Method of reshaping a heart valve annulus using an intravascular device

• US 8,784,482 B2
• Filed: 05/14/2004
• Issued: 07/22/2014
• Est. Priority Date: 09/20/2000
• Status: Expired due to Term

• Current Assignee: MVRx, Inc.
• Original Assignee: MVRx, Inc.
• Inventors: Rahdert, David A., Machold, Timothy R., Macoviak, John A., Chang, Robert T.
• Primary Examiner(s): PELLEGRINO, BRIAN E
• Application Number:
  US10/846,850
• Publication Number:
  US 20040260393A1
• Time in Patent Office: 3,721 Days
• Field of Search: 606/151, 606/213, 623/2.36, 623/2.37, 623/904, 623/1.16, 623/1.24, 623/1.26, 600/37, 128/898
• US Class Current: 623/2.36
• CPC Class Codes: A61B 17/00234 for minimally invasive surgery A61B17/0218, A61B17/0469, A61B17/12013, A61B17/1285, A61B17/29, A61B17/320016 take precedence
• CPC Class Codes: A61B 17/0401 Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors A61B17/0642 takes precedence; fixation devices for tendons or ligaments A61F2/0811
• CPC Class Codes: A61B 17/064 Surgical staples, i.e. penetrating the tissue
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61B 2017/00783 Valvuloplasty
• CPC Class Codes: A61B 2017/00876 magnetic
• CPC Class Codes: A61B 2017/0412 having anchoring barbs or pins extending outwardly from suture anchor body
• CPC Class Codes: A61B 2017/0414 having a suture-receiving opening, e.g. lateral opening lateral eyelet for attaching suture to needle A61B2017/06019
• CPC Class Codes: A61B 2017/0417 T-fasteners
• CPC Class Codes: A61B 2017/0419 H-fasteners
• CPC Class Codes: A61B 2017/0427 having anchoring barbs or pins extending outwardly from the anchor body
• CPC Class Codes: A61B 2017/0437 the barbs being resilient or spring-like
• CPC Class Codes: A61B 2017/0464 for soft tissue
• CPC Class Codes: A61B 2017/0496 for tensioning sutures
• CPC Class Codes: A61B 2017/0641 having at least three legs as part of one single body
• CPC Class Codes: A61B 2017/0647 having one single leg, e.g. tacks
• CPC Class Codes: A61F 2/2445 Annuloplasty rings in direct contact with the valve annulus
• CPC Class Codes: A61F 2002/30079 magnetic
• CPC Class Codes: A61F 2210/009 magnetic
• CPC Class Codes: Y10S 623/904 Heart

Abstract

Devices, systems, and methods employ an implant that is sized and configured to attach in, on, or near the annulus of a dysfunctional heart valve. In use, the implant extends either across the minor axis of the annulus, or across the major axis of the annulus, or both. The implant restores to the heart valve annulus and leaflets a more functional anatomic shape and tension. The more functional anatomic shape and tension are conducive to coaptation of the leaflets, which, in turn, reduces retrograde flow or regurgitation.

Claims

1. A method comprising

identifying for treatment a heart having a right atrium and a left atrium separated by an interatrial septum, the left atrium including a mitral valve having an annulus with a minor axis with a native length extending along an annular plane in a posterior-to-anterior direction within the left atrium,

providing an implant comprising a rail portion, a posterior portion joined to the rail portion, and an anterior portion joined to the rail portion,

deploying the implant through an intravascular path from the right atrium through the interatrial septum into the left atrium including

positioning the anterior portion of the implant entirely inside the heart and solely within the right atrium in contact solely with the interarterial septum above an anterior region of the annulus,

positioning the posterior portion of the implant entirely inside the heart and solely within the left atrium in contact solely with tissue above a posterior region of the annulus, and

positioning the rail portion of the implant entirely inside the heart and solely within the left atrium in a path that spans across the minor axis of the annulus between the posterior region above the annulus and the interarterial septum above the anterior region of the annulus, and

shortening the native length of the minor axis of the annulus including

anchoring the posterior portion of the implant solely to tissue inside the heart in a wall of the left atrium above the posterior region of the annulus, and

pulling on the anterior portion of the implant from within the right atrium to place the rail portion in tension within the left atrium, whereby the pulling exerts a pulling force on tissue within the left atrium at or near the posterior region of the annulus to draw the posterior region of the annulus inwardly toward the anterior region of the annulus without exerting a pulling force on the anterior region of the annulus, to thereby shorten the annulus along the minor axis, and

anchoring the anterior portion of the implant solely to tissue in the interatrial septum solely within the right atrium above the anterior region of the annulus to hold the tension on the rail portion.

2. A method according to claim 1, wherein the rail portion comprises a wire-form structure.

3. A method according to claim 1, wherein the rail portion comprises an elastic material.

4. A method according to claim 1, wherein the deploying the implant includes collapsing the implant for placement within a catheter.

5. A method according to claim 1, wherein anchoring the anterior portion includes coupling a tissue-engaging fixation element on the anterior portion solely within the right atrium above the anterior region of the annulus.