U.S. patent application number 17/221586 was filed with the patent office on 2021-07-22 for device for filtering embolic material in a vascular system.
This patent application is currently assigned to Keystone Heart Ltd.. The applicant listed for this patent is Keystone Heart Ltd.. Invention is credited to Amit ASHKENAZI, Tzeela MIKOVSKI SHEMESH, Valentin PONOMARENKO.
Application Number | 20210220110 17/221586 |
Document ID | / |
Family ID | 1000005495203 |
Filed Date | 2021-07-22 |
United States Patent
Application |
20210220110 |
Kind Code |
A1 |
ASHKENAZI; Amit ; et
al. |
July 22, 2021 |
Device For Filtering Embolic Material In A Vascular System
Abstract
An embolic protection device for transvascular delivery to an
aortic arch of a patient for protection of side branch vessels of
said aortic arch from embolic material. The device comprises a
support frame, wherein at least a distal or a proximal portion of
the support frame is a spring section configured for providing a
radial force between the support frame and a wall of the aortic
arch when in an expanded state.
Inventors: |
ASHKENAZI; Amit; (Caesarea,
IL) ; MIKOVSKI SHEMESH; Tzeela; (Caesarea, IL)
; PONOMARENKO; Valentin; (Caesarea, IL) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Keystone Heart Ltd. |
Caesarea |
|
IL |
|
|
Assignee: |
Keystone Heart Ltd.
Caesarea
IL
|
Family ID: |
1000005495203 |
Appl. No.: |
17/221586 |
Filed: |
April 2, 2021 |
Related U.S. Patent Documents
|
|
|
|
|
|
Application
Number |
Filing Date |
Patent Number |
|
|
15760203 |
Mar 14, 2018 |
11000357 |
|
|
PCT/EP2018/052953 |
Feb 6, 2018 |
|
|
|
17221586 |
|
|
|
|
Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61B 2018/00351
20130101; A61F 2/013 20130101; A61F 2002/016 20130101; A61F 2/01
20130101; A61F 2230/0006 20130101 |
International
Class: |
A61F 2/01 20060101
A61F002/01 |
Foreign Application Data
Date |
Code |
Application Number |
May 12, 2017 |
EP |
17170949.6 |
Claims
1. An embolic protection device for transvascular delivery to an
aortic arch of a patient, for protection of side branch vessels of
said aortic arch from embolic material, said device including: a
support frame, wherein at least a distal or a proximal portion of
said support frame is a spring section configured for providing a
radial force between said support frame and a wall of said aortic
arch when in an expanded state; a filter member attached to said
support frame, and configured for preventing said embolic material
from passage with a blood flow into said side branch vessels of
said aortic arch; wherein a shape of said filter member is a
heat-set three-dimensional shape; and, wherein said filter member
is configured to be substantially flat when said support frame is
non constrained.
2. The device of claim 1, wherein said support frame is a complete
hoop.
3. The device of claim 1, where said support frame is made from at
least four separate sections including a distal and proximal spring
section being heat treated, and at least two central sections.
4. The device of claim 1, wherein said support frame includes at
least two central sections which are straight.
5. The device of claim 4 , wherein said at least distal or proximal
spring section is heat treated while said at least two central
sections are not heat treated.
6. The device of claim 1, wherein said at least distal or proximal
spring section includes at least one spring element configured to
increase said force of said spring sections.
7. The device of claim 1, where said filter member is
dome-shaped.
8. The device of claim 7, wherein said dome-shaped filter member
has a three-dimensional shape.
9. The device of claim 1, wherein said support frame is made from a
wire or is laser cut.
10. The device of claim 1, wherein said support frame is thicker at
least at said distal section or said proximal section, compared to
any other part of said support frame.
11. The device of claim 1, further comprising a transvascular
delivery unit which comprises a wire or tube.
12. The device of claim 11, wherein a connection point is arranged
at a proximal portion of said filter member or said support
frame.
13. The device of claim 11, wherein said wire or tube continues in
a longitudinal direction under said support frame and said filter
member toward a distal end of said device when arranged in the
aortic arch.
14. The device of claim 13, wherein said wire or tube is bent after
said connection to said connection point.
15. The device of claim 11, wherein said wire or tube has a dilator
tip at a distal end which is atraumatic.
16. The device of claim 6, wherein said at least one spring element
is a loop arranged at about a center of each of said at least
distal or proximal spring section.
17. The device of claim 16, wherein each of said at least distal or
proximal spring section is arranged at a proximal or at a distal
end of said support frame.
Description
RELATED APPLICATIONS
[0001] This application is a continuation of and claims priority to
patent application Ser. No. 15/760,203, filed Mar. 14, 2018,
entitled A Device For Filtering Embolic Material In A Vascular
System, which is a U.S. National Phase of and claims benefit of and
priority to International Patent Application No. PCT/EP2018/052953,
International Filing Date Feb. 6, 2018 entitled A Device For
Filtering Embolic Material In A Vascular System, which claims
benefit of European Application No. 17170949.6 filed May 12, 2017,
all of which are hereby incorporated herein by reference in their
entireties.
BACKGROUND OF THE INVENTION
Field of the Invention
[0002] This disclosure pertains in general to intra-aortic devices
and methods to prevent emboli from entering arteries branching from
the aorta, e.g., arteries that lead to the brain.
Background of the disclosure
[0003] Particles such as emboli may form, for example, as a result
of the presence of particulate matter in the bloodstream.
Particulate matter may originate from for example a blood clot
occurring in the heart. The particulate may be a foreign body, but
may also be derived from body tissues. For example,
atherosclerosis, or hardening of the blood vessels from fatty and
calcified deposits, may cause particulate emboli to form. Moreover,
clots can form on the luminal surface of the atheroma, as
platelets, fibrin, red blood cells and activated clotting factors
may adhere to the surface of blood vessels to form a clot.
[0004] Blood clots or thrombi may also form in the veins of
subjects who are immobilized, particularly in the legs of bedridden
or other immobilized patients. These clots may then travel in the
bloodstream, potentially to the arteries of the lungs, leading to a
common, often-deadly disease called pulmonary embolus. Thrombus
formation, and subsequent movement to form an embolus, may occur in
the heart or other parts of the arterial system, causing acute
reduction of blood supply and hence ischemia. The ischemia damage
often leads to tissue necrosis of organs such as the kidneys,
retina, bowel, heart, limbs, brain or other organs, or even
death.
[0005] Since emboli are typically particulate in nature, various
types of filters have been proposed in an attempt to remove or
divert such particles from the bloodstream before they can cause
damage to bodily tissues.
[0006] Various medical procedures may perturb blood vessels or
surrounding tissues. When this occurs, potentially harmful
particulates, such as emboli, may be released into the blood
stream. These particulates can be damaging, e.g., if they restrict
blood flow to the brain. Devices to block or divert particulates
from flowing into particular regions of the vasculature have been
proposed but may not eliminate the risks associated with the
release of potentially harmful particulates into the blood stream
during or after particular medical procedures.
[0007] Improved devices for blocking or diverting vascular
particulates are under development, but each intravascular
procedure presents unique risks.
[0008] As intravascular devices and procedures, such as
transcatheter aortic valve implantation (TAVI), become more
advanced, there is an emerging need for features that provide these
devices with improved ease of use, intravascular stability, and
embolic protection.
[0009] Possible areas of improvements of such devices and
procedures include "windsailing" of devices with pulsatile blood
flow, leakage of fluid and/or particulate matter at peripheral
portions of devices during use thereof, secure positioning in a
patient during use and/or retrievability, etc.
[0010] Hence, an improved intravascular device, system and/or
method would be advantageous and in particular allowing for
increased flexibility, cost-effectiveness, and/or patient safety
would be advantageous.
SUMMARY OF THE INVENTION
[0011] Accordingly, examples of the present disclosure preferably
seek to mitigate, alleviate or eliminate one or more deficiencies,
disadvantages or issues in the art, such as the above-identified,
singly or in any combination by providing a device, system or
method according to the appended patent claims for providing a
collapsible embolic protection device for transvascular delivery to
an aortic arch of a patient, for protection of side branch vessels
of the aortic arch from embolic material.
[0012] In some aspects of the disclosure, an embolic protection
device for transvascular delivery to an aortic arch of a patient
for protection of side branch vessels of the aortic arch from
embolic material is described. The device includes a support frame,
wherein at least a distal or a proximal portion of the support
frame may be a spring section configured for providing a radial
force between the support frame and a wall of the aortic arch when
in an expanded state. The device may further include a filter
member attached to the support frame, and configured for preventing
the embolic material from passage with a blood flow into the side
branch vessels of the aortic arch.
[0013] Further examples of the embolic protection device are
disclosed in accordance with the description and the dependent
claims.
[0014] It should be emphasized that the term "comprises/comprising"
when used in this specification is taken to specify the presence of
stated features, integers, steps or components but does not
preclude the presence or addition of one or more other features,
integers, steps, components or groups thereof.
BRIEF DESCRIPTION OF THE DRAWINGS
[0015] These and other aspects, features and advantages of which
examples of the disclosure are capable of will be apparent and
elucidated from the following description of apparent and
elucidated from the following description of examples of the
present disclosure, reference being made to the accompanying
drawings, in which the schematic illustrations of
[0016] FIGS. 1A and 1B are illustrating an example of an embolic
protection device for transvascular delivery;
[0017] FIGS. 2A and 2B are illustrating an example of an embolic
protection device for transvascular delivery;
[0018] FIG. 3A to 3D are illustrating examples of assembly embolic
protection devices for transvascular delivery;
[0019] FIG. 4 is illustrating an example of an embolic protection
device for transvascular delivery with an extended or enlarged
filter member;
[0020] FIGS. 5 and 6 are illustrating additional examples of spring
segments for improving the spring effect;
[0021] FIGS. 7A and 7B are illustrating examples of connecting the
device to a delivery unit;
[0022] FIGS. 8A to 8D are illustrating an example of an embolic
protection device connected to a delivery system including a wire
or tube;
[0023] FIGS. 9A to 9C are illustrating a further example of
connecting the device to a delivery unit;
[0024] FIGS. 10A to 10C are illustrating a further example of
connecting the device to a delivery unit;
[0025] FIGS. 11A to 11B are illustrating an example of a stopper
member;
[0026] FIG. 12A to 12C are illustrating examples of an embolic
protection devices positioned in an aortic arch; and
[0027] FIGS. 13A to 13E are illustrating an example of a
dome-shaped filter member;
[0028] FIGS. 14A to 14C are illustrating an example of stickers or
patches that may be used at a distal and/or a proximal end of the
embolic protection device; and
[0029] FIGS. 15A to 15C are illustrating a further example of
connecting the device to a delivery unit.
DESCRIPTION OF EXAMPLES
[0030] The following disclosure focuses on examples of the present
disclosure applicable to an embolic protection device, such as a
collapsible embolic protection device, for transvascular delivery
to an aortic arch of a patient for protection of side branch
vessels of the aortic arch from embolic material.
[0031] FIG. 1A is illustrating an embolic protection device 1000.
The embolic protection device is collapsible, such as crimpable, to
be arranged in a transvascular delivery unit. The protection device
1000 includes a support frame 10 and a filter member 11 attached to
the support frame 10. The support frame may be, in some examples, a
complete hoop completely surrounding a periphery of the filter
member 11. In some examples, the filter member 11 may extend
(partly or entirely) outside the periphery defined by support fame
10, and thereby create a collar or rim, as illustrated in FIG. 4.
The collar or rim may improve apposition with the vessel wall rough
texture. In some examples, the collar or rim may be made from a
different material than the filter member 11.
[0032] The protection device 1000 may further include a connection
point either at the support frame 10 or at the filter member 11.
The connection point is used for connecting the embolic protection
device 1000 to a transvascular delivery unit. Preferably the
connection point is arranged off-centre at a proximal portion of
the embolic protection device 1000. In some examples, a connection
point may be arranged on a stem at distance from the filter
membrane 11 and the support frame 10.
[0033] For positioning a protection device 1000 in an aorta, the
device 1000 of the disclosure may be attached to and delivered by a
transvascular delivery unit, for example as illustrated in FIG. 1B.
The transvascular delivery unit may be, for example, a catheter or
sheath, and the protection device 1001 may be attached to the
transvascular delivery unit according to methods known in the art,
or by a connector mechanism 20. In some examples, the transvascular
delivery unit may comprise a connector mechanism 20, such as a
wire, rod or tube, for example, a tether, a delivery wire, or a
push wire etc. The connector mechanism 20 may be connected to the
connection point. In some examples, the connector mechanism 20 may
be permanently connected to the embolic protection device 1001.
Thereby the embolic protection device 1001 may be delivered and
withdrawn using the same connector mechanism 20. Further, the
connector mechanism 20 may be used to hold the embolic protection
device 1001 in place during a medical procedure. In some examples,
the connector mechanism 20 may be detachably connected to the
embolic protection device 1001.
[0034] The distal end and/or the proximal end of the support frame
10 may be made from a spring section 12, 13. Each spring section
12, 13 is a pre-loaded spring that function as an engine and is
configured for quickly expand or open-up a collapsed or crimped
embolic protection device 1000 from a collapsed state to an
expanded state and for providing a radial force between the support
frame 10 and a wall of the aortic arch, when the support frame 10
is in an expanded state. The spring sections 22, 23 are engines
being pre-shaped open springs. The spring sections 22, 23 may have
a radius wider than the embolic protection device. Different radius
of the opening may provide different forces.
[0035] The spring sections may provide improved apposition with
aortic arch walls which may improve fixation of the device 1000 and
the sealing between the device and the wall of the aorta, which may
reduce paraframe leakage. The force from the spring sections may
also avoid distortion of the support frame 10 when a radial force
is applied. The force from the spring sections 12, 13 also tends to
position the embolic protection device 1000 at about mid-vessel
diameter, as illustrated for example in FIGS. 12A to 12C. Hence
provides an embolic protection device with improved
self-positioning and alignment properties.
[0036] The force provided by the spring sections 12, 13 may also
reduce windsailing, in most cases to none.
[0037] The spring sections 12, 13 are preferably heat treated to
form the spring sections and to provide spring properties. The
spring sections are in some examples, formed as open springs and
are wider than the protection device before the device is
assembled.
[0038] By arranging a spring section 13 proximally, there will be
an improved coverage of the landing zone. The landing zone is the
area every guidewire will hit the aortic arch, see reference 80 in
FIG. 12C. An improved coverage and sealing of the landing zone may
help to prevent the passage of devices over (along) the protection
device 1000 (through the aortic arch), for example by leading a
guide wire below the protection device 1000.
[0039] Each spring section 12, 13 has a bend shape, such as a
shallow U-shape, or is curved. In examples where the support frame
10 only has one spring section 12, 13 at either the distal or the
proximal end, the rest of the support frame 10 has a deeper
U-shaped form. This deeper U-shaped form does not have the same
springy properties as the spring section 12, 13. In examples where
the support frame 10 has a spring section 12, 13 at both the distal
and the proximal ends, the support frame may have straight central
sections 18, 19 formed between spring sections 12, 13. When using
straight central sections 18, 19, these are substantially straight
before the device is assembled. After the device is assembled, the
straight central sections 18, 19 may bulge or obtain a curvature
due to forces in the support frame from the spring sections,
compare e.g. FIG. 2B.
[0040] In some examples, the support frame 10 may be made of two
parts, wherein the first part may be a distal spring section 12
which may be pre-shaped to a shallow U-shape. The second part may
be the proximal spring section 13 and the side sections 18, 19,
which may be pre-shaped to a deeper U-shape than the first
part.
[0041] Alternatively, and/or additionally, in some examples, the
support frame 10 may be made of two parts, wherein the first part
may be a distal spring section 12 which may be pre-shaped to a
shallow U-shape. The second part may be the proximal spring section
13 and the side sections 18, 19 which may be a straight wire (apart
from a possible spring element) which get shaped into a deeper
U-shape when attached to the distal spring section 12.
[0042] Alternatively, the support frame 10 may be made of two
parts, wherein the first part may be a proximal spring section 13
which may have a shallow U-shape. The second part may be the distal
spring section 12 and the side sections 18, 19 which may be shaped
to a deeper U-shape than the first part. In some examples, the
straight central sections may function as spring engines in a
longitudinal direction of the embolic protection device.
[0043] Additionally, and/or alternatively, in some examples, the
spring sections 12, 13 are heat treated to form the spring
sections, while the rest of the support frame 10 is not heat
treated. This will give the support frame 10 a flexibility that may
further improve apposition of the embolic protection device 1000
with the aortic arch walls as it complies better with the rough
texture of the vessel wall.
[0044] Further, by heat treating all sections there may be forces
at the transitions between the segments, such as at joints between
segments, applicable to the wall of the aortic arch. Also, if the
wire is made from a single wire being heat treated, there will be
fewer connectors for joining the different sections, which may also
improve the forces from the transitions between the segments to the
wall of the aortic arch.
[0045] An advantage of only heat treating the spring sections 12,
13, and not the other sections, is that the forces from the spring
sections will be comparatively stronger.
[0046] To further improve the force, some segments may be made
thicker than others, for example, at the distal end of the support
frame 10, the distal spring section 12 may be thicker than the rest
of the support frame, and weaker proximally. This may also make it
easier to crimp the support frame 10, e.g. into a catheter lumen
for delivery, or for improved exiting such lumen when deploying the
embolic protection device.
[0047] Alternatively, in some examples, both the distal and the
proximal spring sections are made thicker than the rest of the
support frame. This will improve the spring forces at both the
proximal and the distal end. The thicker spring sections may open
up the support frame while the thinner sections are more compliant
with the vessel wall.
[0048] Alternatively, in some examples, the distal spring section
12 may be made thicker than the proximal spring section 13.
Additionally, in some examples, the middle sections 18, 19, may be
made of the same thickness as the proximal section 13. In some
other examples, are the middle sections 18, 19, made of the same
thickness as the distal section 12.
[0049] Alternatively, in some examples, both the spring sections
and the central sections are made thicker than the joints or
transition segment(s) between the thicker sections that may be made
thinner. This will provide strong forces on all sides while
avoiding the issues of making the whole support frame rigid. Making
the whole support frame rigid may force the spring sections to
close and not efficiently cover tortuous anatomies with the embolic
protection device.
[0050] By utilizing different thicknesses or cross sections of
different sections, a support frame may be obtained having a
configuration with different forces at different segments.
Additionally, and or alternatively, the at least distal or proximal
spring section 12, 13 may include a spring element 14, 15. The
spring element 14, 15 may in some examples be a loop or helix, a
small spring or any other type of spring arranged at about the
centre of each of the distal or proximal spring section 12, 13. The
spring element, 14, 15 is used for increasing the force applied by
the support frame 10 on the walls of the aortic arch.
[0051] As previously described, the spring sections 12, 13 are used
for applying a force by the support frame 10 on the wall of aortic
arch which may improve the sealing effect between the collapsible
embolic protection device and the wall of the aortic arch, as well
as provide an improved self-stabilizing effect. Additionally, the
use of spring sections 12, 13 may improve the positioning and
self-alignment of the device in the aortic arch.
[0052] Additionally and/or alternatively, in some examples, the
connector mechanism 20 may be attached to the support frame 10
allowing the protection device to pivot axially but not radially at
the joint between the support frame and the connector mechanism 20,
for example by attaching the connector element via the proximal
loop 15.
[0053] The spring element, especially the proximal spring element
14, may in some examples function as a crimp element to improve the
collapsibility of the embolic protection device by elongating the
device longitudinally. Thereby allows to embolic protection device
1000 to be crimped into a sheath with small diameter.
[0054] Spring elements 14, 15 may in some examples, for example
when the spring elements 14, 15 are loops, be formed to either
protruding outwards (relative the periphery/footprint defined by
the support frame) or formed to be protruding inwards (relative the
periphery/footprint defined by the support frame) as illustrated in
FIG. 1A. Arranging or forming one or more of the spring elements
14, 15 to protrude inwards improves attachment of the filter member
11 to the support frame 10. Also, having one or more of the spring
elements 14, 15 arranged to protrude inwards improves the contact
between the support frame 10 and the walls of the aortic arch as
there is nothing protruding or extending further than the support
frame 10 (smooth apposition to the aortic wall vessel tissue,
further improvable by a collar mentioned herein).
[0055] The support frame 10 may be made from a wire, such as a
spring wire, or being laser cut from a tube, ribbon, sheet, or flat
wire, etc. The support frame 10 may be of a single wire. In some
examples, the support frame 10 is made from a twisted single wire.
Alternatively, in some examples the support frame 10 may be made of
at least two wires being twisted, braided or knitted.
[0056] The support frame 10 may be in some examples made from joint
free ring. In other examples the support frame 10 made be formed
from a ring having at least one joint 17. A joint 17 may be for
example a fixation like a soldering, welding, or a clamp.
[0057] The support frame 10 may be shaped into an elongated shape,
substantially elliptical, oblong, oval, or cone slot shaped.
Alternatively, other shapes may be used, such as circular or
rectangular. Because the aortic anatomy can vary between
individuals, examples of the intra-aortic device of the disclosure
may be shaped to adapt to a variety of aortic anatomies.
[0058] An example of an elongated or oblong shaped support frame 10
may be a slot shaped support frame 10 as illustrated in FIG. 1A. A
collapsible embolic protection device 1002 having a cone slot
shaped support frame 10 is illustrated in FIG. 2A. A collapsible
embolic protection device 1003 having an elliptic shaped support
frame 10 is illustrated in FIG. 2B.
[0059] The size of the collapsible device may be pre-sized and
pre-formed to accommodate various patient groups (e.g., children
and adults) or a particular aortic anatomy. The support frame 10
may be, in some examples, substantially planar. In some examples,
the support frame 10 may have a width greater than the diameter of
the aortic arch into which it is configure to be positioned in use,
such as about 50% greater than the diameter of the aortic arch,
such as 50% greater than the cross-sectional chord of an aorta of a
subject, in which the collapsible embolic protection device 1000
may be placed. Additionally, in some examples, a support frame 10
may be longer than the aortic arch opening, such as about 20%
longer than the arch opening, such as 20% longer than an
approximate distance between an upper wall of an ascending aorta of
a subject, distal to an opening of an innominate artery, and an
upper wall of a descending aorta of a subject, proximal to an
opening of a left subclavian artery.
[0060] By making the support frame 10 wider than the diameter of
the arch, such as about 50% wider, and longer than the aortic arch
opening, such as about 20% longer, as defined above, the
self-positioning of the device positioning about mid vessel
diameter may be improved and thus improve the apposition with
aortic arch walls. This will make it easier to deploy the embolic
protection device and improve the sealing against the walls. It may
also improve the coverage of all three side vessels, innominate
(brachiocephalic) artery, left common carotid artery, or left
subclavian artery) which are supplying blood to the brain.
[0061] The support frame 10 may be fabricated in whole or in part
from, e.g., nitinol or metal, superelastic or shape memory alloy
material, readily malleable material, or polymer, e.g., nylon. The
metal may include, e.g., tantalum or platinum.
[0062] The filter member 11 prevents particles (e.g., emboli)
typically having a dimension between about 50 .mu.m and about 5 mm
(e.g., 50 .mu.m, 100 .mu.m, 200 .mu.m, 300 .mu.m, 400 .mu.m, 500
.mu.m, 750 .mu.m, 1 mm, 2 mm, 3 mm, 4 mm, or 5 mm) in an aorta from
passing into blood vessels (e.g., innominate (brachiocephalic)
artery, left common carotid artery, or left subclavian artery)
supplying blood to the brain. Accordingly, one or more lateral
dimensions of the pores of the filter can be between about 50 .mu.m
and about 5 mm (e.g., 50 .mu.m, 100 .mu.m, 200 .mu.m, 300 .mu.m,
400 .mu.m, 500 .mu.m, 750 .mu.m, 1 mm, 2 mm, 3 mm, 4 mm, or 5 mm).
The filter may be, e.g., a mesh made from a plurality of fibers
made of polymer, nylon, nitinol, or metal, or a combination
thereof. The mesh may be made from woven fibers. Fibers may be from
about 20 to 50 .mu.m in thickness. Alternatively, the filter may be
a perforated film. When a perforated film is present, the pores
formed in the perforated film may include pores of varied or
unvaried shape (e.g., rectilinear or rhomboid pores), have a varied
or constant density across the film, and/or have a constant or
varied size. The size of the pores of the filter allows passage of
blood cells (e.g., red blood cells (erythrocytes), white blood
cells (leukocytes), and/or platelets (thrombocytes)) and plasma,
while being impermeable to particles (e.g., emboli) larger than the
pore dimensions. Emboli filtered by the mesh of the filter of the
present disclosure are typically particles larger in one or more
dimensions than an aperture of the mesh of the filter.
[0063] In some embodiments, a filter member or mesh may be
configured from woven fibers and is affixed to a support frame so
that its yarn orientation is at angles that are not right angles to
the support frame. For example, in some embodiments, the mesh may
be affixed to the support frame so that the weave (warp and weft)
of the mesh or weave may be at for example 45.degree. angles from a
base or lateral portion of the support frame. In some examples, the
weave (warp and weft) of mesh may be at for example 30-60.degree.,
such as 35-55.degree., angles from a base or lateral portion of the
support frame. When set at a non-right angle to the support frame,
the mesh may stretch, expand or contract with greater flexibility
than when such weave is at right angles to the support frame.
Collapsibility or crimpability of the embolic protection device is
advantageously improved in this manner.
[0064] Various catheters or sheath may be used as part of the
present disclosure. Any catheter or sheath known in the art to be
configured for guiding medical instruments through vasculature may
be used (e.g., stent installation catheter, ablation catheter, or
those used for transcatheter aortic valve implantation (TAVI) or
percutaneous aortic valve replacement (PAVR) procedures, e.g., as
described in U.S. Pat. No. 5,026,366). Additionally or
alternatively, the device may include a pigtail catheter, which may
be of size 6F or smaller (e.g., 1F, 2F, 3F, 4F, 5F, or 6F) and
include a radiopaque material to facilitate tracking the progress
of various elements of the device. Other catheters that can be used
as part of the disclosure include any catheter used in procedures
associated with a risk of embolism, which would benefit by
including an intravascular filter as part of the procedure.
[0065] The filter member 11 may be substantially flat or dome
shaped. The dome shape of the filter member 11 may be in some
examples about the size of the support frame 10. Alternatively, in
some examples, the filter member 11 may be dome shaped at either
the distal or proximal end. A dome shaped filter membrane 11 may
improve the space underneath the embolic protection device 1000. It
may also improve the filtering due to a larger filter area.
[0066] A device of the disclosure may incorporate radiopaque
elements. Such radiopaque elements can be affixed to, or
incorporated into the device. For example, portions of the frame,
filter, or catheter may be constructed of OFT wire. Such wire can
contain, e.g., a core of tantalum and/or platinum and an outer
material of, e.g., nitinol.
[0067] FIG. 1B is illustrating a system 1001 of a collapsible
embolic protection device 100 in accordance to the description,
such as illustrated in FIG. 1A. The embolic protection device 100
is connected to a transvascular delivery unit. The transvascular
delivery unit is here illustrated with a connection mechanism 20
being a wire or tether. The connection mechanism 20 may be made
from a biocompatible metal and is attached to the support frame of
the embolic protection device 100. The frame connection mechanism
20 is here illustrated as connected directly to the spring element
of the support frame. The attachment may be made by a loop, latch
or with a clamp. The attachment should be strong and flexible
enough to push the device out of the sheath. FIG. 1B further
illustrates a tube or sheath 21 used for delivering the embolic
protection device 100 used for delivering the embolic protection
device 100 to the working zone.
[0068] FIG. 3A is illustrating one way of manufacturing the support
frame of the protection device. FIG. 3A illustrates here a wire
1100, such as a spring wire, that has been heat treated to form the
different sections of the support frame. 110 and 111 are spring
sections that will form the distal and proximal spring section when
the two ends of the wire are joined. The spring sections are
pre-loaded and shaped to be straight; hence they are open springs
with an opening larger than the width of the final device. When the
two ends of the wire are joined, the straight sections 100 and 102
will provide one straight central section, while the straight
section 101 will provide the second straight central section. In
some examples, the straight sections are heat treated to be
straight. Alternatively, in some examples, the straight sections
are not heat treated.
[0069] FIG. 3B is illustrating an alternative way of manufacturing
the support frame of the protection device from a wire 1101, such
as a spring wire. In this example the wire 1101 has been heat
treated to form the different sections of the support frame. 130
and 131 are spring sections that will form the distal and proximal
spring section when the two ends of the wire are joined. The spring
sections are pre-loaded and shaped to be curved. The openings of
the spring sections are here larger than the width of the final
device. When the two ends of the wire are joined, the straight
sections 120 and 122 will provide one straight central section,
while the straight section 121 will provide the second straight
central section. In some examples, the straight sections are heat
treated to be straight. Alternatively, in some examples, the
straight sections are not heat treated.
[0070] FIG. 3C is illustrating an alternative way of manufacturing
the support frame of the protection device from a wire 1102. The
wire 1102 is a grinded wire having more than one tapered section.
In illustration there are three thicker sections and two thinner
sections 151, 152. The thinner sections may be forms into two
straight central sections while the three thicker sections 140,
141, 142 will form two spring sections when the two ends of the
wire 1102 are joined.
[0071] Additionally, and/or alternatively, in some examples, the
thicker sections 140, 141, 142 that will form the two spring
sections may have spring elements. In some examples the thicker
sections 140, 141, 142 that will form the two spring sections may
be curved as in FIG. 3B.
[0072] Additionally, and/or alternatively, in some examples, the
wire 1102 may include thicker tapered sections, similar as the
sections used for the spring sections, to be used for the straight
central sections. Between the thicker tapered sections there will
be thinner sections forming joints or transitions between the
different spring sections and the straight central sections.
[0073] A wire 1102 with tapered thicker sections with thinner
sections between may allow one wire 1102 to be configured to result
in a support frame with different forces at different segments.
[0074] Further, instead of having one single grinded wire 1102 as
in FIG. 3C each section may be formed from a single grinded wire
with only one tapered thicker section and thinner segments at the
sides. These sections may then be joined as illustrated in FIG.
3D.
[0075] FIG. 3D is illustrating an embolic protection device 1004
wherein the support frame is made from 4 separate segments,
functioning as engines. The segments include, a distal spring
section 22, a proximal spring section 23, and two central straight
sections 24a, 24b. A filter member 11 is attached to the support
frame.
[0076] Each of the distal and proximal spring sections 22, 23 may
have a spring element 14, 15. The spring sections 22, 23 are
engines being pre-shaped open springs, which in some examples has a
shallow U-shape. In some other examples the spring sections are
straight before the support frame is assembled. The spring sections
22, 23 may have a radius wider than the embolic protection device.
Different radius of the opening may provide different forces.
[0077] In between the spring sections 22, 23 are straight central
segments 24a, 24b arranged. In some examples, the straight central
segments 24a, 24b are not heat treated while the spring sections
22, 23 are.
[0078] In some examples, the proximal 23 and distal 22 spring
section may differ, for example by providing different amount of
forces. The distal spring section 22 may provide improved
apposition with aortic arch walls which may improve fixation of the
device 1004 and the sealing between the device and the aortic wall,
which may reduce paraframe leakage. The proximal spring section 23
covers the landing zone of the embolic protection device. The
landing zone is the area every guidewire will hit the aortic arch
inner vessel wall when femorally introduced into the aortic arch.
Hence a better apposition between the embolic protection device and
the walls of the aortic arch is obtained as an advantage.
[0079] Due to the positioning of the proximal end, a strong force
is not as important as at the distal end of the device. The
different forces may be provided by making the distal spring
section 22 thicker than the proximal spring section 23. The spring
element 14 at the distal section 22 may also be configured to
provide a stronger force than the spring element 15 at the proximal
spring section 23.
[0080] In some examples only one of the spring sections 22, 23
includes a spring element 14, 15. The spring element 14, 15 may
also be used to improve the crimping of the device. Further, having
the proximal spring section 23 being made of a thinner material
than the distal spring section 22, may also improve the crimping of
the device as the force will be weaker at the proximal section
23.
[0081] FIG. 4 is illustrating a collapsible embolic protection
device 1005 having a filter element 11 may extend outside the
support fame 10, and thereby create a collar or rim 25. The collar
or rim 25 may improve apposition with the vessel wall rough
texture. Peripheral sealing may thus be improved, in particular as
pulsatile flow presses the collar or rim against the inner aortic
arch vessel tissue. In some examples, the collar or rim may be made
from a different material than the filter member 11, such as PTFE
or a fabric, e.g. Dacron. The collar may have in addition or
alternatively a non-filtering configuration, such as a sheet of
material without filter, e.g. a film.
[0082] FIGS. 5 and 6 are illustrating two examples of spring
elements 14 at the distal spring section of the device 1006. The
same type of spring element may be used at the proximal spring
section.
[0083] In some examples, different spring elements are used at the
distal and the proximal end.
[0084] Those skilled in the art will readily appreciate that other
spring elements than those illustrated here may be used to achieve
the same effect of improving the force of the spring section
against the wall of the aortic arch.
[0085] FIG. 5 is illustrating a spring element 14 being a loop 27
formed from the material 26 used to shape the distal spring
section, here it is illustrated as a wire, such as a spring
wire.
[0086] FIG. 6 is illustrating a spring element 14 being a spring 28
attached to a gap in the distal spring section by clamps 29a, 29b.
Cross section of the frame may in this manner be held at that of
the frame by having an intermediate spring, such as crimped in FIG.
6.
[0087] FIGS. 7A and 7B are illustrating two examples of connecting
the device 1007 to a connector mechanism 20, such as a wire, rod or
tube, for example, a tether, a delivery wire, or a push wire
etc.
[0088] FIG. 7A is illustrating the connection point 30 is arranged
at the proximal spring section of the support frame. The connector
mechanism 20 is here a twisted wire 31 twisted around the support
frame. In some examples, the connector mechanism 20 is locked at a
pre-set angle. In some other examples, the connector mechanism 20
is made so that the protection device may pivot in an axial
direction at the connection point. In some examples, the device is
prevented to pivot in a radial direction. In some examples, the
connection is made to fixate the protection device in a predefined
angle.
[0089] FIG. 7B is illustrating the connection point 30 is arranged
at the proximal spring section of the support frame. The connector
mechanism 20 is here a single wire 32 connected to a loop at the
proximal spring section. In some other examples, the connector
mechanism 20 is made so that the protection device may pivot in an
axial direction at the connection point. In some examples, the
device is prevented to pivot in a radial direction. In some
examples, the connection is made to fixate the protection device in
a predefined angle.
[0090] FIGS. 8A to 8D are illustrating an example of embolic
protection device 1008 being arranged over a wire, ribbon, or tube,
such as a leading tube or shaft tube, 35. The wire, ribbon, or
tube, such as a leading tube or shaft tube, 35 is used for
delivering the embolic protection device 1008. The wire, ribbon, or
tube, may be made from either plastic commonly used for catheters
or metal, such as a shape memory alloy, such as Nitinol.
[0091] In FIG. 8A a twisted wire 36 is used as a connector
mechanism. The twisted wire 36 is shaped into a loop 33 at the
distal end being connected to the spring element 15, which here
also function as a connector point. The twisted wire 36, is
attached to the wire, ribbon or tube 35 using at least tone ring
34a, 34b.
[0092] The wire 36 may be made from a shape memory alloy, such as
Nitinol. The wire 36 may be a wire twisted and heat treated on a
jig and thereby formed into flexible connector mechanism. The wire
36 may place the embolic protection device 1008 perpendicular to
the wire tube bend 37, as seen in FIG. 8B to 8D. In some examples,
the device may pivot at the connection point in an axial direction,
for example during deployment in the aortic arch. In some examples,
the device is prevented to pivot in a radial direction. The over
the wire arrangement helps to support the filter member by pushing
or forcing the filter member or support frame upwards by a
dedicated bent tube or wire 37. The arrangement also helps to keep
the embolic protection device 1008 in place by the same upward push
or force by the bent tube or wire 37. The arrangement may also
improve the positioning of the embolic protection device 1008 in
the aortic arch.
[0093] FIGS. 9A to 9C are illustrating a further example of embolic
protection device 1009 being connected to be arranged over a wire
or tube 35 used for delivering the embolic protection device
1009.
[0094] In the illustrated example, the connection mechanism 41 is
made from a laser cut tube. The distal end of the connection
mechanism 41 is cut as a loop or hole 38 used for attaching the
connection mechanism 41 to the embolic protection device 1009. The
connection mechanism 41 may be attached either to the frame or to a
spring section 15 shaped as a loop. The distal end of the
connection mechanism 41 may be shaped to have two branches as seen
in FIG. 9B, each branch having a loop or hole.
[0095] The proximal end of the connection mechanism 41 is formed as
a connector 39 and used to connect the connection mechanism 41 to
the wire or tube 35. To fixate the connection mechanism 41 to the
wire or tube 35 a stopper 40 is used. An example of a stopper 40 is
illustrated in FIGS. 11A and 11B.
[0096] In some examples, the stopper 40 is welded to wire or tube
35 to better fixate the connection mechanism 41 at the needed
position.
[0097] In some examples, the device may pivot at the connection
point in an axial direction, for example during deployment in the
aortic arch. In some examples, the device is prevented to pivot in
a radial direction.
[0098] FIGS. 10A to 10C are illustrating a further example of
embolic protection device 1010 connected to be arranged over a wire
or tube 35 used for delivering the embolic protection device
1010.
[0099] In the illustrated example, the connection mechanism 42 is
made from a laser cut tube. The distal end of the connection
mechanism 42 has a ring 43 welded to it. The ring 43 is used for
attaching the connection mechanism 42 to the embolic protection
device 1010. The connection mechanism 42 may be attached either to
the frame or to a spring section 15 shaped as a loop.
[0100] The proximal end of the connection mechanism 42 is formed as
a connector 44 and used to connect the connection mechanism 42 to
the wire or tube 35. To fixate the connection mechanism 42 to the
wire or tube 35 a stopper 40 is used. An example of a stopper 40 is
illustrated in FIGS. 11A and 11B.
[0101] In some examples, the stopper 40 is welded to wire or tube
35 to better fixate the connection mechanism 42 at the needed
position. In some examples, the device may pivot at the connection
point in an axial direction, for example during deployment in the
aortic arch. In some examples, the device is prevented to pivot in
a radial direction.
[0102] FIG. 12A is illustrating a protection device 1012 arranged
in the aortic arch. The device is delivered and held by the
catheter or sheath 60 during the procedure. In the illustrated
example the protection device 1012 covers all three side branches
of the aortic arch.
[0103] FIGS. 12B and 12B are illustrating a protection device 1013
arranged in the aortic arch. The device is connected to a wire or,
ribbon or tube 72 by a connection mechanism 71. The device is
delivered by the catheter or sheath 70.
[0104] The wire or, ribbon or tube 72 has a dilator tip 73. The
dilator tip 73 may be an atraumatic tip.
[0105] FIGS. 12B and 12B are illustrating are illustrating that the
bend of the wire or, ribbon or tube 72 helps to support the filter
member by pushing or forcing the filter member or support frame
upwards. The arrangement also helps to keep the embolic protection
device 1013 in place using the same upward push or force by the
bent tube or wire 72. FIG. 12C is illustrating the landing zone
80.
[0106] In some examples, the wire, ribbon or tube 72 may be
pre-bend. The pre-bend may be calculated based on the curvature of
the anatomy of the aortic arch. An advantage of this is that it may
prevent the embolic protection device from flipping during
insertion or during a procedure when the embolic protection device
is arranged in the aortic arch.
[0107] FIGS. 13A to 13E are illustrating a method for making a dome
shaped filter element 1011. The dome-shaped filter member 1011 may
be made from a woven mesh 50 made from, for example a polymer, such
as Polyetereterketon (PEEK). The dome-shaped filter member 1011 may
be formed by cutting openings or wedges 51a to 51d into the mesh
material 50, see e.g. four wedges in FIG. 13A.
[0108] The dome-shape is then shaped by attaching the edges of each
openings or wedges 51a to 51d. By gluing, heat welding, ultrasonic
welding etc., 4 seams 52a to 52d will be obtained, as illustrated
in FIG. 13B.
[0109] The heat forming allows the dome-shaped filter member 1011
to obtain a three-dimensional shape from a flat 2d mesh layer. The
three-dimensional dome-shape is illustrated in FIGS. 13C to 13E. In
some examples, the three-dimensional dome-shape is seamless. In
some examples the three-dimensional dome-shape is thus formed
without creases as illustrated in FIGS. 13C to 13E.
[0110] In some examples, the three-dimensional structure, such as
the dome-shape, may appear almost flat when attached to the frame
and the frame is not constrained. When the frame is constrained,
such as by the walls of the aortic arch, mesh will go back to the
formed three-dimensional structure.
[0111] FIGS. 14A to 14C are illustrating an example of stickers or
patches 1014, 1015 that may be arranged at a distal and/or a
proximal end of the embolic protection device 1016. The sticker or
patch 1014, 1015 may preferably be made from an elastic material,
such as polyurethane. The sticker or patch 1014, 1015 may be either
solid or porous, such as made as a mesh. The sticker or patch 1014,
1015 may be shaped like a square or rhombus, such as having a
diamond-like shape.
[0112] In FIGS. 14A and 14B the distal patch 1015 and the proximal
patch 1014, are dimensioned as rhombuses but with a cut out in the
middle, creating a waist section 102. The waist section 102, 104
makes it easier to attach the sticker or patch 1014, 1015 to the
embolic protection device 1016, since there will be less material
folded over or stretched around the frame 103 and thereby attached
thereto. Because of the curvature of the frame, the patch or
sticker 1014, 1015 may not be smoothly folded or stretched over and
attached to the frame 103, which may cause wrinkles in the sticker
or patch 1014, 1015 at the frame 103. This may be prevented by
having a waist section 102, 104 as illustrated in FIGS. 14A and
14B.
[0113] Alternatively, in some examples, the stickers or patches
1014, 1015 may be triangular. When triangular, the sticker or patch
1014, 1015 is not folded around the frame 103, instead they are
only attached to one side of the filter of the embolic protection
device 1016.
[0114] The proximal patch 1014, illustrated in FIG. 14A, has a
cut-out in the middle 104, which allows a connection mechanism 101
to be used to connect the embolic protection device 1016 to a wire,
ribbon or tube, as previously described herein.
[0115] The stickers or patch 1014, 1015 is adhered to the filter
mesh of the embolic protection device 1016. The sticker or patch
1014, 1015 may adhered to the embolic protection device using glue
or an adhesive layer. The sticker or patch 1014, 1015 may also be
attached using heat. In some examples both glue or an adhesive
layer, is used with heat to attach the sticker or patch 1014, 1015
to the embolic protection device 1016.
[0116] The sticker or patch 1014, 1015, may provide more strength
to the embolic protection device 1016 when crimped. The sticker or
patch covers part of the structure from blood where otherwise
thrombus may be formed.
[0117] The sticker or patch 1014, 1015, may also be used to attach
the mesh of the embolic protection device 1016 to the frame 103 at
the distal and/or proximal end. This may have an advantage when the
distal and/or proximal spring section has a spring element, such as
a loop or helix. By avoid gluing the mesh to the spring element and
instead using the sticker or patch 1014, 1015 to attach the distal
end proximal end of the mesh to the frame 103 at these point, the
spring elements may be more effective, because they are not
restricted by the mesh or by glue. This may be archived by not
having any adhesive means, such as glue at the waist section 102,
104 which is stretched over the frame and the spring element.
[0118] FIGS. 15A to 15C are illustrating a further example of
connecting the device to a delivery unit. The example illustrated
in FIG. 15A to 15C is similar to the examples described in relation
to FIGS. 8 to 11. The connector mechanism 111 illustrated in FIG.
15A has a distal end section 112 and a proximal end section 110.
The distal end section is designed to be connected to the frame of
an embolic protection device and the proximal end section is
designed to be connected to a wire, tube or ribbon which goes under
the embolic protection device, see for example FIGS. 8B and 21B and
12C. The proximal end section 110 of the connector mechanism 111
forms a hollow cylindrical body which may be slide over the wire,
tube or ribbon 114 (in the illustrations only a small portion of
the wire, tube or ribbon is shown) until it is securely locked.
[0119] The locking may be made by a first locking member 113 of the
proximal end section of the connector mechanism 111 engaging with a
second locking member 115 of the wire, tube or ribbon. The first
locking member 113 may be a letch which is angled into the hollow
cylindrical body and engages with a hole or window 115 of the wire.
The hole or window may have the same width as the letch, preventing
rotation of the connector mechanism 111 around the wire, tube or
ribbon after the letch has engaged with the hole or window.
[0120] Alternatively, the second locking element 115 of the wire,
tube or ribbon may be a letch which is angled outwards so it may
engage with a first locking element 113 of the proximal end section
110 of the connector mechanism 111, being a hole or window. Again,
the hole or window may have the same width as the letch to avoid
rotation of the embolic protection device.
[0121] The distal end section 112 of the connecting mechanism is
formed by a portion of the connector mechanism 111 being folded
back over itself providing a gap 118 therebetween in which a frame
of an embolic protection device, such as a wire, may be slide. The
distal end of the distal end section 112 may have a wider gap 117.
The wider gap 117 may be configured to have a similar diameter as
the diameter of the frame of the embolic protection device.
[0122] This arrangement is allowing the frame to be arranged firmly
at the distal end section 112 while still provide pivotability
axially but not radially at the joint between the frame and the
connector mechanism 111 when applying a force on the embolic
protection device.
[0123] To lock the frame in the gap 118, 117 and prevent it from
slipping out, a locking ring 116 is slipped over the fold backed
portion of the distal end section 112. The locking ring 116 is the
locked by having a section 119 of the fold backed portion being
wider than the hole through the locking ring. The wider section of
the fold backed portion will be crimped when the locking ring 116
is slipped over, and will thereafter expand preventing the locking
ring 116 form slipping off. To enhance the flexibility of the wider
section of the fold backed portion, and thereby allow it to crimp
and expand easier, a slit 119 may be arranged at the middle of at
least the wider section.
[0124] The connection mechanism 111 illustrated in FIG. 15A, is
designed to providing stability and flexibility and to allow a
certain degree of freedom without rotation, which allows the wire,
tube or ribbon to stay in the right position while the embolic
protection device is arranged in the intended position.
[0125] While several examples of the present disclosure have been
described and illustrated herein, those of ordinary skill in the
art will readily envision a variety of other means and/or
structures for performing the functions and/or obtaining the
results and/or one or more of the advantages described herein, and
each of such variations and/or modifications is deemed to be within
the scope of the present disclosure. More generally, those skilled
in the art will readily appreciate that all parameters, dimensions,
materials, and configurations described herein are meant to be
exemplary and that the actual parameters, dimensions, materials,
and/or configurations will depend upon the specific application or
applications for which the teachings of the present disclosure
is/are used. Also, different method steps than those described
above, performing the method by hardware, may be provided within
the scope of the disclosure. The different features and steps of
the disclosure may be combined in other combinations than those
described. The scope of the disclosure is only limited by the
appended patent claims.
* * * * *