U.S. patent application number 16/814991 was filed with the patent office on 2020-07-02 for delivery device for medical implant and medical procedure.
The applicant listed for this patent is AEEG AB. Invention is credited to Anders Jonsson.
Application Number | 20200205976 16/814991 |
Document ID | / |
Family ID | 46456597 |
Filed Date | 2020-07-02 |
United States Patent
Application |
20200205976 |
Kind Code |
A1 |
Jonsson; Anders |
July 2, 2020 |
DELIVERY DEVICE FOR MEDICAL IMPLANT AND MEDICAL PROCEDURE
Abstract
A catheter based medical system and medical procedure for
reducing cardiac valve regurgitation are disclosed. The system
comprises a resilient curvilinear shaped annuloplasty implant for
reducing the size of a dilated annulus of said valve for reducing
said regurgitation having resilient anchoring elements, and a
delivery device for said annuloplasty implant having a distal
curvilinear shaped portion that is hollow to mount said
annuloplasty implant and has an annular opening arranged to be in
apposition against an annulus of said cardiac valve. A plurality of
suction units allows for a atrial approach and symmetric
implantation of said implant.
Inventors: |
Jonsson; Anders; (Bromma,
SE) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
AEEG AB |
Helsingborg |
|
SE |
|
|
Family ID: |
46456597 |
Appl. No.: |
16/814991 |
Filed: |
March 11, 2020 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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15430215 |
Feb 10, 2017 |
10639153 |
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16814991 |
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14236603 |
Feb 19, 2014 |
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PCT/EP12/62931 |
Jul 3, 2012 |
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15430215 |
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61514693 |
Aug 3, 2011 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61B 2034/108 20160201;
A61F 2250/0096 20130101; A61F 2220/0008 20130101; A61F 2/2445
20130101; A61B 34/10 20160201; A61B 2034/104 20160201; A61F 2/2466
20130101 |
International
Class: |
A61F 2/24 20060101
A61F002/24; A61B 34/10 20060101 A61B034/10 |
Claims
1. A catheter based medical system, including a retractable
delivery device for delivery of a medical implant, such as an
annuloplasty implant for reducing cardiac valve regurgitation,
having a distal portion for releasably holding said implant, and
for apposition against a target tissue for said implant, such as an
annulus of a cardiac valve, wherein said distal portion comprises a
plurality of suction units for providing and/or determining a
desired apposition of said distal portion at said target tissue
prior to releasing said medical implant to said tissue and
retracting said delivery device.
2. The system of claim 1, wherein said suction units are
provideable with a negative pressure for suction to said tissue,
and wherein said medical implant is not releasable before all
suction units are confirmed in apposition with said tissue.
3. The system of claim 1, wherein said plurality of suction units
are distributed along a periphery of said distal portion.
4. The system of claim 1, wherein a firm seat at said tissue is
confirmed by an absence of a reflow of blood from said suction
units.
5. The system of claim 1, wherein said suction units are arranged
to provide for a symmetric delivery of said implant when release to
said tissue.
6. The system of claim 1, wherein said tissue is a cardiac valve
annulus and said implant is an annuloplasty implant, such that said
distal portion is arrangeable for a synchronous and simultaneous
reshaping procedure of said annulus by said implant.
7. The system of claim 1, wherein apposition of said suction units
is measurable based on a signal for a pressure in said suction unit
an energy consumption of a flow generator generating said
pressure.
8. The system of claim 1, wherein said distal portion has arranged
thereon a plurality of sensors for indicating contact with said
annulus tissue, such as piezo transducers.
9. The system of claim 1, wherein said cardiac valve is a mitral
valve, and wherein said system is adapted for transseptal
percutaneous delivery into the left atrium to said atrial side of
said mitral valve, and wherein a delivery portion of said delivery
device is distally connected to said distal portion and has a
distal curvature to allow access from a septal opening towards said
mitral valve.
10. The system of claim 1, wherein said cardiac valve is a
tricuspid valve, and wherein said system is adapted for
percutaneous delivery into the right atrium to said atrial side of
said tricuspid valve, and wherein a delivery portion of said
delivery device is distally connected to said distal portion and
has a distal curvature to allow suitable access towards said
tricuspid valve.
11. The system of claim 1, wherein said implant is a resilient
curvilinear shaped annuloplasty implant that has a tissue engaging
conformation based on a desired downsized shape where said
regurgitation of said valve is reduced, and said distal portion has
a delivery conformation based on a shape of said dilated valve
annulus shape, wherein said delivery conformation has a dimension
that is larger than said tissue engaging conformation of said
annuloplasty implant, such that said annuloplasty implant is
resiliently kept in said delivery conformation before release from
said distal portion.
12. The system of claim 1, wherein said distal portion has at least
one fiducial marker, wherein said fiducial marker is preferably
arranged at a periphery of said distal portion; and/or wherein one
of said fiducial markers is an annular fiducial marker arranged
along said periphery; and/or having a plurality of fiducial markers
distributed along said distal curvilinear shaped portion for
identifying said distal curvilinear shaped portion inside a body of
a patient having said cardiac valve.
13. The system of claim 12, wherein said fiducial markers include
an air inclusion for detection by ultrasound.
14. A medical procedure for reducing cardiac valve regurgitation
including the steps of: measuring the geometry of a dilated cardiac
valve of a patient including the shape and size of a dilated
annulus thereof; determining the downsized shape and size of said
annulus; selecting a resilient annuloplasty implant having in a
tissue engaging conformation a shape and size to be arranged at
said downsized annulus based on said determined downsized shape and
size of said annulus; introducing said annuloplasty implant in a
delivery device in a compressed state via a catheter to said
cardiac valve; releasing an aggregate of a distal portion of said
delivery device and said annuloplasty implant in a stretched state
in said delivery device from said catheter such that implant
assumes an expanded shape; positioning said aggregate at said
annulus; fixation said distal portion to said annulus, e.g. by
activating suction of suction units; providing and/or verifying a
desired apposition of said distal portion at said annulus prior to
releasing said implant; releasing and anchoring said annuloplasty
implant into said annulus; reducing the size of said delivery
device and/or annuloplasty implant for reshaping said annulus to
said downsized shape; optionally determining a reduction of said
cardiac valve regurgitation, and removing said delivery device and
catheter if the reduction is satisfactory, or removing said
annuloplasty implant together with said delivery device when said
reduction is determined as not being satisfactory.
15. The procedure of claim 14, including ultrasonic measurement for
said measuring the geometry of said dilated cardiac valve, and/or
said determining a reduction of said cardiac valve
regurgitation.
16. The procedure of claim 14, including: applying a catheter based
medical system for reducing said cardiac valve regurgitation,
having said resilient curvilinear shaped annuloplasty implant for
reducing the size of a dilated annulus of said valve for reducing
said regurgitation, and a delivery device for said annuloplasty
implant having a distal portion receiving said annuloplasty implant
and has an opening arranged to be in apposition against an annulus
of said cardiac valve; said procedure including releasably mounting
said annuloplasty implant in said hollow with said resilient
anchoring elements arranged in a restrained spring loaded delivery
conformation in said hollow, for said introducing; positioning said
aggregate at said annulus; fixation said distal portion to said
annulus, e.g. by activating suction of suction units; providing
and/or verifying a desired apposition of said distal portion at
said annulus prior to releasing said implant; releasing and
anchoring said annuloplasty implant into said annulus.
17. The procedure of claim 14, including restraining said
annuloplasty implant in said hollow of said distal portion with a
second restraining unit, and releasing said annuloplasty implant
from said hollow upon releasing said second restraining unit,
wherein said second restraining unit preferably is only released
when a correct position of said annuloplasty implant is confirmed,
allowing for removing said annuloplasty implant from said annulus
if the correct positioning of said annuloplasty implant is not
confirmed, and avoiding undesired embolization of said annuloplasty
implant.
18. The procedure of claim 14, including making a transseptal
puncture in said heart; wherein said cardiac valve is a mitral
valve, and wherein said introducing is a transseptal percutaneous
delivery into the left atrium to said atrial side of said mitral
valve, and wherein a delivery portion of said delivery device is
distally connected to said distal curvilinear shaped portion and
has a distal curvature to allow access from a septal opening
towards said mitral valve.
19. The procedure of claim 14, including making a transseptal
puncture in said heart; wherein said cardiac valve is tricuspid
valve, and wherein said system is adapted for percutaneous delivery
into the right atrium to said atrial side of said tricuspid valve,
and wherein a delivery portion of said delivery device is distally
connected to said distal curvilinear shaped portion and has a
distal curvature to allow suitable access towards said tricuspid
valve.
20. The procedure of claim 14, including generating a negative
pressure in suction units of said distal portion for suction of
said distal portion to said annulus.
Description
FIELD OF THE INVENTION
[0001] This invention pertains in general to the field of medical
devices and methods. More particularly the invention relates to
cardiac valve repair devices and methods, and even more
particularly to a system of cardiac valve annuloplasty implants and
corresponding delivery tools for said implants, as well as
associated methods and procedures.
BACKGROUND
[0002] The human heart is a hollow muscular organ having four
pumping chambers separated by four heart valves. The mitral and
tricuspid valves, present at the left and right atrioventricular
junctions, open and close in response to a pressure gradient during
each cardiac cycle of relaxation and contraction to control the
flow of blood to a particular region of the heart.
[0003] These valves are comprised of a dense fibrous ring known as
the annulus, leaflets or cusps attached to the annulus, and a
complex of chordae tendinae and papillary muscles securing the
leaflets. The size of the leaflets or cusps is such that when the
heart contracts the resulting increased blood pressure formed
within the ventricular cavity forces the leaflets towards the
arterial cavity. As a result, the leaflets or cusps come in
apposition to each other thereby closing the atrio-ventricular
passage.
[0004] Natural defects and heart disease are common causes of
valvular dysfunction within the heart of a patient. One common
example of valvular dysfunction occurs, when the annulus becomes
excessively dilated or the valve geometry results in ineffective
valve closure, which results in regurgitation. Due to the increased
diameter of the annulus, the leaflets or cusps fail to meet during
systolic contraction, thereby resulting in the regurgitation of
blood during ventricular contractions. As such, sufficient back
pressure exists within the chambers of the heart capable of forcing
some blood flow to traverse the atrio-ventricular junction from the
ventricle to the atria.
[0005] One manner of repairing this problem involves surgically
implanting a prosthetic implant, often referred to as "annuloplasty
rings", about the dilated annulus, thereby restoring the annulus to
the normal size and shape and allowing the valve leaflets to
function normally. Commonly, a surgeon positions the annuloplasty
ring near the valve annulus and sutures the device in place.
[0006] One approach to correcting or remodelling the valve annulus
has required the implantation of a rigid annuloplasty ring.
Typically, an annuloplasty ring having the desired internal
diameter is positioned near the heart valve and sutured in place.
As a result, the diameter of the valve is reduced to the diameter
of the annuloplasty ring.
[0007] The previously published US patent application 2005/055087
A1, describes methods for "Introducing a stabilizing member beneath
one or more heart leaflets" in-conjunction with an optional "Second
stabilizing member . . . introduced above the (valve) leaflets for
further stabilization". A catheter is utilised to deliver the
stabilizing member(s), as well as "Hydraulically driven tethered
anchors" which provide for cinching of the dilated annulus, through
adjustment of the tether. The anchors are separate entities not
attached to the tether. The tether is merely guided in an eyelet of
each of the anchors. An annuloplasty ring is not described. After
deployment, the device is not retrievable from the patient other
than by open chest surgery. This may be a major disadvantage when
the device is malpositioned.
[0008] In US 2007/0016287 an "Implantable device is provided for
controlling shape and/or size of an anatomical structure or lumen."
Wherein the implantable ring utilises an adjustment means to
regulate the size of the annulus and is attached to the tissue
through drawing of a deployment suture which releases tissue
anchors which previously were flush to the annulus. The number of
anchor elements is limited as the total number of anchor elements
is defined by the specific length of each of the adjacent anchoring
elements when flush. This also means that the maximum anchoring
depth of the anchor when released is limited. Thus, there is a need
to improve reliability of anchoring. Moreover, the annuloplasty
ring may not comprise a collar element around the ring, sometimes
desired to improve sealing of the ring against the annulus, as the
anchors would be hindered from their movement. After deployment,
the device is not retrievable from the patient other than by open
chest surgery. This may be a major disadvantage when the device is
malpositioned.
[0009] Although these provide possible treatment modalities,
improved treatment means are required to provide enhanced tissue
attachment in-conjunction with greater ease of regulating annular
size to limit the procedure time and safeguard against misplacement
which can lead to e.g. embolization.
[0010] Catheter based delivery via an atrial approach would be
desired to avoid interference with the subvalvular apparatus.
[0011] An automated annuloplasty procedure or device/system
allowing this would be desired.
[0012] A symmetrical reshaping of the annulus by a device would be
desired.
[0013] Open chest surgery or other invasive procedures, like
intercostal transapical cardiac access paths are desired to be
avoided.
SUMMARY
[0014] Accordingly, embodiments of the present invention 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 medical system,
procedures and methods, according to the appended patent
claims.
[0015] In an aspect, a catheter based medical system is disclosed.
The system includes a retractable delivery device for delivery of a
medical implant, such as an annuloplasty implant for reducing
cardiac valve regurgitation. The delivery device having a distal
portion for releasably holding the implant, and for apposition
against a target tissue for the implant, such as an annulus of a
cardiac valve. The distal portion comprises a plurality of suction
units for providing and/or determining a desired apposition of the
distal portion at the target tissue prior to releasing the medical
implant to the tissue and retracting the delivery device.
[0016] Advantageously, the suction units are provideable with a
negative pressure for suction to the tissue, and wherein the
medical implant is not releasable before all suction units are
confirmed in apposition with the tissue.
[0017] Advantageously, the plurality of suction units are
distributed along a periphery of the distal portion.
[0018] Advantageously, a firm seat at the tissue is confirmed by an
absence of a reflow of blood from the suction units.
[0019] Advantageously, the suction units are arranged to provide
for a symmetric delivery of the implant when release to the
tissue.
[0020] Advantageously, the tissue is a cardiac valve annulus and
the implant is an annuloplasty implant, such that the distal
portion is arrangeable for a synchronous and simultaneous reshaping
procedure of the annulus by the implant.
[0021] Advantageously, apposition of the suction units is
measurable based on a signal for a pressure in the suction unit an
energy consumption of a flow generator generating the pressure.
[0022] Advantageously, the distal portion has arranged thereon a
plurality of sensors for indicating contact with the annulus
tissue, such as piezo transducers.
[0023] The cardiac valve may be a mitral valve, and wherein the
system is adapted for transseptal percutaneous delivery into the
left atrium to the atrial side of the mitral valve, and wherein the
delivery portion of the delivery device is distally connected to
the distal portion and has a distal curvature to allow access from
a septal opening towards the mitral valve.
[0024] The cardiac valve may be a tricuspid valve, and wherein the
system is adapted for percutaneous delivery into the right atrium
to the atrial side of the tricuspid valve, and wherein the delivery
portion of the delivery device is distally connected to the distal
portion and has a distal curvature to allow suitable access towards
the tricuspid valve.
[0025] In this manner, the subvalvular apparatus is avoided during
delivery. Delivery is made from the atrial side of the cardiac
valve. Open chest surgery, or intercostal delivery, and/or
transapical delivery is avoided.
[0026] Advantageously, the implant is a resilient curvilinear
shaped annuloplasty implant that has a tissue engaging conformation
based on a desired downsized shape where the regurgitation of the
valve is reduced. The distal portion has a delivery conformation
based on a shape of the dilated valve annulus shape, wherein the
delivery conformation has a dimension that is larger than the
tissue engaging conformation of the annuloplasty implant, such that
the annuloplasty implant is resiliently kept in the delivery
conformation before release from the distal portion.
Advantageously, the distal portion has at least one fiducial
marker, wherein the fiducial marker is preferably arranged at a
periphery of the distal portion. One of the fiducial markers may be
an annular fiducial marker arranged along the periphery. A
plurality of fiducial markers may be distributed along the distal
curvilinear shaped portion for identifying the distal curvilinear
shaped portion inside a body of a patient having the cardiac valve.
A trace of a plurality of fiducial markers gives a 3D identifiable
position.
[0027] Advantageously, the fiducial markers include an air
inclusion for detection by ultrasound.
[0028] In another aspect, a medical procedure is disclosed. The
procedure is provided for reducing cardiac valve regurgitation. The
method may include the following steps, namely measuring the
geometry of a dilated cardiac valve of a patient including the
shape and size of a dilated annulus thereof; determining the
downsized shape and size of the annulus; selecting a resilient
annuloplasty implant having in a tissue engaging conformation a
shape and size to be arranged at the downsized annulus based on the
determined downsized shape and size of the annulus; introducing the
annuloplasty implant in a delivery device in a compressed state via
a catheter to the cardiac valve; releasing an aggregate of a distal
portion of the delivery device and the annuloplasty implant in a
stretched state in the delivery device from the catheter such that
implant assumes an expanded shape; positioning the aggregate at the
annulus; fixation the distal portion to the annulus, e.g. by
activating suction of suction units; providing and/or verifying a
desired apposition of the distal portion at the annulus prior to
releasing the implant; releasing and anchoring the annuloplasty
implant into the annulus; reducing the size of the delivery device
and/or annuloplasty implant for reshaping the annulus to the
downsized shape; optionally determining a reduction of the cardiac
valve regurgitation, and removing the delivery device and catheter
if the reduction is satisfactory, or removing the annuloplasty
implant together with the delivery device when the reduction is
determined as not being satisfactory.
[0029] Advantageously, the procedure includes ultrasonic
measurement for the measuring the geometry of the dilated cardiac
valve, and/or the determining a reduction of the cardiac valve
regurgitation.
[0030] Advantageously, the procedure includes applying a catheter
based medical system for reducing the cardiac valve regurgitation,
having the resilient curvilinear shaped annuloplasty implant for
reducing the size of a dilated annulus of the valve for reducing
the regurgitation, and a delivery device for the annuloplasty
implant having a distal portion receiving the annuloplasty implant
and has an opening arranged to be in apposition against an annulus
of the cardiac valve. The procedure may include further releasably
mounting the annuloplasty implant in the hollow with the resilient
anchoring elements arranged in a restrained spring loaded delivery
conformation in the hollow, for the introducing; positioning the
aggregate at the annulus; fixation the distal portion to the
annulus, e.g. by activating suction of suction units; providing
and/or verifying a desired apposition of the distal portion at the
annulus prior to releasing the implant; releasing and anchoring the
annuloplasty implant into the annulus.
[0031] Advantageously, the procedure includes restraining the
annuloplasty implant in a hollow of the distal portion with a
second restraining unit, and releasing the annuloplasty implant
from the hollow upon releasing the second restraining unit, wherein
the second restraining unit preferably is only released when a
correct position of the annuloplasty implant is confirmed, allowing
for removing the annuloplasty implant from the annulus if the
correct positioning of the annuloplasty implant is not confirmed,
and avoiding undesired embolization of the annuloplasty
implant.
[0032] Advantageously, the procedure includes making a transseptal
puncture in the heart; wherein the cardiac valve is a mitrel valve,
and wherein the introducing is a transseptal percutaneous delivery
into the left atrium to the atrial side of the mitral valve, and
wherein a delivery portion of the delivery device is distally
connected to the distal curvilinear shaped portion and has a distal
curvature to allow access from a septal opening towards the mitral
valve.
[0033] Advantageously, the procedure includes making a transseptal
puncture in the heart; wherein the cardiac valve is tricuspid
valve, and wherein the system is adapted for percutaneous delivery
into the right atrium to the atrial side of the tricuspid valve,
and wherein a delivery portion of the delivery device is distally
connected to the distal curvilinear shaped portion and has a distal
curvature to allow suitable access towards the tricuspid valve.
[0034] Catheter access to the left atrium is e.g. achieved by
positioning a catheter in central or peripheral veins, thereby
achieving access to the right atrium. In such a situation, the
tricuspid valve may be accessed from above the valve. Then a
standard atrial trans-septal approach may be utilized to access the
left atrium by creation of an iatrogenic atrial septal defect
(ASD). In such a situation, the mitral valve maybe accessed from
above the valve, see FIG. 3.
[0035] Advantageously, the procedure includes generating a negative
pressure in suction units of the distal portion for suction of the
distal portion to the annulus.
[0036] Advantageously, the procedure includes measuring the
negative pressure and determining a contact of the suction units(s)
with the annulus tissue from the measured pressure or an energy
consumption of a flow generator generating the pressure.
[0037] Advantageously, the procedure includes indicating contact
with the annulus tissue with a sensor arranged on the distal
portion, such as based on sound waves emitted and received from a
piezo transducer, such as an ultrasonic transducer.
[0038] Advantageously, the procedure includes identifying the
distal portion inside a body of a patient having the cardiac valve
by means of detecting at least one fiducial marker of the delivery
device, such as a plurality of fiducial markers distributed along
the distal portion for the identifying and/or a fiducial marker
that is arranged at a periphery of the distal portion, and/or
wherein one of the fiducial markers is an annular fiducial marker
arranged along the periphery.
[0039] In another aspect, a method of virtually planning an
annuloplasty implantation is disclosed for a medical procedure. The
method comprises, in a computer environment, image based, such as
ultrasonic based, measuring a geometry of a dilated cardiac valve
from patient image data, and determining a reduction of a
regurgitation of the valve when downsizing the annulus of the
dilated valve; selecting a patient adapted shape and size of a
resilient annuloplasty implant, such as described herein, for a
tissue engaging conformation to be arranged at the downsized
annulus based on the determined downsized shape and size of the
annulus; and providing production data for the device and/or a
delivery system thereof
[0040] Advantageously, the method includes measuring the geometry
of a dilated cardiac valve of a patient including the shape and
size of a dilated annulus thereof, and the determining the
downsized shape and size of the annulus are made in a computer
based, virtual environment.
[0041] In another aspect, a method of producing a medical device is
disclosed from production data obtained by the virtual planning of
the afore aspect.
[0042] A medical device may be provided for reducing cardiac valve
regurgitation. The device includes an elongate resilient
curvilinear shaped annuloplasty implant for reducing the size of a
dilated annulus of the valve for reducing the regurgitation. The
annuloplasty implant has resilient anchoring elements protruding
radially outwards from the annuloplasty implant. The anchoring
elements are arrangeable in a spring loaded first radial direction
for delivery, and when released from the delivery position anchor
the annuloplasty implant to tissue at the annulus in a second
radial direction, different from the first radial direction.
[0043] Multiple of the anchoring elements may be arranged at
different radial positions around the cross section of the
annuloplasty implant. The anchoring elements may preferably be
arranged opposite each other. The anchoring elements may preferably
be arranged at the same longitudinal position on the annuloplasty
implant.
[0044] According to another aspect, a system is disclosed provided,
namely a catheter based medical system for reducing cardiac valve
regurgitation, comprising a resilient and/or elastic curvilinear
shaped annuloplasty implant for reducing the size of a dilated
annulus of the valve for reducing the regurgitation having
resilient anchoring elements; a delivery device for the
annuloplasty implant having a distal curvilinear shaped portion
that is hollow in which to mount the annuloplasty implant and has
an annular opening arranged to be appositioned against an annulus
of the cardiac valve; wherein the annuloplasty implant is
releasably mounted in the hollow and has the resilient anchoring
elements arranged in a restrained spring loaded delivery
conformation in the hollow, and wherein the resilient anchoring
elements when released from the restraining unit'are arranged in a
tissue engaging conformation protruding out of the opening.
[0045] The system is minimally invasive deliverable via a
transluminal catheter.
[0046] Advantageously, the resilient elastic curvilinear shaped
annuloplasty implant has a tissue engaging conformation based on a
desired downsized shape where the regurgitation of the valve is
reduced, and the distal curvilinear shaped portion has a delivery
shape based on a shape of the dilated valve annulus shape, wherein
the delivery shape has a dimension that is larger than the relaxed
shape of the annuloplasty implant, such that the annuloplasty
implant is resiliently mounted in the hollow in the delivery shape
before being released from the hollow.
[0047] The annuloplasty implant may be of a closed ring shape. The
ring may be round or oval in shape. Alternatively, the annuloplasty
implant may be of an interrupted ring shape, such as a C-shape. The
cross section of the elongate member forming the (partial) ring may
be circular, flattened, oval, or have other shapes suitable for
apposition to the annulus tissue. The implant may have a shape with
a desired 3D topography.
[0048] Advantageously, the delivery device has a sizing actuator,
and wherein the distal curvilinear shaped portion is reducible from
the delivery shape by the actuator.
[0049] Advantageously, the delivery device has a first restraining
unit for restraining the anchoring elements in the restrained
spring loaded delivery position.
[0050] Advantageously, the delivery device has a second restraining
unit for restraining the annuloplasty implant in the hollow of the
distal curvilinear shaped portion. The restraining unit is e.g. a
tether line. In this manner, additional security is provided as the
implant may be retracted when it is still mounted in the delivery
device. Thus e.g. embolization of the device is avoided, which
otherwise would make a surgical retrieval procedure necessary,
likely including open chest surgery with all its disadvantages.
[0051] Advantageously, the delivery device has a third restraining
unit for keeping the annuloplasty implant in the hollow of the
distal curvilinear shaped portion.
[0052] Advantageously, the system has a first, second and third
restraining unit, wherein the third restraining unit is arranged to
release the annuloplasty implant by withdrawing the delivery device
when the first restraining unit has released the anchoring elements
from the restrained spring loaded delivery conformation and
anchored the anchoring elements into the annulus tissue.
[0053] Advantageously, the hollow of the distal curvilinear shaped
portion is of a fluid impermeable material. Thus it may be provided
with a negative pressure for suction of the hollow to the annulus.
In some embodiments a pressure in the hollow is measured and a
contact with the annulus tissue is determinable from the measured
pressure or an energy consumption of a flow generator generating
the pressure.
[0054] Advantageously, the distal curvilinear shaped portion has
arranged thereon a sensor for indicating contact with the annulus
tissue, such as a piezo transducer.
[0055] Advantageously, the distal curvilinear shaped portion has at
least one fiducial marker. The fiducial marker may be arranged at a
periphery of the distal curvilinear shaped portion; and/or wherein
one of the fiducial markers is an annular fiducial marker arranged
along the periphery. A plurality of fiducial markers may be
distributed along the distal curvilinear shaped portion for
identifying the distal curvilinear shaped portion inside a body of
a patient having the cardiac valve.
[0056] After positioning the aggregate at the annulus the position
of the aggregate relative the annulus may be validated and adjusted
if deemed necessary. This provides for flexibility and reliability
of deployment of the aggregate.
[0057] As the annuloplasty implant may be retrieved, together with
the delivery device, even after releasing the anchor elements, the
procedure provides for retrievability of the implant in a manner
that hitherto was not possible.
[0058] Advantageously, delivery of a patient adapted annuloplasty
curvilinear shaped structure is provided. Patient adaptation of the
device may be based on imaging data of the dilated valve structure.
The shape of the device, number of anchoring elements, depth of
anchoring elements, etc. is chosen to effectively treat the valve
leakage.
[0059] Advantageously, the procedure includes image based
measurement, such as ultrasonic measurement, for the measuring a
geometry of the dilated cardiac valve, and/or the determining a
reduction of the cardiac valve regurgitation.
[0060] Advantageously, the procedure further includes subsequently
to the positioning the aggregate at the annulus: determining a
position of the delivery device at the annulus, and repositioning
the delivery device and annuloplasty implant.
[0061] Advantageously, the procedure includes applying a catheter
based medical system for reducing the cardiac valve regurgitation,
having the resilient curvilinear shaped annuloplasty implant for
reducing the size of a dilated annulus of the valve for reducing
the regurgitation having resilient anchoring elements, and a
delivery device for the annuloplasty implant having a distal
curvilinear shaped portion that is hollow to mount the annuloplasty
implant and has an annular opening arranged to be appositioned
against an annulus of the cardiac valve; the procedure comprising
mounting the releasable annuloplasty implant in the hollow with the
resilient anchoring elements arranged in a restrained spring loaded
delivery position in the hollow, for introducing and releasing; and
releasing the resilient anchoring elements and arranging the
resilient anchoring elements in a tissue engaging conformation
protruding out of the opening of the annulus for the releasing.
[0062] Advantageously, the procedure is a minimally invasive
procedure.
[0063] Advantageously, the resilient curvilinear shaped
annuloplasty implant has a tissue engaging conformation based on
the desired downsized shape where the regurgitation of the valve is
reduced, and the distal curvilinear shaped portion has a delivery
shape based on a shape of the dilated valve annulus shape, wherein
the delivery shape has a dimension that is larger than the tissue
engaging conformation of the annuloplasty implant, and mounting the
annuloplasty implant resiliently in the hollow in the delivery
shape before releasing from the hollow.
[0064] Advantageously, the delivery device comprises a sizing
actuator, for reducing the distal curvilinear shaped portion from
the delivery shape by the actuator.
[0065] Advantageously, the procedure includes restraining the
anchoring elements in the restrained spring loaded delivery
positiOn with a first restraining unit for, and releasing the
anchoring elements by releasing the first restraining unit for
anchoring the anchoring elements into the annulus.
[0066] Advantageously, the procedure includes restraining the
annuloplasty implant in the hollow of the distal curvilinear shaped
portion with a second restraining unit, and demounting the
annuloplasty implant from the hollow upon releasing the second
restraining unit, wherein the second restraining unit preferably is
only demounted when a correct position of the annuloplasty implant
is confirmed, allowing for removing the annuloplasty implant from
the annulus if correct position of the annuloplasty implant is not
confirmed, and avoiding undesired embolization of the annuloplasty
implant.
[0067] Advantageously, the procedure includes restraining the
annuloplasty implant in the hollow of the distal curvilinear shaped
portion with a third restraining unit for mounting the annuloplasty
implant in the hollow of the distal curvilinear shaped portion,
thus preventing an undesired release of the annuloplasty implant
from the hollow.
[0068] Advantageously, the procedure includes a system having the
first, second and third restraining unit, wherein the third
restraining unit is releasing the annuloplasty implant by
withdrawing the delivery device when the first restraining unit has
released the anchoring elements from the restrained spring loaded
delivery position and anchored the anchoring elements into the
annulus tissue.
[0069] Further embodiments of the invention are defined in the
dependent claims, wherein features for the second and subsequent
aspects of the invention are as for the first aspect mutatis
mutandis.
[0070] Advantageously, a mitral valve repair system is provided
comprising a delivery tool and an annuloplasty curvilinear shaped
structure for transluminal delivery. The delivery device comprises
a hollow for the annuloplasty curvilinear shaped structure. The
annuloplasty curvilinear shaped structure is positioned with the
opening of the hollow of the tool oriented towards the annulus to
be affixed thereto. The annuloplasty curvilinear shaped structure
has anchoring elements that are released into the tissue of the
annulus thus anchoring the curvilinear shaped structure in the
tissue. The anchoring elements are e.g. hooks resiliently kept in a
position away from the tissue, then released, e.g. by removing a
restraining wire, digging into the tissue. The delivery tool is
then removed
[0071] 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 FIGURES
[0072] These and other aspects, features and advantages of which
embodiments of the invention are capable of will be apparent and
elucidated from the following description of embodiments of the
present invention, reference being made to the accompanying
drawings, in which
[0073] FIG. 1 is a schematic illustration of a portion of a heart
10 including a left ventricle 14, a left atrium 12 and a mitral
valve 15;
[0074] FIG. 2 is a schematic illustration of a mitral valve 15
having an anterior valve leaflet 17 and a posterior valve leaflet
16;
[0075] FIG. 3 is a schematic illustration of a portion of a heart
10 including right atrium 11, a catheter 4 and a medical system
1;
[0076] FIG. 4 is a schematic illustration of a delivery device 2
arranged and pushed down on a mitral valve annulus 18, wherein the
valve is dilated as seen at the opening 19 between the leaflets 16,
17;
[0077] FIG. 5 is a schematic illustration of an aggregate of a
delivery device 2 and the annuloplasty curvilinear shaped structure
3;
[0078] FIGS. 6A-6D are a elevated, partly cross sectional vie (6A),
and sectional views, FIGS. 6C and 6D at A (in FIG. 5) and FIG. 6B
at B, of a distal portion of the aggregate of FIG. 5,
respectively;
[0079] FIGS. 7A-7C illustrate the example of delivery of an
annuloplasty curvilinear shaped structure 2 by means of a delivery
device 3 to a mitral valve and downsizing of the valve; and
[0080] FIG. 8 is a flowchart illustrating a medical procedure.
DETAILED DESCRIPTION
[0081] Specific embodiments of the invention now will 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 embodiments set forth herein; rather,
these embodiments 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 embodiments illustrated in the
accompanying drawings is not intended to be limiting of the
invention. In the drawings, like numbers refer to like
elements.
[0082] In an embodiment of the invention according to the Figures,
a catheter 4 based medical system 1 for reducing cardiac valve
regurgitation is shown. The system 1 has a resilient and/or elastic
curvilinear shaped structure annuloplasty implant 3 for reducing
the size of a dilated annulus 18 of the valve for reducing the
regurgitation having resilient anchoring elements 300. The
anchoring elements 300 may be provided as barbs or hooks.
[0083] The system further has a delivery device 2 for the
annuloplasty implant 3 having a distal curvilinear shaped portion
200 that is hollow to Mount the annuloplasty implant 3 and has an
annular opening 201 arranged to be in apposition against an annulus
18 of the cardiac valve. The annuloplasty implant 3 is mounted to
be releasable in the hollow and has the resilient anchoring
elements 300 arranged in a restrained spring loaded delivery
conformation in the hollow, and wherein the resilient anchoring
elements 300 when unrestrained, are arranged in a tissue engaging
conformation protruding out of the opening.
[0084] The number of anchoring elements, depth of anchoring
elements, etc. may be chosen to effectively treat the valve leakage
and reliably anchor the annuloplasty implant to the surrounding
tissue. The length of an anchoring element is not limited by other
anchoring elements. Thus, relatively long anchoring elements may be
provided resulting in a deep tissue anchoring of the implant.
[0085] Anchoring elements 300 may be formed integrally with the
annuloplasty implant 3. The implant 3 and the anchoring elements
300 may be formed as a monolithic structure. Alternatively the
anchoring elements 300 may be affixed to the annuloplasty implant
3, e.g. by welding, gluing etc. Some of the anchoring elements 300
may be part of a collar (not shown) surrounding the annuloplasty
implant 3. The collar may be a fabric collar to improve sealing
and/or ingrowth of the implant when implanted. The collar may also
provide for an effective assembly of the annuloplasty implant 3 and
the anchoring elements 300 by means of the collar. Alternatively,
the anchoring elements may protrude radially through the collar at
their positions along the implant. In the latter case, such
anchoring elements may be positioned outside of the collar element,
originating from the annuloplasty implant 3 arranged therein.
[0086] Thus, in embodiments, medical devices are provided for
reducing cardiac valve regurgitation. The device includes an
elongate resilient curvilinear shaped annuloplasty implant 3 for
reducing the size of a dilated annulus of the valve for reducing
the regurgitation. The annuloplasty implant has resilient anchoring
elements 300 protruding radially outwards from the annuloplasty
implant 3. The anchoring elements are arrangeable in a spring
loaded first radial direction for delivery, and when released from
the delivery position anchor the annuloplasty implant to tissue at
the annulus in a second radial direction, different from the first
radial direction. This is illustrated in FIGS. 5 and 6A-6D.
[0087] Multiple of the anchoring elements may be arranged at
different radial positions around the cross section of the
annuloplasty implant. In the Figures it is illustrated that the
anchoring elements 301, 302 are arranged as pairs opposite each
other. Multiple anchoring elements are shown arranged at the same
longitudinal position on the annuloplasty implant. Alternatively or
in addition, the anchoring elements may be arranged at different
radial positions as single elements at different longitudinal
positions (not shown). This allows for flexibility and a reliable
anchoring of the annuloplasty implant, e.g. in dependence of
anatomical structures that should be avoided to be penetrated by
anchoring elements, such as blood vessels.
[0088] The system is minimally invasive deliverable via a
transluminal catheter 4, as shown in FIG. 3.
[0089] The resilient curvilinear shaped annuloplasty implant 3 has
a tissue engaging conformation based on a desired downsized shape
where the regurgitation of the valve is reduced, and the distal
curvilinear shaped portion 200 has a delivery conformation based on
a shape of the dilated valve annulus shape, wherein the delivery
shape has a dimension that is larger than the tissue engaging
conformation of the annuloplasty implant 3, such that the
annuloplasty implant 3 is resiliently kept in the hollow 201 in the
delivery conformation before demounting from the hollow.
[0090] In some embodiments the delivery device may a sizing
actuator (not shown), and wherein the distal curvilinear shaped
portion 200 is reducible from the delivery conformation by the
actuator. In this manner, the delivery device 3 or tool may be
affixed to the annuloplasty curvilinear shaped structure 2 during
the downsizing step before releasing the curvilinear shaped
structure 3 from the tool, and after affixing the curvilinear
shaped structure 3 to the annulus tissue by means of the attachment
units 300. In this manner, the curvilinear shaped structure 3 is
readily retrievable from the cardiac valve in case the positioning
thereof is not satisfactory, e.g. as detected via ultrasound based
examination of the positioning result.
[0091] As e.g. shown in FIGS. 5, 6A, 6B and 6C, the delivery device
2 has a first restraining unit 321 for restraining the anchoring
elements 300 in the restrained spring loaded delivery conformation.
The first restraining unit 321 may be a wire against which the
anchoring elements 300 are spring loaded, as illustrated. The wire
may alternatively be guided through loops 320 inside the hollow
(FIG. 6A).
[0092] The delivery device 2 has a second restraining unit 221 for
restraining the annuloplasty implant 3 in the hollow of the distal
curvilinear shaped portion 200. The second restraining device is
shown as a tethered line holding the curvilinear shaped structure 3
in the hollow against loop eyes 220. In this manner, additional
security is provided as the implant may be retracted when it is
still restrained to the delivery device by means of the second
restraining unit 221. Thus e.g. embolization of the device is
avoided, which otherwise would make a surgical retrieval procedure
necessary, likely including open chest surgery with all its
disadvantages.
[0093] In the illustrated embodiment the delivery device 2 further
has a third restraining unit 210 for keeping the annuloplasty
implant 3 in the hollow of the distal curvilinear shaped portion
200. The third restraining unit 210 has two arms 210, 212 that hold
the curvilinear shaped structure 3 in the hollow. The second
restraining device may be omitted. When the curvilinear shaped
structure has anchoring elements 300 deployed in the annulus, the
third restraining units are provided with such a holding force,
that a retraction of the delivery device 2 will release the latter
from the curvilinear shaped structure 3.
[0094] In the embodiment having the first, second and third
restraining units, the third restraining unit 210 is arranged to
release the annuloplasty implant 3 by withdrawing the delivery
device 2 when the first restraining unit has released the anchoring
elements 300 from the restrained spring loaded delivery
conformation and anchored the anchoring elements 300 into the
annulus tissue.
[0095] In the illustrated embodiment the cardiac valve is a mitral
valve 15, and the system is facilitating transseptal percutaneous
delivery into the left atrium to the atrial side of the mitral
valve. A delivery portion 202 of the delivery device 2 is distally
connected to the distal curvilinear shaped portion 200 and has a
distal curvature to allow access from a septal opening towards the
mitral valve. The transition may be provided as shown.
Alternatively, several arms may be provided at the transition to
the hollow. The delivery portion 202 may be tubular hollow
[0096] In some embodiments the cardiac valve is the tricuspid
valve, and the system is adapted for percutaneous delivery into the
right atrium to the atrial side of the tricuspid valve, and a
delivery portion 202 of the delivery device 2 is distally connected
to the distal curvilinear shaped portion 200 and has a distal
curvature to allow suitable access towards the tricuspid valve.
[0097] Access of catheter 4 or a similar guide is provided to the
left atrium, and is e.g. achieved by positioning the catheter 4 in
central or peripheral veins, thereby achieving access to the right
atrium. In such a situation, the tricuspid valve (not shown) may be
accessed from above the valve. The tricuspid valve is alternatively
accesses via other vessels, e.g. the jugular vein, for access from
above. Then a standard atrial trans-septal approach may be utilized
to access the left atrium by creation of an iatrogenic atrial
septal defect (ASD). In such a situation, the mitral valve may be
accessed from above the valve, see e.g. FIG. 3 and FIG. 4.
[0098] In some embodiments the hollow of the distal curvilinear
shaped portion 200 is provided with a negative pressure for suction
of the hollow to the annulus. The pressure may e.g. be provided
through the hollow delivery portion 202 when the latter has a lumen
distally connected to the hollow at the junction thereof.
Alternatively, or in addition, separate lumen may be provided for
fluid communication with the hollow. A pressure generator is in
these embodiments arranged proximally, outside the patient. The
pressure in the hollow may be measured. Thus a contact with the
annulus tissue is determinable from the measured pressure or an
energy consumption of a flow generator generating the pressure.
This improves reliability, patient safety, and user acceptance of
the system and procedure considerably.
[0099] In some embodiments, alternatively or additional to the
entire hollow of the curvilinear shaped portion 200 being provided
with a negative pressure for suction of the hollow to the annulus,
discrete suction units (not shown in the figures) are provided at
that portion 200.
[0100] The distal portion may thus comprise a plurality of suction
units for providing and/or determining a desired apposition of the
distal portion at the target tissue prior to releasing the medical
implant to the tissue and retracting the delivery device.
[0101] In some embodiments, the suction units are provideable with
a negative pressure for suction to the tissue, and wherein the
medical implant is not releasable before all suction units are
confirmed in apposition with the tissue.
[0102] In some embodiments, the plurality of suction units are
distributed along a periphery of the distal portion.
[0103] In some embodiments, a firm seat at the tissue is confirmed
by an absence of a reflow of blood from the suction units.
[0104] In some embodiments, the suction units are arranged to
provide for a symmetric delivery of the implant when release to the
tissue.
[0105] In some embodiments, the tissue is a cardiac valve annulus
and the implant is an annuloplasty implant, such that the distal
portion is arrangeable for a synchronous and simultaneous reshaping
procedure of the annulus by the implant.
[0106] In some embodiments the distal curvilinear shaped portion
200 has arranged thereon a sensor (not shown) for indicating
contact with the annulus tissue, such as a piezo transducer. The
senor is preferably integrated into the edge of the distal
curvilinear shaped portion 200, oriented towards the annulus. In
this manner, a clear difference can be identified between blood and
valve tissue. This improves reliability, patient safety, and user
acceptance of the system and procedure considerably. In addition,
the correct seating and positioning of the curvilinear shaped
structure 3 and the delivery device may be checked with other
measurements, e.g. ultrasonic imaging based measurements.
[0107] In some embodiments the distal curvilinear shaped portion
200 has at least one fiducial marker. The fiducial marker may be
arranged at a periphery of the distal curvilinear shaped portion
200; and/or wherein one of the fiducial markers is an annular
fiducial marker arranged along the periphery. A plurality of
fiducial markers may be distributed along the distal curvilinear
shaped portion 200 for identifying the distal curvilinear shaped
portion 200 inside a body of a patient having the cardiac valve.
The fiducial markers may e.g. be air filled gaps in the wall of the
distal curvilinear shaped portion 200. The fiducial markers may be
made integrally with the distal curvilinear shaped portion 200.
[0108] As illustrated in FIG. 8 a medical procedure 8 for reducing
cardiac valve regurgitation is now described. The procedure
comprises the steps described hereinafter.
[0109] The geometry of a dilated cardiac valve of a patient
including the shape and size of a dilated annulus thereof is
measured 80.
[0110] Then a downsized shape and size of the annulus is
determined. The procedure continues with selecting 84 a resilient
annuloplasty implant having in a tissue engaging conformation a
shape and size to be arranged at the downsized annulus based on the
determined downsized shape and size of the annulus. This may be
done in a virtual environment, planning the delivery of a patient
adapted annuloplasty curvilinear shaped structure 3. The patient
adapted annuloplasty curvilinear shaped structure 3 may be produced
from manufacturing data output from the virtual planning.
Alternatively, an annuloplasty curvilinear shaped structure 3 may
be chosen from a library of pre-manufactured curvilinear shaped
structures 3. In more detail, a method of virtually planning an
annuloplasty implantation for a medical procedure may comprise,
performing in a computer environment, an image based, such as
ultrasonic based, measuring of a geometry of a dilated cardiac
valve. This is based on patient image data. Further, the virtual
planning may comprise determining a reduction of a regurgitation of
the valve when downsizing the annulus of the dilated valve. The
determining may be based on a simulation algorithm emulating the
patient tissue performance in the computer environment. Moreover,
the planning includes selecting a patient adapted shape and size of
a resilient annuloplasty implant 3 for a tissue engaging
conformation to be arranged at the downsized annulus based on the
determined downsized shape and size of the annulus. From this
planning, production data may be provided for the annuloplasty
implant 3, components thereof, and/or a delivery system thereof In
a method of producing a medical device the production data obtained
by the virtual planning may be used for producing the element(s).
Production may be done my rapid prototyping techniques, or other
manufacturing methods that the skilled person will be aware of in
the present context.
[0111] The procedure then continues with introducing 86 the
annuloplasty implant in a delivery device 3 in a compressed state
via a catheter to the cardiac valve. The annuloplasty curvilinear
Shaped structure may e.g. be stretched into an elongate
configuration to fit into catheter 4 for delivery.
[0112] When the distal end of the catheter is at the release site
at the valve, the procedure continues with releasing 88 an
aggregate of a distal portion of the delivery device and the
annuloplasty implant in a stretched state in the delivery device
from the catheter such that implant resumes an expanded shape. The
expanded shape is determined by the delivery device shape and size,
and the annuloplasty curvilinear shaped structure 3 is expanded in
relation to its tissue engaging conformation. The expanded shape
corresponds to the shape of the dilated cardiac valve, allowing for
easy positioning of the aggregate.
[0113] Then the procedure includes positioning 90 the aggregate at
the annulus, e.g. by pushing against the annulus as shown in FIGS.
4, 6A-6D, and 7A,B.
[0114] The aggragate may be fixated to the annulus by activating
suction of suction units. P providing and/or verifying a desired
apposition of the distal portion at the annulus prior to releasing
the implant
[0115] The anchoring elements 300 of the annuloplasty implant are
released and are anchoring the anchoring elements into the annulus
(FIGS. 6D, 7B).
[0116] Alternatively, or in addition to the anchoring elements
described herein, the implant may be permanently affixed to the
tissue by sutures, e.g. using a transcatheter deliverable suturing
unit, which does not need to be described in more detail
herein.
[0117] Then the shape or size of the delivery device and/or
annuloplasty implant is reduced for reshaping the annulus to the
downsized shape; determining 96 a reduction of the cardiac valve
regurgitation; and removing 98 the delivery device and catheter if
the reduction is satisfactory, or removing 99 the annuloplasty
implant together with the delivery device when the reduction is
determined as not being satisfactory.
[0118] In some embodiments the procedure includes ultrasonic
measurement for the measuring 80 a geometry of the dilated cardiac
valve, and/or the determining 96 a reduction of the cardiac valve
regurgitation.
[0119] In some embodiments the procedure further includes
subsequently to the positioning 90 the aggregate at the annulus:
determining a position of the delivery device at the annulus, and
repositioning the delivery device and annuloplasty implant.
[0120] In some embodiments the procedure includes applying a
catheter 4 based medical system 1 for reducing the cardiac valve
regurgitation, having the resilient curvilinear shaped annuloplasty
implant 3 for reducing the size of a dilated annulus 18 of the
valve for reducing the regurgitation having resilient anchoring
elements 300, and a delivery device 2 for the annuloplasty implant
3 having a distal curvilinear shaped portion 200 that is hollow in
which to mount the annuloplasty implant 3 and has an annular
opening 201 arranged to be in apposition against an annulus 18 of
the cardiac valve; the procedure comprising arranging the
annuloplasty implant 3 to be releasable in the hollow with the
resilient anchoring elements 300 arranged in a restrained spring
loaded delivery conformation in the hollow, for the introducing 86
and releasing 88;
[0121] The resilient anchoring elements 300 are unrestrained by
withdrawing the restraining unit 321. Thus the anchoring elements
300 are moving into the tissue of the adjacent annulus and the
resilient anchoring elements 300 are arranged in a tissue engaging
conformation protruding out of the opening into the annulus to be
released 92. The annulus curvilinear shaped structure 30 is thus
anchored to the annulus' 18 tissue of the cardiac valve, but still
affixed to the delivery device. The delivery device may then be
removed by releasing the second and/or third restraining unit.
Alternatively, the aggregate may be retracted if so desired.
[0122] The procedure is a minimally invasive procedure.
[0123] The resilient curvilinear shaped annuloplasty implant 3 has
in embodiments a tissue engaging conformation based on the desired
downsized shape where the regurgitation of the valve is reduced,
and the distal curvilinear shaped portion 200 has a delivery
conformation based on a shape of the dilated valve annulus shape,
wherein the delivery conformation has a dimension that is larger
than the tissue engaging conformation of the annuloplasty implant
3, and mounting the annuloplasty implant 3 resiliently in the
hollow 201 in the delivery conformation before releasing from the
hollow.
[0124] In some embodiments the delivery device comprises a sizing
actuator, and reducing the distal curvilinear shaped portion 200
from the delivery conformation by the actuator.
[0125] In some embodiments the procedure includes restraining the
anchoring elements 300 in the restrained spring loaded delivery
position with a first restraining unit 321 for, and releasing the
anchoring elements 300 by releasing the first restraining unit 321
for mounting the anchoring elements into the annulus.
[0126] In some embodiments the procedure includes restraining the
annuloplasty implant 3 in the hollow of the distal curvilinear
shaped portion 200 with a second restraining unit 221, and
releasing the annuloplasty implant 3 from the hollow upon releasing
the second restraining unit, wherein the second restraining unit
preferably is only released when a correct position of the
annuloplasty implant is confirmed, allowing for removing the
annuloplasty implant from the annulus if correct position of the
annuloplasty implant is not confirmed, and avoiding undesired
embolization of the annuloplasty implant.
[0127] In some embodiments the procedure includes restraining the
annuloplasty implant 3 in the hollow of the distal curvilinear
shaped portion 200 with a third restraining unit 210 for keeping
the annuloplasty implant 3 in the hollow of the distal curvilinear
shaped portion 200, thus preventing an undesired release of the
annuloplasty implant 3 from the hollow.
[0128] In some embodiments the procedure includes a system having
the first, second and third restraining unit, wherein the third
restraining unit 210 is releasing the annuloplasty implant 3 by
withdrawing the delivery device 2 when the first restraining unit
has released the anchoring elements 300 from the restrained spring
loaded delivery conformation and anchored the anchoring elements
300 into the annulus tissue.
[0129] In some embodiments the procedure includes making a
transseptal puncture in the heart; wherein the cardiac valve is a
mitral valve, and wherein the introducing 86 is a transseptal
percutaneous delivery into the left atrium to the atrial side of
the mitral valve, and wherein a delivery portion 202 of the
delivery device 2 is distally connected to the distal curvilinear
shaped portion 200 and has a distal curvature to allow access from
a septal opening towards the mitral valve.
[0130] In some embodiments the procedure includes making a
transseptal puncture in the heart; wherein the cardiac valve is
tricuspid valve, and wherein the system is adapted for percutaneous
delivery into the right atrium to the atrial side of the tricuspid
valve, and wherein a delivery portion 202 of the delivery device 2
is distally connected to the distal curvilinear shaped portion 200
and has a distal curvature to allow suitable access into the atrium
towards the tricuspid valve.
[0131] In some embodiments the procedure includes generating a
negative pressure in the hollow of the distal curvilinear shaped
portion 200 for suction of the hollow to the annulus. The procedure
may include measuring the pressure in the hollow and determining a
contact with the annulus tissue from the measured pressure or an
energy consumption of a flow generator generating the pressure.
[0132] In some embodiments the procedure includes indicating
contact with the annulus tissue with a sensor arranged on the
distal curvilinear shaped portion 200, such as based on sound waves
emitted and received from a piezo transducer, such as an ultrasonic
transducer.
[0133] In some embodiments the procedure includes identifying the
distal curvilinear shaped portion 200 inside a body of a patient
having the cardiac valve by means of detecting at least one
fiducial marker of the delivery device, such as a plurality of
fiducial markers distributed along the distal curvilinear shaped
portion 200 for the identifying and/or a fiducial marker that is
arranged at a periphery of the distal curvilinear shaped portion
200, and/or wherein one of the fiducial marker is an annular
fiducial marker arranged along the periphery.
[0134] Some embodiments of the invention provide for an alternative
system and method of reducing cardiac valve regurgitation. Some
embodiments of the invention provide for catheter based minimally
invasive procedure in accordance with clinical procedures for
accessing an atrium. Clinical personal has thus not to be trained
with completely new access procedures to the atrium and will
readily learn to apply the inventive concept described herein.
[0135] By means of an atrial delivery path approach, navigation and
fixation of a distal portion of the delivery device, prior to
release of the implant, a symmetrical implantation of the implant
is provided. A synchronous and simultaneous reshaping procedure is
provided.
[0136] This is a major progress in the minimally invasive
implantation of annuloplasty implants. A reliable implantation is
provided. As reshaping is done synchronous and simultaneous upon
release of the implant from the distal portion of the delivery
device, any tensions or undesired tissue movements are avoided that
would need to be corrected by surgical interventions. As
additionally, a patient specific implant may be provided and the
procedure may be computer simulated in advance of the real medical
procedure, results are improved considerably while the procedure is
simplified.
[0137] The present invention has been described above with
reference to specific embodiments. However, other embodiments than
the above described are equally possible within the scope of the
invention. Different method steps than those described above,
performing the method by hardware or software, may be provided
within the scope of the invention. The different features and steps
of the invention may be combined in other combinations than those
described. The scope of the invention is only limited by the
appended patent claims.
* * * * *