Conformable prostheses for implanting two-piece heart valves and methods for using them

• US 8,163,014 B2
• Filed: 04/05/2010
• Issued: 04/24/2012
• Est. Priority Date: 02/28/2005
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Lane, Ernest, Drews, Michael J., Gurskis, Donnell W.
• Primary Examiner(s): Isabella, David
• Assistant Examiner(s): Ganesan, Suba
• Application Number:
  US12/754,596
• Publication Number:
  US 20100191327A1
• Time in Patent Office: 750 Days
• Field of Search: 623/2.1, 623 212- 219, 623 236- 241
• US Class Current: 623/2.4
• 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 2/2427 Devices for manipulating or deploying heart valves during implantation
• CPC Class Codes: A61F 2210/009 magnetic
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2250/006 modular
• CPC Class Codes: A61F 2250/0097 Visible markings, e.g. indicia

Abstract

A heart valve assembly includes an annular prosthesis and a valve prosthesis. The annular prosthesis includes an annular ring for dilating tissue within a biological annulus and a conformable sewing cuff extending radially from the annular member. The valve prosthesis includes a frame and a valve component. The annular ring is introduced into the biological annulus to dilate tissue surrounding the biological annulus and the sewing cuff conforms to tissue above the biological annulus. Fasteners are directed through the sewing cuff to secure the annular prosthesis to the biological annulus. The annular prosthesis may include a baleen element for biasing fabric on the annular ring outwardly to enhance sealing against the biological annulus. A valve prosthesis is then advanced into the sinus cavity, and secured relative to the annular prosthesis. The sewing cuff may enhance a seal between the valve prosthesis and annular prosthesis.

Claims

1. A prosthesis for receiving a prosthetic valve, comprising:

an annular member sized for delivery within a biological annulus, the annular member comprising a fabric covering;

a baleen element disposed radially around an outer surface of the annular member and also substantially enclosed within the fabric covering for biasing a portion of the fabric covering outwardly away from the annular member at an angle relative to a longitudinal axis of the annular member;

a sewing cuff extending radially outwardly from an upper portion of the annular member, the sewing cuff comprising a core resiliently conformable with anatomy surrounding the biological annulus and fabric covering at least a portion of the core; and

one or more connectors for engaging a valve prosthesis.

3. The prosthesis of claim 1, wherein the sewing cuff extends outwardly from an upper edge of the annular member.

4. The prosthesis of claim 1, wherein the core comprises elastomeric material.

2. A prosthesis for receiving a prosthetic valve, comprising:

an annular member sized for delivery within a biological annulus, the annular member comprising a fabric covering;

a baleen element disposed radially around an outer surface of the annular member and also substantially enclosed within the fabric covering for biasing a portion of the fabric covering outwardly away from the annular member at an angle relative to a longitudinal axis of the annular member;

a sewing cuff extending radially outwardly from the annular member, the sewing cuff comprising a core resiliently conformable with anatomy surrounding the biological annulus and fabric covering at least a portion of the core; and

one or more connectors for engaging a valve prosthesis,

wherein the sewing cuff extends from an upper edge of the annular member, and the baleen element biases the fabric covering radially outwardly along a lower edge of the annular member.