the housing and operatively coupled to the outer sheath to retain the outer sheath in an insertion configuration;

a biasing element positioned within the chamber and coupled to a distal end of the housing, the biasing element biasing the outer sheath towards the distal end; and

a retracting element operatively coupled to the inner sheath and rotatable with respect to the housing between a locked position and an unlocked position, where in the unlocked position the retraction element is slidably movable with respect to the housing in a distal direction to retract the inner sheath; and

a second biasing element positioned within the chamber and coupled to the distal end of the housing, the second biasing element biasing the inner sheath towards the distal end.

18. A delivery system for deploying an endoluminal prosthesis within a body lumen at a target location, comprising:

a delivery sheath having a proximal end and a distal end and configured to retain the prosthesis within the delivery system in an unexpanded configuration at the delivery sheath distal end;

a support member having a proximal end and a distal end positioned at least partially within the delivery sheath, where the proximal end of the support member is adjacent to the distal end of the prosthesis; and

a handle configured to impart relative movement to at least one of the delivery sheath and the support member.

19. The delivery system of claim 18 where the handle is configured to simultaneously axially retract the delivery sheath in a distal direction and axially advance the support member in a proximal direction, such that the support member engages the distal end of the prosthesis and maintains the prosthesis at the target location.

20. The delivery system of claim 19, where the prosthesis is releasable during deployment from the delivery sheath along a longitudinal axis by an axial force from the support member, and where the axial force is greater than a frictional force between the delivery sheath and the prosthesis.

21. The delivery system of claim 20, where the support member is configured to move a distance within the delivery sheath, the distance determined by a foreshortening percentage of the prosthesis.

22. A delivery system comprising:

a shaft defining a guide wire passage;

a support member having a proximal end and a distal end movably coupled to the shaft, and configured to advance in a proximal direction along the shaft; and

a tubular delivery sheath configured to at least partially surround the support member and to retract in a distal direction along the shaft.

23. The delivery system of claim 22, further comprising a radially expandable prosthesis having a proximal end and a distal end, and where the support member is positioned within the delivery sheath and adjacent the distal end of the prosthesis.

24. The delivery system of claim 23 further comprising a handle configured to impart relative axial movement to the delivery sheath in a distal direction and to the support member in an opposing proximal direction substantially simultaneously, where the prosthesis decreases in length upon radial expansion, and where the support member contacts the prosthesis and maintains the proximal end of the prosthesis at a target location.

25. A delivery system for deploying a stent graft in a body vessel, comprising:

a wire lumen;

a support stent slidably positioned about the wire lumen and having a proximal end and a distal end, the support stent expandable from a compressed delivery configuration to an expanded configuration;

an inner sheath retractably positioned about the support stent with the support stent in the compressed delivery configuration;

an anchor stent slidably positioned about the inner sheath and having a proximal end and a distal end, the anchor stent deployable from a compressed insertion configuration to a deployed configuration,

a tubular graft having a proximal end and a distal end, the graft proximal end coupled to the anchor stent and deployable with the anchor stent from a compressed delivery configuration to a deployed configuration; and

an outer sheath retractably positioned about the anchor stent and the graft in the compressed delivery configuration; and

a capture mechanism operatively coupled to the proximal end of the anchor stent, the capture mechanism initially configured to retain the proximal end of the stent in a delivery configuration, the capture mechanism actuatable to release the proximal end of the anchor stent.