System and method for treating valve insufficiency or vessel dilatation

• US 9,289,282 B2
• Filed: 05/31/2012
• Issued: 03/22/2016
• Est. Priority Date: 05/31/2011
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Olson, Christopher, Rabito, Glen T., Armer, Dustin P., Hauser, David L.
• Primary Examiner(s): Sharma, Yashita
• Assistant Examiner(s): PRESTON, REBECCA STRASZHEIM
• Application Number:
  US13/485,358
• Publication Number:
  US 20120310328A1
• Time in Patent Office: 1,391 Days
• Field of Search: 623/2.38
• US Class Current: 1/1
• CPC Class Codes: A61F 2/07 Stent-grafts
• CPC Class Codes: A61F 2/2409 Support rings therefor, e.g. for connecting valves to tissue annuloplasty rings A61F2/2442
• CPC Class Codes: A61F 2/2412 with soft flexible valve members, e.g. tissue valves shaped like natural valves check valves with flexible valve members in general F16K15/14
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2433 using balloon catheter
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2/2469 with resilient valve members, e.g. conical spiral
• 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 2/91 made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes
• CPC Class Codes: A61F 2002/077 having means to fill the space between stent-graft and aneurysm wall, e.g. a sleeve
• CPC Class Codes: A61F 2002/823 Stents, different from stent-grafts, adapted to cover an aneurysm
• CPC Class Codes: A61F 2210/0061 swellable
• CPC Class Codes: A61F 2210/0085 hardenable in situ, e.g. epoxy resins
• 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 2230/0054 V-shaped
• CPC Class Codes: A61F 2250/0003 having an inflatable pocket filled with fluid, e.g. liquid or gas
• CPC Class Codes: A61F 2250/006 modular
• CPC Class Codes: A61F 2250/0069 Sealing means
• CPC Class Codes: A61F 2250/007 : O-rings

Abstract

A medical device for treating aortic insufficiency (and associated aneurysms or defects of any other vessel associated with a valve) includes a support structure, a stent, a prosthetic valve and a deflector. Generally, the support structure is configured to cooperate with the prosthetic valve to pinch the native valve therebetween and provide an anchor for the stent which extends into the aorta and supports the deflector which is positioned to abate blood flow against the aneurysm.

Claims

1. A medical device for use in a heart having a native heart valve and a vessel extending from the native heart valve, the medical device comprising:

a support structure;

a stent, separate from the support structure, configured to couple to the support structure using a plurality of retaining arms and extend from the support structure into the vessel;

a prosthetic heart valve configured for implantation in the native heart valve without a direct coupling to the support structure or the stent; and

a deflector configured to be supported by the stent and abate blood flow against the vessel;

wherein the support structure is configured to extend around the leaflets of the native heart valve and wherein the leaflets of the native heart valve are pinched between the prosthetic heart valve and the support structure after implantation.

2. The medical device of claim 1, wherein the stent has openings configured for placement adjacent arteries extending from the vessel.

3. The medical device of claim 1, wherein the deflector is configured to expand to fill at least a portion of a space defined between an external surface of the stent and the vessel.

4. The medical device of claim 3, wherein the deflector includes a foam.

5. The medical device of claim 4, wherein the foam is configured for 300% compression.

6. The medical device of claim 5, wherein a compressed diameter of the foam and stent is 8 mm or less.

7. The medical device of claim 6, wherein an uncompressed diameter of the foam and stent is 50 mm to 90 mm.

8. The medical device of claim 1, further comprising one or more mechanical clot facilitators configured for placement between the deflector and the vessel.

9. The medical device of claim 1, wherein the prosthetic heart valve is balloon-expandable.

10. The medical device of claim 1, wherein the support structure comprises an undulating ring.

11. A medical device for use in a heart having a heart valve and a vessel associated with the heart valve, the medical device comprising:

a support structure configured to engage the heart valve, the support structure comprising an undulating ring;

a stent configured to couple to the support structure and extend from the support structure into the vessel; and

a foam deflector configured to be supported by the stent and abate blood flow against the vessel, wherein an uncompressed diameter of the foam deflector and stent is 50 mm to 90 mm;

a prosthetic heart valve configured for implantation in the native heart valve wherein the prosthetic heart valve is balloon-expandable.