Novel Device and Method for Transcatheter Retrieval of Mechanical Valve Leaflets

Tech ID: kho000708-1

 

Introduction

Treatments of valvular heart disease can often involve the replacement of a defective heart valve with a mechanical or a bioprosthetic one.

Although a mechanical valve (MVH) could last through the remainder of the patient’s life, some patient will require surgical revision. These surgical revision patients generally fall into two categories: (1) those with a malfunctioning MVH due to pannus and/or significant hemolysis, (2) those with contraindication for mandatory systemic anticoagulation such as patients with a cerebral or gastrointestinal bleeding, elderly patients at risk for falling, and young women desiring to have a pregnancy. Only a high-risk open-heart operation can currently achieve such revision.

Where patients with bioprosthetic heart valve have the option of Transcatheter Valve Replacement (TAVR), such procedures has yet to be adapted for patients with MHV.

The benefits of valve-in-valve TAVR are faster recovery, shorter hospital stay, as well as reduced morbidity and mortality since it obviates the need for open-heart. With the valve-in-valve TAVR technique, a new valve is delivered on a catheter directly into the existing bioprosthetic heart valve. This can be done without removing the prior valve because the bioprosthetic valve leaflets can be draw aside like the natural valve leaflets. For patients with previous bioprosthetic heart valve, the valve-in-valve TAVR has become a feasible and safe alternative.

 

Technology Description

Dr. Khoynezhad of Cedars-Sinai Medical Center has developed an apparatus and method for transcatheter removal of MVH leaflets. The invention also teaches methods for subsequent transcatheter valve-in-valve placement of a bioprosthetic heart valve within the annulus that remains after the leaflets are removed.

The apparatus comprises:

•       a catheter;

•       a sheath; and

•       a leaflet capturing component;

The method of removal comprises:

•       introducing an apparatus into the heart of a subject having a MVH with  leaflets attached to a annulus

•       introducing a balloon of a balloon catheter between the leaflets of the MVH

•       inflating the balloon until the leaflets are separated from the annulus of the MVH;

•       forming a basket with the leaflet capturing component of the apparatus by advancing the sliding end of the leaflet capturing component in the direction of the attaching end of the leaflet capturing component;

•       enveloping the separated leaflets with the basket;

•       withdrawing the basket in the direction of the second end of the catheter, thereby substantially containing the leaflets within the basket; and

•       removing the apparatus and the leaflets from the subject

 

Stage of Development

•       Alpha prototype with in vitro data completed; and

•       Beta prototype with animal data in process.

 

Advantages/Novelty

At this time, only a high-risk open-heart operation can achieve surgical revisions for MVH patients. Where TAVR answers this drawback for patients with bioprosthetic heart valves, there is a need for a safe, minimally-invasive and efficient transcatheter surgical revision method as an alternative to open-heart surgery for patient with MVH.

 

Applications

Transcatheter removal of MVH leaflets

 

Intellectual Property

•       PCT application PCT/US2014/053727 filed nationalized in US, Europe, India, and China.

Patent Information:
Category(s):
Device(s)
For Information, Contact:
Julien Brohan
julien.brohan@cshs.org
Inventors:
Ali Khoynezhad
Paul Philipp Heinisch
Ralf Brecht
Selena Akra
Keywords:
Cardiovascular
Surgery