Instrument of patterning cusp for cardiac valve reconstruction and component thereof

• US 9,414,920 B2
• Filed: 11/04/2013
• Issued: 08/16/2016
• Est. Priority Date: 04/13/2010
• Status: Active Grant

• Current Assignee: Sanamedi, Inc.
• Original Assignee: Japanese Organization for Medical Device Development, Inc.
• Inventors: Ozaki, Shigeyuki
• Primary Examiner(s): THOMSON, WILLIAM D
• Assistant Examiner(s): Downey, John R
• Application Number:
  US14/070,706
• Publication Number:
  US 20140058504A1
• Time in Patent Office: 1,016 Days
• Field of Search: 606/1, 623 21- 242
• US Class Current: 1/1
• CPC Class Codes: A61F 2/2415 Manufacturing methods
• CPC Class Codes: A61F 2/2445 Annuloplasty rings in direct contact with the valve annulus
• CPC Class Codes: A61F 2/2496 Devices for determining the dimensions of the prosthetic valve to be implanted, e.g. templates, sizers

Abstract

In a case of repairing an aortic valve by forming a valve cusp with a biomembrane, the shape and the size of a valve cusp can be determined easily. An instrument including a valve cusp sizer for measuring the size of the valve cusp and a template for scribing lines for the shape of a valve cusp conforming to the measured size of the valve cusp, in which the valve cusp sizer has a plurality of differently-sized sizer blocks attached to each of the top ends of grip members respectively and each sizer block has an arcuate surface formed by cutting each of differently-sized circular cylinders at an angle conforming to the central angle for the commissure portions and, the template is formed with a scribing portion including a substantially semi-circular valve cusp base forming portion.

Claims

1. A method of treatment of abnormal valve cusp syndrome, the method comprising:

excising one or two abnormal valve cusps selected from the group of left coronary cusp, right coronary cusp and noncoronary cusp, without excising a remaining valve cusp or valve cusps that can function normally;

inserting a cusp sizer at a portion where the one or two abnormal valve cusps are excised,

wherein the cusp sizer comprises a sizer block with an arcuate surface with an angle conforming to the central angle for commissure portions of an aortic valve, the arcuate surface comprising two probe portions disposed on both ends thereof;

an upper surface of the sizer block being curved in a concave shape and comprising an index which is a center marker for defining a central point from which stitching is started;

measuring the size of the excised valve cusp or valve cusps by;

making the sizer block abut the valve annulus of an aorta from which the valve cusp or valve cusps are excised, the central point for the base of the valve cusp between the commissure portions being visible;

confirming the two probe portions of the sizer block fit to both of the commissure portions of the excised valve cusp or one of the excised two abnormal valve cusps, thereby reading nominal diameter of the cusp sizer;

obtaining a new valve cusp formed of a pericardium by;

scribing lines for a cusp shape by drawing along an inner peripheral surface of a scribing portion of a template which relates to the nominal diameter to the pericardium; and

cutting the pericardium in accordance with the lined cusp shape;

dipping the new valve cusp formed of a pericardium in saline;

abutting the cusp sizer having the nominal diameter in a manner that the two commissure portions of the excised valve cusp conforms to the two probe portions of the sizer block;

putting a thread to a valve annulus at a position indicated by the index;

stitching the central point of the base of the valve cusp; and

stitching toward the commissure points from the central point, thereby reconstructing the aortic valve.

2. The method in accordance with claim 1,

wherein dipping the new valve cusp comprises dipping the new valve cusp in one of a left coronary cusp dipping portion, right coronary cusp dipping portion and a noncoronary cusp dipping portion of a vessel,

the left coronary cusp dipping portion comprising an identification tag of the left coronary cusp dipping portion;

the right coronary cusp dipping portion comprising an identification tag of the right coronary cusp dipping portion; and

the noncoronary cusp dipping portion comprising an identification tag of the noncoronary cusp dipping portion.

3. The method in accordance with claim 1,

wherein obtaining the new valve cusp comprises obtaining the new valve cusp by:

lining for a cusp shape by drawing along an inner peripheral surface of a scribing portion of a template which relates to the nominal diameter to the pericardium,

the inner peripheral surface of the scribing portion comprising;

an inner peripheral surface of a valve cusp base forming portion of the template which has a diameter as a sum of a diameter defined as the nominal diameter and an allowance for stitching margins; and

an inner peripheral surface of a coaptation zone forming portion in which both end edges thereof are extended in a manner that the portion is gradually widened from both ends of the valve cusp base forming portion angled shape portion of the template to a free margin portion thereof, and a center of the free margin portion being protruded at the top end thereof and having an angled shape.