Combination anatomical orifice sizer and heart valve

• US 6,846,324 B2
• Filed: 01/22/2002
• Issued: 01/25/2005
• Est. Priority Date: 01/26/1999
• Status: Expired due to Fees

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Stobie, Robert
• Primary Examiner(s): Isabella, David J.
• Assistant Examiner(s): Chattopadhyay, Urmi
• Application Number:
  US10/054,469
• Publication Number:
  US 20020103531A1
• Time in Patent Office: 1,099 Days
• Field of Search: 623/2.1, 623/2.11, 623/66.1, 623/1, 623/2, 623/900, 600/587, 335/11, 335/12, 335/142, 606/151, 606/153, 128/898
• US Class Current: 623/2.11
• 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 cylindrical heart valve sizer in combination with a prosthetic heart valve having a mounting portion, the sizer having indicated thereon a size corresponding to an indicated valve size of the prosthetic heart valve, wherein the actual diameter of the heart valve sizer is larger than the actual diameter of the valve mounting portion.

2. The combination of claim 1 wherein the diameter of the sizer is between about 0.2 mm to 0.4 mm larger than the valve mounting portion.

3. The combination of claim 2 wherein the diameter of the sizer is about 0.3 mm larger than the valve mounting portion.

4. The combination of claim 2 wherein the length of the sizer is substantially cylindrical in shape and has a length of between about 19 mm to 22 mm.

5. The combination of claim 1 wherein the length of the sizer is substantially cylindrical in shape and has a length of between about 19 mm to 22 mm.

6. The combination of claim 5 wherein the sizer has rim edges on one end thereof, and wherein said rim edges are rounded to a minimum 1 mm radius.

7. The combination of claim 1 wherein the sizer has rim edges on one end thereof, and wherein said rim edges are rounded to a minimum 1 mm radius.

8. A kit for installing a prosthetic heart valve comprising:

at least one prosthetic heart valve having a rigid mounting portion having a diameter D, the prosthetic heart valve denoted by a size identifier; and

,

at least one cylindrical sizer having a diameter S and denoted by a size identifier corresponding to the size identifier of the valve;

wherein the actual diameter S of the sizer is larger than the actual diameter D of the rigid mounting portion of the heart valve.

9. The kit of claim 8 wherein the diameter of the sizer is between about 0.2 mm to 0.4 mm larger than the diameter of the rigid mounting portion of the corresponding heart valve.

10. The kit of claim 9 wherein the diameter of the sizer is about 0.3 mm larger than the diameter of the rigid mounting portion of the corresponding heart valve.

11. The kit of claim 10 wherein the sizer has a cylindrical length of between about 19mm to 22 mm.

12. The kit of claim 8 wherein the sizer has a cylindrical length of between about 19 mm to 22 mm.

13. The kit of claim 12 wherein the sizer has edges that are rounded to a minimum 1 mm radius.

14. The kit of claim 8 wherein the sizer has edges that are rounded to a minimum 1 mm radius.