Valve sizer

Surgery – Diagnostic testing – Measuring anatomical characteristic or force applied to or...

Reexamination Certificate

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Details

C623S002220, C623S900000

Reexamination Certificate

active

06322526

ABSTRACT:

FIELD OF THE INVENTION
The present invention is directed to methods and apparatus for determining the appropriate replacement valve size when replacing a patient's cardiac valve.
BACKGROUND OF THE INVENTION
Replacement of a diseased or malfunctioning cardiac valve requires accurate sizing of the valve annulus. After the diseased or malfunctioning cardiac valve has been removed, the surgeon measures the patient's valve annulus to determine the appropriate replacement valve size.
A conventional system for measuring a patient's valve annulus includes a number of varying size discs which can be attached to a rod. Each of the discs has a size which corresponds to an available valve size. The surgeon attaches one of the discs to the rod, inserts the disc into the patient's valve annulus and checks the fit of the disc within the valve annulus. If the surgeon is not satisfied with the fit, the surgeon removes the disc from the rod, attaches another disc to the rod and inserts the new disc into the valve annulus. This procedure is repeated until the surgeon is satisfied that the appropriate valve size has been identified.
A problem with the known method and apparatus for sizing a patient's valve annulus is the time required to try a number of discs. For each valve size the surgeon tries, the surgeon must remove one of the discs and attach another one. This procedure increases the overall surgery time which increases the risk to the patient and also increases the cost of the procedure.
Thus, it is a specific object of the present invention to reduce the amount of time required to size a patient's valve annulus by providing a device which can identify a number of different appropriate valve sizes without requiring withdrawal of the device from the patient.
SUMMARY OF THE INVENTION
The present invention solves the problems with the prior art by providing a valve sizer which is only introduced into the patient once and can identify a number of appropriate replacement valve sizes. The valve sizer includes an elongate shaft having a proximal end and a distal end with a movable element coupled to the distal end of the shaft. A valve sizing portion has an outer dimension which is at least partially defined by the movable element. A valve size indicator is provided at the proximal end of the shaft. An actuator is also provided at the proximal end for moving the movable element so that the valve sizing portion corresponds to the various valve sizes.
In a preferred embodiment, the movable element includes a plurality of arms having outer surfaces generally forming a circular shape. A rod extends through the shaft and is operatively coupled to the actuator. The rod is rotatable relative to the shaft so that rotation of the rod moves the movable element. A disc is attached to the rod. The disc has a plurality of slots which receive pins attached to the plurality of arms. Camming surfaces are coupled to the shaft and configured to engage and cam the plurality of arms when the actuator is actuated to move the movable element.
In another preferred embodiment, the valve sizer includes a ring mounted to an elongate shaft. An actuator is mounted to the proximal end of the shaft and is operatively coupled to the ring for expanding and retracting the ring. The ring preferably includes a first part and a second part slidably coupled to the first part. The second part is slidably received in a recess in the first part. Two levers are connected to the ends of the first part. One of the levers is attached to the shaft and another lever is attached to a rod extending through the shaft so that rotation of the rod relative to the shaft expands and retracts the ring.
In yet another preferred embodiment, the valve sizer has a balloon mounted to a tube having a lumen therethrough. The balloon is coupled to the lumen so that the balloon may be inflated with a fluid passing through the lumen. The tube preferably includes a valve size indicator which indicates an outer dimension of the balloon when the balloon is inflated.
These and other features will become apparent with the following description of the preferred embodiments.


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