U.S. patent application number 16/049426 was filed with the patent office on 2018-11-22 for valve for short time replacement, for taking over the function of and/or for temporary or partial support of a native valve in a heart and a method for delivery therefor.
This patent application is currently assigned to Medtentia International Ltd Oy. The applicant listed for this patent is Medtentia International Ltd Oy. Invention is credited to Olli Keranen.
Application Number | 20180333257 16/049426 |
Document ID | / |
Family ID | 47747354 |
Filed Date | 2018-11-22 |
United States Patent
Application |
20180333257 |
Kind Code |
A1 |
Keranen; Olli |
November 22, 2018 |
Valve For Short Time Replacement, For Taking Over The Function Of
And/Or For Temporary Or Partial Support Of A Native Valve In A
Heart And A Method For Delivery Therefor
Abstract
Disclosed is a valve for short time replacement, for taking over
the function of and/or for temporary support of a native valve in a
heart, the valve being positioned through the native valve upon
implantation, the valve comprising an at least partially
collapsible and/or at least partially expandable tube and a flange.
The valve allows for fast and easy replacement of a native valve,
and more time for medical personnel to make decisions, prepare
and/or perform surgery/medical intervention. Thus, the valve may
provide for an improved quality of surgery/medical
intervention.
Inventors: |
Keranen; Olli; (Bjarred,
SE) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Medtentia International Ltd Oy |
Helsinki |
|
FI |
|
|
Assignee: |
Medtentia International Ltd
Oy
Helsinki
FI
|
Family ID: |
47747354 |
Appl. No.: |
16/049426 |
Filed: |
July 30, 2018 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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14762413 |
Jul 21, 2015 |
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PCT/EP2014/051540 |
Jan 27, 2014 |
|
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16049426 |
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61756649 |
Jan 25, 2013 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61F 2/2436 20130101;
A61F 2/2403 20130101; A61F 2/2457 20130101; A61F 2/2412 20130101;
A61F 2/2466 20130101; A61F 2/2418 20130101; A61F 2/2445 20130101;
A61F 2230/0069 20130101; A61F 2250/0059 20130101 |
International
Class: |
A61F 2/24 20060101
A61F002/24 |
Foreign Application Data
Date |
Code |
Application Number |
Jan 25, 2013 |
EP |
13152770.7 |
Claims
1. An artificial valve for taking over the function of a native
valve in a heart, the artificial valve is configured for being
positioned through the native valve upon implantation, the
artificial valve comprising an at least partly collapsible and/or
at least partly expandable tube, a flange for preventing the
artificial valve from moving out of position, a collecting unit for
collecting and arranging chordae of the heart towards the
artificial valve, whereby the artificial valve is secured in a
desired position by the collecting unit.
2. An artificial valve according to claim 1, wherein the collecting
unit is rotatable into position at the artificial valve.
3. An artificial valve according to claim 1, wherein the collecting
unit comprises a clip shaped as a helix, wherein the chordae are
kept in position towards the artificial valve with the helix-shaped
clip.
4. An artificial valve according to claim 3, wherein the clip is a
separate piece and not integrated with the artificial valve.
5. An artificial valve according to claim 1, wherein the flange is
expandable.
6. An artificial valve according to claim 1, wherein the flange is
flexible.
7. An artificial valve according to claim 1, comprising a steerable
delivery catheter having a lumen, the collecting unit comprises a
wire to be arranged in the steerable delivery catheter to exit the
lumen and surround the chordae.
8. An artificial valve according to claim 7, wherein the wire
comprises an end unit to pull the chordae together towards the
artificial valve upon activation of the end unit.
9. An artificial valve according to claim 7, wherein the wire is
steerable.
10. An artificial valve according to any of claims 7-9, wherein the
delivery catheter is steerable to be positioned around the
chordae.
11. A method of delivering an artificial valve for taking over the
function of a native valve in a heart, the method comprising
gaining trans-apical, trans-septal, or trans-aortic access to the
heart, forwarding a catheter, via a trans-apical route, via an
aortic route, or transseptally, positioning the artificial valve
inside the native valve with the catheter, pulling a plurality of
chordae of the heart towards the artificial valve for fixation of
the artificial valve.
12. Method according to claim 11, comprising deploying a collecting
unit to surround the artificial valve to keep the chordae in
position towards the artificial valve.
13. Method according to claim 12, comprising rotating the
collecting unit into position to surround the artificial valve.
14. Method according to claim 12, wherein the collecting unit
comprises a clip shaped as a helix, wherein the chordae are kept in
position towards the artificial valve with the helix-shaped
clip.
15. Method according to claim 11, comprising creating a space
between the chordae and a ventricular wall of the heart by pulling
the plurality of chordae towards the artificial valve.
16. Method according to claim 12, wherein the collecting unit
comprises a wire, and the catheter is a steerable catheter having a
lumen, the method comprising arranging the wire in the catheter to
exit the lumen, and surrounding the chordae with the wire.
17. Method according to claim 16, comprising pulling the chordae
together towards the artificial valve upon activation of an end
unit of the wire.
18. Method according to claim 12, comprising steering the catheter
and/or wire into a position surrounding the artificial valve.
Description
RELATED APPLICATIONS
[0001] This application is a continuation of and claims priority to
U.S. patent application Ser. No. 14/762,413 filed Jul. 21, 2015
entitled A Valve For Short Time Replacement, For Taking Over The
Function Of And/Or For Temporary Or Partial Support Of A Native
Valve In A Heart And A Method For Delivery Therefor, which is the
U.S. National Phase of and claims priority to International Patent
Application No. PCT/EP2014/051540, International Filing Date Jan.
27, 2014, entitled A Valve For Short Time Replacement, For Taking
Over The Function Of And/Or For Temporary Or Partial Support Of A
Native Valve In A Heart And A Method For Delivery Therefor, which
claims benefit of European Application No. EP13152770.7, filed Jan.
25, 2013 entitled A Valve For Short Time Replacement For Taking
Over The Function Of, And/Or For Temporary Or Partial Support Of, A
Native Valve In A Heart; and U.S. Provisional Application Ser. No.
61/756,649, filed Jan. 25, 2013 entitled A Valve For Short Time
Replacement, For Taking Over The Function Of And/Or For Temporary
Or Partial Support Of A Native Valve In A Heart And A Method For
Delivery Therefor; all of which are incorporated herein by
reference in their entireties.
[0002] This application is related to application "A medical device
and method for facilitating selection of an annuloplasty implant"
filed 25 Jan. 2013 having EP application nr: EP13152774 and U.S.
provisional application No. 61/756,633, application "A medical
system, and a device for collecting chordae and/or leaflets" filed
25 Jan. 2013 having EP application nr: EP13152769 and U.S.
provisional application No. 61/756,657, application "Temporary
atrium support device" filed 25 Jan. 2013 having EP application nr:
EP13152771 and U.S. provisional application No. 61/756,663, and
application "A system for cardiac valve repair" filed 25 Jan. 2013
having EP application nr: EP13152768 and U.S. provisional
application No. 61/756,670. The above applications are incorporated
herein by reference in their entirety for all purposes.
BACKGROUND OF THE INVENTION
Field of the Invention
[0003] This invention pertains in general to the field of medical
devices for improvement of heart valves, such as mitral, aortic or
tricuspid valves, as well as tools and methods therefore. More
particularly the invention relates to a valve for short time
replacement or support of a native valve, such as a mitral, an
aortic or a tricuspid valve, in a heart and a method of delivery
therefor.
Description of the Prior Art
[0004] During heart surgery, a premium is placed on reducing the
amount of time used to replace and repair valves as the heart is
frequently arrested and without perfusion.
[0005] Thus, it would be advantageous to have a short time
replacement valve temporarily replacing a native valve to be
repaired or replaced during such repair, replacement or
preparations therefor in order to allow for e.g. a beating heart
intervention.
[0006] Furthermore, since a premium is placed on reducing the
amount of time used to replace and repair valves, there is not a
lot of time for making decisions, preparing or performing surgery
or medical intervention. Thus, it would also be advantageous to
have more time to make decisions, for preparations and/or for
performing surgery or medical intervention. This may be important,
especially since more time may lead to an improved quality of the
replacement or repair.
[0007] The use of a temporary valve has been disclosed in
US20070219630 A1.
[0008] In US2012/101571A1 a mitral valve prosthesis is disclosed,
for replacing failed/failing mitral valve in heart of patient. The
valve prosthesis is for permanent implantation in the ventricle of
the heart only and has multiple components to be assembled in the
heart.
[0009] In US2008/077235 A1 an inflatable balloon is disclosed for
the placement and treatment of an insufficient or stenotic cardiac
valve, such as the mitral valve. Balloon may deflate, dislocate,
punctured during delivery, etc.
[0010] In WO2012/095159 A2 a ring-shaped prosthetic valve is
disclosed for permanently replacing an atrioventricular heart valve
that comprises an annular body on which valvular cusps are fastened
for insertion into a valve annulus of the heart.
[0011] In US2007/255396 A1 a girdle is disclosed for surrounding
the chordae tendinae of a heart valve.
[0012] In US2007/038293 A1 a device and methods for endoscopic
annuloplasty are disclosed. Opposed valve leaflets may be
temporarily grasped and held into position prior to permanent
attachment. No replacement valve is disclosed in US2007/038293
A1.
[0013] However, as can be seen from e.g. FIGS. 5 and [0130] in this
document, the temporary valve is placed away from the mitral valve.
Furthermore, as can be seen in [0076] of this document, a mitral
valve separation unit is needed for proper function. Moreover, the
flow is in the examples described in this document directed through
conduits, such as conduits 130, 140, 330, 340, 430, 440, and thus
not through the native valve.
[0014] The construction of the temporary valve function as a whole
is thus rather complicated.
[0015] It may thus be advantageous to have a temporary valve which
is of a simple, effective and cost-effective construction. Such a
construction may utilize parts of or the whole native valve.
SUMMARY OF THE INVENTION
[0016] Accordingly, examples of the present disclosure preferably
seek to mitigate, alleviate or eliminate one or more deficiencies,
disadvantages or issues in the art, such as the above-identified,
singly or in any combination by providing a valve for short time
replacement of a native valve in a heart and a method of delivery
therefor, according to the appended patent claims.
[0017] The invention is advantageous, since by the use of the
temporary valve disclosed herein, there may be more time for making
decisions about how to perform surgery or intervention, for
preparing surgery and/or for performing surgery or medical
intervention. Thus, quality of repair or replacement of a native
valve may be improved.
[0018] According to aspects of the disclosure, a valve for short
time replacement of a native valve in a heart and a method of
delivery therefor are disclosed.
[0019] According to one aspect of the disclosure, a valve for short
time replacement, for taking over the function of and/or for
temporary or partial support of a native valve in a heart is
provided. The valve is positioned through the native valve upon
implantation. The valve comprises a tube and a flange. The tube is
at least partially collapsible. The tube may alternatively or in
addition be at least partially expandable. The expandable flange
prevents the valve from moving out of position from the left atrium
towards the left ventricle or from the ascending aorta towards the
aortic arc or to the descending aorta.
[0020] According to another aspect of the disclosure, a method of
delivering a valve for short time replacement of a native valve,
such as a mitral valve, in a heart, is provided. The method
comprises gaining trans-apical or trans-aortic access to the heart
or transseptal access to the heart via a venous route for a mitral
valve. The method further comprises forwarding a catheter, via a
trans-apical route or via an aortic route, i.e.
trans-catheter-based, into the left ventricle of the heart.
Alternatively, the catheter may be forwarded transseptally via a
venous route. During the forwarding, the catheter passes at least
partly through the native valve. Thereafter the valve is positioned
inside the native valve. The method may also comprise pulling a
plurality of chordae together and towards the valve for fixation of
the valve. Furthermore, the method may comprise deploying of a clip
to surround the valve and/or to keep the chordae in position
towards the valve. The method also comprises removing the
catheter.
[0021] Further examples of the disclosure are defined in the
dependent claims, wherein features for the second and subsequent
aspects of the disclosure are as for the first aspect mutatis
mutandis.
[0022] Some examples of the disclosure provide for more time for
making decisions about how to perform surgery or medical
intervention.
[0023] Some examples of the disclosure provide for more time for
preparing surgery.
[0024] Some examples of the disclosure provide for more time for
performing surgery or medical intervention.
[0025] Some examples of the disclosure provide for an improved
quality of repair or replacement of a native valve.
[0026] Some examples of the disclosure provide for a simple and/or
a reliable temporary valve function.
[0027] Some examples of the disclosure provide for that the tube
does not interfere with any annuloplasty device or similar
device.
[0028] Some examples of the disclosure provide for reliable
securing of the temporary valve.
[0029] Some examples of the disclosure provide for fast and/or easy
replacement of a native valve.
[0030] Some examples of the disclosure provide for fast and/or easy
positioning of a temporary valve.
[0031] Some examples of the disclosure provide for that simple
and/or fast deployment of a clip is enabled.
[0032] Some examples of the disclosure provide for a fast and easy
collection of chordae.
[0033] Some examples of the disclosure provide for fast and easy
securing of the temporary valve.
[0034] Some examples of the disclosure provide for fast and easy
tightening to minimize paravalvular leakage.
[0035] Some examples of the disclosure provide for a procedure that
is less prone to errors and thus a faster and easier securing of
the valve.
[0036] Some examples of the disclosure provide for reliable
securing of a temporary valve and/or chordae.
[0037] Some examples of the disclosure enable precise positioning
of an implant or a valve in the anatomically correct position.
[0038] Some examples of the disclosure provide for that the
procedure or surgery can be performed with high accuracy.
[0039] Some examples of the disclosure provide for an easier and/or
less invasive delivery method.
[0040] Some examples of the disclosure provide for fast and easy
collection of chordae.
[0041] Some examples of the disclosure provide for a fast and easy
way of delivering, positioning and/or securing a temporary valve
from outside the body of a patient.
[0042] Some examples of the disclosure enable beating heart
surgery.
[0043] Some examples of the disclosure provide for a reduced
leakage.
[0044] Some examples of the disclosure provide for a minimized
regurgitation during e.g. beating heart surgery.
[0045] It should be emphasized that the term "comprises/comprising"
when used in this specification is taken to specify the presence of
stated features, integers, steps or components but does not
preclude the presence or addition of one or more other features,
integers, steps, components or groups thereof.
BRIEF DESCRIPTION OF THE DRAWINGS
[0046] These and other aspects, features and advantages of which
examples of the disclosure are capable of will be apparent and
elucidated from the following description of examples of the
present disclosure, reference being made to the accompanying
drawings, in which
[0047] FIG. 1A is a cross-sectional view of a patient with a
heart;
[0048] FIG. 1B is a perspective view of a mitral valve and an
aortic valve;
[0049] FIG. 2 is a schematic cross-sectional view of a mitral
valve;
[0050] FIG. 3A is a cross-sectional view of a mitral valve with a
catheter inserted into the left ventricle;
[0051] FIG. 3B is a schematic cross-sectional view of an aortic
valve with a catheter inserted into the aortic arc and partly into
the ascending aorta;
[0052] FIG. 4A is a schematic cross-sectional view of a mitral
valve with a catheter partly in the left atrium;
[0053] FIG. 4B is a schematic cross-sectional view of an aortic
valve with a catheter partly in the ascending aorta;
[0054] FIG. 5A is a schematic cross-sectional view of a mitral
valve with a valve being delivered;
[0055] FIG. 5B is a schematic cross-sectional view of an aortic
valve with a valve being delivered;
[0056] FIG. 6A is a schematic cross-sectional view of a mitral
valve with a valve for short time replacement of the mitral
valve;
[0057] FIG. 6B is a schematic cross-sectional view of an aortic
valve with a valve for short time replacement of the aortic
valve;
[0058] FIG. 7A-C are schematic illustrations of a principle of a
valve for short time replacement of a native valve;
[0059] FIGS. 8A-B are schematic perspective views of a collecting
unit for collecting and arranging chordae towards a valve;
[0060] FIG. 9 is a schematic view of a clip used to secure a
valve;
[0061] FIGS. 10 and 11 are schematic perspective views of various
collecting units for collecting and arranging chordae towards a
valve;
[0062] FIGS. 12A-B are schematic perspective views of a collecting
unit for collecting and arranging chordae towards a valve, which
unit comprises two hooks, arms or balloons; and
[0063] FIGS. 13A and 13B are schematic perspective views in partial
cross-section which illustrate retracting of chordae.
DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0064] Specific examples of the disclosure will now be described
with reference to the accompanying drawings. This invention may,
however, be embodied in many different forms and should not be
construed as limited to the examples set forth herein. Rather,
these examples are provided so that this disclosure will be
thorough and complete, and will fully convey the scope of the
invention to those skilled in the art. The terminology used in the
detailed description of the examples illustrated in the
accompanying drawings is not intended to be limiting of the
invention. In the drawings, like numbers refer to like
elements.
[0065] The following description focuses on an example of the
present disclosure applicable to a native valve of the heart and in
particular to a mitral and an aortic valve. However, it will be
appreciated that the disclosure is not limited to this application
but may be applied to many other native valves including for
example a tricuspid valve or a pulmonary valve.
[0066] FIG. 1A illustrates a patient 10 having a heart 12 shown in
cross-section including a left ventricle 14 and a right ventricle
16. The concepts of the present invention are suitable to be
applied, for example, to a mitral valve 18, which supplies blood
into the left ventricle 14 or to an aortic valve 34. The tricuspid
valve (15) and the pulmonary valve (17) are also shown in FIG. 1A.
Native mitral valve 18, also shown in FIG. 1B, includes an annulus
20 and a pair of leaflets 22, 24 which selectively allow and
prevent blood flow into the left ventricle 14. Leaflets 22, 24 are
supported for coaptation by chordae tendinae, chordae or chords 26,
28 extending upwardly from respective papillary muscles 30, 32.
Blood enters the left ventricle 14 through the mitral valve 18 and
is expelled during subsequent contraction of heart 12 through
aortic valve 34. The aortic valve 34 controls blood flow to the
aorta and organs connected to the aorta. It will be appreciated
that the present invention may also be applicable to a tricuspid
heart valve (15).
[0067] FIG. 2 is a cross-sectional view of a mitral valve 18 and
surroundings. The left atrium 44, the left ventricle 14, the
chordae 26, 28 and the mitral valve 18 can be seen in this
figure.
[0068] FIG. 3A illustrates a catheter 310, which is being utilized
for delivering a valve for short time replacement of a native
valve, such as the mitral valve 18. The catheter 310 may be
inserted into the left ventricle 14 of the heart in any known way.
The catheter 310 is in some examples inserted via a transapical
route. In these examples trans-apical access to the heart is gained
and the catheter 310 will be forwarded, via the trans-apical route,
into the left ventricle 14 of the heart.
[0069] Once the catheter has entered the left ventricle 14, the
catheter is forwarded so that it is at least partly put through the
mitral valve 18 and partly into the left atrium 44 as illustrated
in FIG. 4A. The catheter 310 may be the delivery system for all
implements used in the procedure. Thus, the catheter 310 may be
utilized also for delivery of chordae collection devices,
commissure locating tools and/or annuloplasty devices for long-term
use. Thereafter, the valve for short-time replacement 502, which
may be an artificial valve, is positioned inside the native mitral
valve 18. This is illustrated in FIG. 5A. In order to facilitate
the delivery of the valve 502 and to enable the positioning of the
valve 502, the valve 502 may be collapsible for delivery and/or
expandable upon delivery. This may be achieved by the use of an at
least partly flexible valve. As an example, a flange of the valve
502 may be flexible during delivery. Once the valve 502 has been
positioned inside the native valve, a plurality of chordae may be
pulled together and towards the valve 502 for fixation of the valve
502.
[0070] Pulling of a plurality of chordae together is in some
examples performed for creation of a temporary space between at
least one chorda and a ventricular wall of the heart. Within this
temporary space, an annuloplasty device may pass for delivery.
Thus, an additional space may be created between e.g. at least two
chordae and a ventricular wall of the heart by pulling a plurality
of chordae together. Through the additional space an annuloplasty
device may be advanced into position. The insertion of an
annuloplasty device is preferably performed after the valve 502 has
been positioned.
[0071] The plurality of chordae may in some examples be pulled
together by rotation or twisting of the valve 502. The rotation of
the valve 502 for pulling the chordae together is preferably
specified to one direction, such as anticlockwise rotation. The
rotation of the valve 502 may be actuated by rotating a catheter.
As an example, a two-axis steerable catheter may be used for
actuating the rotation of the valve 502.
[0072] A clip may thereafter be deployed to surround the valve 502
and/or to keep the chordae in position towards the valve 502. In
some examples, the clip is deployed by pushing it out of the
catheter 310 and into position with a pusher or a pushing catheter.
Alternatively or in addition, the clip may be delivered with a
special clip guide tube. The catheter 310 may thereafter be removed
or utilized for inserting further implants or devices, such as an
annuloplasty device. The valve 502 may remain inside the native
valve during positioning of an annuloplasty device. Once an
annuloplasty device has been inserted for permanent implantation,
positioned and secured, the temporary, short-term, valve 502 is
removed.
[0073] FIG. 3B illustrates a catheter 310, which is being utilized
for delivering a valve for short time replacement of a native
valve, such as the aortic valve 34. The catheter 310 may be
inserted via the aortic arc at least partly into the ascending
aorta 52. In these examples, the catheter enters for instance
trans-femorally from the groin and goes via aorta at least partly
into the ascending aorta 52 for delivery of the valve at the aortic
valve 34.
[0074] Once the catheter has entered the ascending aorta 52, the
catheter is forwarded so that it is at least partly put through the
aortic valve 34 and partly into the left ventricle 14 as
illustrated in FIG. 4B. The catheter 310 may be the delivery system
for all implements used in the procedure. Thus, the catheter 310
may in addition be utilized also for delivery of chordae collection
devices, commissure locating tools and/or annuloplasty devices for
long-term use. Thereafter, the valve for short-time replacement
502, which may be an artificial valve, is positioned inside the
native aortic valve 34. This is illustrated in FIG. 5B. In order to
facilitate the delivery of the valve 502 and to enable the
positioning of the valve 502, the valve 502 may be collapsible for
delivery and/or expandable upon delivery. This may be achieved by
the use of an at least partly flexible valve. As an example, a
flange of the valve 502 may be flexible during delivery. Once the
valve 502 has been positioned inside the native valve, a plurality
of chordae may be pulled together and towards the valve 502 for
fixation of the valve 502.
[0075] Pulling of a plurality of chordae together is in some
examples performed for creation of a temporary space between at
least one chorda and a ventricular wall of the heart. Within this
temporary space, an annuloplasty device may pass for delivery.
Thus, an additional space may be created between e.g. at least two
chordae and a ventricular wall of the heart 12 by pulling a
plurality of chordae together. Through the additional space an
annuloplasty device may be advanced into position. The insertion of
an annuloplasty device is preferably performed after the valve 502
has been positioned.
[0076] The plurality of chordae may in some examples be pulled
together by rotation or twisting of the valve 502. The rotation of
the valve 502 for pulling the chordae together is preferably
specified to one direction, such as anticlockwise rotation. The
rotation of the valve 502 may be actuated by rotating a catheter.
As an example, a two-axis steerable catheter may be used for
actuating the rotation of the valve 502.
[0077] A clip may thereafter be deployed to surround the valve 502
and/or to keep the chordae in position towards the valve 502. In
some examples, the clip is deployed by pushing it out of the
catheter 310 and into position with a pusher or a pushing catheter.
Alternatively or in addition, the clip may be delivered with a
special clip guide tube. The catheter 310 may thereafter be removed
or is alternatively utilized for inserting further implants or
devices, such as an annuloplasty device. The valve 502 may remain
inside the native valve during positioning of an annuloplasty
device. Once an annuloplasty device has been inserted, positioned
and secured, the valve 502 is removed.
[0078] The valve 502, shown in FIGS. 6A and 6B, is for short time
replacement of a native valve in a heart and the valve 502 may be
positioned through the native valve upon implantation. The valve
502 comprises an at least partially collapsible and/or at least
partially expandable tube 602. Furthermore, the valve 502 comprises
a flange 604. The flange 604 may be flexible during delivery, and
is preferably somewhat rigid once the valve 502 has been implanted.
The flange 604 prevents the valve 502 from moving out of position
from e.g. the left atrium 44 towards the left ventricle 14 if the
valve is for the mitral valve 18 and from moving out of position
from e.g. the ascending aorta towards the aortic arc if the valve
is for the aortic valve 34.
[0079] In some examples, the valve 502 is a one-way valve
comprising a tube 602 having an inlet side 704 and an outlet side
706. This is depicted in FIG. 7A-C. The tube 602 may be flexible.
This may be advantageous, since the use of a flexible tube prevents
interference between the tube 602 and annuloplasty devices.
Alternatively, the tube 602 may be rigid or at least somewhat
rigid. The valve 502 may further comprise a flexible inner sleeve
702 attached to an inlet side 704 of the tube 602 and positioned
inside the tube 602. This is depicted in FIG. 7A. The flexible
inner sleeve 702 may be made of a flexible material such as rubber.
In FIG. 7A, the pressure inside the tube 602 is similar to the
pressure at the inlet side 704 of the tube 602. Therefore, the
flexible inner sleeve 702 has more or less a same pressure on an
inside of the sleeve 702 which is in contact with the inlet side
704, as on an outside of the flexible inner sleeve 702 which is in
contact with the outlet side 705, thus making the valve partly
open. In FIG. 7b the pressure inside the tube 602 has increased so
that the pressure inside the tube 602, outside of the flexible
inner sleeve 702 and in the left ventricle 14 is larger than the
pressure at the inlet of the tube 602, inside of the flexible inner
sleeve 702 and the left atrium 44. When the pressure inside the
tube 602 becomes higher than the pressure at and/or outside the
inlet of the tube, the valve 502 closes by the flexible inner
sleeve 702 contracting together. In FIG. 7C the pressure inside the
tube 602 and outside of the flexible inner sleeve 702 is lower than
the pressure at or outside the inlet of the tube 704 and inside of
the flexible inner sleeve 702. When the pressure inside the tube
602 becomes lower than the pressure at or outside the inlet of the
tube, the valve 502 and flexible inner sleeve 702 opens. Thus, a
simple, yet reliable replacement valve is obtained by the
construction of a valve 502 as illustrated in FIGS. 7A-7C. The
flange 708 can also be seen in FIG. 7A. The flange 708 may be
expandable. In one example, the flange 708 is an expandable
balloon.
[0080] FIG. 8A illustrates an example, wherein a collecting unit
802 is utilized for collecting and arranging chordae towards the
valve 502. The collecting unit 802 may together with the tube 602
form one integral part. Alternatively, the collecting unit 802 may
be attachable or attached to the tube 602. In some examples, the
collecting unit 802 comprises a single arm or a single hook.
Alternatively or in addition, the collecting unit 802 comprises a
ring and/or a fluid-filled balloon. A collection unit 802
comprising a fluid-fillable or fluid-filled balloon 804 is depicted
in FIG. 8B. The collection unit 802 may in addition to the
fluid-fillable or fluid-filled balloon 804 comprise a single
arm.
[0081] In some examples the valve 502 comprises the collecting unit
802 for collecting and arranging chordae towards the valve 502. The
valve may be secured, held and/or stabilized in a desired position
by the collecting and arranging of chordae towards the valve 502.
Thus, a reliable securing of the valve 502 may be achieved.
[0082] By the use of a collecting unit 802, fast and easy
replacement of a native valve may be achieved. Furthermore, fast
and easy positioning of a temporary valve may be obtained.
Therefore, the use of a collecting unit may contribute to give more
time to make decisions related to surgery, more time to prepare for
surgery and/or more time to perform surgery or medical
intervention. Thus, overall quality of valve replacement or repair
may be improved. The securing of the valve with chordae together
with the shape of the valve 502 and a correct dimensioning of the
valve 502 may be advantageous, since a valve with proper dimensions
secured by the chordae does not press against any ventricular wall.
Thus, there will be no damage to the ventricular walls. Although,
there may be a small leakage outside the valve 502, this may be
acceptable for a short period of time, such as minutes, hours or a
few days.
[0083] The valve may thus in certain examples include a collecting
unit for collecting and arranging chordae towards the valve. The
valve is thus secured, held and/or stabilized in a desired position
by the collecting unit and arranging of chordae towards said valve.
In an example the collecting unit includes a clip, wherein the
chordae and/or leaflets are kept in position towards the valve with
said clip. The clip may form a helix. The clip, in particular when
in form of a helix, may be integral with or connected to the
collecting unit and not a separate piece. Hence, in some examples,
the collecting unit 802 may comprise a clip. FIG. 9 illustrates
such a clip 902. The chordae are kept in position towards the valve
502 with the clip 902. The clip 902 may be formed as a ring or
ring-like structure. Alternatively, the clip 902 may be formed or
shaped as a helix. Thereby, the clip 902 can easily be rotated into
position. Rotation is preferably made together with the valve when
the collecting unit, such as a clip, in particular when in form of
a helix, is integral with the collecting unit. The chordae and/or
leaflets are the kept in position towards the valve with said
collecting unit and secured with said clip. This may be
advantageous, since a simple and/or fast deployment of the clip 902
is enabled thereby. Furthermore, reliable securing, simple and/or
fast deployment of a clip is enabled. Alternatively, when the clip,
in particular when in form of a helix, is a separate piece and not
integral with or unconnected with the valve, the collecting unit
may be rotated separately into position. The clip may then be
applied to the collecting unit for securing the latter in position
at the chordae and/or leaflets.
[0084] FIG. 10 illustrates a valve 502 having a collecting unit for
collecting and arranging chordae towards the valve 502 according to
some examples. In these examples the collecting unit is shaped as a
ring or ring-like structure. The ring-shaped unit 1002 may be
extended to a rod-like structure for delivery and changeable into a
ring-like structure upon delivery or implantation. Thus, it may be
advantageous to have a collecting unit shaped as a ring, since it
may facilitate delivery.
[0085] FIG. 11 illustrates a valve 502 having a collecting unit for
collecting and arranging chordae towards the valve 502 according to
some examples. In these examples the collecting unit is a
fluid-filled balloon 1102. The fluid-filled balloon 1102 may be
ring-like The use of a fluid-filled balloon 1102 as a collecting
unit may be advantageous, since the use of a balloon facilitates
delivery and since fluid may be used to stabilize the balloon
and/or give some rigidity to the balloon. In one example, the
balloon is filled with fluid upon or after delivery at the native
valve.
[0086] FIG. 12A illustrates a collecting unit for collecting and
arranging chordae towards the valve 502 according to some examples.
In these examples the collecting unit comprises two hooks 802, 1202
or arms. Alternatively, the collecting unit comprises a plurality,
such as four, of hooks or arms. The hooks or arms are preferably
positioned equidistantly around the valve 502, i.e. the hooks or
arms are preferably equidistantly distributed exteriorly along the
valve 502. A collection unit comprising two fluid-fillable or
fluid-filled balloons 804, 1206 is depicted in FIG. 12B. The
collection unit may in addition to the fluid-fillable or
fluid-filled balloons 804, 1206 comprise two arms. Alternatively,
the collecting unit comprises a plurality, such as four, of
fluid-fillable or fluid-filled balloons. The fluid-fillable or
fluid-filled balloons are preferably positioned equidistantly
around the valve 502, i.e. the fluid-fillable or fluid-filled
balloons are preferably equidistantly distributed exteriorly along
the valve 502.
[0087] In some examples, the collecting unit collects and arranges
the chordae towards the valve 502 during rotation of the valve 502.
The rotation is preferably anticlockwise rotation. The rotation of
the valve 502 may be actuated by rotating a catheter, such as a
two-axis steerable catheter. Thus, fast and easy collection of
chordae may be achieved. Furthermore, fast and easy securing of the
valve may be achieved. In addition, with a steerable catheter, fast
and easy collection of chordae from outside the body of a patient
may be achieved. Moreover, by specifying a direction of rotation,
such as clockwise or anticlockwise, a procedure that is less prone
to errors, and thus a faster and easier securing of the valve, may
be obtained. In addition, reliable securing of the valve 502 and
the chordae may be achieved.
[0088] In some examples, the valve 502 comprises a collecting unit
for collecting and arranging leaflets towards the valve 502. In
these examples, the valve 502 is secured, held and/or stabilized in
a desired position by the collecting and arranging of leaflets
towards the valve 502. In one example, the valve 502 is secured,
held and/or stabilized in a desired position by the collecting and
arranging of leaflets towards the valve 502 and by the collecting
and arranging of chordae towards the valve 502. In some examples,
the valve comprises a collecting unit for collecting and arranging
chordae and leaflets towards the valve 502.
[0089] FIGS. 13A and 13B illustrate retracting of chordae. FIG. 13A
illustrates retracting of chordae with a collection unit comprising
a hook, an arm or a wire. A first end of a steerable catheter or
wire 1310 exits a side lumen 1302 of the delivery catheter 310. The
steerable catheter 1310 is then moved and manipulated by a user so
as to surround the chordae 1340, without touching any ventricular
wall 1320. The end of the catheter 1310 moves in a radial direction
away from the delivery catheter 310 towards the ventricular wall
1320 as it is advanced and/or rotated. Once the catheter 1310 has
encircled all the chordae 1340 and 360 degree coverage of the space
is achieved, an end unit of the steering catheter or wire 1310 is
activated to pull the chordae 1340 together. Activation may include
rotation of the catheter or valve 502 whereupon the curvature of
the end of the catheter having grasped the chordae pulls them
together towards the valve. The delivery catheter 310 is held
stationary during the whole deployment of the steerable catheter or
wire 1310.
[0090] FIG. 13B illustrates retracting of chordae 1340 with a
collection unit comprising two fluid-fillable or fluid-filled
balloons. The delivery catheter 310 has two side lumens, which are
equidistantly distributed around the delivery catheter 310, i.e.
180 degrees apart. The two balloon catheters 1330, 1332 exits the
side lumens of the delivery catheter 310. The balloon catheters
1330, 1332 are then manipulated and moved towards a ventricular
wall 1320 past the chordae 1340. Once the two balloon catheters are
in position between the ventricular wall 1320 and the chordae 1340,
the balloons may be inflated or filled with a fluid. When the
balloons have been inflated or filled with a fluid, the balloons
will fill the space between the ventricular wall 1320 and the
chordae 1340 and press the chordae 1340 away from the ventricular
wall and towards the centre and towards each other, i.e. the
balloons will encapsulate the chordae 1340 and tighten the native
valve and bring the chordae 1340 towards the delivery catheter 310.
The surfaces of the balloons may be provided with grooves, which
form hollow channels when the balloons are fully inflated or
fluid-filled. These channels may then guide a ring or a replacement
valve during deployment. Below, a medical system for short time
replacement and repair of a native valve is described. The medical
system comprises a valve 502. The valve 502 is in these examples an
artificial valve. Furthermore, the medical system comprises a
device for collecting and arranging chordae to hold and/or
stabilize the artificial valve in a desired position. The device
comprises a unit for grasping a plurality of chordae. With the
medical system a fast and easy replacement of a native valve may be
achieved. Furthermore, fast and easy positioning of a temporary
artificial valve may be achieved. Moreover, use of the medical
system may contribute to give more time to make decisions related
to surgery, more time to prepare for surgery and/or more time to
perform surgery/medical intervention. Thus, overall quality of e.g.
valve replacement may be improved.
[0091] In some examples, the medical system comprises a steerable
catheter for delivering the artificial valve; an annuloplasty
device, which may be used to perform annuloplasty, i.e. to reshape
the valve annulus, in order to improve the function of the valve; a
location valve expander and/or a clip for locking the chordae in
positions towards the artificial valve. This may enable fast and
easy replacement of a native valve. Furthermore, it may enable fast
and easy positioning of a temporary artificial valve.
[0092] Below, a device for collecting and arranging chordae to hold
and/or stabilize an artificial valve in a desired position is
described. The device may be a medical device, and comprises a unit
for grasping a plurality of chordae. With the device, a fast and
easy replacement of a native valve may be achieved. Furthermore,
fast and easy positioning of a temporary artificial valve may be
achieved. Moreover, use of the medical system may contribute to
give more time to make decisions related to surgery, more time to
prepare for surgery and/or more time to perform surgery/medical
intervention. Thus, overall quality of e.g. valve replacement may
be improved.
[0093] In some examples, the unit for grasping a plurality of
chordae comprises an arm, a hook, a ring and/or a fluid-filled
balloon. These examples provide for an easy way of grasping and/or
collecting the chordae.
[0094] In some examples, the artificial valve is collapsible for
delivery. Alternatively or in addition, the artificial valve may be
expandable upon delivery. Furthermore, the device may be attachable
to or integrable with the artificial valve. Thus, the device may be
attached to or integrated with the artificial valve. These examples
provide for an easier and less invasive delivery.
[0095] In some examples, the unit for grasping a plurality of
chordae comprises a plurality of hooks. The number of hooks may be
three, four or any other suitable number. Preferably, the hooks are
positioned on opposite sides of the artificial valve. The hooks may
also be equidistantly or symmetrically distributed exteriorly along
the artificial valve.
[0096] In some examples, the catheter 310 enters from the groin and
goes via a venous route transseptally to the right atrium 44 for
delivery of the valve 502.
[0097] The medical system described herein may be utilized for
short-term replacement of a native valve and/or for temporary use
during beating heart surgery. The device described herein may be
utilized for short-term replacement of a native valve and/or for
temporary use during beating heart surgery. The valve 502 may be
utilized during beating heart surgery. Thus, the system, the device
and/or the valve 502 may enable beating heart surgery. Furthermore,
the valve 502 may be utilized during life saving intervention,
intervention in acute leaflet and/or chordate rupture.
[0098] The system, the device and or the valve 502 may provide for
a reduced leakage and/or a minimized regurgitation during e.g.
beating heart surgery. Furthermore, the system, the device and or
the valve 502 may enable precise positioning of an implant or valve
502 in the anatomically correct position. Moreover, the procedure
used for delivering a valve 502 described herein enables high
accuracy of delivery, positioning and securing of a temporary valve
502.
[0099] Within this disclosure the term short-time or short-time
replacement has been used. Short-term replacement and/or repair of
native valves is considered to be a temporary replacement. Such a
temporary replacement may be a replacement that last for minutes,
hours or possibly up to a few days. Short-term replacement includes
non-indwelling, i.e. non-permanently implanted, devices and methods
described herein. Short-term replacement devices are intended to be
removed from the body after use. With a long-time replacement is
herein meant a replacement, which last for several days, weeks,
months or longer. Such a long-time replacement may be made with
devices intended to be permanently implanted and not removed from
the body, such as indwelling annuloplasty devices. Structural
requirements for such devices are thus different for short-term use
and long-term use.
[0100] As used herein, the singular forms "a", "an" and "the" are
intended to include the plural forms as well, unless expressly
stated otherwise. It will be further understood that the terms
"includes," "comprises," "including" and/or "comprising," when used
in this specification, specify the presence of stated features,
integers, steps, operations, elements, and/or components, but do
not preclude the presence or addition of one or more other
features, integers, steps, operations, elements, components, and/or
groups thereof. It will be understood that when an element is
referred to as being "connected" or "coupled" to another element,
it can be directly connected or coupled to the other element or
intervening elements may be present. Furthermore, "connected" or
"coupled" as used herein may include wirelessly connected or
coupled. As used herein, the term "and/or" includes any and all
combinations of one or more of the associated listed items.
[0101] Unless otherwise defined, all terms (including technical and
scientific terms) used herein have the same meaning as commonly
understood by one of ordinary skill in the art to which this
disclosure belongs. It will be further understood that terms, such
as those defined in commonly used dictionaries, should be
interpreted as having a meaning that is consistent with their
meaning in the context of the relevant art and will not be
interpreted in an idealized or overly formal sense unless expressly
so defined herein.
[0102] The present disclosure has been described above with
reference to specific examples. However, other examples than the
above described are equally possible within the scope of the
disclosure. Different method steps or a different order thereof
than those described above may be provided within the scope of the
disclosure. The different features and steps of the disclosure may
be combined in other combinations than those described. The scope
of the disclosure is only limited by the appended patent
claims.
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