U.S. patent application number 09/965571 was filed with the patent office on 2003-10-09 for valve sizer and method of use.
Invention is credited to Daniel, Sean Christopher, Garrison, Michi E., Rosenman, Daniel C..
Application Number | 20030191416 09/965571 |
Document ID | / |
Family ID | 24594718 |
Filed Date | 2003-10-09 |
United States Patent
Application |
20030191416 |
Kind Code |
A1 |
Rosenman, Daniel C. ; et
al. |
October 9, 2003 |
Valve sizer and method of use
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.
Inventors: |
Rosenman, Daniel C.; (San
Mateo, CA) ; Garrison, Michi E.; (Belmont, CA)
; Daniel, Sean Christopher; (San Francisco, CA) |
Correspondence
Address: |
AUDLEY A. CIAMPORCERO JR.
JOHNSON & JOHNSON
ONE JOHNSON & JOHNSON PLAZA
NEW BRUNSWICK
NJ
08933-7003
US
|
Family ID: |
24594718 |
Appl. No.: |
09/965571 |
Filed: |
September 27, 2001 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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09965571 |
Sep 27, 2001 |
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09514453 |
Feb 25, 2000 |
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6322526 |
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09514453 |
Feb 25, 2000 |
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08646850 |
May 8, 1996 |
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5885228 |
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Current U.S.
Class: |
600/587 |
Current CPC
Class: |
A61F 2/2496 20130101;
Y10S 623/90 20130101 |
Class at
Publication: |
600/587 |
International
Class: |
A61B 005/103 |
Claims
What is claimed is:
1. A valve sizer for determining an appropriate replacement valve
size when performing a valve replacement procedure, comprising: a
shaft having a proximal end and a distal end; 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 shaft having a distal end and a proximal end; 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.
16. A valve sizer for measuring a patient's valve annulus,
comprising: a shaft having a proximal end, a distal end, and an
inflation lumen; a balloon mounted to the distal end of the shaft,
the balloon being fluidly coupled to the lumen; and an indicator
which indicates an outer dimension of the balloon when the balloon
is inflated.
17. The valve sizer of claim 16, further comprising: a cylinder
mounted to the proximal end of the shaft, the cylinder having a a
piston slidably disposed within the cylinder; the indicator
comprising markings on the cylinder.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application is a divisional of copending U.S. patent
application Ser. No 08/646,850, filed May 8, 1996.
FIELD OF THE INVENTION
[0002] 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
[0003] 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.
[0004] 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.
[0005] 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.
[0006] 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
[0007] 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.
[0008] 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.
[0009] In another preferred embodiment, the valve sizer includes a
ring mounted to and 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 level is attached to a
rod extending through the shaft so that rotation of the rod
relative to the shaft expands and retracts the ring.
[0010] In yet another preferred embodiment, the valve sizer has a
balloon mounted to 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.
[0011] These and other features will become apparent with the
following description of the preferred embodiments.
BRIEF DESCRIPTION OF THE DRAWINGS
[0012] FIG. 1 is a perspective view of a first valve sizer having
arms in an expanded position.
[0013] FIG. 2 shows the first valve sizer of FIG. 1 with the arms
in a retracted position.
[0014] FIG. 3 is an exploded perspective view of the distal end of
the first valve sizer.
[0015] FIG. 4 is a bottom perspective view of the first valve sizer
with the arms in the expanded position.
[0016] FIG. 5 is a perspective view of a second valve sizer having
arms in an expanded position with a sheath exploded from the
assembly for clarity.
[0017] FIG. 6 shows the second valve sizer of FIG. 5 with the arms
in a retracted position and the sheath exploded from the assembly
for clarity.
[0018] FIG. 7 is an exploded perspective view of the distal end of
the second valve sizer.
[0019] FIG. 8 is a perspective view of a third valve sizer having
an expandable ring.
[0020] FIG. 9 shows the ring of the third valve sizer in a
retracted position.
[0021] FIG. 10 shows the ring of the third valve sizer in an
expanded position.
[0022] FIG. 11 shows a fourth valve sizer having an inflatable
balloon.
[0023] FIG. 12 is a perspective view of a fifth valve sizer.
[0024] FIG. 13 is a partial cut-away of the distal end of the fifth
valve sizer.
[0025] FIG. 14 is a cross-sectional view of the distal end of the
fifth valve sizer.
DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0026] 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 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.
[0027] 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.
[0028] The arms 8 include pins 22 which are positioned in slots 24
of the slotted discs 18. Rotation of the rod 20 causes the pins 22
to slide in the slots 24 of the slotted discs 18 thereby moving the
arms 8 in the slots 14 of the spacer 10 between the expanded and
retracted positions. Referring to FIG. 4, a bottom view is shown
with the arms 8 in the expanded position.
[0029] 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 Ser.
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
[0030] Referring again to FIGS. 1 and 2, the actuator 6 includes a
slot 28 with markings 30 indicating various valve sizes. A pointer
32 is coupled to the tube 4 an points to the marking 30 indicating
the valve size corresponding to the outer dimension of the arms 8.
The actuator 6 is coupled to the rod 20 so that rotation of the
actuator 6 causes the pointer 32 to move along the slot 28. The
markings 30 preferably indicate an outer diameter of 19 to 33 mm.
Although it is preferred to use the rotating actuator 6 to move the
arms 8, any other actuation mechanism may be used including a
trigger, sliding lever, or scissors-type actuator 6.
[0031] 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
Ser. 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 and in the retracted position of FIG. 2 for removing the
valve sizer 2 from the patient.
[0032] Referring to FIGS. 5 and 6, a second preferred valve sizer
50 is shown. The valve sizer 50 includes a tube 52 having an
actuator 54 at the proximal end. A number of arms 56 are movable
from the retracted position shown of FIG. 1 to the expanded
position shown in FIG. 2. A flexible sheath 58 is positioned around
the arms 56 but is shown separated from the device for clarity. The
sheath 58 is preferably made of silicone, however, any other
suitable material may be used.
[0033] An exploded view of the distal end of the second preferred
valve sizer 50 is shown in FIG. 7. A shaft 60 extends through the
tube 52 and is connected to the actuator 54 as will be described
below. Two discs 62 having holes 64 therein are mounted to the
shaft 60. The arms 56 have pins 66 which engage the holes 64 in the
discs 62 so that the arms 56 are free to rotate relative to the
discs 62. The arms 56 are preferably curved but may take any other
shape. The outer dimensions of the valve sizer 50 in the expanded
and retracted positions are preferably the same as the first the
patient's valve annulus when the actuator 54 is positioned outside
the patient's chest.
[0034] Top and bottom plates 68, 70 are attached a sealing plate 76
which is attached to the tube 52. The bottom plate 70 has a number
of camming elements 72 which engage the arms 56 for moving the arms
56 from the retracted to expanded position a described below. The
top plate 68 has openings 74 which receive the camming elements 72.
Thus, the top and bottom plates 68, 70, sealing plate 76 and tube
52 form a unitary structure. Although it is preferred to provide
the top plate 68, the top plate 68 may be omitted and the camming
elements 72 may be attached directly to the sealing plate 76.
[0035] The camming elements 72 are positioned and configured to
engage and deflect the arms 56 outward when the shaft 60 is
rotated. The camming elements 72 are curved members but may take
any other shape which cooperates with the arms 56 to cam the arms
56 outward when the shaft 60 is rotated with respect to the tube
52. The valve sizer 50 may include a locking mechanism (not shown),
such as a ratchet and pawl, for locking the valve sizer 50.
Alternatively, the actuator 54 may be designed with frictional
resistance to turning which effectively locks the arms 56.
[0036] Referring again to FIGS. 5 and 6, the actuator 54 has a slot
78 which receives a pointer 80. The pointer 80 is coupled to the
tube 52 so that the pointer 80 moves along the slot 78 when the
actuator 54 is rotated. The actuator 54 includes markings 82 which
indicate the valve size corresponding to the size defined by the
outer dimension of the arms 56 and sheath 58. The markings 82
preferably indicate an outer diameter of between 19 and 33 mm.
Although it is preferred to use the rotating actuator 54, any other
actuation mechanism may be used. The method of using the second
valve sizer 50 is the same as the first valve sizer 2 and a
description of the method of use is omitted here.
[0037] Referring to FIGS. 8-10, a third valve sizer 100 is shown.
The third valve sizer 100 has a ring 102 which is movable between
the retracted position of FIG. 9 to the expanded position of FIG.
10. An actuator 104 is mounted to the proximal end of a tube 106
and is used to move the ring 102 between the retracted and expanded
positions as will be described in greater detail below.
[0038] The ring 102 includes a first part 108 and a second part 110
slidably coupled 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.
[0039] The actuator 104 has an arcuate slot 128 therein which
receives a pin 130 attached to the tube 106. The actuator 104 is
attached to the shaft 124 so that rotation of the actuator 104
moves the first lever 116 with respect to the second lever 118. The
actuator 104 also preferably includes size indicators 132 which
indicate the valve size corresponding to the size of the ring 102.
The ring 102 preferably has the same dimensions as the arms 56 of
the first valve sizer when in the expanded and retracted
positions.
[0040] Use of the third valve sizer 100 is now described. The valve
sizer 100 is introduced into the patient with the ring 102 in the
retracted position of FIG. 9. The surgeon positions the ring 102
within the valve annulus and rotates the actuator 104 until the
ring 102 engages the valve annulus. The surgeon then reads the
indicators 132 to determine the appropriate valve size. The
actuator 104 is rotated so that the ring 102 assumes the retracted
position and the valve sizer 100 is removed from the patient.
Although it is preferred to provide the first and second levers
116, 118 for the expandable ring 102, any other mechanism may be
used including a ring 102 having teeth which engage a rotatable
gear. Alternatively, the ring 102 may be a flexible ring which
simply extends from the distal end of the shaft with the ring being
expanded and retracted by simply lengthening or shortening the
flexible ring. Furthermore, although the ring 102 is preferably
relatively flat, the ring 102 may be somewhat thick to form a
cylinder without departing from the scope of the invention.
[0041] Referring to FIG. 11, a fourth preferred valve sizer 150 is
shown. The valve sizer 150 includes a balloon 152 mounted to the
distal end of a rigid tube 154. A cylinder 156 is attached to the
proximal end of the tube 154 and a plunger 158 having a piston 160
is slidable within the cylinder 156. The tube 154 has a hole 162
through made of any conventional elastomeric material and is
preferably made of polyurethan or a thermoplastic elastomer.
[0042] The cylinder 156 is calibrated so that a given volume of
fluid or gas injected into the balloon 152 expands the balloon 152
to a known size. The cylinder 156 preferably includes indicators
164 which indicate the valve size corresponding to the diameter of
the balloon 152. The balloon 152 is inflated and deflated by
manipulating the plunger 158. The balloon 152 preferably has a
maximum outer dimension of no more than 17 mm, and more preferably
no more than 19 mm, and expands to a maximum outer dimension of at
least 30 mm and more preferably at least 33 mm. Although the
balloon 152 is shown as being somewhat elongate the balloon 152 may
also take any other shape such as a torus, sphere or any other
suitable shape. Furthermore, although it is preferred that the
balloon 152 expand around the entire periphery of the tube the
balloon 152 may be configured to expand from a side of the tube 154
rather than all around the tube 154. Although tube 154 is
preferably rigid, the tube 154 may be malleable to allow the tube
154 to conform to a desired shape.
[0043] A method of using the fourth valve sizer 150 is now
described. The balloon 152 is inserted into the patient's valve
annulus in the deflated condition and the surgeon depresses the
plunger 158 until the balloon 152 engages the valve annulus. The
surgeon then reads the indicators 164 to determine the appropriate
valve size. The balloon 152 is then deflated and the valve sizer
150 is removed from the patient.
[0044] Referring to FIGS. 12-14, a fifth valve sizer 200 is shown.
The fifth valve size 200 has a handle 202 from which extends a tube
204 and a shaft 206. A first element 208 is attached to the tube
204. A second element 210 is linearly slidable with respect to the
first element 208 from the retracted solid-line position of FIG. 13
to the expanded, dotted-line position of FIG. 13. A pair of springs
212 bias the first and second elements 208, 210 toward the expanded
position.
[0045] Referring to FIGS. 13 and 14 the tube 204 is attached to the
first element 208 at a flange. The shaft 206 extends through the
first element 208 toward a deflectable tongue 214 attached to the
second element 210. The first and second elements 208, 210 are
locked to one another by moving the shaft 206 downward into contact
with first element 208 by actuating thumb switch 216 (FIG. 12)
which is coupled to the shaft 206. The tongue 214 is deflected
downwardly by the shaft 206 into frictional together. The second
element 210 preferably includes valve size indications 218 which
indicate the valve size corresponding to the size between outer
edges 220 of the first and second elements 208, 210. The fifth
valve sizer 200 preferably has the same dimensions as the first
valve sizer 2 when in the expanded and retracted positions.
Although it is preferred to use the springs 212 and the deflectable
tongue 214 to move and lock the first and second elements 208, 210
together, it is within the scope of the invention to provide any
other moving and locking mechanism. For example, the fifth valve
sizer 200 may include a rotatable shaft having a gear which engages
a rack in the second element 210 for moving the second element 210
with respect to the first element 208. A proximal size indicator
could be used with the gear and rack configuration.
[0046] Use of the fifth valve sizer 200 is now described. The valve
sizer 200 is introduced into the patient's valve annulus with the
first and second elements 208, 210 in the retracted position. The
surgeon then manipulates the thumb switch 216 so that the shaft 206
moves proximally and releases the tongue 214. The first and second
elements 208, 210 are then biased outwardly by the springs 212
until they contact the valve annulus. The surgeon then manipulates
the thumb switch 216 again to lock the first and second elements
208, 210 together. The surgeon then removes the valve sizer 200 and
reads the valve sizer indications 218 to determine the appropriate
valve size.
[0047] The above description merely describes the preferred
embodiments and it is understood that variations of the preferred
embodiment are within the scope of the invention which is defined
by the claims. For example, although the preferred valve sizers are
attached to shafts which do not articulate it is within the scope
of the invention to provide articulating or malleable shafts so
that the distal ends may be pivoted. Furthermore, although it is
preferred to use the valve sizers when performing a minimally
invasive valve replacement procedure, the valve sizer may also be
used in a conventional open-chest procedure.
* * * * *