Source: https://patents.justia.com/patent/6322526
Timestamp: 2019-11-19 21:20:06
Document Index: 408842381

Matched Legal Cases: ['application No. 08', 'application No. 08', 'art 108', 'art 110', 'art 108', 'arts 108', 'art 108', 'art 110', 'art 110', 'arts 108', 'art 108', 'art.\n14']

US Patent for Valve sizer Patent (Patent # 6,322,526 issued November 27, 2001) - Justia Patents Search
Justia Patents Measuring Anatomical Characteristic Or Force Applied To Or Exerted By BodyUS Patent for Valve sizer Patent (Patent # 6,322,526)
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.
This application is a continuation of U.S. patent application Ser. No. 09/273,955 filed Mar. 22, 1989, now U.S. Pat. No. 6,042,554 which is a divisional of U.S. patent application Ser. No. 08/646,850, filed May 8, 1996, now U.S. Pat. No. 5,885,228.
The present invention is directed to methods and apparatus for determining the appropriate replacement valve size when replacing a patient's cardiac valve.
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.
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.
FIG. 1 is a perspective view of a first valve sizer having arms in an expanded position.
Referring to FIGS. 1 and 2, a first valve sizer 2 is shown. The valve sizer 2 has a tube 4 and an actuator 6 at the proximal end of the tube 4. A number of arms 8 extend radially outward from a spacer 10 which is coupled to the tube 4 as described below. FIG. 1 illustrates the arms 8 in an extended position and FIG. 2 illustrates the arms 8 in a retracted position. Rotation of the actuator 6 moves the arms 8 from the retracted position to the expanded position as will be described below.
Referring to FIG. 3, the distal end of the valve sizer 2 is shown. The spacer 10 is attached to the bottom of a disc 12 which is attached to the tube 4. The spacer 10 includes slots 14 which guide movement of the arms 8 between the retracted and extended positions. The spacer 10 includes two recesses 16, only one of which is shown, which receive slotted discs 18. The slotted discs 18 are mounted to a rod 20 which extends through the tube 4. As will be discussed below, the rod 20 and tube 4 are coupled to the actuator 6 so that rotation of the actuator 6 rotates the rod 20 and slotted discs 18 with respect to the tube 4. Thus, the rod 20 and slotted discs 18 form a unitary structure while the tube 4. disc 12 and spacer 10 form another unitary structure.
The arms 8 are preferably T-shaped with a curved outer surface 26 but may take any other shape. The outer surfaces 26 of the arms 8 generally form a circular peripheral shape when in the retracted and expanded positions. The outer surfaces 26 of the arms 8 define a valve sizing portion which engages the patient's valve annulus when sizing the replacement valve. The maximum outer dimension of the valve sizer 2 is preferably no more than 17 mm, more preferably no more than 18 mm, and most preferably no more than 19 mm, when in the retracted position. The outer surfaces 26 of opposing arms 8 preferably have a maximum outer dimension of at least 30 mm and more preferably at least 33 mm when in the expanded position. The preferred dimensions of the valve sizer 2 in the retracted position permits insertion of the valve sizer 2 between adjacent ribs in a patient when performing a minimally invasive valve procedure such as described in U.S. patent application No. 08/163,241 to Sterman et al., filed Dec. 6, 1993, which is incorporated herein by reference. Alternatively, the valve sizer 2 may be provided in two size ranges, preferably 17-27 mm and 23-33 mm.
A method of selecting an appropriate valve size is now described with reference to FIGS. 1-3. A method of replacing a patient's cardiac valve is described in U.S. patent application No. 08/163,241. The valve sizer 2 is preferably introduced into the patient between adjacent ribs in the patient without cutting or significantly deflecting the ribs. The valve sizer 2 is sized and configured so that it has a profile of no more than 20 mm, and more preferably no more than 19 mm, so that the valve sizer 2 may be introduced between adjacent ribs in the patient. The surgeon then positions the arms 8 in the valve annulus and rotates the actuator 6 until the arms 8 contact the valve annulus. The surgeon then reads the appropriate valve size with the pointer 32 and markings 30. The actuator 6 is then rotated again so that the arms 8 are in the retracted position of FIG. 2 for removing the valve sizer 2 from the patient.
The ring 102 includes a first part 108 and a second part 110 slidably coupled to the first part 108. Both the first and second parts 108. 110 are flexible so that they can assume the expanded and retracted positions of FIGS. 9 and 10. The first part 108 has recesses 112 which are sized to slidably receive the second part 110. The second part 110 includes stops 114 which prevent the first and second parts 108, 110 from becoming detached. First and second levers 116, 118 are attached to first and second ends 120, 122 of the first part 108, respectively. The first lever 116 is attached to a shaft 124 and the second lever 118 is attached to the tube 106 so that rotation of the shaft 124 relative to the tube 106 moves the first and second levers 116, 118 with respect to one another.
1. A valve sizer for determining an appropriate replacement valve size when performing a valve replacement procedure, comprising:
a movable element coupled to the distal end of the shaft, the movable element being movable between a first position and a second position;
a valve sizing portion having an outer dimension, the valve sizing portion being at least partially defined by the movable element;
an indicator at the proximal end of the shaft, the indicator indicating a replacement valve size corresponding to the outer dimension of the valve sizing portion; and
an actuator at the proximal end of the elongate shaft, the actuator being operatively coupled to the movable element for moving the movable element between the first and second positions.
2. The valve sizer of claim 1, wherein:
the movable element includes a plurality of arms, the plurality of arms having outer surfaces generally forming a generally circular shape in a plane perpendicular to a longitudinal axis defined by the shaft, the plurality of arms being movable between the first and second positions.
3. The valve sizer of claim 1, wherein:
the plurality of arms move in a plane substantially perpendicular to a longitudinal axis defined by the shaft.
4. The valve sizer of claim 1, further comprising:
a rod extending through at least a portion of the shaft, the rod being operatively coupled to the actuator.
5. The valve sizer of claim 4, wherein:
the rod is rotatable relative to the shaft, the rod being coupled to the actuator so that rotation of the rod relative to the shaft moves the movable element between the first and second positions.
6. The valve sizer of claim 4, further comprising:
a disc attached to the rod;
the movable element including a plurality of arms;
the disc having a plurality of slots which receive pins attached to the plurality of arms.
7. The valve sizer of claim 1, further comprising:
a plurality of camming surfaces coupled to the shaft, the plurality of camming surfaces being configured to engage and cam the plurality of arms when the actuator is actuated to move the movable element from the first position to the second position.
8. The valve sizer of claim 1, wherein:
the outer dimension is no more than 21 mm when the movable element is in the first position.
9. The valve sizer of claim 8, wherein:
the outer dimension is no more than 19 mm when the movable element is in the first position.
10. The valve sizer of claim 8, wherein:
the outer dimension is at least 31 mm when the movable element is in the second position.
11. The valve sizer of claim 8, wherein:
the outer dimension is at least 33 mm when the movable element is in the second position.
12. A valve sizer for measuring a patient's valve annulus, comprising:
a ring mounted to the distal end of the shaft, the ring being movable from a first position to a second position, the first position having a smaller diameter than the second position; and
an actuator mounted to the proximal end of the shaft, the actuator being operatively coupled to the ring for moving the ring from the first position to the second position.
13. The valve sizer of claim 12, wherein:
the ring includes a first part and a second part slidably coupled to the first part.
14. The valve sizer of claim 12, wherein:
the second part is slidably received in a recess in the first part, the first part having first and second ends.
15. The valve sizer of claim 14, further comprising:
a first lever coupled to the first end of the first part;
a second lever coupled to the second end of the first part, the second lever being rotatable relative to the first lever;
the actuator being operatively coupled to at least one of the first and second levers for rotating the first lever with respect to the second lever.
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Patent number: 6322526
Inventors: Daniel C. Rosenman (San Mateo, CA), Michi E. Garrison (Belmont, CA), Sean Christopher Daniel (San Franciso, CA)
Attorney, Agent or Law Firm: Hoekendijk & Lynch, LLP
Application Number: 09/514,453
Current U.S. Class: Measuring Anatomical Characteristic Or Force Applied To Or Exerted By Body (600/587); 623/2; Stent For Heart Valve (623/900)