Heart valve prosthesis and methods of manufacture and use

12076,238

17/844032

June 19, 2022

A heart valve prosthesis is provided having a self-expanding multi-level frame that supports a valve body comprising a skirt and plurality of coapting leaflets. The frame transitions between a contracted delivery configuration that enables percutaneous transluminal delivery, and an expanded deployed configuration having an asymmetric hourglass shape. The valve body skirt and leaflets are constructed so that the center of coaptation may be selected to reduce horizontal forces applied to the commissures of the valve, and to efficiently distribute and transmit forces along the leaflets and to the frame. Alternatively, the valve body may be used as a surgically implantable replacement valve prosthesis.

MEDTRONIC CV LUXEMBOURG S.A.R.L. (Luxembourg, LU)

Medtronic CV Luxembourg S.A.R.L. (Luxembourg, LU)

1. A valve prosthesis comprising: a valve body comprising a plurality of leaflets, adjoining leaflets affixed together to form commissures; a self-expanding frame configured to radially expand from a radially contracted delivery configuration to a radially expanded deployed configuration, the self-expanding frame comprising an inflow section having a first row of cells in a circumferentially repeating pattern, the first row of cells being a proximal-most row of cells of the frame with the frame in the radially contracted delivery configuration, and an outflow section having a second row of cells in a circumferentially repeating pattern, the second row of cells being a distal-most row of cells with the frame in the radially contracted delivery configuration; and a skirt attached to the leaflets along a joint line, a first portion of the skirt being affixed to an interior surface of the frame, wherein an area of individual cells in the first row of cells is less than an area of individual cells in the second row of cells, wherein when the frame is in the radially expanded deployed configuration, an outflow section diameter of the outflow section defined by a distal edge of the second row of cells is larger than an inflow section diameter of the inflow section defined by a proximal edge of the first row of cells, and wherein the first row of cells and the second row of cells have an equal number of cells.

2. The valve prosthesis of claim 1 , wherein the frame comprises a middle region between the inflow section and the outflow section, wherein in the radially expanded deployed configuration, a middle region diameter of the middle region is smaller than the inflow section diameter.

3. The valve prosthesis of claim 1 , wherein the commissures are coupled to the frame between the first row of cells and the second row of cells.

4. The valve prosthesis of claim 1 , wherein the second row of cells includes extensions extending beyond the distal edge configured for use in loading the heart valve prosthesis into a delivery catheter.

5. The valve prosthesis of claim 4 , wherein at least one of the extensions is an eyelet.

6. The valve prosthesis of claim 5 , wherein all of the extensions are eyelets.

7. The valve prosthesis of claim 1 , wherein the skirt further comprises a plurality of end tabs affixed to the first row of cells.

8. The valve prosthesis of claim 1 , wherein the leaflets comprise porcine, bovine, equine, other mammalian pericardial tissue, synthetic material, or polymeric material.

9. The valve prosthesis of claim 1 , wherein the outflow section diameter is between 30 mm and 55 mm and the inflow section diameter is between 19 mm and 34 mm.

10. The valve prosthesis of claim 1 , wherein the frame includes a third row of cells and a fourth row of cells, the third and fourth rows of cells positioned between the first and second rows of cells.

11. The valve prosthesis of claim 1 , wherein: the proximal edge of the first row of cells defines an inflow edge of the frame; and the joint line is a curved joint line curving towards and away from the inflow edge of the frame such that a point of the curved joint line that is closest to the inflow edge of the frame is at a location within two rows of cells of the plurality of rows of cells from the inflow edge of the frame.

12. The valve prosthesis of claim 11 , wherein the skirt has a bottom edge sewn to the inflow edge of the frame.

13. The valve prosthesis of claim 11 , wherein a portion of the skirt is folded over the inflow edge of the frame.

14. The valve prosthesis of claim 13 , wherein the skirt further comprises a plurality of end tabs, wherein the end tabs are folded over the inflow edge of the frame.

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Expert report of Dr. Rodolfo Quijano, dated Jan. 9, 2009, Edwards' United Kingdom action for invalidity, Claim No. HC 08CO0934. cited by applicant
First Expert report of Prof. David Williams, dated Jan. 12, 2009, Edwards' United Kingdom action for invalidity, Claim No. HC 08CO0934. cited by applicant
First Expert report of Prof. Martin Rothman, dated Jan. 12, 2009, Edwards' United Kingdom action for invalidity, Claim No. HC 08CO0934. cited by applicant
Fourth Expert report of Prof. Martin Rothman, dated Apr. 22, 2009, Edwards' United Kingdom action for invalidity, Claim No. HC 08CO0934. cited by applicant
Second Expert report of Dr. Nigel Buller, dated Feb. 25, 2009, Edwards' United Kingdom action for invalidity, Claim No. HC 08CO0934. cited by applicant
Second Expert report of Dr. Rodolfo Quijano, dated Feb. 26, 2009, Edwards' United Kingdom action for invalidity, Claim No. HC 08CO0934. cited by applicant
Second Expert report of Prof. David Williams, dated Feb. 5, 2009, Edwards' United Kingdom action for invalidity, Claim No. HC 08CO0934. cited by applicant
Second Expert report of Prof. Martin Rothman, dated Feb. 5, 2009, Edwards' United Kingdom action for invalidity, Claim No. HC 08CO0934. cited by applicant
Third Expert report of Dr. Nigel Buller, dated Apr. 21, 2009, Edwards' United Kingdom action for invalidity, Claim No. HC 08CO0934. cited by applicant
Third Expert report of Dr. Rudolfo Quijano, dated Apr. 27, 2009, Edwards' United Kingdom action for invalidity, Claim No. HC 08CO0934. cited by applicant
Third Expert report of Prof. David Williams, dated Apr. 22, 2009, Edwards' United Kingdom action for invalidity, Claim No. HC 08CO0934. cited by applicant
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www.corevalve.com (https://web.archive.org//web/20041211102847/http://www/corevalve.com/corevalve.htm), Dec. 11, 2004. cited by applicant
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First Expert report of Professor John R. Pepper (20 pages), Corevalve, Inc. v. Edwards Lifesciences AG and Edwards Lifesciences PVT, Inc., High Court of Justice—Chancery Division Patents Court, United Kingdom, Case No. HC-07-C01243, Apr. 2008. cited by applicant
Second Expert report of Professor John R. Pepper (3 pages), Corevalve, Inc. v. Edwards Lifesciences AG and Edwards Lifesciences PVT, Inc., High Court of Justice—Chancery Division Patents Court, United Kingdom, Case No. HC-07-C01243, Jun. 2008. cited by applicant
First Expert report of Dr. Anthony C. Lunn (7 pages), Corevalve, Inc. v. Edwards Lifesciences AG and Edwards Lifesciences PVT, Inc., High Court of Justice—Chancery Division Patents Court, United Kingdom, Case No. HC-07-C01243, May 2008. cited by applicant
First Witness statement of Stanton Rowe (9 pages), Corevalve, Inc. v. Edwards Lifesciences AG and Edwards Lifesciences PVT, Inc., High Court of Justice—Chancery Division Patents Court, United Kingdom, Case No. HC-07-C01243, May 2008. cited by applicant
Second Witness statement of Stanton Rowe (3 pages), Corevalve, Inc. v. Edwards Lifesciences AG and Edwards Lifesciences PVT, Inc., High Court of Justice—Chancery Division Patents Court, United Kingdom, Case No. HC-07-C01243, Jun. 2008. cited by applicant
First Expert report of Professor Martin Terry Rothman (75 pages), Corevalve, Inc. v. Edwards Lifesciences AG and Edwards Lifesciences PVT, Inc., High Court of Justice—Chancery Division Patents Court, United Kingdom, Case No. HC-07-C01243, Jun. 2008. cited by applicant
Reply Expert report of Professor Martin Terry Rothman (9 pages), Corevalve, Inc. v. Edwards Lifesciences AG and Edwards Lifesciences PVT, Inc., High Court of Justice—Chancery Division Patents Court, United Kingdom, Case No. HC-07-C01243, Jun. 2008. cited by applicant
First Expert report of Richard A. Hillstead (41 pages), Corevalve, Inc. v. Edwards Lifesciences AG and Edwards Lifesciences PVT, Inc., High Court of Justice—Chancery Division Patents Court, United Kingdom, Case No. HC-07-C01243, Apr. 2008. cited by applicant
Reply Expert report of Richard A. Hillstead (9 pages), Corevalve, Inc. v. Edwards Lifesciences AG and Edwards Lifesciences PVT, Inc., High Court of Justice—Chancery Division Patents Court, United Kingdom, Case No. HC-07-C01243, May 2008. cited by applicant
International Search Report for PCT/US06/18514, Jan. 24, 2007. cited by applicant
PVT slides naming Alain Cribier, Martin Leon, Stan Rabinovich and Stanton Rowe (16 pages), Corevalve, Inc. v. Edwards Lifesciences AG and Edwards Lifesciences PVT, Inc., High Court of Justice—Chancery Division Patents Court, United Kingdom, Case No. HC-07-C01243, from 2000 according to First Witness Statement of Stanton Rowe. cited by applicant

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