U.S. patent application number 10/204918 was filed with the patent office on 2003-08-07 for anchoring system for implantable heart valve prostheses.
Invention is credited to Damm, Christoph, Dorrer, Peggy, Ferrari, Markus, Figulla, Hans-Reiner, Guyenot, Volker, Harnisch, Gerd, Lang, Klaus, Mohaupt, Matthias, Risse, Stefan, Weber, Carsten.
Application Number | 20030149476 10/204918 |
Document ID | / |
Family ID | 7633174 |
Filed Date | 2003-08-07 |
United States Patent
Application |
20030149476 |
Kind Code |
A1 |
Damm, Christoph ; et
al. |
August 7, 2003 |
Anchoring system for implantable heart valve prostheses
Abstract
The invention relates to an anchoring system for heart valve
prostheses which can be implanted by introduction via the aorta
without any major surgical operation. With the heart valve
prosthesis according to the invention it shall be achieved that
this can be safely and quickly guided through the aorta toward the
heart, and can be fixed there. With this, hook-shaped elements are
secured to the commissures of the heart valve prosthesis the hooks
of which are guided in an outward direction through the heart valve
prosthesis material.
Inventors: |
Damm, Christoph; (Jena,
DE) ; Weber, Carsten; (Jena, DE) ; Risse,
Stefan; (Jena, DE) ; Guyenot, Volker; (Jena,
DE) ; Mohaupt, Matthias; (Altengonna, DE) ;
Harnisch, Gerd; (Jena, DE) ; Dorrer, Peggy;
(Gottingen, DE) ; Ferrari, Markus; (Jena, DE)
; Lang, Klaus; (Cospeda, DE) ; Figulla,
Hans-Reiner; (Jena, DE) |
Correspondence
Address: |
Barnes & Thornburg
11 South Meridian Street
Indianapolis
IN
46204
US
|
Family ID: |
7633174 |
Appl. No.: |
10/204918 |
Filed: |
November 27, 2002 |
PCT Filed: |
February 28, 2001 |
PCT NO: |
PCT/DE01/00836 |
Current U.S.
Class: |
623/2.1 ;
606/151; 623/1.14; 623/1.36 |
Current CPC
Class: |
A61F 2220/0016 20130101;
A61F 2/2418 20130101; A61F 2220/0008 20130101 |
Class at
Publication: |
623/2.1 ;
606/151; 623/1.14; 623/1.36 |
International
Class: |
A61F 002/24; A61F
002/06 |
Foreign Application Data
Date |
Code |
Application Number |
Feb 28, 2000 |
DE |
100 10 073.2 |
Claims
1. An anchoring system for implantable heart valve prostheses,
characterized in that hook-shaped elements (2) are secured to the
commissures of the heart valve prosthesis (1) the hooks of which
are guided in an outward direction through the heart valve
prosthesis material.
2. An anchoring system according to claim 1, characterized in that
additional hook-shaped elements (2) are secured to the outer ring
of said heart valve prosthesis (1).
3. An anchoring system according to claim 1 or claim 2,
characterized in that said hook-shaped elements (2) are sewn on to
said heart valve prosthesis (1).
4. An anchoring system according to claim 1 or claim 2,
characterized in that said hook-shaped elements (2) push through
said heart valve prosthesis (1), and are supported inside by means
of a ridge (3) or a base member.
5. An anchoring system according to any one of claims 1 to 4,
characterized in that a plurality of hook-shaped elements (2) are
arranged on a common ridge (3), and at least one said ridge (3)
each is secured to one commissure.
6. An anchoring system according to claim 5, characterized in that
at least two said hook-shaped elements (2) are each located on said
one ridge (3).
7. An anchoring system according to any one of claims 1 to 6,
characterized in that said ridges (3) are aligned in the
longitudinal direction of the aorta.
8. An anchoring system according to any one of claims 1 to 6,
characterized in that said ridges (3) are designed in a helical
shape.
9. An anchoring system according to any one of claims 1 to 8,
characterized in that said ridges (3) at least are as long as said
commissures.
10. An anchoring system according to any one of claims 1 to 9,
characterized in that at least said hook-shaped elements (2) are
made of a form storage metal.
11. An anchoring system according to any one of claims 1 to 10,
characterized in that for anchoring in the aorta wall said
hook-shaped elements (2) have an effective height of at least 2 mm
in the deployed condition wherein they protrude from said heart
valve prosthesis (1).
12. An anchoring system according to any one of claims 1 to 11,
characterized in that said hook-shaped elements (2) are designed in
a pin-shaped manner and with barbs provided thereon.
13. An anchoring system according to any one of claims 1 to 12,
characterized in that said hooks of said hook-shaped elements (2)
are bent into various directions.
14. An anchoring system according to any one of claims 1 to 13,
characterized in that an annular element is secured inside said
heart valve prosthesis (1) in the area of said outer ring.
15. An anchoring system according to claim 14, characterized in
that said annular element is made of an elastomer material or a
form storage metal.
Description
[0001] The invention relates to an anchoring system for heart valve
prostheses which is implantable via the aorta by introduction
without any major surgical operation wherein in conventional manner
complete opening of the thorax has been required.
[0002] In the past the most different attempts have been made and
solutions have been offered as well wherein heart valve prostheses
should be guided through the aorta towards the heart, and be
fixedly implanted there after a deploying and stretching over
operation.
[0003] Thus, in U.S. Pat. No. 5,855,601 i.a. is described a
so-called stent to which a heart valve prosthesis can be secured.
This stent is essentially formed of a wire-shaped form storage
metal which represents a cylindrical structure within a grid
structure. The form storage metal can be folded at temperatures
below of 37.degree. C., and shall be guided by means of a catheter
via the aorta towards the heart, and there it shall take up the
memorized shape after a cooling system has been switched off and a
temperature of about 37.degree. C. has been achieved, and shall
closely fit in the respective deployed condition on the inside
aorta wall.
[0004] Due to the limitations of the form storage metal, however,
it is difficult for such a stent to be miniaturized and folded up
so far in order to be guided through the aorta problem-free, and
also to be dimensioned in the deployed state such that then it
closely fits on the inside aorta wall, and will be safely supported
as well.
[0005] Moreover, manufacturing an anchoring support which is
constructed and designed in such a manner and made of conventional
form storage metal (e.g. Nitinol) being suitable in the required
temperature range is encountered with problems and requires an
appropriate high manufacturing amount since as a rule such a body
is cut out of solid material by laser beam cutting.
[0006] Hence, it is an object of the invention to suggest a
possibility wherein heart valve prostheses are allowed to be guided
via the aorta towards the heart, and be fixed there.
[0007] According to the invention this object is solved with the
features of claim 1. Advantageous embodiments and improvements of
the invention result from the features mentioned in the
subclaims.
[0008] According to the invention, hook-shaped elements are secured
immediately to the commissures of a biological heart valve
prosthesis which can be removed from a pork heart, e.g., or
otherwise to an artificial heart valve prosthesis, which hooks
thereof are guided outside through the heart valve prosthesis
material, and which in the implanted condition are sticked into the
aorta wall and piercing the aorta wall, respectively such that the
heart valve prosthesis can be safely secured to the aorta wall.
[0009] Further additional hook-shaped elements can also be secured
to the outer ring of the heart valve prosthesis.
[0010] On that occasion, the hook-shaped elements can be sewn on to
the heart valve prosthesis.
[0011] However, it is simplier and requires less amount for the
hook-shaped elements to be introduced from the inside into the
heart valve prosthesis, and at least for the hooks to be pushed
through the heart valve prosthesis material wherein it is proper
for the hook-shaped elements to be formed on a ridge or with a base
element whereby it will be assured that merely the hooks of the
hook-shaped elements protrude from the heart valve prosthesis, and
the remaining portion having a respective size maintains the
retention inside the heart valve prosthesis.
[0012] Thus, for example, a ridge can be in the form of a flat bar
and an elongated plate, respectively, on which at least two
hook-shaped elements are designed.
[0013] A base element, for example, can be designed in a
plate-shaped manner of a circular form, wherein the cross-sectional
area of the circle can prevent the heart valve prosthesis material
from being pierced.
[0014] The hook-shaped elements which are arranged on ridges and
base elements, respectively, are allowed to be substantially formed
in a pin-shaped manner. On that occasion, one or a plurality of
barbs are formed on the pin-shaped portion for anchoring in the
aorta wall which interlock in or behind the aorta wall after
pressing-in.
[0015] On that occasion, the barb shape can be memorized into a
form storage metal such that the barbs protrude outwardly directed
above the transition temperatures only, and so cutting-in and
piercing the aorta wall is facilitated.
[0016] If ridges are used on which the hook-shaped elements are
formed or secured to, these are allowed to be secured to the
commissures of a heart valve prosthesis such that they are aligned
in the longitudinal direction of the aorta in the implanted
state.
[0017] However, it can also be particularly advantageous for the
ridges to be designed in a helical manner such that they are
adapted to the inner contour of the aorta due to the helical shape,
and closely fit immediately to this by means of the hooks wherein a
greater circumferential area of the inner aorta wall can be covered
and an increased degree of closeness can be achieved due to the
helical shape.
[0018] If individual hook-shaped elements being otherwise separated
from each other are used with base elements these should also be
arranged over the commissures in a distributed manner wherein a
configuration following the helical shape or a configuration of two
counterwound spirals is possible as well.
[0019] If ridges having hook-shaped elements are used these ridges
should have a length which is at least as large as the length of
the commissures of the heart valve prosthesis.
[0020] The ridges secured to the different commissures are not
connected to one another.
[0021] For introducing the heart valve prosthesis with the
anchoring system secured thereto it is also favourable if at least
the hook-shaped elements are made of a form storage metal which
maintains that the hook-shaped elements sit flat during the phase
of introduction, and only low resistance of introduction and low
volume are obtained and the desired shape and erecting the hooks
for anchoring in the aorta wall only occur at the site of
implantation.
[0022] The effective height of the hook-shaped elements then at
least should be 2 mm such that they protrude from the heart valve
prosthesis in this height, and penetrate into the aorta wall and
pierce it, respectively.
[0023] It is also advantageous to bend the hooks of the various
hook-shaped elements in different directions such that a secure
fixation of the anchoring system according to the invention can be
achieved while taking into account the conditions inside the aorta,
pressure and flow conditions in the vicinity of the heart as
well.
[0024] Advantageously, the adjacent hook-shaped elements can be
bent directed towards each other, and such a position can be
memorized, respectively, with the use of form storage metal. That
results in cramping of the adjacent hook-shaped elements inside the
aorta wall with reaching and exceeding the transition temperature,
respectively.
[0025] Further, inside the heart valve prosthesis in the area of
the outer ring thereof an additional annular member is allowed to
be secured which can also be pressed during the phase of
introduction through the aorta, and which demands a smaller volume.
For this, an elastomer material such as for example a suitable
plastic and rubber, respectively, provided with a helical spring as
the case may be or only a helical spring as well or a form storage
metal can be used.
[0026] The heart valve prosthesis provided with the anchoring
system according to the invention can be introduced into the aorta
by means of a catheter on which a corresponding mechanism is formed
wherein the mechanism should maintain deploying the heart valve
prosthesis and releasing the heart valve prosthesis placed in the
desired position.
[0027] It is also possible to employ a balloon catheter wherein the
heart valve prosthesis provided with the anchoring system according
to the invention can be plonked on and introduced in this position
into the aorta. If the site of implantation is reached the balloon
is pressurized then, and the heart valve prosthesis is pressed with
the hook-shaped elements against the aorta wall, and then the hooks
are allowed to be anchored inside the aorta wall wherein using the
form storage metal the balloon catheter can also be used for
required cooling.
[0028] The surface of the balloon of such a catheter can be
appropriately contoured such that, e.g. the base elements and the
ridges, respectively, are safely supported in the phase of passing
through the aorta due to the elasticity of the balloon and the
appropriately designed contour of the ridges and base elements,
respectively, and this retention can be released.
[0029] However, a catheter having a self-deploying mechanism can
also be used which in turn consists of a form storage metal as
well, to ensure the attachment of the heart valve prosthesis with
the anchoring system according to the invention.
[0030] In each case, however, in the phase of passing through the
aorta it is appropriate to envelope the heart valve prosthesis in
order to avoid undesired injuries of the aorta wall before arriving
at the site of implantation, and also to ensure an appropriate
thermal insulation with the required cooling as well. After
arriving at the site of implantation this enclosure can be teared,
and a dislocking mechanism can be activated, respectively, and
removed again along with the catheter from the aorta.
[0031] If a deploying mechanism made of a form storage metal is
used, as already mentioned, this is allowed to be designed as an
annular element which is secured to the heart valve prosthesis in
the area of the outer ring thereof. Such an annular element is
allowed then to ensure the stability of the implanted heart valve
prosthesis, and an increased sealing function.
[0032] In the text that follows the invention will be explained in
more detail according to an embodiment in which
[0033] FIG. 1 shows an embodiment of the anchoring system according
to the invention on a heart valve prosthesis.
[0034] With the embodiment of an anchoring system according to the
invention for a heart valve prosthesis 1 as shown in FIG. 1 there
are hook-shaped elements 2 formed on ridges 3, and such each ridge
3 is located on a commissure of the heart valve prosthesis 1, and
is secured there.
[0035] With this embodiment, both the ridges 3 and the hook-shaped
elements 2 are made of a form storage metal as it is available e.g.
under the designation of Nitinol. For the attachment the ridges 3
are introduced from the inside into the heart valve prosthesis 1
and simply pressed through the commissures of the heart valve
prosthesis 1 such that this will be pierced.
[0036] The form storage metal can be memorized into the shape as
shown in FIG. 1 which will be taken up after the transition
temperature of 37.degree. C. has been exceeded. In the phase of
introduction of the heart valve prosthesis 1, however, the
hook-shaped elements 2 should be inclined almost 90.degree. in the
direction towards the longitudinal axis of the ridges 3 as far as
possible such that they require a relatively small volume and
slightly protrude such that introducing is facilitated, and
injuries of the aorta wall can be avoided.
[0037] With the embodiment as shown herein, five hook-shaped
elements each are formed on the ridge 3. Altogether, at least
fifteen hook-shaped elements should be used, however.
[0038] However, the number of the hook-shaped elements 2 can be
readily varied, and moreover it is possible for a plurality of such
ridges 3 having hook-shaped elements 2 to be secured to a
commissure of the heart valve prosthesis 1.
[0039] On that occasion, the ridges 3 are allowed to be aligned
inclined with an angle which is not shown here, wherein two such
ridges 3 can also be inclined opposite to each other.
[0040] In the form which is not shown, an additional annular
element can be secured to the heart valve prosthesis 1 in the area
of the outer ring 4 thereof.
[0041] In addition, barbs can be formed on the hook-shaped elements
2 and the hooks thereof, respectively, to improve fastening.
* * * * *