VASCULAR IMPLANT AND DELIVERY SYSTEM

• US 20100298931A1
• Filed: 04/15/2010
• Published: 11/25/2010
• Est. Priority Date: 04/15/2009
• Status: Active Grant

• Current Assignee: Edwards Lifesciences CardiAQ LLC (Edwards Lifesciences Corporation)
• Original Assignee: Cardiaq Valve Technologies Incorporated
• Inventors: Ratz, J. Brent, Quadri, Arshad
• Granted Patent: US 8,414,644 B2
• Time in Patent Office: Days
• US Class Current: 623/2.11
• CPC Class Codes: A61F 2/0805 Implements for inserting tendons or ligaments
• CPC Class Codes: A61F 2/2409 Support rings therefor, e.g. for connecting valves to tissue annuloplasty rings A61F2/2442
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/243 Deployment by mechanical expansion
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2/2439 Expansion controlled by filaments
• 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 2002/0882 Anchor in or on top of a bone tunnel, i.e. a hole running through the entire bone
• CPC Class Codes: A61F 2002/9534 for repositioning of stents
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2220/0033 made by longitudinally pushing a protrusion into a complementary-shaped recess, e.g. held by friction fit
• 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 2230/0013 Horseshoe-shaped, e.g. crescent-shaped, C-shaped, U-shaped
• CPC Class Codes: A61F 2250/001 for adjusting a diameter

Abstract

A vascular implant for replacing a native heart valve comprises a self expanding stent supporting a valve body having leaflets. The stent preferably comprises an anchoring structure configured to prevent the implant from passing through the valve annulus. For delivery, the implant is compacted within a delivery device and secured at one end. During delivery the implant is partially released from the delivery device, and positioning of the implant is verified prior to full release. The implant can be at least partially resheathed and repositioned if desired.

Claims

1. A method of loading a device for delivering a self-expanding vascular implant, comprising:

drawing a relaxed, expanded vascular implant through an elongate form having a decreasing diameter to a load tube portion having a compacted diameter;

engaging a locking end of the implant with a locking mechanism disposed on a support tube;

advancing an outer sheath over the engaged locking end and support tube so as to capture the locking end between the sheath and support tube; and

advancing the outer sheath over the compacted implant so as to transfer the implant from within the load tube to within the outer sheath.

2. A method as in claim 1, wherein transferring the implant from within the load tube to within the outer sheath comprises further compacting the implant.

3. A vascular implant delivery device, comprising:

an elongate support tube having a distal end, a locking mechanism being disposed at or adjacent the distal end;

an elongate sheath adapted to slide over the support tube; and

a self-expanding vascular implant having a locking member;

wherein the support tube locking mechanism is configured to engage the implant locking member so as to block axial movement of the implant when the locking mechanism and locking member are engaged; and

wherein the sheath has an inner lumen sized to block the implant locking member from moving radially relative to the support tube locking mechanism sufficient to release from the support tube locking mechanism.

4. A vascular implant delivery device as in claim 3, wherein the self-expanding vascular implant remains connected to the support tube so long as the sheath extends distally past the support tube locking mechanism, and wherein the device is configured so that when the sheath is moved proximally past the support tube locking mechanism, the implant locking member moves radially out of engagement with the support tube.

5. A method of delivering a self-expanding vascular implant, comprising:

advancing the implant within a patient'"'"'s vasculature to a desired delivery location, the implant being advanced while maintained in a compacted configuration within a sheath, a first end of the implant being captured between the sheath and a support tube locking mechanism;

withdrawing the sheath proximally sufficient to enable a second end of the self-expanding implant to expand radially to a fully expanded size while the first end of the implant remains captured;

positioning the second end of the implant in a desired position and orientation while the first end of the implant remains captured; and

withdrawing the sheath proximally sufficient to release the first end of the implant.

6. A method as in claim 5, wherein if it is determined that the second end of the implant is not positioned as desired, the method additionally comprises moving the sheat distally so as to at least partially recapture the implant within the sheath, repositioning the delivery device, and again withdrawing the sheath proximally sufficient to enable the second end of the implant to expand radially.