U.S. patent application number 15/063353 was filed with the patent office on 2016-06-30 for catheter-based clutched heart valve sizer.
The applicant listed for this patent is Edwards Lifesciences Corporation. Invention is credited to Da-Yu Chang, Brian S. Conklin.
Application Number | 20160183843 15/063353 |
Document ID | / |
Family ID | 49775067 |
Filed Date | 2016-06-30 |
United States Patent
Application |
20160183843 |
Kind Code |
A1 |
Conklin; Brian S. ; et
al. |
June 30, 2016 |
CATHETER-BASED CLUTCHED HEART VALVE SIZER
Abstract
A valve sizer for determining an appropriate replacement valve
size when performing a heart valve replacement procedure is
provided. In one version the valve sizer has a hollow shaft with
proximal and distal ends. A movable sizing element couples to the
distal end of the shaft and is radially expandable between first,
contracted and second, expanded positions. An actuator assembly on
a handle includes an actuator coupled to a clutch member via a
ball-spring-detent clutch. A rod extends through the shaft and
maintains a fixed distance between the handle and a distal hub in
the sizing element. Movement of the actuator causes axial movement
of the shaft, thereby causing radial expansion of sizing petals
relative to the hub. The clutch slips when a predetermined reaction
force from the surrounding valve annulus is met by the petals.
Inventors: |
Conklin; Brian S.; (Orange,
CA) ; Chang; Da-Yu; (Irvine, CA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Edwards Lifesciences Corporation |
Irvine |
CA |
US |
|
|
Family ID: |
49775067 |
Appl. No.: |
15/063353 |
Filed: |
March 7, 2016 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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14011602 |
Aug 27, 2013 |
9277996 |
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15063353 |
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13707395 |
Dec 6, 2012 |
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14011602 |
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61568913 |
Dec 9, 2011 |
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Current U.S.
Class: |
600/587 |
Current CPC
Class: |
A61B 2090/066 20160201;
A61B 5/1076 20130101; A61B 2090/065 20160201; A61F 2/2496 20130101;
A61B 5/6859 20130101; A61B 5/02028 20130101; A61B 2090/064
20160201; A61F 2/243 20130101 |
International
Class: |
A61B 5/107 20060101
A61B005/107; A61B 5/02 20060101 A61B005/02; A61B 5/00 20060101
A61B005/00; A61F 2/24 20060101 A61F002/24 |
Claims
1. A percutaneously delivered heart valve sizer for determining an
appropriate replacement prosthetic heart valve size when performing
a valve replacement procedure, the replacement prosthetic heart
valves having a range of specific sizes, comprising: a proximal
handle having an actuator mounted for movement thereon; a shaft
extending distally from the actuator and housing an actuation rod
axially displaceable by the actuator; a sizing element coupled to a
distal end of the shaft, the sizing element having a central hub
with a central bore along a central axis that receives the
actuation rod and a plurality of petals each radially movable
between a radially retracted first position and a radially expanded
second position, the petals being connected to transition between
the first and second positions upon displacement of the actuation
rod in the shaft, wherein the petals remain parallel to the axis of
the hub while being displaced between the first and second
positions; a catheter configured for percutaneous delivery that
receives the sizer with the petals in their first position and
through which the sizer may be advanced to a heart valve annulus
and expelled for sizing a surrounding heart valve annulus; and a
clutch mechanism connected between the actuator and the actuation
rod in the shaft so as to transmit movement forces therebetween,
wherein movement of the actuator causes displacement of the
actuation rod and consequently outward radial expansion of the
petals in the sizing element from their first to their second
positions and into contact with the heart valve annulus, wherein
the clutch mechanism slips at a predetermined reaction force
imparted by the heart valve annulus against further outward radial
expansion of the petals.
2. The valve sizer of claim 1, wherein the actuation rod acts on a
plurality of first levers pivotally connected to the central hub
that move outward in conjunction with a plurality of second levers
pivotally connected to the central hub to radially displace the
petals, and the lengths of the first and second levers are the
same.
3. The valve sizer of claim 2, wherein the central hub comprises a
generally cylindrical body having a series of radially-projecting
axial ribs, and the first and second levers rotate about pins
journaled in the sides of adjacent axial ribs.
4. The valve sizer of claim 2, wherein the actuation rod acts on
small fingers on both the first and second levers so as to produce
an outward force on both levers.
5. The valve sizer of claim 2, wherein the first and second levers
are connected together and move outward in a scissor-like
fashion.
6. The valve sizer of claim 5, wherein the actuation rod has a
plurality of movement tabs projecting outward through axial slots
in the central hub to which a proximal end of each of the first
levers connects via a pivot pin, and a distal end of each of the
first levers connects via a pivot pin to a distal end of a sizing
petal, and wherein a distal end of each of the second levers
connects via a pivot pin to a fixed point at a distal end of the
central hub, while a proximal end of each of the second levers
connects via a pivot to a proximal section of the corresponding
sizing petal, and wherein each pair of first and second levers are
connected where they cross each other at their midpoints by a
fulcrum pin.
7. The valve sizer of claim 2, wherein the central hub comprises a
generally cylindrical member having a plurality of axial recesses
between axial ribs on its outer surface that receive and
accommodate the first and second levers as well as the petals in
their radially retracted first positions so as to form a cylinder,
with the outer surfaces of the petals lying flush with the
ribs.
8. The valve sizer of claim 1, wherein the actuator comprises an
actuator ring mounted for rotation on the handle, and the actuation
rod is fixed with respect to a clutch ring that is coupled for
rotation to the actuator ring via the clutch mechanism, and wherein
the clutch ring is connected via a screw thread to the handle so
that rotation of the clutch ring causes axial movement of the
actuation rod.
9. The valve sizer of claim 8, wherein the clutch ring is coupled
for rotation to the actuator via a plurality of bearings biased by
springs into detents.
10. The valve sizer of claim 1, wherein the actuator comprises an
actuator ring mounted for rotation on the handle, and the actuation
rod is fixed with respect to a clutch ring that is coupled for
rotation to the actuator ring via the clutch mechanism, and wherein
the handle also includes a window at one circumferential location
and the clutch ring has a number of numerical markings thereon
indicating different sizes of replacement prosthetic heart valves,
the numerical markings being sized and aligned to show one at a
time through the window on the handle upon rotation of the clutch
ring relative to the handle such that a desired valve size shows
through the window when the clutch mechanism slips.
11. The surgical sizer of claim 1, wherein the sizing element has a
diameter of less than about 6 mm when the petals are in their
radially retracted first positions, and the sizing element has a
diameter of about 29 mm when the petals are in their radially
expanded second positions.
12. A percutaneously delivered heart valve sizer for determining an
appropriate replacement prosthetic heart valve size when performing
a valve replacement procedure, the replacement prosthetic heart
valves having a range of specific sizes, comprising: a proximal
handle having an actuator mounted for movement thereon; a shaft
extending distally from the actuator and housing an actuation rod
axially displaceable by the actuator; a sizing element coupled to a
distal end of the shaft, the sizing element having a plurality of
petals each radially movable between a radially retracted first
position and a radially expanded second position upon displacement
of the actuation rod in the shaft, wherein the sizing element has a
diameter of less than about 6 mm when the petals are in their
radially retracted first positions; a catheter configured for
percutaneous delivery that receives the sizer with the petals in
their first position and through which the sizer may be advanced to
a heart valve annulus and expelled for sizing a surrounding heart
valve annulus; and a clutch mechanism connected between the
actuator and the actuation rod in the shaft so as to transmit
movement forces therebetween, wherein movement of the actuator
causes displacement of the actuation rod and consequently outward
radial expansion of the petals in the sizing element from their
first to their second positions and into contact with the heart
valve annulus, wherein the clutch mechanism slips at a
predetermined reaction force imparted by the heart valve annulus
against further outward radial expansion of the petals.
13. The valve sizer of claim 11, wherein the sizing element has a
central hub with a central bore along a central axis that receives
the actuation rod, and the actuation rod acts on a plurality of
first levers pivotally connected to the central hub that move
outward in conjunction with a plurality of second levers pivotally
connected to the central hub to radially displace the petals, and
the lengths of the first and second levers are the same.
14. The valve sizer of claim 12, wherein the central hub comprises
a generally cylindrical body having a series of radially-projecting
axial ribs, and the first and second levers rotate about pins
journaled in the sides of adjacent axial ribs.
15. The valve sizer of claim 12, wherein the actuation rod acts on
small fingers on both the first and second levers so as to produce
an outward force on both levers.
16. The valve sizer of claim 12, wherein the first and second
levers are connected together and move outward in a scissor-like
fashion.
17. The valve sizer of claim 15, wherein the actuation rod has a
plurality of movement tabs projecting outward through axial slots
in the central hub to which a proximal end of each of the first
levers connects via a pivot pin, and a distal end of each of the
first levers connects via a pivot pin to a distal end of a sizing
petal, and wherein a distal end of each of the second levers
connects via a pivot pin to a fixed point at a distal end of the
central hub, while a proximal end of each of the second levers
connects via a pivot to a proximal section of the corresponding
sizing petal, and wherein each pair of first and second levers are
connected where they cross each other at their midpoints by a
fulcrum pin.
18. The valve sizer of claim 12, wherein the central hub comprises
a generally cylindrical member having a plurality of axial recesses
between axial ribs on its outer surface that receive and
accommodate the first and second levers as well as the petals in
their radially retracted first positions so as to form a cylinder,
with the outer surfaces of the petals lying flush with the
ribs.
19. The valve sizer of claim 11, wherein the actuator comprises an
actuator ring mounted for rotation on the handle, and the actuation
rod is fixed with respect to a clutch ring that is coupled for
rotation to the actuator ring via the clutch mechanism, and wherein
the clutch ring is connected via a screw thread to the handle so
that rotation of the clutch ring causes axial movement of the
actuation rod.
20. The valve sizer of claim 18, wherein the clutch ring is coupled
for rotation to the actuator via a plurality of bearings biased by
springs into detents.
21. The valve sizer of claim 11, wherein the actuator comprises an
actuator ring mounted for rotation on the handle, and the actuation
rod is fixed with respect to a clutch ring that is coupled for
rotation to the actuator ring via the clutch mechanism, and wherein
the handle also includes a window at one circumferential location
and the clutch ring has a number of numerical markings thereon
indicating different sizes of replacement prosthetic heart valves,
the numerical markings being sized and aligned to show one at a
time through the window on the handle upon rotation of the clutch
ring relative to the handle such that a desired valve size shows
through the window when the clutch mechanism slips.
22. The surgical sizer of claim 11, wherein the sizing element has
a diameter of about 29 mm when the petals are in their radially
expanded second positions.
Description
RELATED APPLICATIONS
[0001] This application is a continuation of U.S. patent
application Ser. No. 14/011,602, filed Aug. 27, 2013, now U.S. Pat.
No. 9,277,996, which is a continuation-in-part of U.S. patent
application Ser. No. 13/707,395, filed Dec. 6, 2012, which claims
the benefit of U.S. Application No. 61/568,913, filed Dec. 9, 2011,
the disclosures all of which are incorporated by reference.
FIELD
[0002] The present disclosure is directed to methods and apparatus
for determining a size of a valve annulus. More particularly, the
present disclosure relates to a heart valve sizer.
BACKGROUND
[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
removably or fixedly attached to a rod. The size of each of the
discs corresponds to an available valve size. The surgeon 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 body and inserts a
new disc into the valve annulus. The size of a patient's native
heart valve annulus is determined by inserting sizers of various
diameters until the surgeon determines which one feels correct.
This is a time-consuming method since for each valve size the
surgeon inserts, the surgeon must remove one of the discs and try
another one. This procedure increases the overall surgery time
which increases the risk to the patient and also increases the cost
of the procedure. Further, the determination of the appropriate
size is based on the feeling of the surgeon rather than any
mechanical feature. This determination based on the feeling of the
surgeon may not be accurate. Thus there is a need for a sizer that
is accurate in determining the size of the annulus of a valve.
[0005] Alternatively, a heart valve sizer may be used which is
introduced into the patient only once, and the same sizer is
capable of gauging a number of appropriate valve sizes. However,
these sizers are dimensionally the same as the valves they
represent. Due to size constraints, insertion of the heart valve
sizers may be a hindrance for certain procedures, especially for
minimally invasive surgical incisions such as thoracotomies. With
minimally invasive surgical (MIS) type procedures performed through
small surgical incisions, the surgeon may not have a good approach
angle to the native annulus, thus hindering an accurate tactile
feedback to the surgeon when the sizer is in place.
[0006] Additionally, it is essential for the replacement heart
valve to be of the right fit. In determining the optimal
replacement device for a diseased heart valve, a surgeon generally
exerts some level of force to determine a tight fit size. Each
surgeon may have a different definition of a tight fit and what is
the optimal force that may be exerted. Also, excessive force if
applied may result in inaccurate sizing of the annulus, or even
tissue damage. Also, traditional valves involve parachuting the
valve down to the annulus with 12 to 14 sutures, and thus sizing is
somewhat less sensitive. However, newer valves sometimes employ
only three or in some cases no sutures making sizing accuracy more
challenging. It is more difficult to avoid paravalvular leaks and
risk of embolization if three of no sutures are used and there is a
sizing mistake.
[0007] Given the above limitations, it is desirable to have a
single, one-size-fits-all sizer which could be used to quickly and
accurately determine the appropriate valve size for a patient's
heart through a minimal sized incision. It is desirable to have a
sizer that does not rely entirely on the surgeon's feel, but on a
mechanism that consistently and more accurately determines the
patient's annulus size.
SUMMARY
[0008] The embodiments of the present disclosure have several
features, no single one of which is solely responsible for their
desirable attributes. Without limiting the scope of the present
embodiments as expressed by the claims that follow, their more
prominent features will now be discussed briefly. After considering
this discussion, and particularly after reading the section
entitled "Detailed Description", one will understand how the
features of the present embodiments provide advantages, which
include providing an adjustable force-based heart valve sizer
system that can be used to determine the size of patient's heart
valve annulus using a single sizer through minimal size
incision.
[0009] In one embodiment, an adjustable valve sizer is provided.
The valve sizer includes an elongate shaft having a proximal end
and a distal end with a movable sizing 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 sizing
element. An actuator assembly is provided at the proximal end for
moving the movable sizing element so that the valve sizing portion
corresponds to the various valve sizes.
[0010] In a preferred device, a heart valve sizer for determining
an appropriate replacement prosthetic heart valve size when
performing a valve replacement procedure comprises a proximal
actuator, a shaft extending distally from the actuator and having a
movable member and a stationary member, and a sizing element
coupled to the distal end of the shaft. The sizing element has a
hub and a plurality of petals each radially movable between a first
retracted position and a second expanded position. The hub is fixed
to the stationary member in the shaft and the petals are connected
to expand radially upon displacement of the movable member in the
shaft. A clutch mechanism connected between the actuator and the
movable member in the shaft transmits movement forces therebetween,
wherein movement of the actuator causes displacement of the movable
member and consequently outward radial expansion of the petals in
the sizing element into contact with a surrounding heart valve
annulus. The clutch mechanism slips at a predetermined reaction
force imparted by the heart valve annulus against further outward
radial expansion of the petals.
[0011] A preferred method of sizing a patient's cardiac valve
annulus disclosed herein comprises the steps of:
[0012] providing a valve sizer having a shaft with a proximal end
and a distal end and an expandable sizing element coupled to the
distal end of the shaft, the sizing element being radially
expandable between a first retracted position and a second expanded
position, the valve sizer further having an actuator assembly
comprising an actuator that moves relative to a handle, a clutch
ring mounted at the proximal end of the shaft and coupled for
rotation to the actuator via a clutch mechanism, and a stationary
rod extending through at least a portion of the shaft, wherein the
shaft is connected to the clutch ring so that movement of the
actuator transmits through the clutch mechanism to the clutch ring
and shaft and causes axial movement of the shaft, wherein the axial
movement of the shaft causes radial expansion of the sizing
element;
[0013] inserting the valve sizer in the first retracted position
into the patient so that the movable element is positioned within
the valve annulus; and
[0014] rotating the handle until the clutch mechanism of the
actuator assembly begins to slip indicating that the sizer has
fully engaged the annulus.
[0015] In both the preferred device and method, shaft preferably
comprises a rod extending through a hollow shaft and the actuator
comprises an actuator ring, where the rod is the stationary member
fixed with respect to both the handle and the hub, and the hollow
shaft is fixed with respect to a clutch ring that is coupled for
rotation to the actuator ring via the clutch mechanism. In this
configuration, the clutch ring is connected via a screw thread to
the stationary handle so that rotation of the clutch ring causes
axial movement of the hollow shaft. The clutch mechanism may
comprise a plurality of bearings biased by springs into detents.
The plurality of bearings and the springs are desirably held within
the clutch ring and the detents are formed on an inner surface of
the actuator ring. The bearings and springs may be separate
elements held within channels in the clutch mechanism, or may be
cantilevered fingers formed in a sidewall of the clutch ring.
[0016] In one version, the plurality of sizer petals move in a
plane substantially perpendicular to a longitudinal axis defined by
the shaft. The movable member may move axially along the shaft and
contact and pivot a lever for each of the petals, wherein pivoting
of the levers causes radial expansion of the petals. Or, the
movable member may move axially along the shaft and connect to a
camming member that directly contacts and causes radial expansion
of the petals. The plurality of petals may define a cylindrical
annulus portion and an outwardly-extending flange on a proximal end
of the cylindrical annulus portion, and the outwardly-extending
flange may have an axially undulating peripheral shape.
[0017] In a percutaneous version, the sizer is configured for
delivery through a catheter and the petals in their first retracted
position limit the diameter of the sizing element to be small
enough to enable passage through the catheter, and the petals
remain parallel to an axis of the hub while being displaced
outward. Desirably, the sizing petals comprise axial bars that
retract within recesses within a central hub so as to form a flush
cylindrical shape for passing through the catheter. An actuation
rod moves within a central bore within the hub and acts on a
plurality of struts or levers connected to displace the sizing
petals radially outward. In one embodiment, the sizing petals are
displaced directly radially outward without axial movement. For
example, the levers may be connected to move in a scissor-like
fashion with one having a distal end fixed at a pivot point on the
central hub so that the proximal end of the levers move axially in
concert.
[0018] In another embodiment, a force feedback-based heart valve
sizer is provided. A force feedback-based sizer provides a
calibrated force indication that allows the surgeon to apply the
optimal (or at least a known) level of force. The force
feedback-based sizer provides tactile and visual feedback to the
surgeon that a desired force has been reached. The force
feedback-based sizer may additionally measure the force applied and
display the value. It may further comprise a force limiter, or
clutch, that prevents forces above a pre-determined level from
being transmitted through to the sizer.
[0019] These and other features will become apparent with the
following description of the preferred embodiments.
BRIEF DESCRIPTION OF THE DRAWINGS
[0020] The embodiments of the present disclosure will now be
discussed in detail with an emphasis on highlighting the
advantageous features. These embodiments depict the novel and
non-obvious features shown in the accompanying drawings, which are
for illustrative purposes only. These drawings include the
following figures, in which like numerals indicate like parts:
[0021] FIGS. 1A-1C show a perspective view of a heart valve sizer
with a sizing element having sizing petals in radially expanded
positions, according to one embodiment;
[0022] FIG. 1D shows the heart valve sizer with the sizing element,
and the sizing petals in radially retracted positions;
[0023] FIGS. 2A-2C show cross sectional views of an actuator
assembly for the various sizing elements disclosed herein;
[0024] FIGS. 3A-3B show an alternative clutch ring with valve size
markings according to one embodiment for use in the actuator
assemblies disclosed herein;
[0025] FIG. 3C shows an exploded view of an actuator assembly
including an actuator ring and the clutch ring of FIGS. 3A-3B;
[0026] FIG. 3D shows an exploded view of an actuator assembly
similar to that in FIG. 3C and showing an alternative clutch ring
with bearings and springs integrated into the clutch ring as
cantilevered fingers;
[0027] FIGS. 3E and 3F are perspective and plan views of the
alternative clutch ring of FIG. 3D;
[0028] FIGS. 3G-3I are alternative bearing shapes for the
integrated springs;
[0029] FIG. 3J is a still further clutch ring where the springs are
cantilevered fingers coupled to the clutch ring via an elastomeric
interface;
[0030] FIG. 3K shows a clutch ring assembly with a housing that
receives a sheet metal ring that forms cantilevered bearings and
springs;
[0031] FIGS. 4A and 4B show an alternative actuator assembly
exploded and assembled with a sizing element having a hub
cover;
[0032] FIG. 5A shows the sizing element with sizing petals in a
semi-expanded position, and FIG. 5B is a cross section thereof;
[0033] FIG. 5C shows a petal and a hub assembly from the sizing
element of FIG. 5A, while FIG. 5D shows a single petal and a lever
that links the petal to the hub;
[0034] FIGS. 6A and 6B are assembled and exploded views of an
alternative sizing element of the present application;
[0035] FIGS. 7A and 7B are sectional views through an alternative
actuator assembly and sizing element having a conical camming
hub;
[0036] FIG. 7C shows a ratchet mechanism for use in the actuator
assembly of FIG. 7A;
[0037] FIG. 8A shows the sizing element coupled at the distal end
of a shaft with sizing petals in a retracted position;
[0038] FIG. 8B shows a cross-section along lines A-A' of the sizing
element of FIG. 8A;
[0039] FIG. 8C shows an individual sizing petal;
[0040] FIG. 9A shows the sizing element with sizing petals in an
expanded position;
[0041] FIG. 9B shows a cross-section along lines B-B' of the sizing
element of FIG. 9A;
[0042] FIG. 10 shows the disc that cooperates with the hub in the
sizers of FIGS. 8A-9B and 13A-14B;
[0043] FIG. 11 shows one embodiment of the hub;
[0044] FIG. 12 shows a cylindrical sizing element with expanded
petals covered with an extendable membrane;
[0045] FIGS. 13A-13B show a tapered conical sizing element with
petals in retracted and expanded positions, respectively, according
to another embodiment;
[0046] FIGS. 14A-14B show a concave shaped sizing element with
petals in retracted and expanded positions, according to yet
another embodiment;
[0047] FIG. 15 is a schematic view of a feedback-based heart valve
sizer that utilizes a torque sensor and display in conjunction with
a sizing element to determine the valve orifice size;
[0048] FIG. 16A-16B show a force feedback-based heart valve sizer,
according to another embodiment;
[0049] FIG. 17A-17B show a force feedback-based heart valve sizer,
according to yet another embodiment;
[0050] FIGS. 18A-18B show a heart valve sizer with a flexible
coil;
[0051] FIGS. 19A-19E show a heart valve sizer with stackable valve
hubs;
[0052] FIG. 20 shows a heart valve sizer with a pressure gauge.
[0053] FIG. 21 shows a cross-sectional view of a force
feedback-based heart valve sizer, according to yet another
embodiment;
[0054] FIGS. 22A-22C show a catheter-based sizing element in
accordance with the present application in several stages of
expansion;
[0055] FIGS. 23 and 24A-24B are further views of the catheter-based
sizing element;
[0056] FIGS. 25 and 26 are enlarged views of two components of the
catheter-based sizing element;
[0057] FIGS. 27A-27D are perspective and sectional views of an
alternative catheter-based sizing element;
[0058] FIGS. 28-30 are enlarged views of components of the
alternative catheter-based sizing element; and
[0059] FIGS. 31 and 32 are schematic views of a balloon catheter
inflation system that utilizes a clutch-limiter as described herein
to limit the maximum inflation pressure.
DETAILED DESCRIPTION
[0060] Referring to FIGS. 1A-1D, a first valve sizer 100 is shown.
The valve sizer 100 includes an elongate hollow shaft 104 extending
along the length of the sizer. An actuator assembly 106 is coupled
to the proximal end of the shaft 104, while a radially expandable
sizing element 107 is coupled to the distal end. The shaft 104 is
preferably malleable ensuring that it is flexible enough to allow
the sizer 100 access to the annulus from different angles, or
through curved or bent access passages. The handle 102 is
preferably static and is used for keeping the valve sizer steady in
the hands of the operator.
[0061] With reference to FIGS. 1C and 2A-2C, the actuator assembly
106 includes an actuator 105, a handle 102, a clutch ring 121 (also
referred to as ring 121), and a clutch cover 126 mounted within the
actuator 105. The handle 102 threadingly engages a tubular threaded
portion 121B ending axially up from the ring 121 which, in turn, is
mounted to the shaft 104. Rotation of the clutch ring 121 relative
to the handle 102 causes axial displacement therebetween. The
handle 102 is used for positioning the radially expandable sizing
element 107 on the end of the shaft 104 within the annulus. As will
be seen, rotation of the actuator 105 and clutch ring 121 expands
and retracts the radially expandable sizing element 107 so that the
valve sizing portion corresponds to various valve sizes, as will be
discussed in detail below.
[0062] The radially expandable sizing element 107 defines an outer
dimension of the valve sizing portion. The sizing element 107 has a
hub 117 with a number of sizing petals 108 that extend radially
outward from the hub 117 and are mounted to move radially in and
out. FIGS. 1A-1C illustrate the sizing petals 108 in radially
expanded positions while FIG. 1D illustrates the sizing petals 108
in radially retracted positions. Rotation of the actuator 105
controls the radial expansion of the sizing petals 108 from the
retracted position to the expanded position as will be described
below.
[0063] As best seen in FIG. 1A and also in FIG. 1D, the distal end
of the handle 102 has a window 130 which shows a number of
numerical markings 133 on the ring 121 indicating the size of the
valve sizer. The ring 121 has a circular base 121A with markings
133 (see FIGS. 3A and 3B) for indicating the valve size, and the
tubular threaded portion 121B extending laterally in the handle.
Rotation of the actuator 105 rotates the clutch ring 121 and
markings 133 thereon past the window 130 until a predetermined
torque limit is reached, at which point a clutch mechanism slips,
as will be explained, and further rotation of the actuator 105 is
decoupled from the ring 121. The valve size corresponding to the
torque limit is displayed in the window 130. In other words, the
actuator 105 continues to expand the sizing element 107 outward
until it contacts the surrounding annulus, at which point the
resistance imparted to the sizing element 107 transmits back
through the clutch mechanism, decoupling rotation of the actuator
105 from the clutch ring 121.
[0064] FIGS. 2A-2C show various cross-sectional views of the
actuator assembly 106. FIG. 3C shows an exploded view of the
actuator 105 and the ring 121. Ring 121 is inserted in the actuator
105 where the tubular threaded section 121B extends from the top
recess 128A towards the bottom recess 128B. FIG. 4A shows an
exploded view of the actuator assembly 106 mounted on the shaft
104. A clutch cover 126 snap fits on the actuator 105 over the
clutch ring 121.
[0065] With reference again to FIGS. 1C and 2A-2C, the actuator
assembly 106 comprises the actuator 105 having a top recess 128A
and a bottom recess 128B. The handle 102 engages the tubular
threaded portion 121B on the clutch ring 121 within the actuator
top recess 128A. The clutch ring 121 is fixed with respect to the
hollow shaft 104, while the handle 102 mounts to a fixed length
cable or rod 120 extending laterally through the shaft 104. The
length of the cable or rod 120 extending between the hub 117 and
the handle 102 is fixed, and in this sense the rod 120 forms a
stationary member between the handle 102 and the hub 117.
[0066] As seen in FIG. 2C, a stepped washer 140 abuts the lower end
of the clutch ring 121 towards the bottom recess 128B of the
actuator 105 and mounts such as with adhesive to the shaft 104. A
clutch cover 126 snap fits over the clutch ring 121, and threads
within the actuator 105, and therefore locks the washer 140 and the
ring 121 within the actuator 105 at the bottom recess 128B of the
actuator. The washer 140 is captured between the lower cover 126
and the lower surface of the clutch 121A, and along with the shaft
104 moves distally and proximally with the actuator mechanism.
[0067] FIG. 2B shows the ratchet mechanism for the ring 121
according to one embodiment. As will be described below, the shaft
104 attaches to a mechanism that expands the sizer 100 and is
coupled to the clutch actuator 105 by a ratcheting mechanism. As
seen also in FIG. 3A, a cylindrical base 121A of the ring 121 has
springs 124 inserted into or extending across at least one
diametric hole 123. Spring-loaded bearings 122 seat into a series
of cutouts or detents 125 formed on an inner surface of the
surrounding actuator ring 105. Rotation of the actuator ring 105
thus rotates the clutch ring 121 until the bearings 122 slip from
the detents 125 against the force of the springs 124.
[0068] The clutch ring 121 and the actuator 105 function as a
ratcheting mechanism such that when a predetermined amount of
torque is applied, the actuator 105 ratchets and does not drive the
shaft 104 any further. Therefore, the size of the annulus is
determined by rotating the actuator 105 until the ring 121 begins
to ratchet. The actuator 105 is coupled to the ring 121 such that
the rotation of the actuator 105 causes the shaft 104 to move. The
force needed to overcome the ratchet mechanism is set to correspond
to the reaction force being applied to the sizing petals by the
annulus being sized. That is, the reaction force imparted by the
annulus to the sizer as the sizer expands gradually increases until
the sizing petals fully engage the annulus. The reaction force
creates a reaction torque in the shaft 104 which will eventually
overcome the springs 124 in the ratchet mechanism such that the
clutch slips. The markings 133 indicate an outer diameter of the
annulus. The torque at which the clutch slips may be calibrated to
match a particular reaction force experienced by the sizing element
107, such as by varying the spring force or number or character of
the bearings 122, springs 124, and detents 125.
[0069] Also, although it is preferred to use the rotating actuator
105 to move the sizing petals 108, any other actuation mechanism
may be used including a trigger, sliding lever, or scissors-type
actuator 106. The hollow shaft 104 forms a movable member between
the handle 102 and hub 117, and transmits the force needed to
operate the petals 108. Other movable members are possible, and the
movement need not be linear but could also be rotational.
Essentially, there is a stationary member (e.g., rod 120) that
holds the hub 117 from moving relative to the handle, 102, and a
movable member (e.g., the shaft 104) that transmits the driving
force from the handle to the hub to operate the petals 108, and a
variety of such mechanisms are within the scope of the present
application.
[0070] The ball-spring-detent type of clutch mechanism is preferred
in the heart valve sizing context as sensitivity to environmental
factors is relatively low. That is, the accuracy of the torque
limit is known with a high degree of accuracy and is not affected
by temperature, fluids such as blood, etc. Repeatable results in
the operating room make such a clutch system preferable to one
which relies on frictional forces, as the coefficient of friction
of the contact surfaces may change when subjected to a wet
environment, temperature fluctuations, or after being
sterilized.
[0071] FIG. 3D shows another ball-spring-detent type of clutch
mechanism similar to that in FIGS. 2-3 but with an alternative
clutch ring 121', while FIGS. 3E and 3F are perspective and plan
views of the alternative clutch ring.
[0072] As in the earlier embodiment, the ratchet mechanism for the
clutch ring 121' spring-loaded bearings 122' seat into a series of
cutouts or detents 125 formed on an inner surface of the
surrounding actuator ring 105. Rotation of the actuator ring 105
thus rotates the clutch ring 121' until the bearings 122' slip from
the detents 125 against the force of the springs. Instead of
separate springs and ball bearings, as described above, the clutch
ring 121' has cantilevered springs 124' formed into the sidewall of
the cylindrical base 121A'. The finger-like springs 124' are
defined by L-shaped slits 124A cut into the sidewall, first axially
and then circumferentially. The bearings 122' comprise outward
dome-shaped bumps or protrusions integral with and located at the
terminal end of the finger-like springs 124'.
[0073] In addition to the dome-shaped bearings 122' shown in FIGS.
3D-3F, the bearings 122' can be formed in other shapes. For
instance, FIG. 3G shows the bearings 122' as semi-circular disks,
FIG. 3H as prisms, and FIG. 3I as cones. FIG. 3J illustrates a
cantilevered spring 124'' configured as a solid cantilevered beam
terminating in the bearing 122' that is coupled to the larger
cylindrical base 121A' via an elastomeric interface. For instance,
the beam may be coupled using elastomeric polymer adhesive, or be
overmolded or two-shot molded with an elastomer. In other words,
the cantilevered spring 124'' is a separate element from the
surrounding base 121A'.
[0074] Still further, FIG. 3K illustrates a plurality of
cantilevered springs 124''' formed from a continuous sheet metal
ring 129, with the bearings 122'' bent outward at the end of each
spring. The ring 129 then assembles into mating slots and recesses
formed on the underside of an alternative cylindrical base 121A''
to form the clutch ring. The sheet metal ring 129 may be formed
from thin-walled tubing, or first formed flat and then rolled.
Techniques of fabrication may include stamping, forging and
electroplating. The bearings 122'' are shown as rounded bends, but
any of the previously mentioned shapes, and others, could be
utilized.
[0075] The function of the separate ball bearings and springs has
thus been consolidated into the cantilevered springs 124' and
bearings 122'. This consolidation helps reduce the cost and
assembly time of the device. Further, the cantilevered springs 124'
offer low dimensional variation between parts which ensures
consistency in the torque-slip force between units. Calibration of
the length, shape and material spring rate of the springs 124'
allows the designer to control the torque at which the clutch will
slip, as with the ball bearing/spring mechanism. Indeed, there are
a number of ways to provide the clutch mechanism, the illustrated
embodiments merely being representative.
[0076] Details of the components and function of an exemplary
sizing element 107 will now be described. FIG. 4A shows the
actuator assembly 106 mounted on the shaft 104, which terminates in
an actuation bearing 109. FIG. 4B shows the shaft 104 and actuation
bearing 109 positioned just proximal to the sizing element 107. As
will be explained, axial displacement of the actuation bearing 109
within the sizing element 107 causes radial movement of the petals
108 via a camming and linkage system shown best in FIGS. 5A-5D.
[0077] As seen in FIGS. 5B and 5C, the hub 117 includes a top
portion 117B and a bottom portion 117A connected through a shaft
stub 119, which extends through the top portion 117B to the bottom
portion 117A of the hub. As shown in FIG. 5B, the fixed length
cable or rod 120 extends into and is fastened within the shaft stub
119, and thus the hub 117. In this way, the distance between the
handle 102 and hub 117 remains constant. The top portion 117B and
the bottom portion 117A include a plurality of features, such as
slots 117C in the top portion 117B, splaying outward around a
central axis for interacting with the linkages for moving the
petals 108.
[0078] The camming assembly further comprises a hub cover 109A that
snap fits to the hub 117, and the actuation bearing 109 extends
through the hub cover 109A and fits within a bore in the top
portion of the hub 117B. As seen in FIGS. 4B and 5B, the actuation
bearing 109 has a distal end 109B and a proximal end 109C. The hub
cover 109A rests over the proximal end 109C of the actuation
bearing 109. The distal end 109B of the actuation bearing 109 is
shaped like a disc. Actuation bearing 109 is coaxially placed
around and fastened to the hollow shaft 104, and is aligned with
the shaft stub 119 of the hub 117. Both the hollow shaft 104 and
actuation bearing 109 slide over the rod 120, which again is
anchored in the hub 117. Displacement of the hollow shaft 104 thus
displaces the actuation bearing 109 relative to the hub 117.
[0079] The camming assembly includes a number of levers 113 for
coupling the petals 108 with the hub 117, seen for one petal in
FIG. 5D. The number of levers 113 corresponds to the number of
petals 108. Proximal ends 113A of the tapered lever 113 extend
through the slots 117C of the hub 117. As seen in FIG. 5B, a finger
113C of the lever 113 extends into an annular groove 109D (FIG. 5A)
between the distal end 109B and proximal end 109C of the actuation
bearing 109. An outer end 113B of each lever 113 is connected, such
as via a journal pin, to a bifurcated pair of inwardly-extending
arms 111 on the sizing petal 108, as seen in FIG. 5C. FIG. 5D shows
the coupling of the lever 113 with the petal 108, where the distal
end 113B of the lever 113 couples with the inwardly-extending arms
111. Rotation of the actuator 105 ultimately leads to axial
movement of the shaft 104 and actuation bearing 109. Axial movement
of the actuation bearing 109 causes movement of the lever 113 by
virtue of the camming interaction between the annular groove 109D
and the lever finger 113C. The distal end of the 113B pivots
outward from distal movement of the actuation bearing 109, thus
causing radial expansion and retraction of the petals 108. The
converse is true also, wherein proximal retraction of the shaft 104
and actuation bearing 109 constricts the petals 108 radially
inward, thus reducing the profile of the sizing element 107 to
facilitate removal from the native annulus after a sizing
procedure.
[0080] FIGS. 6A and 6B illustrate a modified sizing element 107'
much like the previously-described element 107, and as such like
parts will be given like numbers with a prime designation. The
sizing element 107' has a plurality of petals 108' that constrict
about a hub 117' into a first, reduced diameter configuration as
seen in FIG. 6A. In contrast to the earlier petals 108, each
modified petal 108' has a proximal flange that in aggregate defines
an undulating or scalloped peripheral flange 112. More
particularly, adjacent petals 108' have either a convex up flange
112A or a concave up flange 112B, as seen best in the exploded view
of FIG. 6B. Preferably, there are six (6) petals 108' with three
having a convex up flange 112A and three having a concave up flange
112B. The aggregate flange 112 therefore defines an undulating
peripheral shape with three peaks and three valleys, mimicking the
natural contours of an aortic annulus and the shape of the sewing
ring of a prosthetic heart valve, where the peaks correspond to the
commissures and the valleys to the cusps in between. Provision of
the scalloped peripheral flange 112 helps the surgeon properly seat
the sizer down into the aortic annulus so that the cylindrical body
formed by the petals extends fully within and accurately reflects
the size of the annulus orifice.
[0081] The petals 108' also have slightly modified
inwardly-extending arms 111' which have pointed inner ends for ease
of assembly with the distal ends of the levers 113' and into the
receiving channels formed in the bottom portion 117A' of the hub
117'. The pointed inner ends also provide maximum overlap between
the internal radial channels in the hub 117' and the petals 108',
which is especially important at full expansion for larger
annuluses (e.g., 29 mm). Additionally, the actuation bearing 109'
has axial ribs that mate with axial grooves in the hub cover 109A'
to prevent relative rotation therebetween. Aside from the
aforementioned modifications, the sizing element 107' functions in
the same way as the earlier-described element 107, and thus will
not be further described.
[0082] A method of selecting an appropriate valve size is now
described with reference to the aforementioned figures. In a
minimally invasive procedure, the valve sizer 100 is preferably
introduced into the patient between adjacent ribs in the patient
without cutting or significantly deflecting the ribs. At least one
dimension of the delivery profile of the retracted valve sizer 100
is such that it is no more than 19 mm, and more preferably no more
than 17 mm, so that the valve sizer 100 can be easily introduced
between adjacent ribs in the patient. The surgeon then positions
the sizing petals 108 in the valve annulus and rotates the actuator
105 until the sizing petals 108 contact the valve annulus. The
actuator 105 is rotated until the ratchet begins to slip thus
indicating that the sizer has fully engaged the annulus and that a
predetermined amount of force is being applied. When in the
expanded position, the outer surfaces of opposing sizing petals 108
preferably have a maximum outer dimension of at least 29 mm and
more preferably at least 33 mm. The surgeon then reads the
appropriate valve size using the markings 133 that appear in the
window 130 of the actuator. Following the sizing of the annulus,
the actuator 105 is then rotated again so that the sizing petals
108 moves into the retracted position (as shown in FIG. 1D) for
removing the valve sizer 100 from the patient.
[0083] When in the retracted position, the maximum outer dimension
of the valve sizer 100 is preferably no more than 17 mm, more
preferably no more than 18 mm, and most preferably no more than 19
mm. The preferred dimensions of the valve sizer 100 in the
retracted position permits insertion of the valve sizer 107 between
adjacent ribs in a patient when performing a minimally invasive
valve procedure. For minimally invasive surgery approaches, the
valve sizer could be made to collapse smaller than 17 mm, as
described below with respect to FIGS. 22-26.
[0084] In another embodiment shown in FIG. 7-14, a disc that
directly cams the sizer petals outward is provided instead of a
lever arm assembly. FIGS. 7A and 7B show a proximal handle 202 that
is rigidly connected to a distal hub 210 via a fixed-length cable
or rod 220. An actuator assembly including an actuator ring 205
causes axial displacement of a hollow shaft 204 surrounding the rod
220, a distal end of the hollow shaft being fixed to a camming disc
212. More particularly, the hollow shaft 204 has a series of inner
threads that cooperate with external threads on the rod 220 such
that rotation of the shaft 204 relative to the handle 202 and rod
220 displaces the shaft and attached camming disc 212. The camming
disc 212, in turn, directly acts on a plurality of sizing petals
208 of a sizing element 207 to convert them from a first, reduced
diameter configuration as seen in FIG. 8A to a second, expanded
configuration as seen in FIG. 9A.
[0085] FIG. 7B shows a ratchet mechanism that interposes a clutch
between rotation of the actuator ring 205 and the hollow shaft 204,
according to one embodiment. As mentioned, the shaft 204 is
attached to the disc 212 that expands the sizing element 207. The
ratcheting mechanism uses bearings 222 biased outward by springs
224 held in bores in a clutch ring 221. The clutch ring 221, in
turn, is fixed around the hollow shaft 204. The bearings 222 seat
into detents on the inner surface of the actuator ring 205, much
like the clutch embodiment described above. The force needed to
overcome the ratchet mechanism is set to correspond to the force
being applied to the petals by the annulus being sized. That is,
the reaction force applied by the annulus to the sizer as the sizer
expands is transmitted to a reaction torque against rotation of the
hollow shaft 204 and clutch ring 221, and the force needed to
overcome the ratchet mechanism is set to the force needed to size
the annulus.
[0086] FIG. 7C shows a slight variation on the clutch mechanism,
wherein the bearings 222 are biased inward by the springs 224 into
detents formed in an outer surface of the hollow shaft 204. In this
version, there is no need for a separate actuator ring 205 as the
user manually rotates the clutch ring 221 directly.
[0087] Referring to FIGS. 8A-9B, according to one embodiment, the
radially expandable sizing element 207 is shown. The hub 210
includes radial slots (or holes) 214 shown in FIG. 9B which guide
radial in and out movement of the sizing petals 208 between the
retracted and expanded positions. The shaft 204 is coupled to the
actuator 205 via the clutch mechanism described above so that
rotation of the actuator 205 rotates the shaft 204 and the disc 212
with respect to the rod 220. Rotation of the shaft 204 causes
radial movement of the sizing petals 208 in the slots 214 of the
hub 210 between the expanded and retracted positions. That is,
distal axial displacement of the shaft 204 and affixed disc 212
forces the distal conical surface of the disc directly against the
conical proximal faces 208B of the petals 208, thus camming them
outward. The taper the proximal face 208B of each sizing petal, its
shape and its dimensions conforms to the shape and dimensions of
the disc 212.
[0088] In one embodiment, the disc 212 is conical in shape (FIGS.
8B and 9B), with the taper of the disc 212 matching the taper of
the sizing petals 208. The disc 212 is shown by itself in FIG. 10
having an internally threaded an axial hole 216 that the threaded
shaft 204 engages. The disc 212 moves axially up and down with the
threaded hollow shaft 204 to which it is mounted. The axial
movement of the disk 212 provides a camming action to force the
sizing petals to move due to their matching tapers on the disc 212
and the inner surfaces 108B of the sizing petals.
[0089] FIG. 11 shows the hub 210 by itself. The hub 210 has the
radial holes 214 that correspond to pins 208A on the sizing petals
208, as seen in FIG. 8C. The central, axial hole 215 is to receive
the threaded shaft 204. Each sizing petal 208 has at least one pin
208A that slides radially in the matching holes 214 in the hub 210.
Preferably, each sizing petal 208 has at least two pins 208A that
slide in the matching holes 214 of the hub 210 for better
alignment. The number of pins 208A in each sizing petal 208
corresponds to the number of holes in that sector of the hub 210.
The sizing petals 208 preferably have a curved outer surface 232
that together generally form a cylindrical peripheral shape when in
the retracted and expanded positions. Taken together, the outer
surfaces 232 of the sizing petals 208 define a valve sizing portion
which engages the patient's valve annulus when sizing the
replacement valve.
[0090] The device disclosed here shows a sizer with 8 sizer petals
208 which form a cylindrical sizer. More or fewer sizer petals
could be used in the same way if it were deemed advantageous.
Likewise, the shape of the sizer petals could be such that they
form a sizer with a non-cylindrical shape.
[0091] In one embodiment, as shown in FIG. 12, the outside of the
distal end of the sizer is covered by an extendible membrane 250
made out of a material such as silicone rubber. This would make the
outside of the sizer smoother when expanded.
[0092] For instance, their shape could form a tapered conical
shape. FIGS. 13A-13B show tapered conical petals 208 forming a
tapered sizer. FIGS. 14A and 14B show a concave shaped sizer formed
by petals 208 having concave outer surfaces. The concave shape of
the sizer ensures that the sizer is properly engaged with the
annulus. This may be especially beneficial in MIS procedures where
visibility of the annulus is limited.
[0093] Up to now, clutch-based sizers have been described using a
clutch mechanism with a pre-calibrated torque threshold. This is
believed to provide excellent accuracy for a majority of patients
and sizing procedures, especially using the relatively robust
ball-detent clutch mechanism. However, certain sizing tasks may
involve a high degree of variability or require a relatively fine
force threshold determination which may not be satisfied by a
pre-calibrated clutch having a single torque threshold.
Consequently, the present application contemplates a number of
force feedback-based sizing systems that supply information to the
user on the actual force magnitude experienced by the sizing
element. Such systems can be used in actual sizing procedures, or
for analysis of different orifice characteristics to provide
empirical information for use in calibrating the ball-detent
clutch-based sizers described above.
[0094] For example, FIG. 15 shows a first embodiment of a force
feedback-based sizing system 300 having a handle 302, a shaft 304,
an actuator dial 305, and a sizing element 307 such as described
above. A torque sensor 310 connected to a proximal end of the
handle 302 is connected to sense the torque imparted to the
actuator dial 305, for example, which expands the sizing element
307 against the surrounding orifice. The torque sensor 310 connects
via a wire 312 to a display/data recording unit 314 to monitor and
collect torque readings.
[0095] In use, the sizing element 307 is inserted into the annulus,
orifice or structure whose diameter is being measured. While
holding the torque sensor 310, the actuator dial 305 is rotated
slowly until the next size increment is displayed in the window
316. The peak torque shown on the display/data recording unit 314
is then noted/recorded along with the diameter of the sizing
element 307. The process is repeated for greater size increments.
Ultimately, the torque data is converted to outward radial force or
pressure data exerted by the sizing element 307 on the surrounding
annulus. This information can be useful in calibrating a
ball-detent clutch system as described above, such as by
identifying the proper springs to use for a particular type of
tissue or type of patient. More directly, the force feedback based
sizer system 300 can be used to size a valve annulus, with the
surgeon identifying the appropriate size not based on when the
clutch slips but instead when a particular torque is reached. In
that case, the clutch system may be set to have a relatively high
torque threshold before it slips, though not too high to cause any
tissue damage.
[0096] It should be noted that instead of the torque sensor 310
connected to sense the torque applied, a linear force sensor may be
coupled to measure the tension in one or the other of the elements
described previously for actuating the sizing elements. For
example, in the embodiment of FIGS. 1-6 (e.g., FIG. 5B) the hollow
shaft 104 is driven distally while the cable or rod 120 is place in
tension between the handle 102 and the hub 117. A force sensor in
the handle 102 could be attached to the proximal end of the cable
120 to measure the tension, which can be used to determine the
level of the reaction force of the annulus against the petals 108.
Sensing the force in the cable 120 would actually be a more direct
method than sensing torque, though either method is suitable. For
the purpose of definition of terms, both the torque sensor and
linear force sensor methods will be termed force-feedback
sensors.
[0097] In another embodiment, a force feedback-based sizer 600 is
provided. As shown in FIG. 16A, the sizer 600 has a hollow shaft
604 extending along the length of the sizer. A movable sizing
element 607 is provided at the distal end of the shaft 604 and an
actuation assembly 606 is provided at the proximal end of the shaft
604. The actuation assembly 606 includes an actuator 602 with a
handle, and a force gauge disposed in the handle. The force gauge
measures the force applied for operating the sizer.
[0098] The force gauge may provide a digital readout 640a of the
force applied on a screen 640. In one embodiment, the force gauge
may use varying colors (or colored lights) 640b to indicate if the
applied pressure varies from a predetermined target range for the
sizer. For example, if the force applied is within a predetermined
target range the light may indicate green color. If the force
applied is below the target range the color may be yellow, or red
if the force applied is above the target range.
[0099] In one embodiment, as shown in FIG. 16B, the movable sizing
element 607 includes a compliant spacer 610 that is filled with
fluid and deforms with force. As force is applied, pressure within
the spacer increases and is measured by a pressure gauge integrated
into the handle.
[0100] FIGS. 17A and 17B show a heart valve sizer 700 where the
electronic (light or digital readout) system of sizer 600 is
replaced with a mechanical system. The system 700 features a
malleable outer tube 703 with a flexible inner shaft 709 extending
along the length of the sizer 700. The outer tube 703 is malleable
and can be bent to any desired shape depending on the surgeon's
preference and patient anatomy. The malleable outer tube 703 has a
valve sizer 707 disposed at the distal end, and an actuation
assembly 705 with a handle 702 disposed at its proximal end. A
shaft marker (not shown) is attached to the shaft (not shown) that
indicates an optimal force range of the force that may be applied
to the heart valve sizer 700. A window 740 on the handle 702 of the
actuator assembly 706 allows the surgeon to see the position of a
marker attached to the shaft. Markings on the handle 702 indicate
that the force level is optimal when aligned with the shaft marker
(not shown). The spacer 707 is attached to a flexible inner shaft
709 which is inside the malleable outer tube 703. The flexible
shaft 709 can move longitudinally within the outer tube 703 with
minimal resistance. When in use, the sizer 700 is introduced
between adjacent ribs in the patient. The surgeon then positions
the spacer 707 in the valve annulus. The annulus exerts axial
forces on the spacer 707. These axial forces from the spacer 707
are transmitted along the flexible inner shaft 705 to the spring
system within the handle 702, and markings on the handle provide
the feedback to the surgeon.
[0101] In yet another embodiment, as shown in FIGS. 18A and 18B, a
sizer 800 is provided where the electronic (light or digital
readout) system 600 is replaced with a mechanical system. The
system 800 features a flexible outer helical coil 804 and malleable
inner shaft 802 extending along the length of the system 800. The
malleable inner shaft 802 can be bent to any desired shape
depending on surgeon's preference and patient's anatomy. A valve
sizer 807 is disposed at the distal end of the helical coil 804,
while an actuation assembly 805 is disposed at the proximal end of
the helical coil 804. A handle 801 operates the actuation assembly
805. A shaft marker (not shown) is attached to the shaft 802 that
indicates an optimal force range of the force that may be applied
to the heart valve sizer. A window 840 is provided which allows the
user to see the position of a marker attached to the shaft.
Markings on the handle 801 indicate that the force level is optimal
when aligned with the shaft marker. The sizer 807 can slide over
the malleable inner shaft 802 which is inside a flexible outer
helical coil 804. The flexible outer helical coil 804 pushed by the
spacer 807 can move longitudinally over the malleable inner shaft
802 with minimal resistance. When in use, the sizer 800 is
introduced between adjacent ribs in the patient. The surgeon then
positions the spacer 807 in the valve annulus. The annulus exerts
axial forces on the spacer 807. These axial forces from the spacer
807 are transmitted along the flexible coil 804 to the spring
system within the handle 801, and markings on the handle provide
the feedback to the surgeon.
[0102] FIGS. 19A-19E show a heart valve sizer 900 with stackable
hubs sliding over the same flexible outer helical coil and
malleable inner shaft mechanism. The valve sizer 900 has a tube 904
extending along the length of the system. A valve sizer 907 is
disposed at its distal end, while an actuation assembly 905 is
disposed at the proximal end of the tube 904. The hubs 910 of
varying diameters may be used to measure the annulus by stacking a
next size hub onto existing smaller hubs. These hubs with
incremental diameters mounted against the distal end of the outer
spiral coil slide over a malleable inner shaft till an optimal fit
is attained. If the sizer hub seems undersized when being pushed
through the annulus, a bigger hub head can be moved down the tube
904 and attached to the initial hub either by a snapping connection
or a luer-like quick connection. FIGS. 19B-19D show three hubs 910
stacked onto the distal end of the tube 904, while FIG. 19E shows a
cross-sectional view of the distal end of the sizer 900 with three
hubs 910 stacked on the coil 904.
[0103] FIG. 20 shows an alternate embodiment of a force-based heart
valve sizer 1000 with a syringe 1004 and a pressure gauge 1006. The
compliant hub 1002 is inflated with fluid pressurized by the
syringe 1004. The pressure applied to the hub 1002 to size the
valve annulus is measured by the pressure gauge 1006.
[0104] FIG. 21 shows a cross-sectional view of a force-based sizer
1100. The hub 1107 is attached to the distal end of the shaft 1104.
The handle 1102 of the actuator assembly 1106 has an actuation
mechanism comprising at least a spring 1105. As the hub 1107 moves
towards the handle 1102, the shaft 1104 moves into the handle
cavity 1103. Interfering features on the shaft 1104 and handle
cavity 1103 eventually come into contact. As this interference is
overcome, a tactile and/or audible `click` is experienced. By
adjusting the amount of interference, the device can be calibrated
to a target force level. If no spring is present, then the device
would provide minimal feedback to the operator until the
interfering features came into contact. A spring 1105 that presents
less force than the target force level would provide increasing
tactile resistance to the operator as force was applied. Once
actuated, the shaft 1104 would remain positioned proximally within
the handle 1102. If a spring 1105 that is strong enough to overcome
the target force level is used, then the device would return to its
expanded length after the operator stops applying force to the
device.
[0105] A force feedback-based heart valve sizer enables limiting,
controlling and measuring axial forces at the sizer's distal end
being inserted into the heart. The force feedback-based heart valve
sizer enables sizing the heart valve annulus in a controlled
manner, thereby limiting the maximum force applied and minimizing
the risk of tissue damage.
[0106] The force feedback-based valve sizer disclosed here has
several advantages over the currently used valve sizers. The first
advantage is its adjustability, which allows a single sizer to
cover the entire range of valve sizes. The use of a single
one-size-fits-all sizer instead of multiple static sizers reduces
clutter in the operating field and makes sizing the patient's
annulus quicker, thereby potentially reducing bypass time during
the procedure. Another advantage of the device over existing valve
sizers is its ability to collapse radially. This feature has the
potential to facilitate MIS surgical procedures which are performed
through small surgical incisions. A static sizer may be too large
to fit though an MIS incision, particularly if the procedure takes
advantage of a collapsible MIS surgical valve. A further advantage
of this device is the use of force-based sizing. The mechanism used
to expand the sizer contains a ratchet mechanism that limits the
amount of force the sizer applies to the annulus. The force limit
can be set to achieve proper sizing of the annulus while
eliminating the potential for over-expanding and damaging the
annulus. This may be particularly important in MIS valve
replacement procedures where visualization is poor and the surgeon
may not be able to use their sense of "feel" to determine the
proper annulus size.
[0107] Heart valve sizers, as well as other body cavity sizers, may
be reduced in profile (diameter) to be used in minimally-invasive
or percutaneous contexts. For instance, currently there is a great
deal of ongoing work to develop systems for replacing heart valves
percutaneously through a patient's vasculature without the need to
stop the heart and place the patient on cardiopulmonary bypass.
Currently, sizing for such procedures is done using fluoroscopy,
which aside from exposing the patient and operating room staff to
radiation is not as accurate as desirable. Accurate sizing of the
heart valve annulus remains an issue, and the present application
provides a clutch-based sizer in FIGS. 22-26 that may be used
percutaneously.
[0108] FIGS. 22A-22C show a catheter-based sizing element 1200 in
several stages of expansion. The sizing element 1200 includes a
central hub 1202 that receives an actuation rod 1204 through a
central bore at a proximal end thereof. As will be shown, the
actuation rod 1204 acts on a plurality of proximal levers 1206 that
move outward in conjunction with a plurality of distal levers 1208
to radially displace axial sizing petals 1210. Because the lengths
of the proximal and distal levers 1206, 1208 are the same, the
sizing petals 1210 remain parallel to the hub 1202 axis while being
displaced outward.
[0109] In a collapsed, delivery configuration, shown in FIG. 22A,
the sizing element 1200 may have an outer diameter d of about 6 mm,
sufficiently small to enable passage through an 18Fr percutaneous
catheter (not shown) advanced through the femoral artery to one of
the heart valve annuluses, as is known. The profile of the sizing
element 1200 could be further reduced to pass through even smaller
catheters. A partially expanded sizing element 1200 in FIG. 22B has
an outer diameter D.sub.1 of about 19 mm, while a fully expanded
sizing element 1200 in FIG. 22C has an outer diameter D.sub.2 of
about 29 mm. As with the various sizers discussed previously, the
petals 1210 expand outward into contact with the valve annulus
until a reaction force causes the clutched drive (not shown) to
slip. As before, the clutch drive preferably has a size indicator
(as with size indicators 133 on the clutch ring 121 in FIG. 3A)
that displays the diameter of the sizing element 1200 at all times,
such that when the clutch slips the user is aware of the valve
annulus size, and thus the proper prosthetic heart valve size
needed.
[0110] FIGS. 23 and 24A-24B are further views of the catheter-based
sizing element 1200, and in particular FIG. 24B shows the outward
movement of the connected levers 1206, 1208 and sizing petals 1210.
Distal movement of the actuation rod 1204 acts on a plurality of
small fingers 1212 on each proximal lever 1206 to cause the levers
to pivot outward about pivot pins 1214 journaled in bores in the
hub 1202, as seen in FIGS. 25 and 26. In this regard, the hub 1202
comprises a generally cylindrical body having a series of
radially-projecting axial ribs 1216 between which each movable
"segment" of the sizing element 1200 initially resides. Each
movable segment includes one each of the levers 1206, 1208 and
sizing petals 1210 connected together at hinges. Both the proximal
and distal levers 1206, 1208 rotate about pins journaled in the
sides of adjacent axial ribs 1216, and are each connected to rotate
about opposite ends of a sizing petal 1210. Although not shown, the
actuation rod 1204 desirably continues the length of the hub 1202
so that it can also act on similar fingers formed on the distal
levers 1208, and thus produce an outward force on both levers.
[0111] The actuation rod 1204 could be driven by a clutch-based
actuator, such as is shown above with respect to FIG. 2A-2C or
7A-7C. In particular, a ball-spring-detent mechanism that drives a
lead screw is preferred as the sensitivity to environmental factors
is relatively low.
[0112] If the sizing element 1200 is used in a beating heart
procedure when the heart is pressurized, the force limit of the
sizer will be set relatively low. The sizing element 1200 will
essentially act as a touch probe and begin to slip when all of the
petals (6 in the illustrated embodiment) contact the annulus with a
minimum amount of force.
[0113] FIGS. 27A-27C illustrate an alternative catheter-based
sizing element 1250 in several stages of expansion. The sizing
element 1250 includes a central hub 1252 that receives an actuation
rod 1254 through a central bore 1255 (see FIG. 28) at a proximal
end thereof. In this description, proximal is synonymous with the
upper end of the sizing element 1250 in the figures, while distal
is synonymous with the lower end. As will be shown, the actuation
rod 1254 acts on a plurality of first levers 1256 that move outward
in conjunction with a plurality of second levers 1258 in a
scissor-like fashion to radially displace axial sizing petals 1260.
Because the lengths of the first and second levers 1256, 1258 are
the same, the sizing petals 1260 remain parallel to the hub 1252
axis while being displaced outward.
[0114] With reference to the sectional view of FIG. 27D as well as
the detailed views of the components in FIGS. 28-30, the central
hub 1252 comprises a generally cylindrical member having the
central bore 1255 that receives the actuation rod 1254, and further
includes a plurality of axial recesses 1262 between axial ribs 1264
on its outer surface that receive and accommodate the folded up
levers 1256, 1258 as well as the sizing petals 1260. As seen in
FIG. 27A, the collapsed configuration of the sizing element 1250
substantially forms a cylinder, with the outer surfaces of the
sizing petals 1260 lying essentially flush with the ribs 1264. As
seen in FIGS. 27D and 28, the central hub 1252 also has a plurality
of axial slots 1266 extending between the recesses 1262 and the
central bore 1255, which will be explained below.
[0115] Still with reference to FIG. 27D, a proximal end of each of
the first levers 1256 connects via a pivot pin between a pair of
movement tabs 1268 projecting outward through the vertical slots
1266 from the actuation rod 1254. A distal end of each of the first
levers 1256 connects via a pivot pin between a pair of flanges 1270
extending inward at the distal end of the corresponding sizing
petal 1260. Conversely, a distal end of each of the second levers
1258 connects via a pivot pin to a fixed point at a distal end of
the central hub 1252, while a proximal end of each of the second
levers connects via a pivot between a pair of elongated flanges
1272 extending inward along a proximal section of the corresponding
sizing petal 1260. The elongated flanges 1272 include axial guide
slots 1274 which receive the pivot pin at the proximal end of each
of the second levers 1258, thus permitting axial movement
therebetween. Finally, each pair of first and second levers 1256,
1258 are connected where they cross each other at their midpoints
by a fulcrum pin 1276. It will thus be understood that distal
displacement of the actuation rod 1254 causes distal displacement
of the proximal end of the first levers 1256, each in turn causing
corresponding distal displacement of the proximal end of the second
levers 1258 through the scissor-like cooperation therebetween.
Because the first and second levers 1256, 1258 are of equal length,
and since the distal ends of the second levers 1258 are axially
fixed with respect to the central hub 1252, the distal ends of both
levers remain at a fixed axial location with respect to the central
hub while the proximal ends move together. This ensures that the
sizing petals 1260 remain oriented axially, and also move only
radially outward, not axially.
[0116] In a collapsed, delivery configuration, shown in FIG. 27A,
the sizing element 1250 may have an outer diameter d of about 6 mm,
sufficiently small to enable passage through an 18Fr percutaneous
catheter (not shown) advanced through the femoral artery to one of
the heart valve annulus, as is known. The profile of the sizing
element 1250 could be further reduced to pass through even smaller
catheters. A partially expanded sizing element 1250 in FIG. 27B has
an outer diameter D.sub.1 of about 19 mm, while a fully expanded
sizing element 1250 in FIG. 27C has an outer diameter D.sub.2 of
about 29 mm. As with the various sizers discussed previously, the
petals 1260 expand outward into contact with the valve annulus
until a reaction force caused the clutched drive (not shown) to
slip. As before, the clutch drive preferably has a size indicator
(as with size indicators 133 on the clutch ring 121 in FIG. 3A)
that displays the diameter of the sizing element 1250 at all times,
such that when the clutch slips the user is aware of the valve
annulus size, and thus the proper prosthetic heart valve size
needed.
[0117] FIGS. 31 and 32 are schematic views of a balloon catheter
inflation system 1300 that utilizes a clutch-limiter as described
herein to limit the maximum inflation pressure. Inflation systems
1300 such as the illustrated embodiment are used for a variety of
purposes, such as angioplasties, valvuloplasties, and for expanding
arterial stents and more recently heart valves. The system 1300
includes a piston/cylinder chamber 1302 having a fluid outlet line
1304 that ultimately supplies pressurized saline or other inert
fluid to a distal balloon 1306. In the illustrated embodiment, the
balloon 1306 is being used to expand an anchoring frame of a
hybrid-type of prosthetic heart valve which has a non-expandable
valve portion as well; however the applications of the balloon
inflation system 1300 should not be considered limited.
[0118] The actuator of the system 1300 includes a piston shaft 1310
that may be threaded within a bore in the piston/cylinder chamber
1302 so as to advance axially upon rotation of a clutch-limited
actuator 1312. As the piston shaft 1310 advances, fluid is forced
through the line 1304 to inflate the balloon 1306. A gauge 1314
displays the pressure within the fluid, and thus the pressure
within the balloon 1306.
[0119] As seen in FIG. 32, the actuator 1312 preferably includes a
series of springs 1316 that bias bearing 1318 outward into detents
(not shown) formed on an inner surface of the handle of the
actuator 1312. As with the embodiment of FIGS. 2A-2C, the springs
1316 and bearings 1318 are retained within an inner clutch member
that is rigid with the shaft 1310. The actuator 1312 may be turned
until the reaction torque from displacing the shaft 1310 exceeds a
threshold value, at which point the bearings 1318 are forced inward
against the springs 1316 and the clutch slips. Also, the
alternative clutch ring shown in FIGS. 3A-3B may also be used.
[0120] The system 1300 is a relatively simple, inexpensive solution
to percutaneous inflation of heart valves and other devices. The
clutch mechanism limits the maximum inflation pressure, which can
be calibrated to induce a predetermined amount of device expansion.
The system 1300 can be retrofitted to existing inflation devices,
and acts as a safety feature to prevent over-inflation and possibly
rupture of the balloon. There is a linear, predictable relationship
between the amount of torque applied by the actuator 1312 and the
fluid pressure generated by the advancing piston shaft 1310, and
the relatively robust and precise action of the ball-spring-detent
clutch makes limiting the pressure in the operating room
environment highly repeatable and accurate.
[0121] 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 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.
* * * * *