Sizing apparatus for heart valve with supra annular suture ring

• US 5,360,014 A
• Filed: 11/10/1993
• Issued: 11/01/1994
• Est. Priority Date: 11/10/1993
• Status: Expired due to Term

• Current Assignee: Carbomedics Inc. (Snia SpA)
• Original Assignee: Carbomedics Inc. (Snia SpA)
• Inventors: Bell, Ronald S., Sauter, Joseph A.
• Primary Examiner(s): RIMELL, SAMUEL G
• Application Number:
  US08/150,595
• Time in Patent Office: 356 Days
• Field of Search: 128/774, 128/780, 623/2, 33/511, 33/512, 33/514.1, 606/102, 606/194
• 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
• CPC Class Codes: Y10S 623/912 Method or apparatus for measuring or testing prosthetic

Abstract

A sizing apparatus for a supra-annular heart valve comprising a sizing probe mounted on a bendable shaft. The sizing probe comprises a cylindrical body with a proximal surrounding lip, the body and lip having a combined height equivalent to a similar height of the supra-annular heart valve. The body has an outside diameter which corresponds to that of the body of the supra-annular heart valve, and the lip has an outside diameter which corresponds to that of the sewing ring brim. Proximal from the lip is an annulus sizer having a shape corresponding to the interior opening or orifice of the selected heart valve. In use, the annulus sizer is placed in the aorta to pass through the annulus in the heart at the site of the excised natural valve, so that the attending physician will be able to recognize the largest permissible size for the supra-annular heart valve. A set of sizers is supplied corresponding to the different sizes of available heart valves.

Claims

1. An apparatus for determining the appropriate size of a supra-annular mechanical prosthetic heart valve, said heart valve having a height, a diameter orthogonal thereto and an orifice extending through said valve for passage of blood therethrough, said apparatus comprising

a handle;

and

probe means mounted proximally from said handle, said probe means comprising

a body portion having a height and a diameter orthogonal to said height, said height approximating the height of said supra-annular heart valve,

a circumferential lip proximal from said body portion, said lip having a proximal edge for preventing said body portion from entering said site of said excised heart valve and having a constant diameter greater than said diameter of said body portion, said lip diameter approximating the diameter of said supra-annular heart valve; and

an annulus portion extending proximally from said circumferential lip, said annulus portion having a side wall congruent with said orifice in said heart valve.

2. The apparatus according to claim 1 wherein said side wall of said annulus portion is substantially cylindrical.

3. The apparatus according to claim 1 further comprising a flexible shaft between said handle and said body portion.

4. The apparatus according to claim 3 wherein said side wall of said annulus portion is substantially cylindrical.

5. A method for determining the appropriate size of a supra-annular prosthetic heart valve, said heart valve having a height, a diameter orthogonal thereto and an orifice extending through said valve for passage of blood therethrough, said method comprising the steps of

extending a sizing apparatus into a patient'"'"'s circulatory system towards a site of an excised heart valve, said sizing apparatus comprising

a handle;

and

probe means mounted proximally from said handle, said probe means comprising

a body portion having a height and a diameter orthogonal to said height, said height approximating the height of said supra-annular heart valve,

a circumferential lip proximal from said body portion, said lip having a proximal edge for preventing said body portion from entering said site of said excised heart valve and having a constant diameter greater than said diameter of said body portion, said lip diameter approximating the diameter of said supra-annular heart valve; and

an annulus portion extending proximally from said circumferential lip, said annulus portion having a side wall congruent with said orifice in said heart valve;

inserting said annulus portion into an annulus at said site;

determining if said annulus portion substantially fills said annulus;

advancing said sizing apparatus until said body portion is adjacent said annulus;

determining if openings for the patient'"'"'s coronary arteries are exposed above said height of said body portion;

withdrawing said sizing apparatus from the heart; and

selecting for implantation a supra-annular heart valve having dimensions similar to said sizing apparatus.

6. The method according to claim 5 wherein said side wall of said annulus portion is substantially cylindrical.

7. The apparatus according to claim 5 further comprising a flexible shaft between said handle and said body portion.

8. The apparatus according to claim 7 wherein said side wall of said annulus portion is substantially cylindrical.