Methods and Devices for Transcatheter Cerclage Annuloplasty


The invention relates to techniques and devices for cardiovascular valve repair, particularly annuloplasty techniques and devices in which tensioning elements are positioned to treat regurgitation of the mitral valve or tricuspid valve. More specifically, the technology pertains to a new device for myocardial septal traversal ("cerclage reentry") that also serves to capture (ensnare) and externalize the traversing guidewire. The focus of the invention is to avoid a phenomenon in cardiac surgery known as "trabecular entrapment." The device features an expandable and collapsible mesh deployed in the right ventricle to simplify capture of a reentering guidewire during transcatheter cerclage annuloplasty. The wire mesh exerts pressure against trabecular-papillary elements of the tricuspid valve to displace them against the right ventricular septal wall. By abutting the right ventricular reentry site of the cercalge guidewire, trabecular entrapment is avoided. The device comprises a shaft having a distal loop which provides a target in the interventrical myocardial septum through which a catheter-delivered tensioning system is guided. The loop ensnares the catheter-delivered tensioning system as it reenters the right ventricle or right atrium. The expandable and collapsible mesh is disposed within the right ventricle such that the catheter-delivered tensioning system is directed from the ventricular septum into the right ventricular cavity through only a suitable opening in the mesh and such that the catheter delivered tensioning system is captured or ensnared within the mesh opening.

Potential Commercial Applications: Competitive Advantages:
Cardiovascular valve repair surgeries. 
  • The device avoids trabecular entrapment of the cerclage guidewire during septal-perforator-to-right-ventricular myocardial guidewire traversal.
  • The device allows ensnarement of reentering guidewire.
  • The device provides an X-ray target for guidewire reentry from the septal perforator veins.
  • Collapsible transcatheter device that can be introduced from a cephalad (typically transjugular or transaxillary) or caudad (typically transfemoral) approach.
  • The device is intended to allow straightforward removal from the same vascular sheath as the cerclage retrograde traversal guidewire, to allow both free ends of the guidewire to be externalized through the same sheath.


Development Stage:
  • Practical usefulness of the technology has been demonstrated.
  • Preclinical testing of extant prototype is planned.
  • Clinical development is planned.


Inventors:

Robert Lederman (NHLBI)  ➽ more inventions...


Intellectual Property:
U.S. Pat: 9,579,200 issued 2017-02-28
US Application No. 61/383,061
US Application No. 13/824,198
US Application No. 15/442,636

Publications:
Kim JH, et al. Mitral cerelage annuloplasty, a novel transcatheter treatment for secondary mitral valve regurgitation: initial results in swine. J Am Coll Cardiol. 2009 Aug 11;54(7):638-651. PMID: 19660696

Collaboration Opportunity:

The National Heart, Lung, and Blood Institute is seeking statements of capability or interest from parties interested in collaborative research to further develop, evaluate, or commercialize this technology. Please contact Peg Koelble at koelblep@nhlbi.nih.gov for more information.


Licensing Contact:
Michael Shmilovich, J.D.
Email: shmilovm@mail.nih.gov
Phone: 301-435-5019

OTT Reference No: E-108-2010/0
Updated: May 25, 2011