U.S. patent application number 16/562484 was filed with the patent office on 2019-12-26 for apparatus and method to reshape geometry of diseased heart valve.
The applicant listed for this patent is Mitral Technologies S.A.. Invention is credited to Luigi P. Tozzi.
Application Number | 20190388216 16/562484 |
Document ID | / |
Family ID | 53494033 |
Filed Date | 2019-12-26 |
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United States Patent
Application |
20190388216 |
Kind Code |
A1 |
Tozzi; Luigi P. |
December 26, 2019 |
APPARATUS AND METHOD TO RESHAPE GEOMETRY OF DISEASED HEART
VALVE
Abstract
Devices and methods are disclosed for treating mitral valve
regurgitation that include members that assist the valve in closing
during the cardiac cycle. Such devices may include members
configured to alter the shape of mitral valve annulus. In certain
embodiments, one or more wires may be anchored on one extremity to
an element positioned along the posterior part of the mitral
annulus, in the coronary sinus, and on another extremity to an
element along the anterior part of the mitral annulus, fibrous
trigon. The reshaping of the mitral annulus may be accomplished by
pulling the wire or wires. Reducing the length of the wire or wires
may provide the displacement of the posterior leaflets towards the
anterior, thereby increasing the coaptation surface for the valve
leaflets and reducing the regurgitation.
Inventors: |
Tozzi; Luigi P.; (Fort
Collins, CO) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Mitral Technologies S.A. |
Liege |
|
BE |
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|
Family ID: |
53494033 |
Appl. No.: |
16/562484 |
Filed: |
September 6, 2019 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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15109437 |
Jun 30, 2016 |
10426620 |
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PCT/US14/73084 |
Dec 31, 2014 |
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16562484 |
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61923319 |
Jan 3, 2014 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61F 2/2451 20130101;
A61B 17/00234 20130101; A61F 2/246 20130101; A61B 2017/00243
20130101; A61F 2/2454 20130101; A61F 2/2466 20130101; A61F 2/2445
20130101; A61F 2220/0025 20130101; A61F 2220/0075 20130101; A61F
2250/0004 20130101 |
International
Class: |
A61F 2/24 20060101
A61F002/24 |
Claims
1. An annuloplasty device, comprising: a first holding element
configured to be located in a coronary sinus of a heart; a second
holding element configured to be located in a fibrous trigon of the
heart; and one or more connecting elements for connecting the first
holding element and the second holding element, the one or more
connecting elements configured to pull the first holding element
toward the second holding element to reduce the distance between an
anterior portion of the mitral annulus of the heart and a posterior
portion of the mitral annulus, thereby increasing mitral valve
leaflets coaptation.
2. The device of claim 1, wherein the one or more connecting
elements are configured to cross the valve area on the atrial
side.
3. The device of claim 1, wherein the first and second holding
elements and the one or more connecting elements are configured to
be deployed into the heart using endovascular techniques.
4. The device of claim 1, wherein at least one of the one or more
connecting elements is configured to change its profile during a
cardiac cycle to prevent mitral leaflets damage due to impingement
of one or more mitral valve leaflets on the at least one connecting
element during ventricular systole.
5. The device of claim 1, wherein at least one of the one or more
connecting elements is configured to change its profile during a
cardiac cycle not to block blood flow from atrium to ventricle.
6. The device of claim 1, wherein a plurality of the one or more
connecting elements are configured to be joined in situ to form a
single connecting element.
Description
I. CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application is a divisional of U.S. patent application
Ser. No. 15/109,437 entitled "Apparatus and method to reshape
geometry of diseased heart valve," and filed on 30 Jun. 2016, which
is the national stage for International Patent Cooperation Treaty
Application PCT/US2014/073084, filed Dec. 31, 2014, which claims
the benefit of U.S. Provisional Patent Application No. 61/923,319,
entitled "Apparatus and method to reshape geometry of diseased
heart valve," and filed on 3 Jan. 2014. The entirety of the
foregoing patent applications is incorporated by reference
herein.
II. TECHNICAL FIELD
[0002] The present disclosure relates to the repair and/or
correction of dysfunctional heart valve. More particularly pertains
to mitral valve regurgitation treatment using only endovascular
techniques deploying devices that passively assist to close a heart
valve to improve valve function.
II. BACKGROUND
[0003] A human heart has four chambers, the left and right atrium
and the left and right ventricles. The chambers of the heart
alternately expand and contract to pump blood through the vessels
of the body. The cycle of the heart includes the simultaneous
contraction of the left and right atria, passing blood from the
atria to the left and right ventricles. The left and right
ventricles then simultaneously contract forcing blood from the
heart and through the vessels of the body. In addition to the four
chambers, the heart also includes a check valve at the upstream end
of each chamber to ensure that blood flows in the correct direction
through the body as the heart chambers expand and contract. These
valves may become damaged, or otherwise fail to function properly,
resulting in their inability to properly close when the downstream
chamber contracts. Failure of the valves to properly close may
allow blood to flow backward through the valve resulting in
decreased blood flow and lower blood pressure.
[0004] Mitral regurgitation occurs when the mitral valve separating
the left atrium and the left ventricle fails to properly close. As
a result, upon contraction of the left ventricle blood may leak or
flow from the left ventricle back into the left atrium, rather than
being forced through the aorta.
[0005] The mitral valve has 2 leaflets, anterior and posterior,
both connected on one side to the mitral annulus and on the free
edges to the cordae and cardiac muscle. In order to close properly,
the free edges of the two leaflets have to touch each other over a
length of several millimeters and this is called leaflets
coaptation. Mitral regurgitation is mainly due to a lack of
leaflets coaptation as a consequence of annulus dilatation or
cardiac muscle dysfunction. Regardless of the cause, mitral
regurgitation may result in a decrease in blood flow through the
body (cardiac output) and deserve surgical treatment.
III. BRIEF DESCRIPTION OF THE DRAWINGS
[0006] FIGS. 1A-B depict cross-sectional views of a normal mitral
valve and a regurgitant mitral valve in accordance with certain
embodiments.
[0007] FIGS. 2A-B depict cross-sectional views of a regurgitant
mitral valve and a reshaped mitral valve in accordance with certain
embodiments.
[0008] FIG. 3 depicts a cross-sectional view of a heart in
accordance with certain embodiments.
[0009] FIG. 4 depicts placement of a posterior holding element in
accordance with certain embodiments.
[0010] FIG. 5 depicts placement of an anterior holding element in
accordance with certain embodiments.
[0011] FIG. 6 depicts placement of one or more wires through the
mitro-aortic junction in accordance with certain embodiments.
[0012] FIG. 7 depicts pulling the one or more wires through the
mitro-aortic junction to correct mitral regurgitation in accordance
with certain embodiments.
[0013] FIG. 8 depicts locking the one or more wires over an
anterior holding element in accordance with certain
embodiments.
[0014] FIG. 9 depicts the one or more wires installed to increase
leaflets coaptation in accordance with certain embodiments.
[0015] FIGS. 10A-B depict a method of installing three wires to
increase leaflets coaptation in accordance with certain
embodiments.
[0016] FIG. 11 depicts a method of installing wires into the trigon
region in accordance with certain embodiments.
[0017] FIG. 12 depicts a method of coupling wires in the trigon
region in accordance with certain embodiments.
[0018] FIG. 13 depicts an assembled posterior holding element and
connecting element in accordance with certain embodiments.
[0019] FIG. 14 depicts a method of connecting the free end of a
connecting element to a wire exiting the femoral vein in accordance
with certain embodiments.
[0020] FIGS. 15A-B depict a method of pulling a wire that exits the
femoral artery until the assembled element reaches the coronary
sinus in accordance with certain embodiments.
[0021] FIG. 16 depicts a method of positioning an anterior holding
element below the aortic valve at the level of the fibrous trigon
in accordance with certain embodiments.
[0022] FIG. 17 depicts a method of adjusting the connecting element
length and locking the anterior holding element to the connecting
element in accordance with certain embodiments.
[0023] FIGS. 18A-B depict changing the profile of one or more wires
during a cardiac cycle in accordance with certain embodiments.
IV. DETAILED DESCRIPTION
[0024] Devices and methods are disclosed for treating mitral valve
regurgitation that include members that assist the valve in closing
during the cardiac cycle. Such devices may include members
configured to alter the shape of mitral valve annulus. In certain
embodiments, one or more wires may be anchored on one extremity to
an element positioned along the posterior part of the mitral
annulus, in the coronary sinus, and on another extremity to an
element along the anterior part of the mitral annulus, fibrous
trigon. The reshaping of the mitral annulus may be accomplished by
pulling the wire or wires. Reducing the length of the wire or wires
may provide the displacement of the posterior leaflets towards the
anterior, thereby increasing the coaptation surface for the valve
leaflets and reducing the regurgitation.
[0025] In certain embodiments, an annuloplasty device is disclosed,
comprising: a first holding element configured to be located in a
coronary sinus of a heart; a second holding element configured to
be located in a fibrous trigon of the heart; and one or more
connecting elements for connecting the first holding element and
the second holding element, the one or more connecting elements
configured to pull the first holding element toward the second
holding element to reduce the distance between an anterior portion
of the mitral annulus of the heart and a posterior portion of the
mitral annulus, thereby increasing mitral valve leaflets
coaptation. The one or more connecting elements may be configured
to cross the valve area on the atrial side. The first and second
holding elements and the one or more connecting elements may be
configured to be deployed into the heart using endovascular
techniques. At least one of the one or more connecting elements may
be configured to change its profile during a cardiac cycle to
prevent mitral leaflets damage due to impingement of one or more
mitral valve leaflets on the at least one connecting element during
ventricular systole. At least one of the one or more connecting
elements may be configured to change its profile during a cardiac
cycle not to block blood flow from atrium to ventricle. A plurality
of the one or more connecting elements may be configured to be
joined in situ to form a single connecting element.
[0026] In certain embodiments, the first holding element may be
configured to be located in a coronary sinus of a heart and one
connecting element for connecting the first holding element and the
second holding element, may be assembled with the first holding
element into a single element before the implant.
[0027] In certain embodiments, a method of inserting an
annuloplasty device is disclosed, comprising: placing a first
holding element into a coronary sinus of a heart; connecting one or
more connecting elements to the first holding element; pulling at
least one of the one or more connecting elements to increase mitral
valve leaflet coaptation; connecting the one or more connecting
elements to a second holding element at the level of the
mitro-aortic junction and fibrous trigon of a heart. The step of
connecting one or more connecting elements to the first holding
element may comprise placing one or more connecting elements
through the mitro-aortic junction of a heart. The step of
connecting the one or more connecting elements to the first holding
element may comprise: piercing the left ventricle outflow tract at
the level of fibrous trigon with a first connecting element;
extending the first connecting element across a valve area towards
the posterior mitral annulus of the heart; piercing the mitral
annulus and the coronary sinus with the first connecting element
and connecting the first connecting element to the first holding
element. One of the one or more connecting elements may be placed
in the left ventricle outflow tract at the level of the fibrous
trigon, below the aortic valve using endovascular techniques. At
least one of the one or more connecting elements may change its
profile during a cardiac cycle to prevent mitral leaflet damage due
to impingement of one or more mitral valve leaflets on the at least
one connecting element during ventricular systole. At least one of
the one or more connecting elements may change its profile during a
cardiac cycle and may not block blood flow from atrium to
ventricle. The method may further comprise adjusting the length of
the connecting element. The step of adjusting the length of the
connecting element may be performed during a selected one of an
initial procedure to install the annuplasty device and a later
procedure after the initial procedure is completed.
[0028] In certain embodiments, a method of inserting an
annuloplasty device is disclosed, comprising: connecting a first
holding element to one or more connecting elements; placing the
first holding element connected to the one or more connecting
elements into the coronary sinus of the heart; connecting the one
or more connecting elements to a second holding element placed at
the level of the mitro-aortic junction and fibrous trigon of a
heart; pulling at least one of the one or more connecting elements
to increase mitral valve leaflets coaptation. The step of
connecting the one or more connecting elements to the second
holding element may comprise: piercing a coronary sinus of the
heart with a first holding element connected to one or more
connecting elements avoiding the circonflex artery of the heart;
extending the first connecting element across a valve area towards
the fibrous trigon on the atrial side of the valve; piercing the
left ventricle outflow tract at the level of the fibrous trigon
with the first connecting element; pulling at least one of the one
or more connecting elements to increase mitral valve leaflets
coaptation; and connecting the first connecting element to the
second holding element. One of the one or more connecting elements
may be placed in the left ventricle outflow tract at the level of
the fibrous trigon, below the aortic valve using endovascular
techniques. At least one of the one or more connecting elements may
change its profile during a cardiac cycle to prevent mitral leaflet
damage due to impingement of one or more mitral valve leaflets on
the at least one connecting element during ventricular systole. At
least one of the one or more connecting elements may change its
profile during a cardiac cycle and may not block blood flow from
atrium to ventricle. A plurality of the one or more connecting
elements may be joined in situ to form a single connecting
element.
[0029] To reduce mitral regurgitation, certain embodiments increase
leaflets coaptation by pulling the posterior annulus toward the
anterior (FIGS. 1 and 2) using 2 holding elements and wires. FIG.
1A depicts a normal mitral valve 110, wherein leaflets coaptation
allows the mitral valve to tightly seal. FIG. 1B depicts a
regurgitant mitral valve 120 that lacks leaflets coaptation due to
mitral annulus dilation, preventing the valve from achieving a
tight seal. In certain embodiments, it is desired to reduce
distance A-P as depicted in FIGS. 2A-B to improve leaflet
coaptation in the mitral valve. FIG. 2A depicts distance A-P in
regurgitant mitral valve 210, which FIG. 2B depicts reshaped mitral
valve 220 with reduced distance A-P.
[0030] In certain embodiments, the procedure can be totally
endovascular, alleviating the need for open-heart surgery, and may
utilize anatomical relationships between the mitral annulus,
coronary sinus 310, fibrous trigon 320 and aortic valve as shown in
FIG. 3.
[0031] In certain embodiments, the procedure may consist of 4
steps:
[0032] In certain embodiments as shown in FIG. 4, Step 1 may
include insertion of posterior holding element into the coronary
sinus through the femoral vein. An exemplary holding element 410 is
shown and described in FIG. 4. The posterior holding element 410
may be a rod that reproduces the saddle shape of the posterior part
of the mitral annulus. In certain embodiments, the posterior
holding element 410 may be made of stainless steel, but one of
ordinary skill in the art will recognize that other metals or
polymers may be used. In certain embodiments, conventional
techniques of placement may be used such as techniques known to one
of ordinary skill in the art for positioning pacemaker electrodes
and/or a Carillon device.
[0033] In certain embodiments as shown in FIG. 5, Step 2 may
include placement of the wires trough the fibrous trigon, which may
be accomplished using existing transcatheter technology. A delivery
catheter 510 may be inserted into femoral artery and advanced into
the aorta, below the aortic valve at the level of the mitro-aortic
junction (FIG. 5). The wire may be inserted into the delivery
catheter 510. The wire may pierce the fibrous trigon 520 and may be
directed toward the posterior holding element 530 under fluoroscopy
control. In certain embodiments as shown in FIG. 6, the wire may
pierce the posterior mitral annulus and may catch the posterior
holding element 530 (FIG. 6). One of ordinary skill in the art will
recognize that the posterior holding element may be attached to the
wire prior to insertion via the catheter.
[0034] In certain embodiments as shown in FIG. 7, Step 3 may
include pulling of the posterior holding element 530. Once the wire
610 is connected to the posterior holding element 530, the wire 610
may be pulled through the delivery catheter 510 to reduce the
Antero-Posterior distance, thereby increasing leaflets coaptation
and correcting mitral regurgitation.
[0035] In certain embodiments as shown in FIG. 8, Step 4 may
include locking wire 610 over anterior holding element 810. An
anterior holding element 810 may be inserted into the delivery
catheter 510. The anterior holding element 810 may have a rod shape
and may be made of metal or polymer or other suitable materials
known to those of skill in the art. The anterior holding element
810 may be placed at the level of the mitro-aortic junction. The
wire may be locked over the anterior holding element 810. In
certain embodiments as shown in FIG. 9, the delivery catheter 510
may be retrieved and the procedure completed.
[0036] The number of wires varies according to the severity of the
mitral regurgitation. In FIGS. 10A and B, an embodiment with 3
wires 1010 is illustrated. FIG. 10A depicts a mitral valve
exhibiting mitral regurgitation due to the absence of leaflet
coaptation. FIG. 10B shows a mitral valve with three wires 1010
used to connect anterior holding element 1020 and posterior holding
element 1030. One of ordinary skill in the art will recognize that
the number of wires 1010 may be varied depending on the severity of
the mitral regurgitation. In certain embodiments, steps 2-4 above
may be repeated for each subsequent wire 1010 until the desired
number of wires 1010 has been installed. Once the desired number of
wires 1010 has been installed, the delivery catheter 510 may be
retrieved and the procedure completed.
[0037] In certain embodiments, the procedure may consist of 5
steps:
[0038] In certain embodiments as shown in FIG. 11, Step 1 may
include placement of the wires through the fibrous trigon, which
may be accomplished without limitation using existing transcatheter
technology or other methods known to those of skill in the art. A
delivery catheter 1110 may be inserted into a femoral artery and
advanced into the aorta, below the aortic valve at the level of the
mitro-aortic junction as shown in FIG. 5. The wire 1120 may be
inserted into the delivery catheter 1110. The wire 1120 may pierce
the fibrous trigon and be kept floating in the left atrium
[0039] In certain embodiments, Step 2 may include placement of the
wires into the coronary sinus using existing transcatheter
technology or other methods known to those of skill in the art. A
delivery catheter 1130 may be inserted into the femoral vein and
advanced into the coronary sinus (great cardiac vein). The wire
1140 may be inserted into the delivery catheter and advanced. The
wire 1140 may pierce the wall of the left atrium at the level where
the connecting element has to be placed. The wire 1140 may be kept
floating in the left atrium.
[0040] In certain embodiments as shown in FIG. 12, Step 3 may
include joining the wire 1120 coming from the fibrous trigon and
wire 1140 coming from the coronary sinus (shown in FIG. 11), using
magnetic coupling force or using other existing transcatheter
technology such as snare wires. This action may result in having
one single wire 1210 going from the femoral vein to the femoral
artery trough the coronary sinus and fibrous trigon.
[0041] In certain embodiments as shown in FIGS. 13-15, Step 4 may
include connection of the assembled device to the wire 1410 on the
vein end. The free end 1310 of the connecting element 1320, the one
to be connected to the holding element 1330 to be located in the
fibrous trigon, is connected to the wire 1410 on the vein end as
shown in FIGS. 13 and 14. Pulling the wire 1410 through the
arterial end as shown in FIG. 15A may allow the positioning of
assembled device into the coronary sinus first. Once the holding
element 1330 to be located in the coronary sinus is in place as
shown in FIG. 15B, the wire 1410 is pulled till the connecting
element 1320 is completely deployed over the mitral valve and
reaches the fibrous trigon, below the aortic valve as shown FIG.
15B.
[0042] In certain embodiments as shown in FIG. 16, Step 5 may
include locking the wire 1410 over anterior holding element 1610.
An anterior holding element 1610 may be inserted into the delivery
catheter. The anterior holding element 1610 may have a rod shape
and may be made of metal or polymer or other suitable material
known to those skilled in the art. The anterior holding element may
be placed at the level of the mitro-aortic junction.
[0043] In certain embodiments as shown in FIG. 17, the locking
system may be released and connecting element length may be
adjusted as many times as necessary. The adjustment may be done
during the implant procedure and/or during a second or subsequent
procedure. The second or subsequent procedure may be done after
days, months or years.
[0044] In another embodiment, at least one of the wires may change
its profile according to the direction of blood flow. FIG. 18
presents a left atrial view. During ventricular filling the wire
may have a very low profile to facilitate the blood flow as shown
in FIG. 18A. During ventricular contraction the wire may increase
its profile as shown in FIG. 18B, improving mitral regurgitation
correction and reducing mechanical stress on mitral valve
leaflets.
[0045] Certain embodiments may provide advantages over the prior
art. For example, certain embodiments may allow treatment of mitral
valve regurgitation without open-heart surgery. Mitral valve repair
or replacement generally is accomplished by a major open-heart
surgical procedure, requiring general anesthesia, full
cardiopulmonary bypass with complete cessation of cardiopulmonary
activity, seven to ten days of hospitalization and months of
recuperation time. The mortality rate with this type of procedure
is about five to six percent.
[0046] One commonly employed repair technique in open-heart surgery
involves the use of annuloplasty rings. An annuloplasty ring has a
diameter that is less than the diameter of the enlarged valve
annulus. The ring is placed in the valve annulus and the tissue of
the annulus sewn or otherwise secured to the ring. This causes a
reduction in the annular circumference and an increase in the
leaflet coaptation area.
[0047] Endovascular heart procedures, in contrast to open heart
surgical procedures, would require only local anesthesia, no
cardiac bypass, one to two days hospitalization, and should have a
reduced mortality rate as compared to open heart procedures.
[0048] Therefore, effective techniques that could improve valve
function without the need for cardiopulmonary bypass may be
advantageous. In particular, passive techniques to change the shape
of the valve reducing regurgitation while maintaining substantially
normal leaflet motion may be desirable. In addition, a technique
that can be employed on a beating heart would allow the
practitioner an opportunity to assess the efficacy of the treatment
and address any inadequacies without the need for additional bypass
support.
[0049] However, as discussed in the literature, there are limited
possibilities to achieve effective endovascular correction of
mitral regurgitation. Existing devices and techniques such as
Mitraclip System (Abbott), Cardioband (Valtech Cardio) and Carillon
(Cardiac Dimensions) have provided limited evidence of clinical
benefit, mainly because they failed to achieve a significant
increase in leaflets coaptation. Certain embodiments of the present
invention overcome the disadvantages of the foregoing
techniques.
[0050] For the first time it is possible to increase leaflets
coaptation similarly to the technique used in open-heart surgery,
using only a transcatheter approach.
[0051] Certain embodiments employ the novel method of using wires
crossing the orifice of the mitral valve, which was not previously
recommended due to potential mitral leaflets damage. The use of
wires having the profile changing over the cardiac cycle should
minimize leaflets damage.
[0052] While the above description contains many specifics, these
should not be construed as limitations on the scope of the
invention, but rather as an exemplification of preferred
embodiments thereof. The invention includes any combination or
subcombination of the elements from the different species and/or
embodiments disclosed herein. One skilled in the art will recognize
that these features, and thus the scope of the present invention,
should be interpreted in light of the following claims and any
equivalents thereto.
* * * * *