Anatomical orifice sizers and methods of orifice sizing

• US 6,383,147 B1
• Filed: 01/26/2000
• Issued: 05/07/2002
• Est. Priority Date: 01/26/1999
• Status: Expired due to Term

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Stobie, Robert
• Primary Examiner(s): Nguyen, Dinh X.
• Assistant Examiner(s): Chattopadhyay, Urmi
• Application Number:
  US09/491,987
• Time in Patent Office: 832 Days
• Field of Search: 623/2.11, 623/2.1, 702/41, 702/104, 702/133, 702/139, 73/11.5, 738/65, 734/321, 604/338, 600/432, 600/587, 128/898, 607/17
• US Class Current: 600/587
• CPC Class Codes: A61B 90/06 Measuring instruments not otherwise provided for
• CPC Class Codes: A61F 2/2409 Support rings therefor, e.g. for connecting valves to tissue annuloplasty rings A61F2/2442
• CPC Class Codes: A61F 2/2496 Devices for determining the dimensions of the prosthetic valve to be implanted, e.g. templates, sizers

Abstract

Anatomical orifice sizers that are optimally proportional to an associated prosthetic device such as a heart valve, and methods of use are provided. The sizers are desirably slightly larger than the rigid mounting diameter of the corresponding heart valve. The heart valve sizer may be cylindrical and have a diameter about 0.3 mm larger than the valve mounting diameter. The sizer preferably has a length of between about 19 mm to 22 mm, and the edges are desirably rounded to a minimum 1 mm radius. The method includes providing a set of cylindrical sizers having varying diameters; sequentially inserting at least two of the sizers through the annulus; measuring the push force needed to pass each sizer through the annulus; selecting a valve corresponding to the sizer for which the measured push force is between about 150 and 300 grams.

Claims

1. A method of sizing an anatomical heart valve annulus, comprising:

providing a set of cylindrical sizers having varying diameters;

sequentially inserting at least two of the sizers through the annulus;

determining the push force needed to pass each sizer through the annulus;

selecting a valve corresponding to the sizer for which the measured push force is between about 150 and 300 grams;

wherein the step of determining is accomplished with a load sensor.

2. The method of claim 1, wherein the step of determining is accomplished at the same time as the step of inserting.