Delivery system for endoluminal implant

• US 20040193252A1
• Filed: 03/27/2003
• Published: 09/30/2004
• Est. Priority Date: 03/27/2003
• Status: Active Grant

• Current Assignee: Lifeport Sciences LLC (Acacia Research Corporation)
• Original Assignee: EndoVascular Technologies Incorporated (Boston Scientific Corporation)
• Inventors: Newhauser, Richard, Escano, Arnold M., Uemura, Shuji, Perez, Juan I., Lemere, Mark
• Granted Patent: US 6,984,244 B2
• Time in Patent Office: Days
• US Class Current: 623/1.23
• 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 2/89 the wire-like elements comprising two or more adjacent rings flexibly connected by separate members
• CPC Class Codes: A61F 2/954 for placing stents or stent-grafts in a bifurcation
• CPC Class Codes: A61F 2002/067 modular
• CPC Class Codes: A61F 2002/9511 the retaining means being filaments or wires
• CPC Class Codes: A61F 2002/9665 with additional retaining means
• CPC Class Codes: A61F 2220/0008 Fixation appliances for connecting prostheses to the body
• 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: A61F 2230/0054 V-shaped

Abstract

The present invention embodies delivery systems and methods for delivering modular endovascular graft devices that allow one portion of the repair device to be deployed while maintaining control of the other portions. The delivery systems are simpler to use, easier to manufacture and facilitate better packing of the repair device.

Claims

1. A system for repairing vasculature, comprising:

an elongate inner member having an inferior end and a superior end and a guide wire lumen extending therethrough;

an elongate outer member having an inferior end and a superior end, the outer member coaxially disposed over a portion of the inner member such that the inner member is longitudinally slidable within the outer member and the superior end of the outer member adapted to releasably secure a medical repair device thereto;

a medical repair device having a proximal end and a distal end, the proximal end releasably secured to the superior end of the inner member; and

a sheath having an inferior end and a superior end, the sheath coaxially disposed and longitudinally slidable over the outer member, inner member and repair device such that the sheath releasably retains the distal end of the repair device against the superior end of the outer member.

2. The system of claim 1, wherein the inner member is releasably secured to the outer member by a locking mechanism at the inferior end of the outer member.

3. The system of claim 1, further comprising a balloon inflation lumen extending through the inner member and an inflatable balloon located underneath the repair device.

4. The system of claim 3, wherein the inflatable balloon has an inflated diameter of 24 to 28 mm and a packed diameter of 0.166″

.

5. The system of claim 3, wherein the inflatable balloon has an inflated diameter of 32 mm to 34 mm and a packed diameter of 0.186″

.

6. The system of claim 1, wherein the repair device is secured to the outer member by an area of raised diameter at the superior end of the outer member, the area of raised diameter pinching the distal end of the repair device against the sheath.

7. The system of claim 1, wherein the sheath is releasably secured to the outer member by a locking mechanism at the inferior end of the sheath.

8. The system of claim 7, the outer member further comprising a stopper coaxially located thereon, the stopper adapted to be longitudinally slidable over and releasably secured to the outer member such that retraction of the sheath is limited by the stopper position.

9. The system of claim 8, the stopper and locking mechanism of the sheath further adapted to releasably secure the locking mechanism to the stopper when the sheath is retracted such that the stopper and locking mechanism may be retracted together.

10. The system of claim 1, wherein:

the repair device further comprises an attachment structure with hooks at the proximal end;

the sheath further comprises a capsule at the superior end, wherein the superior capsule isolates the sheath from the hooks of the attachment structure;

the inner member further comprises a stop ring near the superior end distal the jacket guard, wherein the attachment structure is located between the stop ring and the jacket guard; and

the sheath further comprises a capsule at the superior end, wherein the capsule covers the stent when the sheath is advanced proximally.

11. The system of claim 1, wherein the repair device is a bifurcated endovascular graft component.

12. A system for repairing vasculature, comprising:

an elongated inner member having an inferior end and a superior end and a guide wire lumen extending therethrough, the superior end having a jacket guard and a stop ring, the stop ring located distal the jacket guard;

an elongated outer member having an inferior end, a superior end and a stopper coaxially located and longitudinally slidable thereon, the stopper adapted to be releasably secured to the outer member, the outer member coaxially disposed over a portion of the inner member such that the inner member is longitudinally slidable within the outer member, the inferior end of the outer member having a locking mechanism to releasably secure the inner member to the outer member and the superior end of the outer member having an area of raised diameter;

an endovascular graft component having a proximal end and a distal end, the graft component releasably secured to the superior end of the inner member by a release wire, the proximal end having an attachment structure with hooks, the attachment structure located between the stop ring and jacket guard of the inner member;

an inflatable balloon located underneath the endovascular graft component; and

a sheath having an inferior end and a superior end, the inferior end having a locking mechanism to releasably secure the sheath to the outer member and the superior end having a capsule, the sheath coaxially disposed and longitudinally slidable over the inner member, outer member and graft component such that the distal end of the graft component is pinched between the sheath and the area of raised diameter on the outer member and the capsule covers the attachment structure at the proximal end of the graft component when the sheath is advanced proximally.

13. A system for repairing vasculature, comprising:

a medical repair device including at least one anchor having substructure;

an elongate inner member including an anchor stop ring, the anchor stop ring including a plurality of recesses sized to receive the substructure of the anchor; and

an elongate outer member including a capsule, the elongate outer member configured to slidably receive the elongate inner member and the capsule configured to receive the anchor stop ring.

14. The system of claim 13, wherein:

the outer member further comprises a mechanism to releasably secure the outer member to the inner member;

a sheath slidably disposed over the outer member, inner member and repair device; and

the sheath further comprises a mechanism to releasably secure the sheath to the outer member.

15. The system of claim 13, the anchor further including a plurality of hooks and each of the recesses of the anchor stop ring being sized to accept a portion of the substructure.

16. The system of claim 15, wherein the substructure has a profile with an enlarged cross-section at the distal end.

17. The system of claim 13, wherein the anchor is retained between the anchor stop ring and the capsule.

18. The system of claim 13, the anchor stop ring further comprising an inferior end portion configured with a cap, the cap having a rounded inferior surface and a substantially flat superior surface.

19. The system of claim 18, the anchor stop ring further comprising a tapered midsection and wherein the recesses are defined by grooves formed in a superior end portion of the anchor stop ring.

20. The system of claim 18, wherein the recesses are defined by grooves formed in an inferior part of the anchor stop ring thereby permitting the anchor stop ring to define a more rounded profile.

21. A system for repairing vasculature, comprising:

a medical repair device including at least one anchor having a plurality of hooks, the hooks housed in a structure having a cross-like profile comprising a trunk and at least one arm;

an elongate inner member including an anchor stop ring, the anchor stop ring including a plurality of recesses sized to receive a portion of an anchor hook;

an elongate outer member including a capsule, the elongate outer member configured to slidably receive the elongate inner member and having a mechanism to releasably secure the outer member to the inner member and the capsule configured to receive the anchor stop ring such that the anchor is captured between the anchor stop ring and capsule; and

a sheath slidably disposed over the outer member, inner member and repair device, the sheath having a mechanism to releasably secure the sheath to the outer member.

22. A system for delivering and deploying a modular medical repair device in vasculature, comprising:

a first catheter having an elongated inner member, an elongated outer member, a first medical repair device and a sheath, the outer member coaxially disposed over a portion of the inner member such that the inner member is longitudinally slidable within the outer member, the outer member having a superior end adapted to releasably secure the distal end of the first repair device thereto, and the sheath coaxially disposed and longitudinally slidable over the inner member, outer member and first repair device such that the sheath releasably retains the distal end of the repair device against the superior end of the outer member; and

a second catheter having an elongate inner member, an elongate outer member, and a second medical repair device, the inner member having an anchor stop ring with a plurality of recesses, the outer member configured to slidably receive the inner member and having a capsule configured to receive the anchor stop ring, the second repair device having at least one anchor with a plurality of hooks, and the anchor retained between the anchor stop ring and the capsule with a portion of the anchor retained in the recesses of the anchor stop ring.

23. The system of claim 22, wherein the first medical repair device is a modular bifurcated endovascular main graft component and the second medical repair device is an endovascular limb component.

24. A system for repairing vasculature, comprising:

an elongate inner member having an inferior end and a superior end and a guide wire lumen extending therethrough;

an elongate outer member having an inferior end and a superior end, the outer member coaxially disposed over a portion of the inner member such that the inner member is longitudinally slidable within the outer member;

a sheath coaxially disposed and longitudinally slidable over the outer member and inner member;

means for releasably securing a proximal portion of a medical repair device to the superior end of the inner member; and

means for releasably securing a distal portion of a medical repair device between the superior end of the outer member and the sheath;

wherein the system facilitates deploying the proximal portion of a medical repair device while the distal portion of the medical repair device is retained between the outer member and the sheath.

25. A method for delivering a modular bifurcated endoluminal graft component having a trunk portion, a first limb portion, and a second limb portion to a bifurcation site where a blood vessel branches into a first branched vessel and a second branched vessel, using a delivery system having an outer member, inner member, bifurcated graft component, and sheath, the outer member coaxially disposed about a portion of the inner member such that the inner member may be moved longitudinally relative to the outer member, the outer member adapted to releasably secure the outer member to the inner member and the sheath coaxially disposed over the outer member, inner member, and bifurcated graft component, comprising:

configuring the inner member to releasably secure the trunk portion of the bifurcated graft component thereto;

configuring the outer member to releasably secure the second limb portion of the bifurcated graft component between the superior end of the outer member and the sheath;

inserting the delivery system into vasculature over a guide wire;

partially retracting the sheath to deploy the trunk portion and first limb portion of the bifurcated graft component;

deploying a limb component within the first limb portion of the bifurcated graft component; and

fully retracting the sheath to deploy the second limb portion of the bifurcated graft component.

26. The method of claim 25, further comprising:

inserting a second delivery system over a guidewire; and

deploying a second limb component within the second limb portion.