Methods for reshaping a heart valve annulus using a tensioning implant

• US 8,956,407 B2
• Filed: 07/19/2004
• Issued: 02/17/2015
• Est. Priority Date: 09/20/2000
• Status: Active Grant

• Current Assignee: MVRx, Inc.
• Original Assignee: MVRx, Inc.
• Inventors: Macoviak, John A., Chang, Robert T., Rahdert, David A., Machold, Timothy R.
• Primary Examiner(s): PELLEGRINO, BRIAN E
• Application Number:
  US10/894,433
• Publication Number:
  US 20050055089A1
• Time in Patent Office: 3,865 Days
• Field of Search: 623/2.36, 623/2.37, 623/903, 623/904, 606/151
• US Class Current: 623/2.37
• CPC Class Codes: A61B 17/0469 Suturing instruments for use in minimally invasive surgery, e.g. endoscopic surgery
• CPC Class Codes: A61B 2017/00876 magnetic
• CPC Class Codes: A61F 2/2442 Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
• CPC Class Codes: A61F 2/2445 Annuloplasty rings in direct contact with the valve annulus
• CPC Class Codes: A61F 2/2451 Inserts in the coronary sinus for correcting the valve shape
• CPC Class Codes: A61F 2/2466 Delivery devices therefor
• CPC Class Codes: A61F 2/2487 Devices within the heart chamber, e.g. splints
• CPC Class Codes: A61F 2210/009 magnetic
• CPC Class Codes: A61F 2250/0012 for adjusting elasticity, flexibility, spring rate or mechanical tension
• CPC Class Codes: A61F 2250/0098 radio-opaque, e.g. radio-opaque markers
• CPC Class Codes: Y10S 623/904 Heart

Abstract

Implants or systems of implants apply a selected force vector or a selected combination of force vectors within or across the left atrium, which allow mitral valve leaflets to better coapt. The implants or systems of implants make possible rapid deployment, facile endovascular delivery, and full intra-atrial retrievability. The implants or systems of implants also make use of strong fluoroscopic landmarks.

Claims

1. A method for treating a mitral heart valve comprising

identifying for treatment within a left atrium inside a heart a mitral valve having an annulus, the annulus including a minor axis having a native length, the left atrium also including a great cardiac vein that courses parallel to a posterior region of the annulus above the annulus, the left atrium being separated from a right atrium by an interatrial septum,

providing an implant including a bridging implant member having a posterior implant region and an anterior implant region the implant further including a posterior implant member in the form of an anchor structure configured to be positioned in a generally perpendicular relationship with the bridging implant member and joined to the posterior implant region, and said anterior implant region joined to the bridging implant an anterior implant member defined as an anchor button;

wherein the bridging implant member is defined as a wire form structure

deploying the implant including

positioning the bridging implant member to span the left atrium above the annulus generally in a posterior-to-anterior direction,

positioning the anchor button entirely within the great cardiac vein with the posterior implant region extending into the heart through an atrial wall in the left atrium above a posterior region of the annulus, and

positioning the anchor button entirely inside the heart and solely within the right atrium with the anterior implant region extending through the interatrial septum above an anterior region of the annulus,

anchoring the posterior implant region solely to tissue inside the heart and into the great cardiac vein above the posterior region of the annulus while pulling on the anterior implant region from within the right atrium to place said wire form structure in tension within the left atrium and exert a pulling force on tissue at or near the posterior region of the annulus to draw the posterior region of the annulus inwardly toward an anterior region of the annulus and thereby shorten the annulus along the minor axis, and

anchoring the anterior implant region solely to tissue inside the heart and into the right atrium above the anterior region of the annulus to hold the tension on said wire form structure.

2. A method according to claim 1

wherein the implant comprises a suture material.

3. A method according to claim 1

wherein said anchor structure comprises a cross bar that anchors the posterior implant region solely to tissue inside the heart within the great cardiac vein.

4. A method according to claim 1

wherein said anchor structure comprises, at least in part, a radiopaque material.

5. A method according to claim 1

wherein deploying the implant includes establishing an intravascular path that extends from the right atrium through the interatrial septum into the left atrium, and wherein the implant is deployed, at least in part, through the intravascular path.

6. A method according to claim 5

wherein establishing an intravascular path includes forming a passage through the interatrial septum in or near a fossa ovalis.

7. A method according to claim 1

wherein said anchor structure comprises an expandable scaffold which, prior to deploying, is separate from the posterior implant region,

said expandable scaffold connected to posterior implant region after deploying.

8. A method according to claim 1

wherein said anchor structure is defined as a T-shaped anchor integrally joined to the posterior implant region.