Valve sizer and method of use

• US 5,885,228 A
• Filed: 05/08/1996
• Issued: 03/23/1999
• Est. Priority Date: 05/08/1996
• Status: Expired due to Term

• Current Assignee: Edwards Lifesciences LLC (Edwards Lifesciences Corporation)
• Original Assignee: Heartport, Inc. (Johnson & Johnson)
• Inventors: Garrison, Michi E., Daniel, Sean Christopher, Rosenman, Daniel C.
• Primary Examiner(s): Apley, Richard J.
• Assistant Examiner(s): LaMarca, William
• Application Number:
  US08/646,850
• Time in Patent Office: 1,049 Days
• Field of Search: 128/774, 623/2, 623/900, 606/194, 604/104
• US Class Current: 600/587
• 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 623/90 Stent for heart valve

Abstract

A valve sizer having a movable element mounted to the distal end of a shaft. A valve sizing portion includes the movable element so that the valve sizing portion may be adjusted to correspond to a number of different available replacement valve sizes. An indicator mounted to the proximal end of the shaft indicates the valve size corresponding to the outer dimension of the valve sizing portion.

Claims

1. A method of sizing a patient'"'"'s cardiac valve annulus, comprising the steps of:

providing a valve sizer having a movable element, the movable element being movable between a first position and a second position, the valve sizer having a valve sizing portion which is at least partially defined by the movable element, the valve sizing portion defining a first valve size when in the first position and a second valve size when in the second position, the movable element being an expandable ring, the expandable ring having a first part slidably coupled to a second part when moving from the first position to the second position;

inserting the valve sizer into the patient so that the movable element is positioned in the valve annulus;

adjusting the movable element so that the movable element contacts the valve annulus, the adjusting step is carried out by expanding the ring; and

removing the valve sizer from the patient after the adjusting step.

2. The method of claim 1, wherein:

the providing step is carried out with the valve sizer having a shaft defining a longitudinal axis, the movable element being movable in a plane which is substantially perpendicular to the longitudinal axis.

3. The method of claim 1, wherein:

the providing step is carried out with the valve sizer having a valve size indicator at a proximal end of a shaft, the movable element being mounted to a distal end of the shaft.

4. The method of claim 1, wherein:

the providing step is carried out with the valve sizing portion having an outer dimension at the valve sizing portion, the outer dimension being no more than about 20 mm when the movable element is in the first position; and

the inserting step is carried out with the movable element being in the first position.

5. The method of claim 4, wherein:

the providing step is carried out with the outer dimension being no more than about 18 mm when the movable element is in the first position.

6. The method of claim 4, wherein:

the providing step is carried out with the outer dimension of the valve sizing portion being at least about 30 mm when the movable element is in the second position.

7. The method of claim 4, wherein:

the providing step is carried out with the maximum outer dimension of the valve sizing portion being at least about 33 mm when the movable element is in the second position.

8. A method of sizing a patient'"'"'s valve annulus, comprising the steps of:

providing a valve sizer having an expandable ring mountable to an elongate shaft, the ring being expandable from a first diameter to a second diameter larger than the first diameter, the expandable ring having a first part slidably coupled to a second part to facilitate moving from the first diameter to the second diameter, the valve sizer having an actuator at a proximal end of the elongate shaft, to providing step being carried out with the valve sizer having a valve size indicator at a proximal end of the shaft;

positioning the ring in the valve annulus of a patient;

manipulating the actuator so that the ring expands and engages the valve annuls, and

removing the valve sizer from the patient after the manipulating step.

9. A method of sizing a patient'"'"'s valve annulus, comprising the steps of:

providing a valve sizer having a ring mounted to an elongate shaft, the ring being expandable from a first diameter to a second diameter larger than the first diameter, the valve sizer having an actuator at a proximal end of the elongate shaft, the providing step being carried out with the ring having a first part and a second part slidably coupled to the first part, the first part having first and second ends, the first and second ends being coupled to first and second levers, respectively;

positioning the ring in the valve annulus of a patient; and

manipulating the actuator so that the ring expands and engages the valve annulus, the manipulating step being carried out with the actuator being operatively coupled to the first and second levers for moving the first and second end and removing the valve sizer from the patient after the manipulating step.

10. A method of sizing a patient'"'"'s valve annulus, comprising the steps of:

providing a valve sizer having a ring mounted to an elongate shaft, the ring being expandable from a first diameter to a second diameter larger than the first diameter, the valve sizer having an actuator at a proximal end of the elongate shaft, the providing step being carried out with the ring having a first part and a second part slidably coupled to the first part, the first part having first and second ends, the first and second ends being coupled to first and second levers, respectively;

positioning the ring in the valve annulus of a patient; and

manipulating the actuator so that the ring expands and engages the valve annulus, the manipulating step being carried out with the actuator being operatively coupled to the first and second levers for moving the first and second ends; and

removing the valve sizer from the patient after the manipulating step.