Device and method for assessing the geometry of a heart valve

• US 6,678,962 B1
• Filed: 11/17/2000
• Issued: 01/20/2004
• Est. Priority Date: 11/17/1999
• Status: Expired due to Fees

• Current Assignee: Cardiomend LLC
• Original Assignee: Cardiomend LLC
• Inventors: Hanlon, James G., Love, Jack W.
• Primary Examiner(s): Fulton, Christopher W.
• Assistant Examiner(s): Guadalupe, Yaritza
• Application Number:
  US09/716,140
• Time in Patent Office: 1,159 Days
• Field of Search: 335/11, 335/12, 335/551, 335/014.5, 335/42, 335/43, 623/2.11, 600/587
• US Class Current: 33/512
• CPC Class Codes: A61B 5/1076 for measuring dimensions inside body cavities, e.g. using catheters A61B3/1005 takes precedence
• CPC Class Codes: A61F 2/2427 Devices for manipulating or deploying heart valves during implantation
• 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: A61F 2250/0097 Visible markings, e.g. indicia

Abstract

A sizer for assessing the geometry of a heart valve annulus. The sizer preferably includes a circular sizing portion for measuring the diameter of the valve annulus. The sizing portion has radial spokes. The spokes are used to compare the symmetry of the commissures to the expected symmetry of a normal heart valve. The sizer preferably has one or more legs attached to the sizing portion for comparing the contour of the line of valve leaflet attachment to the expected contour of a normal heart valve having a diameter substantially equivalent to the measured diameter of the valve annulus.

Claims

1. A sizer for a heart valve annulus having a diameter and a contoured line of valve leaflet attachment defining a leaflet shape, the sizer comprising:

a first substantially circular diameter sizing portion for measuring the diameter of the valve annulus; and

a second leaflet sizing portion comprising one or more arched members attached to the diameter sizing portion for assessing the leaflet shape, the leaflet sizing portion comprising one or more arched members, each of which substantially conforms to a predetermined heart valve leaflet height.

2. The sizer of claim 1, wherein each of the arched members substantially conforms to the expected shape of a leaflet of a normal heart valve.

3. The sizer of claim 1, wherein each of the arched members has a proximal end attached to the diameter sizing portion and an arced distal end having an apex, wherein the length of said arched member from the proximal end to the apex of the distal end corresponds to said predetermined leaflet height.

4. The sizer of claim 3, wherein the predetermined leaflet height approximates the expected height of a leaflet of a normal heart valve having a diameter substantially equivalent to the diameter of the diameter sizing portion.

5. The sizer of claim 1, wherein the one or more arched members is three arched members.

6. The sizer of claim 1, wherein the diameter sizing portion further comprises a socket for attaching a handle to the sizer.

7. A sizer for a heart valve annulus having a diameter, a contoured line of valve leaflet attachment defining a leaflet height, and a plurality of commissures, the sizer comprising:

a first circular diameter sizing portion for measuring the diameter of the valve annulus; and

a second leaflet sizing portion comprising one or more arched members attached to the diameter sizing portion for measuring the leaflet height wherein each arched member has a proximal end attached to the diameter sizing portion and an arced distal end having an apex, and the length of each arched member from the proximal end to the apex of the distal end is substantially equal to a predetermined leaflet height.

8. The sizer of claim 7, wherein each of the one or more arched members substantially conforms to the expected shape of a leaflet of a normal heart valve.

9. The sizer of claim 7, wherein the predetermined leaflet height approximates the expected height of a leaflet of a normal heart valve having a diameter substantially equivalent to the diameter of the diameter sizing portion.

10. The sizer of claim 7, wherein the diameter sizing portion has a perimeter, the diameter sizing portion further comprising three radial spokes connected to the perimeter of the circular sizing portion such that the width of each spoke at the perimeter designates an arc width that corresponds to a predetermined acceptable variation from normal symmetry.

11. A sizer for a heart valve annulus having a contoured line of valve leaflet attachment defining a shape of three valve leaflets, three commissures, and a diameter, the sizer comprising:

a first circular diameter sizing portion for measuring the diameter of the valve annulus, the diameter sizing portion comprising a plurality of radial spokes for comparing the symmetry of the commissures to the expected symmetry of a normal heart valve; and

a second leaflet sizing portion comprising three arched members attached to the diameter sizing portion for assessing the leaflet shape, each arched member comprising;

a proximal end attached to the diameter sizing portion; and

an arced distal end having an apex, wherein the length of the arched member from the proximal end to the apex of the distal end approximates the expected leaflet height of a normal heart valve having a diameter substantially equivalent to the diameter of the diameter sizing portion.