U.S. patent application number 13/464367 was filed with the patent office on 2012-11-08 for heart valve stent.
Invention is credited to Lucian Lozonschi, Georg Lutter.
Application Number | 20120283824 13/464367 |
Document ID | / |
Family ID | 40032389 |
Filed Date | 2012-11-08 |
United States Patent
Application |
20120283824 |
Kind Code |
A1 |
Lutter; Georg ; et
al. |
November 8, 2012 |
Heart Valve Stent
Abstract
A heart valve stent having a section equipped to receive a heart
valve implant and several proximally disposed anchoring elements,
characterized by several anchoring threads, which with the one end
thereof are fastened to the stent, and also with a brace fastening
the anchoring threads with the other end thereof to the distal
chamber wall to provide tension between the heart chamber wall and
the proximally anchored anchoring elements.
Inventors: |
Lutter; Georg; (Kiel,
DE) ; Lozonschi; Lucian; (Madison, WI) |
Family ID: |
40032389 |
Appl. No.: |
13/464367 |
Filed: |
May 4, 2012 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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12677958 |
Sep 9, 2010 |
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PCT/DE2008/001515 |
Sep 10, 2008 |
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13464367 |
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Current U.S.
Class: |
623/2.18 |
Current CPC
Class: |
A61F 2/2436 20130101;
A61B 17/0401 20130101; A61F 2/2418 20130101; A61F 2230/0067
20130101; A61F 2230/0008 20130101; A61F 2230/0013 20130101; A61B
2017/00243 20130101; A61F 2230/0078 20130101; A61F 2220/0008
20130101; A61F 2230/0069 20130101; A61F 2/2457 20130101; A61F
2/2445 20130101; A61B 2017/0496 20130101; A61F 2250/001 20130101;
A61F 2/2487 20130101; A61F 2230/005 20130101; A61F 2230/0054
20130101 |
Class at
Publication: |
623/2.18 |
International
Class: |
A61F 2/82 20060101
A61F002/82 |
Foreign Application Data
Date |
Code |
Application Number |
Sep 13, 2007 |
DE |
10 2007 043 830.5 |
Claims
1. A heart valve stent comprising: a body section equipped to
receive a heart valve implant; a plurality of proximally disposed
anchoring elements; a plurality of anchoring threads, each having a
first end portion is attached to the stent, and a second end
portion; and a thrust bearing for securing the second end portions
of the plurality of anchoring threads to a distal heart chamber
wall and the proximally disposed anchoring elements wherein the
heart valve stent is formed as a truncated cone.
2. The heart valve stent according to claim 1, wherein the
plurality of anchoring threads are affixed to an end portion of the
stent body section that opposes the plurality of anchoring
elements
3. The heart valve stent according to claim 1, further comprising
at least one suture-length regulatory element for adjusting a
length of at least one of the plurality of anchoring threads.
4. The heart valve stent according to claim 1, wherein the thrust
bearing constitutes a suture-length regulatory element.
5. The heart valve stent according to claim 1, further comprising a
heart valve implant received in the body section.
6. The heart valve stent according to claim 10, wherein, in a plane
of the mitral valve, an annulus of the heart valve stent is
substantially oval or u-shaped.
7. The heart valve stent according to claim 5, further comprising a
sealing membrane adapted to be arranged between the heart valve
implant and the stent.
8. The heart valve stent according to claim 5, further comprising a
sealing membrane arranged between the plurality of anchoring
elements and the heart valve implant.
9. The heart valve stent according to claim 1, wherein at least one
of the plurality of anchoring elements is made from shape memory
alloy.
10. The heart valve stent according to claim 5, wherein the heart
valve implant constitutes a mitral valve.
11. A prosthetic mitral valve assembly, comprising: a
radially-expandable stent including an outflow portion sized to be
held in place by leaflets of a native mitral valve and an inflow
portion having a flared end, the flared end sized to implant above
or below an annulus of the mitral valve with a pressure or friction
fit, wherein the stent substantially smoothly tapers from the
flared end to an opposite end of the stent, the stent having a
lumen extending therethrough, the lumen having an inflow diameter
at the inflow portion and an outflow diameter at the outflow
portion and wherein the inflow diameter is larger than the outflow
diameter; and a valve portion shaped to fit the contours of the
stent and coupled to the stent, the valve portion comprising
prosthetic leaflets and elongate flexible tension members, each of
the tension members coupled at a first end to one of the prosthetic
leaflets and configured to be coupled at an opposite end to a
patient's heart for preventing eversion of the prosthetic leaflets
during ventricular contraction.
12. The prosthetic mitral valve assembly of claim 11, wherein the
mitral valve assembly is adapted to expand into contact with the
native mitral valve tissue to create the pressure or friction fit
and secure the mitral valve assembly in a fixed position in the
heart.
13. The prosthetic mitral valve assembly of claim 11, wherein the
prosthetic leaflets form a bicuspid or tricuspid valve.
14. The prosthetic mitral valve assembly of claim 11, wherein the
stent has a truncated conical shape.
15. The prosthetic mitral valve assembly of claim 11, wherein the
stent and the valve portion are collapsible to a reduced diameter
for insertion into the heart on a delivery catheter for
implantation.
16. A prosthetic mitral valve assembly, comprising: a
radially-expandable stent including a portion sized to be held in
place by leaflets of a native mitral valve; and a valve portion
coupled to the stent, the valve portion comprising prosthetic
leaflets; elongate flexible tension members, each of the tension
members having a first end coupled to one of the prosthetic
leaflets and an opposite end adapted to be coupled to an inner wall
of the left ventricle of a patient's heart for preventing eversion
of the prosthetic leaflets during ventricular contraction, each
leaflet coupled to a group of tension members, each group of
tension members comprising a plurality of tension members, the
opposite end of each tension member of each group adapted to be
secured at spaced apart locations to an inner wall of the left
ventricle, and a tensioning block corresponding to each group of
tension members, each of the plurality of tension members of each
group extending through the corresponding tensioning block, each
tensioning block slidable upwards and downwards along the
corresponding group of tension members to adjust a tension
thereof.
17. The prosthetic mitral valve assembly of claim 16, wherein the
mitral valve assembly is adapted to expand into contact with the
native mitral valve tissue to create the pressure or friction fit
and secure the mitral valve assembly in a fixed position in the
heart.
18. The prosthetic mitral valve assembly of claim 16, wherein the
prosthetic leaflets form a bicuspid or tricuspid valve.
19. The prosthetic mitral valve assembly of claim 16, wherein the
stent and the valve portion are collapsible to a reduced diameter
for insertion into the heart on a delivery catheter for
implantation.
20. The prosthetic mitral valve assembly of claim 16, wherein each
tension member attaches to the corresponding leaflet at a point
adjacent the outflow edge of the leaflet.
21. A prosthetic mitral valve assembly, comprising: a
radially-expandable stent including an outflow portion sized to be
held in place by leaflets of a native mitral valve with a pressure
or friction fit and an inflow portion having a flared end with a
truncated conical shape, the flared end sized to be implanted above
or below an annulus of the mitral valve with a pressure or friction
fit, wherein the inflow portion has a larger flow area than the
outflow portion and the stent has a substantially smooth and
continuous taper from the flared end to an opposite end of the
stent; and a valve portion shaped to fit the continuous taper of
the stent and coupled to the stent, the valve portion having three
prosthetic leaflets and three groups of two elongate flexible
tension members, wherein each group of two tension members member
is coupled to one of the prosthetic leaflets at a first end and
each tension member comprises an anchor adapted to be coupled to a
patient's heart along the wall of the ventricle at the opposite
end, wherein each group of two tension members member has at least
one slidable tension block configured to be positioned within the
left ventricle between the first ends end and the second ends end
of the group of two tension members, with the group of two tension
members extending therethrough and slidable therealong used to
adjust a the tension applied to each leaflet and wherein the
tension members reduce stress on the prosthetic leaflets and
prevent eversion during ventricular contraction.
22. The prosthetic mitral valve assembly of claim 21, wherein the
tension members are made of polyurethane.
23. The prosthetic mitral valve assembly of claim 21, wherein the
anchor of each tension member comprises a plurality of prongs that
can grab, penetrate, and/or engage surrounding tissue to secure the
device in place.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application represents a continuation of U.S.
application Ser. No. 12/677,958, filed Sep. 9, 2010, pending, a
National Stage application of PCT/DE2008/001515 entitled "Heart
Valve Stent", filed Sep. 10, 2008.
BACKGROUND OF THE INVENTION
[0002] The invention refers to a valve stent with a section
equipped to receive a heart valve implant and several of proximally
disposed anchoring elements.
[0003] Such heart valve stents are known in various forms for the
replacement dysplastic and degenerated heart valves. Thereby, the
surgical implantation of heart valve prostheses is regularly
accomplished in the cardioplegic heart. The old, functionally
degenerated heart valve is resected and the new, implantable heart
valve is sewed in.
[0004] However, when the mitral valve is affected, one tries, as
far as possible, to maintain the old valve in spite of its
malfunctioning so that the entire dynamic mital valve apparatus is
not disturbed. The reason for this is that, for instance, the
chordae tendineae which are attached to the mitral valve are very
important for ventricular function. Therefore, they should
preferably not be removed from the old mitral valve.
[0005] Ideally, the mitral valve (in case the old valve cannot be
reconstructed) will be pushed aside as far as possible to make room
for a new valve. Space does not play such an important roll as
compared to the aortic annulus which can be more easily stenosed
(i.e. during displacement of the old aortic valve for sole
percutaneous implantation).
[0006] The chordae tendineae of the mitral valve shall be, if
possible, structurally maintained to preserve the ventricular
geometry and hence of the left ventricle or achieve optimal
function of the left chamber as far as possible. Therefore, a best
possible function of the left chamber is obtained and achieved. Of
significant relevance is that the anterior mitral valve leaflet is
not pushed aside into the free space toward the left ventricle, but
rather that it is attached to the mitral annulus so that a press
forward of the anterior leaflet into the left ventricular outflow
tract (LVOT) is avoided ("sam" phenomenon: systolic anterior
movement). This is extremely important, because otherwise a left
heart decompensation (massive dysfunction of the left ventricle)
could rapidly occur.
[0007] Surgically the old mitral valve is attached to the old
annulus so that there is a free flow of blood through the valve and
both adjacent heart chambers. After pushing aside (attachment of
the valve onto the annulus) the heart valve prosthesis is
surgically implanted into the annulus.
[0008] This extensive method mandatorily takes place with the help
of a heart- and lung-machine. For high risk patients it is usually
not used and minimally invasive and percutaneous methods to perform
the implantation of a heart valve are sought.
[0009] In this context, the German patent DE 195 46 692 C2 and the
corresponding EP 1469 797 B1 is known. This patent describes a
self-expanding heart valve prosthesis for the implantation into a
human body using a catheter system with a heart valve and a
foldable, valve-connected and expanding stent. Such a
self-expanding heart valve prosthesis can be directed through the
femoral artery with the help of a catheter based system to the area
of cardiac implantation. After the stent reaches the area of
implantation, it can be successively defolded. Along its long axis,
the stent is composed of several, at angles to each other,
self-expanding segments that are defolded gradually. After
expansion, the heart valve prosthesis can be anchored with the
support of hooks at least in the respective blood vessel close to
the heart.
[0010] Another apparatus for the fixation and anchorage of heart
valve prostheses is described in the German Patent 100 10 074 A1
which fundamentally consists of wire-like elements attached
together. Different brackets are hereby used to secure anchorage
and brace a heart valve.
[0011] Even with the known solutions there is still the danger that
a heart valve is mal-implanted due to wrong positioning and
deficient angular adjustment of the heart valve prostheses.
Improved positioning and angular alignment for the aortic valve can
be reached by the stent described in the European Patent EP 1 469
797 B1 which consists of supportive holders which can be inserted
into the aortic pouches and create a defined distance to the aortic
valve. Beyond this, the possibility exists to halt a failed
implantation of a heart valve prosthesis and to push the valved
stent ("a valve integrated into a stent") back into the catheter
delivery system (more precisely the "cartridge"). Thereby, it is
possible that the stent can again slide out when good positioning
for the valved stent has been reached. Thus, the valved stent can
be taken in and out until the optimal positioning has been achieved
("sliding technique").
[0012] A much larger problem for the optimal positioning of the new
heart valve in the stent (alternatively valved stent) still exists
in the following: in most cases the old, native valve will not be
eliminated by the above-described technique of implantation.
[0013] This leads to the fact that the new valve which will be
pressed into (partly squashed into) the old, deformed valve will be
transformed into the original form. The reason for this is that the
location of implantation for the valved stent is affected by the
morphology, the shape and consistency of the old native valve (for
instance by sclerosis or calcification of the native valve).
[0014] Therefore, the old annulus of the valve with the
corresponding changed valves/pouches determines to what extent and
where the native valve will defold and whether its form can
develop. Hence, for the optimal function of the valve and
maintenance of the atrial and ventricular function not only the
anchorage/positioning is important, but also the fitting of the
valve stent into the neo-annulus (old valve annulus with old valve
shapes it) and with it the pushing back of the old valve.
[0015] Based on the fact that there are known problems of the
valved stents, the challenge of this intervention is to produce a
heart valved stent, especially a mitral valved stent, for
minimally-invasive transplantation, which preferably facilitates
the natural functioning of the heart.
SUMMARY OF THE INVENTION
[0016] The basic idea of the invention is to produce a heart valve
stent which establishes the anatomic requirements for the natural
exertion of the function--like a healthy heart. In the process, the
invention-related heart valve stent with its self-expanding,
foldable embodiment establishes a minimally-invasive operation
which assures an exact positioning and secure fixation of the valve
stent. Thereby, a tension between the mitral valve and ventricle
similar to the natural tension of the chordae tendineae is
generated, and at the same time it will be provided that the valve
parts of the old mitral valve (especially the anterior mitral valve
leaflet) will not disturb the flow rate of the blood.
[0017] Therefore, it is intended that the valve stent, according to
the invention, is catheter-inserted into one of the heart chambers
or into the adjacent large vessels of the heart, then defolded in
one of the heart chambers, whereupon its anchoring elements are
fixed in the tissue. Finally, the stent is fixed at its opposed,
subvalvular wall of the heart chamber under development of a
tension between the wall of the heart chamber and the proximal,
supravalvular, fixed anchoring elements with anchoring sutures
(hereafter referred to as neo-chordae).
[0018] The fixation of the anchoring sutures in the distal wall of
the heart chamber exhibits a thrust bearing to the proximal
anchoring elements which will be established by a joint or another
element acting as a thrust bearing. This counter bearing can be
preferentially designed also as an adjusting element for the length
of the sutures.
[0019] Advantages of the heart valve stents which according to the
intervention are the exact and easy fixation of the heart valve
stent and improved contractility of the heart in minimally-invasive
operations inn comparison with customary valve stents.
[0020] Preferentially, the axially, relatively to the longitudinal
axis, arranged anchoring sutures are fixed according to the
invention (the valve stent) with one end to the annulus of the
heart valve implant, so that after development of a tension between
the stent and the wall of the ventricle, the positioning and the
angular arrangement of the valve can be directly impacted. The
anchoring sutures can also be fixed at the distal part of the
circumference of the valve stent. The connection between the
anchoring sutures and the stent has to be conducted so that a
tension which should run fundamentally in an axial direction
relative to the long axis of the stent and is formed between the
proximal anchoring elements and the distal counter bearing.
[0021] According to another preferential design of the invention,
the anchoring sutures (neo-chordae) have elements to adjust the
length of the anchoring sutures so that through the length of the
anchoring sutures a certain tension between the heart valve stent
and the heart wall can be regulated.
[0022] Thereby, an adjusting element, for example, for the
individual length of sutures or for all sutures together can be
allowed for. The adjusting element for the length of sutures is
preferably designed small and can, for instance, be constructed in
such a manner that this element shortens the suture to the desired
length by rolling-up of the excess thread.
[0023] The construction of the elastic anchoring sutures along the
axis are also preferred so that they are able to react to heart
contractions without having too sutures that might negatively
affect the heart function. Here the suture length should be
selected so that the elasticity is not sacrificed due to the
tension between the anchoring elements and the heart wall.
[0024] After adjusting the counter bearing of the adjusting element
to the length of sutures, a notably beneficial design is made so
that also a re-adjustment of the tension between the anchoring
elements and the counter bearing, i.e. a re-tensioning of the
anchoring sutures is possible without opening the heart.
[0025] Especially favoured is the structure of the mitral valve
stent which is fundamentally oval or u-shaped in the plane of the
mitral valve annulus so that no pressure to the LVOT (left
ventricular outflow tract) and/or aortic annulus is exerted.
Therewith damage to the hearts function is stopped (Ma L, Tozzi P,
Huber C H, Taub S, Gerelle G, von Segesser L K. Double-crowned
valved stents for off-pump mitral valve replacement. Eur J
Cardiothorac Surg. 2005 August; 28(2); 194-8; discussion 198-9.).
Additionally, the subvalvular apparatus also completely retains its
natural anatomy and is not compromised (Boudjemline Y, Agnoletti G,
Bonnet D, Behr L, Borenstein N, Sidi D, Bonhoeffer P. Steps toward
the percutaneous replacement of atrioventricular valves an
experimental study. J Am Coll Cardiol. 2005 Jul. 19; 46(2);
360-5).
[0026] This valve stent has for the natural mitral valve apparatus
a completely adapted, exceedingly nestled form so that this
conically tapered (cranial-caudal axis) not entirely circular
(oval-like in the transversal axis) valve stent is able to attach
to and abut to the natural form of the mitral valve. In the area of
the anterior mitral valve annulus, the valve stent is flat and
exerts almost no pressure on and does not constrict the LVOT. In
the area of the posterior mitral valve annulus, it is oval and
replicates a form like the posterior annulus. This valve stent
forms a thin, restricted along the length (cranial-caudal)
structure which in its form aligns completely to the mitral valve
and thus in the area of the natural mitral valve annulus looks like
a negative impression of it. In fact, the valve stent contacts the
old mitral valve and the annulus, but leaves their anatomy
completely unchanged.
BRIEF DESCRIPTION OF THE DRAWINGS
[0027] In the following the invention will be closely elucidated by
means of the attached figures representing the particularly
preferred execution examples. It shows:
[0028] FIG. 1 a favoured execution example of the valve stent
according to the invention in a schematic lateral view;
[0029] FIG. 2 the demonstrated execution example in FIG. 1 with top
view from above;
[0030] FIG. 3 top view on several especially preferred valve stents
according to the invention;
[0031] FIG. 4 a top view from an execution example from below;
[0032] FIG. 5 a schematic view which explains the
minimally-invasive transplantation of the mitral valve stent
according to the invention in a first phase of insertion of the
mitral valve stent into the location of transplantation;
[0033] FIG. 6 a schematic view for the demonstration of the
minimally-invasive transplantation of the mitral valve stents
according to the invention in a second phase after positioning of
the mitral valve;
[0034] FIG. 7 a schematic view for demonstration of the
minimally-invasive transplantation of the mitral valve stent after
completion of the fixation of the anchoring sutures outside of the
apex of the left ventricular heart wall;
[0035] FIG. 8 a schematic view of an alternative, intracardial
fixation of the anchoring sutures in the area of the papillary
muscles;
[0036] FIG. 9 a schematic view of a heart valve stent which is
fixed in the aortic annulus according to the invention;
[0037] FIG. 10 a schematic view of a heart valve stent which is
fixed in the pulmonary position according to the invention;
[0038] FIG. 11 a schematic view of a heart valve stent which is
fixed in the tricuspid position according to the invention;
[0039] FIG. 12 an especially preferred execution example of the
valve stent (according to the invention) in a schematic lateral
view without heart valve and anchoring sutures; and
[0040] FIG. 13 a schematic dorsal, intracardiac view of a heart
valve stent which is fixed in the mitral position according to the
invention.
DETAILED DESCRIPTION OF THE INVENTION
[0041] FIGS. 1 to 11 indicate the stent according to the invention
for the implantation and fixation of heart valve prostheses in
different views to show the configuration of the stents and the
spatial relations of individual parts of the stent to each other in
an unfolded (FIGS. 1-4 and 6-11) and in a folded condition (FIG.
5).
[0042] FIG. 1 shows a foldable mitral valve stent 10 according to
the invention in a perspective lateral view. The stent 10 exhibits
mainly three parts: proximally (supravalvularly) on stent 10 there
are several serrated, arched anchoring (FIG. 3) elements 20
circularly arranged which are able to anchor supravalvularly
(respectively atrially) the valve stent 10 in an implanted
condition. The preferable stent body 30 flattened to the LVOT is
distally adjoined and is conical and in cross section ovally shaped
(compare FIG. 2).
[0043] The stent body 30 forms a basket- or trapezoid-like figure
which nestles to the mitral valve annulus and extends in the
direction of the left ventricle. This stent 10 is held in the
atrium due to its conically-tapered form and due to the atrial
anchoring elements 20. A bi- or tri-leaflet valve 50 can be
integrated into the stent body 30.
[0044] At the distal part of the stent body 30 (to the direction of
the left ventricle) there are anchoring sutures 40 which are
distally equipped to the stent body 30 for the anchorage of the
entire stent 10. These anchoring sutures 40 provide for an
anchorage in the opposed wall of the ventricle or for instance in
the area of the papillary muscles (proximal, medial or distal part
of the papillary muscle): compare FIGS. 7 and 8. With the help of
an adjusting element to regulate the length of sutures 70, these
anchoring sutures 40 can be positioned and adjusted to the optimal
length so that the heart valved stent 10 can be fixed and
anchored.
[0045] FIG. 2 indicates the stent 10 in a top view. Thereby, it can
be distinguished that stent 10 forms a neo-annulus, alternatively a
stent body 30 in which the heart valve prosthesis 50 can be
implanted and in which it can be fixed. Furthermore, it can be
recognized that the invention-like stent 10 can be shaped
asymmetrically in relation to several supravalvular (atrial) stent
brackets 20.
[0046] This can be identified by the fact that the stent body 30 is
oval-like and flattened on one side as seen in this figure, so it
(the stent body 30) can be installed with its flattened side
towards the direction of the LVOT. This flattening has the
consequence that no pressure on this side towards the LVOT and
towards the aortic valve can be exerted from the self-expanding
stent in case the stent 10 is used, i.e. in the mitral position.
Further favoured embodiments of the stent 10 are indicated in FIG.
3 according to the invention.
[0047] FIG. 4 demonstrates the invention-pertaining stent 10 from a
bottom view. From this it is obvious that the diameter, of the
atrial part to the ventricular part of the stent body 30 becomes
smaller so that this looks like a truncated cone from the lateral
view (compare FIG. 1). The anchoring elements 20 as well as the
stent body 30 can be upholstered with cloth (i.e. synthetics,
pericardium, PTFE or Goretex, etc.) to achieve better sealing
between the heart valve prosthesis 50, stent body 30 and the
surrounding heart structure. This sealing membrane is
tapered/alternatively upholstered between the heart valve
prosthesis 50, the stent body 30 or onto the atrial stent struts 20
to achieve optimal sealing of the valve between both heart
chambers.
[0048] In FIGS. 5 to 7 and 8, the retrograde transapical
implantation of the valved stent is described. The retrograde
transaortic as well as the antegrade transatrial approach can
alternatively be performed. The deployment of a valved stent with a
folded valved stent above the old mitral annulus is shown in FIG.
5. A slow unfolding (preferred self-expanding) of the atrial
anchoring elements 20 can be started after successful orientation
with support of labelling at the valve stent 10 (not shown). The
positioning in the left atrium should be done in that way that the
flattened side of the stent body 30 is turned towards the direction
of the LVOT (aortic valve). The stent will be further expanded.
[0049] FIG. 6 indicates the expanded valve stent 10 in the
left-atrio-ventricular in-flow tract. Anchoring sutures 40 are
adjusted in or outside the wall of the heart and later--as shown in
FIG. 7--they will be fixed with the support of the thrust bearing
80 which is favourably designed as an adjusting element for the
length of sutures. During the adjustments for the length of the
anchoring sutures 40, visualization of the mitral valve apparatus
(i.e. Echo, CT, NMR) is carried out so as to optimally pull the
annulus of the new stent 10 toward the ventricular wall,
paravalvular leakage no longer exists, the stent 10 can be fixed in
a good manner, and the mitral valve annulus and--apparatus support
advantageously the left ventricular function.
[0050] Alternatively to FIG. 7, the anchoring sutures 40 can also
be fixed at the papillary muscles (see FIG. 8) so that these
sutures 40 represent the neo chordee and takeover the function of
the functionless chordae tendineae. The fixation of the anchoring
sutures 40 at the wall of the heart in each case result from a
thrust bearing 80 which can be developed as a knot or also as an
independent element. It is also possible that the ventricular
anchoring sutures 40 are not only affixed to the stent body 30, but
also at the integrated valve itself. The caudal anchoring sutures
40 can also be fixed at any other point of the ventricle.
[0051] FIG. 7 shows the accomplished positioning and fixation of
the stent 10. After the length and location of the single anchoring
sutures 40 has been determined, these anchoring sutures 40 will be
fixed with the suture-length adjusting elements 70, for instance,
in the left ventricular wall. The suture-length adjusting element
70 is used for the optimal calibration of the length and position
of the valve stent 10 and therefore for the valve prosthesis 50.
Different sutures 40 can exhibit different length and fixing
positions in the ventricle.
[0052] FIGS. 9 to 11 demonstrate additional examples for the
application of the valve stent 10 according to the invention,
whereas the stent 10 is readjusted to the particular anatomy (for
the aortic- and pulmonary valve position a rather circular form
(compare FIG. 3) and for the tricuspid position a rather oval
form).
[0053] FIG. 12 shows an especially preferred designed execution
example of the valve stent pertaining to the invention in a
schematic lateral view which is shown without heart valve and
anchoring sutures for a better clearness.
[0054] For clarification in FIG. 12 of the positioning of the valve
stent in situ, FIG. 13 demonstrates a schematic, dorsal,
intracardiac view of a fixed heart valved stent in the mitral
position according to the intervention. Note the good alignment of
the valved stent with the left atrial environment. Distances
between the left atrial wall/mitral annulus and the valved stent
are avoided. Heart valve and anchoring sutures for the ventricular
apex have been omitted for simplification.
* * * * *