U.S. patent application number 12/839194 was filed with the patent office on 2011-01-27 for introducer for prosthetic heart valve.
This patent application is currently assigned to EDWARDS LIFESCIENCES CORPORATION. Invention is credited to Louis A. Campbell, Travis Z. Oba.
Application Number | 20110022165 12/839194 |
Document ID | / |
Family ID | 43497986 |
Filed Date | 2011-01-27 |
United States Patent
Application |
20110022165 |
Kind Code |
A1 |
Oba; Travis Z. ; et
al. |
January 27, 2011 |
INTRODUCER FOR PROSTHETIC HEART VALVE
Abstract
The present disclosure concerns embodiments of an introducer
that is adapted to facilitate insertion of a prosthetic device,
such as a prosthetic heart valve, into a patient's vasculature. In
one embodiment, the introducer comprises an elongated body defining
a central lumen extending between distal and proximal ends of the
body. The introducer body can also have a longitudinally extending
gap extending along the length of the body between the distal end
proximal ends. The gap in the introducer allows a user to place the
introducer around implant sutures by passing the sutures through
the gap and into the central lumen. Similarly, the gap allows the
introducer to be easily removed from the sutures and/or a delivery
device by passing them outwardly through the gap.
Inventors: |
Oba; Travis Z.; (Corona,
CA) ; Campbell; Louis A.; (Santa Ana, CA) |
Correspondence
Address: |
EDWARDS LIFESCIENCES CORPORATION
LEGAL DEPARTMENT, ONE EDWARDS WAY
IRVINE
CA
92614
US
|
Assignee: |
EDWARDS LIFESCIENCES
CORPORATION
Irvine
CA
|
Family ID: |
43497986 |
Appl. No.: |
12/839194 |
Filed: |
July 19, 2010 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
61228072 |
Jul 23, 2009 |
|
|
|
Current U.S.
Class: |
623/2.11 |
Current CPC
Class: |
A61B 17/3468 20130101;
A61F 2/2427 20130101; A61B 17/3439 20130101; A61F 2/2433 20130101;
A61B 17/3423 20130101; A61B 2017/3425 20130101 |
Class at
Publication: |
623/2.11 |
International
Class: |
A61F 2/24 20060101
A61F002/24 |
Claims
1. A method of implanting a prosthetic heart valve comprising:
making an incision in the vasculature of a patient's body;
threading one or more sutures through a native annulus of the heart
and extending the one or more sutures outwardly through the
incision and through a portion of the prosthetic valve; placing an
introducer around the one or more sutures and inserting the
introducer into and through the incision such that a distal end and
a proximal end of the introducer are on opposite sides of the
incision; sliding the prosthetic valve along the one or more
sutures and through the introducer until the prosthetic valve
engages the annulus; removing the introducer from the incision; and
securing the valve to the annulus with the one or more sutures.
2. The method of claim 1, wherein: the introducer comprises an
elongated body, a central passageway extending through the body,
and a longitudinally extending gap in the introducer body extending
from the proximal end to the distal end; and the act of placing the
introducer around the one or more sutures comprises passing the one
or more sutures through the gap in the introducer body and into the
central opening of the introducer.
3. The method of claim 2, further comprising, after removing the
introducer from the incision, removing the introducer from a
position surrounding the one or more sutures by passing the one or
more sutures outwardly through the gap in the introducer body.
4. The method of claim 1, wherein the incision is made in the aorta
and the one or more sutures are secured to aortic annulus of the
heart.
5. The method of claim 1, wherein the act of inserting the
introducer into and through the incision comprises positioning the
distal end of the introducer in or immediately adjacent the native
annulus.
6. The method of claim 1, wherein: the introducer comprises an
elongated body, a central passageway extending through the body,
and a longitudinally extending gap in the introducer body extending
from the proximal end to the distal end; and sliding the prosthetic
valve through the introducer causes the introducer body to radially
expand.
7. The method of claim 3, wherein the act of sliding the prosthetic
valve along the one or more sutures and through the introducer
comprises pushing the prosthetic valve through the introducer with
an elongated delivery apparatus having a distal end mounting the
prosthetic valve, and the act of removing the introducer from a
position surrounding the one or more sutures further comprises
removing the introducer from a position surrounding the delivery
apparatus by passing the delivery apparatus outwardly through the
gap in the introducer body.
8. The method of claim 2, wherein the gap widens from a first width
at a location spaced from the proximal end to a second, greater
width at the proximal end.
9. The method of claim 1, further comprising radially expanding a
stent of the prosthetic valve against the annulus to further anchor
the valve to the annulus.
10. The method of claim 9, wherein the act of radially expanding a
stent of the prosthetic valve comprises inflating a balloon to
cause expansion of the stent.
11. The method of claim 1, wherein the introducer comprises a
radially stretchable sleeve and prior to the act of inserting the
introducer into the vasculature, the method further comprises
placing the sleeve over an applicator frame to hold the sleeve in a
radially expanded state, positioning the prosthetic valve in the
applicator frame, and removing the applicator frame from the sleeve
to allow the sleeve to collapse around the prosthetic valve.
12. The method of claim 11, wherein the sleeve comprises a
fabric.
13. The method of claim 1, wherein the introducer comprises a
generally tubular body comprising a flexible outer membrane, a
flexible inner membrane, and a liquid contained between the inner
and outer membranes.
14. A method of implanting a prosthetic heart valve comprising:
making an incision in the vasculature of a patient's body;
inserting the introducer through the incision and into the
vasculature of the patient; providing a prosthetic valve mounted on
a delivery device comprising an elongated handle; advancing the
prosthetic valve and a portion of the handle through the introducer
until the prosthetic valve engages a native annulus of the heart;
and removing the introducer from the incision and away from a
position surrounding the handle by passing the handle through a gap
formed in a side of the introducer.
15. The method of claim 14, wherein prior to the act of sliding the
prosthetic valve and a portion of the handle through the
introducer, the method further comprises threading one or more
sutures through the native annulus and a sewing ring of the
prosthetic valve and placing the introducer around the one or more
sutures by passing the one or more sutures through the gap and into
a central lumen of the introducer.
16. The method of claim 14, wherein the introducer comprises a
tapered distal end portion, the distal end portion comprising a
plurality of circumferentially arrayed, radially expandable fingers
having distal ends defining a distal opening of the introducer, the
fingers being radially expandable from a non-expanded state to an
expanded state as the prosthetic valve is advanced through the
distal end portion.
17. An introducer for introducing a prosthetic device into the
vasculature of a patient comprising: an elongated body having
distal and proximal ends; and a central passageway extending
through the body from the distal end to the proximal end; the body
comprising two opposing longitudinal edges defining a gap
therebetween.
18. The introducer of claim 17, wherein the gap has a first width
at a location spaced from the proximal end and increases to a
second width, greater than the first width, at the proximal
end.
19. The introducer of claim 17, wherein the body comprises a
tapered distal end portion, the distal end portion comprising a
plurality of circumferentially arrayed, radially expandable fingers
having distal ends defining a distal opening of the body, the
fingers being radially expandable from a non-expanded state to an
expanded state so as to expand the distal opening.
20. The introducer of claim 19, wherein the distal end portion
comprises longitudinally extending gaps between the fingers.
21. The introducer of claim 17, wherein the gap extends from the
proximal end to the distal end.
Description
RELATED APPLICATION DATA
[0001] The present application claims priority under 35 U.S.C.
.sctn.119(e) to U.S. provisional application No. 61/228,072 filed
Jul. 23, 2009.
FIELD
[0002] The present invention pertains to an introducer that can be
used to facilitate implantation of a prosthetic heart valve.
BACKGROUND
[0003] Prosthetic heart valves have been used for many years to
treat cardiac valvular disorders. The native heart valves (such as
the aortic, pulmonary, and mitral valves) serve critical functions
in assuring the forward flow of an adequate supply of blood through
the cardiovascular system. These heart valves can be rendered less
effective by congenital, inflammatory, or infectious conditions.
Such conditions can eventually lead to serious cardiovascular
compromise or death.
[0004] When a native valve is replaced, surgical implantation of a
prosthetic valve typically requires an open-chest surgery during
which the heart is stopped and patient placed on cardiopulmonary
bypass (a so-called "heart-lung machine"). In one common surgical
procedure, an incision is made in the aorta and the diseased native
valve leaflets are excised. An array of implant sutures are secured
around the periphery of the native valve, and the opposite ends of
the sutures are pulled through the incision and then threaded
through the sewing ring of the prosthetic valve. The prosthetic
valve is then "parachuted" down the array of sutures until it rests
against the native annulus. Thereafter, the sutures can be tied off
and severed to secure the prosthetic valve to the annulus.
[0005] One specific technique that is used to introduce the
prosthetic valve into the aorta is referred to as the "shoehorn"
technique. In the shoehorn technique, a transverse incision is made
in the aortic root, which typically is smaller than the
cross-sectional profile of the prosthetic valve. In order to pass
the valve through the incision, the valve is inserted into the
aortic root at an angle relative to a plane defined by the
incision, much like passing a button through a button hole. As can
be appreciated, this technique adds complexity to the procedure,
can cause laceration of the tissue, and can cause damage to the
prosthetic valve.
[0006] Another technique used to implant a prosthetic valve
involves making an oblique or "hockey stick" shaped incision in the
aorta. This type of incision creates a larger opening for the
passage of the valve, but is more difficult to close and therefore
is more prone to leakage than a straight transverse incision.
[0007] Accordingly, there exists a need for new and improved
apparatus and methods for introducing a prosthetic valve into the
vasculature of a patient.
SUMMARY
[0008] The present disclosure concerns embodiments of an introducer
that is adapted to facilitate insertion of a prosthetic device,
such as a prosthetic heart valve, into a patient's vasculature. In
particular embodiments, the introducer comprises an elongated body
defining a central lumen extending between distal and proximal ends
of the body. The body is adapted to be inserted through an
incision, such as a transverse aortotomy, and into the vasculature
of the patient. A prosthetic valve can be introduced into the
patient's vasculature by advancing the valve through the
introducer.
[0009] The introducer body can have a longitudinally extending gap
extending along the length of the body between the distal and
proximal ends, which allows the introducer to radially expand and
dilate the incision as the valve is advanced through the incision.
The gap in the introducer also allows a user to place the
introducer around implant sutures by passing the sutures through
the gap and into the central lumen. Similarly, the gap allows the
introducer to be easily removed from the sutures and/or a delivery
device by passing them outwardly through the gap. The introducer
body can have a tapered distal portion to facilitate insertion of
the introducer through an incision.
[0010] In one representative embodiment, a method of implanting a
prosthetic heart valve comprises making an incision in the
vasculature of a patient's body, threading one or more sutures
through a native annulus of the heart and extending the one or more
sutures outwardly through the incision and through a portion of the
prosthetic valve, placing an introducer around the one or more
sutures and inserting the introducer into and through the incision
such that a distal end and a proximal end of the introducer are on
opposite sides of the incision, sliding the prosthetic valve along
the one or more sutures and through the introducer until the
prosthetic valve engages the annulus, removing the introducer from
the incision, and securing the valve to the annulus with the one or
more sutures.
[0011] In another representative embodiment, a method of implanting
a prosthetic heart valve comprises making an incision in the
vasculature of a patient's body, inserting the introducer through
the incision and into the vasculature of the patient, and providing
a prosthetic valve mounted on a delivery device comprising an
elongated handle. The method further comprises advancing the
prosthetic valve and a portion of the handle through the introducer
until the prosthetic valve engages a native annulus of the heart,
and removing the introducer from the incision and away from a
position surrounding the handle by passing the handle through a gap
formed in a side of the introducer.
[0012] In another representative embodiment, an introducer for
introducing a prosthetic device into the vasculature of a patient
comprises an elongated body having distal and proximal ends and a
central passageway extending through the body from the distal end
to the proximal end. The body comprises two opposing longitudinal
edges defining a gap therebetween, the gap extending from the
proximal end to the distal end.
[0013] The foregoing and other features and advantages of the
invention will become more apparent from the following detailed
description, which proceeds with reference to the accompanying
figures.
BRIEF DESCRIPTION OF THE DRAWINGS
[0014] FIG. 1 is a perspective view of an introducer, according to
one embodiment, that can be used to introduce a prosthetic heart
valve into the vasculature of a patient.
[0015] FIG. 2 is a bottom plan view of the introducer shown in FIG.
1.
[0016] FIG. 3 is a perspective view of another embodiment of an
introducer.
[0017] FIGS. 4-10 illustrate one specific procedure for implanting
a prosthetic aortic valve into the heart using the introducer shown
in FIG. 1.
[0018] FIG. 11 illustrates another procedure for implanting a
prosthetic aortic valve into the heart using the introducer shown
in FIG. 1.
[0019] FIG. 12 shows an introducer assembly, according to another
embodiment, that can be used to introduce a prosthetic heart valve
into the vasculature of a patient.
[0020] FIGS. 13-17 illustrate one specific procedure for implanting
a prosthetic aortic valve into the heart using the introducer
assembly shown in FIG. 12.
[0021] FIG. 18 is a perspective view of another embodiment of an
introducer that can be used to introduce a prosthetic heart valve
into the vasculature of a patient.
DETAILED DESCRIPTION
[0022] The present disclosure concerns embodiments of an introducer
that is adapted to facilitate insertion of a prosthetic device,
such as a prosthetic heart valve, into a patient's vasculature. The
examples described below involve the implantation of a prosthetic
valve in the aortic annulus of the heart. However, the introducer
can also be used to facilitate implantation of prosthetic valves
into the other native annuluses of the heart. Further, the
introducer can also be used to introduce various other prosthetic
devices into other body lumens.
[0023] Referring first to FIGS. 1 and 2, an introducer 10,
according to one embodiment, comprises an elongated body 12 having
a proximal end 14 and a distal end 16. The body 12 has a length L
extending from the proximal end 14 to the distal end 16. The body
12 has a proximal opening 18, a distal opening 20, a central lumen,
or passageway, 22 extending longitudinally through the body from
the proximal opening to the distal opening. The body 12 desirably
has a proximal flange 24 that extends circumferentially around the
proximal opening and radially outwardly therefrom. The proximal
flange 24 can have an enlarged portion 26 that functions as a
handle for grasping and manipulating the introducer during use.
[0024] The body 12 in the illustrated embodiment has a generally
cylindrical shape along the majority of its length and a tapered
distal end portion 28 that extends about one third the length of
the body. Thus, as can be seen in FIGS. 1 and 2, the proximal
opening 18 has a larger diameter than that of the distal opening
20. The tapered distal end portion 28 facilitates insertion of the
introducer into a surgical incision, as described below. The body
12 desirably has a plurality of angularly spaced, longitudinally
extending gaps 30 defining a plurality of longitudinally extending,
circumferentially arrayed fingers 32. The fingers 32 can flex
radially outwardly from each other from a non-expanded, or
contracted, state (FIG. 1) to an expanded state (FIG. 8) to expand
the distal opening to accommodate a prosthetic valve as it is
pushed through the distal end portion of the introducer. The
proximal end of each gap 30 can terminate at an enlarged circular
aperture 34 that facilitates bending or flexing of the fingers at
their proximal ends where each finger joins the remaining portion
of the body 12.
[0025] The body 12 desirably has a longitudinal gap 36 extending
the entire length of the body from the proximal end 14 to the
distal end 16 and defining longitudinal edges 38. In the
illustrated embodiment, the gap 36 has a constant width from the
distal end 16 to a location near the proximal end and then flares
or widens from this location toward the proximal end 14 to form an
enlarged mouth 40 of the gap at the proximal end. The gap 36 allows
the introducer 10 to be easily placed around and removed from
sutures and/or a delivery device, as further described below. The
gap 36 also allows the introducer body 12 to radially expand to
accommodate a prosthetic valve having a larger diameter than that
of the introducer as the valve is advanced through the introducer.
In the illustrated embodiment, the gap 36 can be referred to as a
permanent gap because there is a gap or opening between the
longitudinal edges 36 when the introducer is in its nonexpanded, or
contracted, state shown in FIG. 1.
[0026] In an alternative embodiment, the entire length of the gap
36 or a portion thereof can be replaced with a longitudinally
extending slit between the longitudinal edges 38. When the body is
in a non-expanded state, the edges 38 can contact each other to
close the slit. Because the introducer body is made of a flexible
material, the edges 38 can be separated to create an opening or gap
therebetween, such as for placing the introducer around sutures or
a delivery device, as described below. Similarly, the distal end
portion 28 can be formed with a plurality of slits defining the
fingers 32, rather than permanent gaps 30 between adjacent fingers
as shown in the illustrated embodiment.
[0027] The introducer 10 can be formed from any of various suitable
materials, including metals (e.g., stainless steel or Nitinol),
alloys, polymers (e.g., nylon or PTFE), composites, or combinations
thereof. In certain embodiments, the introducer can be sized for
use with a variety of valve sizes (e.g., 17-35 mm valves).
Alternatively, the introducer can be provided in a range of
different sizes with each size adapted for use with one valve size
or a range of valve sizes.
[0028] FIG. 3 shows an introducer 50, according to another
embodiment. The introducer 50 is similar to the introducer 10 shown
in FIGS. 1 and 2 in most respects. Unlike the introducer 10, the
introducer 50 has a flange portion 52 formed with an opening 54.
The opening 54 can be adapted to receive the distal end of an
elongated handle 56 that can be used to assist in positioning and
manipulating the introducer during use.
[0029] FIGS. 4-11 illustrate the use of the introducer 10 in one
specific procedure for implanting a prosthetic heart valve 60 in
the aortic annulus. The prosthetic valve 60 in the illustrated
embodiment includes a substantially rigid, non-collapsible annular
frame 62, a plurality of leaflets 64 supported by the frame, a
sewing ring 66, and a plastically expandable stent, or support
frame, 68 extending downwardly from the sewing ring. The prosthetic
valve 60 can be referred to as a hybrid valve in that it combines a
non-collapsible surgical valve and an expandable stent that is
typically incorporated in expandable prosthetic valves that are
delivered in minimally invasive procedures. The prosthetic valve 60
can be mounted to the distal end of an elongated shaft or handle of
a delivery device 72. Exemplary embodiments of the prosthetic valve
60 and the delivery device 72 are further described in co-pending
U.S. Application No. 61/165, 455 filed Mar. 31, 2009 and U.S.
Application No. 61/220,968, filed Jun. 26, 2009, which are
incorporated herein by reference.
[0030] As shown in FIG. 4, an incision can be made in the aorta to
access the aortic annulus. Typically, although not required, the
native leaflets are excised before implanting the prosthetic valve,
as shown in the figures. A plurality of implant sutures 70 can be
threaded through the periphery of the aortic annulus, extended
outside of the body through the incision and then threaded through
the sewing ring 66 of the prosthetic valve 60 in a conventional
manner. It has been found that three implant sutures are sufficient
to adequately secure the prosthetic valve in place at the
implantation site when the securement of the valve to the annulus
is supplemented by the stent 68. A greater or fewer number of
implant sutures can be used in other applications.
[0031] To assist in passing the prosthetic valve 60 through the
incision in the aorta using the introducer, the introducer 10 is
first placed around the sutures 70 and inserted through the
incision. Because the introducer has a gap 36 extending the length
of the introducer, it can be easily placed around the sutures at a
location between the incision and the valve by passing the sutures
through the gap 36, as depicted in FIGS. 4 and 5. The enlarged
mouth portion 40 of the gap facilitates this process in that it
allows the operator to more easily direct the implant sutures 70
into and through the gap 36.
[0032] As shown in FIG. 6, the introducer 10 can then be inserted
through the incision into the aorta. The tapered distal end portion
28 facilitates the insertion of the introducer through the
incision. The introducer desirably is positioned such that the
distal end 16 is positioned in the native annulus or in the
Valsalva sinuses immediately adjacent the native annulus. In this
manner, the prosthetic valve can be guided directly to the desired
implantation position as it is advanced from the distal end of the
introducer. After the introducer is inserted into the aorta, the
surgeon can push the prosthetic valve through the introducer and
into the aorta. If the outer diameter of the prosthetic valve 60 is
greater than the diameter of the introducer, the introducer can
radially expand as the prosthetic valve passes through the
introducer due to the presence of the gap 36, as depicted in FIGS.
6-8. In addition the fingers 32 can expand radially outwardly from
each other to accommodate the passage of the valve through the
tapered distal end portion 28 of the introducer.
[0033] In the illustrated example, the incision can be made smaller
than the cross-sectional profile of the prosthetic valve taken at
sewing ring 66 (the cross-sectional profile is taken at a plane
that extends through the sewing ring and is perpendicular to the
central axis of the valve). Thus, as the valve passes through the
incision in this example, the incision is caused to dilate by the
radial force of the valve against the introducer, allowing the
valve to slide through the introducer at the location of the
incision while minimizing or preventing laceration of the tissue.
Moreover, the prosthetic valve can be pushed through the incision
while the valve is maintained at a position in which the
cross-sectional profile of the valve is generally perpendicular to
the line of movement through the introducer and the incision; in
other words, the valve need not be tilted or canted in order to
pass the valve through the incision, as required to perform a
conventional "shoehorn" technique.
[0034] As shown in FIG. 9, the valve can be advanced out of the
distal end of the introducer 10 and seated against the aortic
annulus. At this time, the introducer 10 can be removed from the
incision and from its position extending around the sutures 70 and
the delivery device 72. The introducer can be removed from its
position extending around the sutures 70 and the delivery device 72
by simply withdrawing the introducer laterally away from the
sutures and the delivery device while directing them to pass
through the gap 36 in the introducer. Due to the presence of the
gap, the introducer can be removed sideways with respect to the
delivery device and does not need to be withdrawn off of the
proximal end of the delivery device, which is being held in one
hand of the surgeon. Advantageously, this allows the surgeon to
easily and quickly remove the introducer without having to remove
the hand from the proximal end of the delivery device.
[0035] As further shown in FIG. 9, after removing the introducer
10, the expandable stent 68 can be deployed by advancing a balloon
catheter 74 of the delivery device proximally relative to the valve
to displace a nose cone 76 out of engagement with the stent 68 and
to position a balloon 78 of the balloon catheter to extend through
the stent 68. The balloon 78 can then be inflated to cause the
stent 68 to radially expand and engage surrounding tissue.
Thereafter, the balloon is deflated, the sutures 70 are tied off to
secure the sewing ring 66 to the aortic annulus, and the delivery
device is detached from the valve 60 and removed from the body. As
can be appreciated, in the illustrated example, the prosthetic
valve is secured in place against the native annulus by a
combination of the sutures 70 and the radial outward force of the
expandable stent 68.
[0036] It can be appreciated that the introducer can be used to
assist in the implantation of other types of prosthetic valves. For
example, the introducer can be used to introduce a conventional
surgical valve (i.e., one that does not have an expandable stent,
like stent 68 of valve 60) into the patient's vasculature. When
implanting a conventional surgical valve, a greater number of
implant sutures 70, typically about 15-21 sutures, are used to
secure the valve to the native annulus. The introducer can also be
used to introduce into a patient's vasculature a transcatheter
heart valve that can be radially compressed to a reduced diameter
for insertion into the patient's vasculature and radially
expandable to its functional size at the deployment site inside the
body.
[0037] In addition, the introducer 10 can be used introduce a valve
into the patient's vasculature via any type of aortotomy (incision
in the aorta). For example, FIG. 11 illustrates the implantation of
a prosthetic valve 60 via a transverse aortotomy where a transverse
incision is made through the aortic root. A plurality of implant
sutures can be threaded through the native annulus and the sewing
ring 66 of the valve, as described above. As shown, the introducer
10 can be placed around the sutures by passing the sutures through
the gap 36, and then inserting the distal end portion 28 of the
introducer into the aortic root until the distal end is just above
the native annulus. The prosthetic valve 60 can then be pushed
through the introducer, into the aorta and into the native annulus.
The valve can be secured in place by deploying the stent 68 and
tying off the implant sutures 70, as described above. If the
prosthetic valve has a diameter greater than that of the portion of
the aorta through which the valve passes, the introducer 10 causes
the aorta to dilate around the valve as it is passed through the
introducer toward the annulus, thereby allowing for atraumatic
passage of the valve and protecting against damage to the valve
itself. Moreover, the valve can be introduced while held
perpendicular to the line of movement into and through the aorta;
that is, the valve need not be tilted or canted relative to the
line of movement in order pass the relatively larger valve into the
aorta.
[0038] FIG. 12 illustrates an introducer assembly 100, according to
another embodiment, that can be used to introduce a prosthetic
device, such as a prosthetic valve 60, into the vasculature of a
patient. The assembly 100 in the illustrated embodiment comprises
an introducer 101 (also referred to as a sleeve) and an applicator
frame, or mounting frame, 102 configured to mount the introducer
101 around the prosthetic valve. The introducer 101 can comprise a
tubular sleeve made of a stretchable, flexible and/or resilient
material, such as a fabric. The applicator 102 is configured to
retain the introducer 101 in an expanded state having a generally
cylindrical configuration to allow the prosthetic valve to be
placed within the introducer during use. The applicator 102 can
comprise proximal and distal rings 104, 106, respectively,
interconnected by a plurality of longitudinal members 108 extending
between and interconnecting the rings. The applicator 102 desirably
is made of a relatively rigid material as compared to the
introducer, such as metal or plastic.
[0039] FIGS. 13-17 illustrate the implantation of the valve into
the aortic annulus via a transverse aortotomy made at the aortic
root. However, it should be understood that various other
aortotmies can be performed to gain access to the native annulus
for implanting the prosthetic valve using the introducer assembly
100. In any case, as shown in FIG. 13, implant sutures 70 can be
threaded through the native annulus and the sewing ring 66 of the
valve. The introducer 101 is first placed around the applicator
102, and the assembly 100 is placed around the sutures 70, as
depicted in FIG. 13, by inserting the proximal ends of the sutures
70 and the delivery device (the proximal ends are not shown in FIG.
13) into the distal opening of the applicator 102 and sliding the
assembly downwardly to the position shown in FIG. 13. The inner
diameter of the applicator 102 (defined by proximal and distal
rings 104, 106) is dimensioned large enough to permit the valve to
pass easily through the applicator.
[0040] Referring to FIG. 14, the valve 60 can then be positioned
within the expanded introducer 101. With the valve inside of the
introducer 101, the introducer is removed from the applicator, such
as by holding the introducer and the valve stationary and
retracting the applicator 102 upwardly in the direction of arrow
110. The applicator 102 can be removed from its position
surrounding the sutures and the delivery device 72 by withdrawing
the applicator upwardly beyond the proximal ends of the sutures and
the delivery device. When the applicator is removed, the introducer
101 collapses around and desirably extends over and covers the
entire valve such that a distal end portion 112 of the introducer
extends beyond the lower end of the valve, as depicted in FIG.
15.
[0041] Referring to FIG. 16, the distal end portion of the
introducer 101 is then inserted into the aortic root. The valve 60
can then be inserted into the aortic root by maintaining slight
upward tension on the introducer 101 (in the direction of arrow
114) while pushing downwardly on the valve 60 via the delivery
device (in the direction of arrow 116). As the valve is pushed
through the introducer and into the aortic root, the vessel dilates
and allows the valve to be advanced through the vessel to the
implantation site at the aortic annulus. When the valve is at the
desired position, the valve is held firmly in place via the
delivery device and the introducer 101 is pulled out of the aortic
root and then removed from the delivery device (FIG. 17) by moving
the introducer upwardly beyond the proximal ends of the suture and
the delivery device and the sutures. Thereafter, the valve can be
secured in place by deploying the stent 68 and tying off the
implant sutures 70, as described above.
[0042] FIG. 18 shows an introducer 150, according to another
embodiment, that can be used to introduce a prosthetic device, such
as a prosthetic valve 60, into the vasculature of a patient. The
introducer 150 comprises a thin-walled, generally tubular body 152
defining a central lumen, or passageway, 154. The introducer body
152 is constructed from a thin membrane made of a flexible
material, such as a flexible polymer, that forms a tubular outer
membrane 156 and a tubular inner membrane 158. The outer and inner
membranes are joined to each other at the opposite ends of the body
so as to form a sealed inner cavity that can contain a fluid, such
as a sterile liquid. The introducer body exhibits sufficient
flexibility to allow the positions of the inner and outer members
to be reversed; that is, the outer membrane 156 can be turned and
pushed inwardly into the lumen 154 at one end of the body to become
part of the inner membrane (as indicated by arrows 160) while the
inner membrane 158 at the opposite end of the body is caused to
turn and move outwardly (as indicated by arrows 162) so as to
become part of the outer membrane.
[0043] In use, a prosthetic valve 60 (or other prosthetic device),
which can be mounted to the distal end of a delivery device as
described herein, can be inserted into the lumen 154 of the
introducer 150. This can be accomplished by pushing or urging the
valve into the opening at one end of the introducer. The rolling or
reversing action of the membranes causes the introducer to "roll"
onto and over the valve. With the introducer 150 covering the
valve, one end of the introducer is inserted into an incision made
in the aorta (or another part of the patient's vasculature). The
valve can then be pushed through the introducer and into the aorta.
As the valve is advanced through the introducer, the membranes 156,
158 can roll relative to the valve to facilitate its passage
through the lumen 154.
[0044] In view of the many possible embodiments to which the
principles of the disclosed invention may be applied, it should be
recognized that the illustrated embodiments are only preferred
examples of the invention and should not be taken as limiting the
scope of the invention. Rather, the scope of the invention is
defined by the following claims. We therefore claim as our
invention all that comes within the scope and spirit of these
claims.
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