U.S. patent application number 14/477353 was filed with the patent office on 2014-12-18 for emboli guarding device.
The applicant listed for this patent is Medtronic, Inc.. Invention is credited to Mark C.S. Shu, Charles Paul Tabor.
Application Number | 20140371783 14/477353 |
Document ID | / |
Family ID | 42038430 |
Filed Date | 2014-12-18 |
United States Patent
Application |
20140371783 |
Kind Code |
A1 |
Shu; Mark C.S. ; et
al. |
December 18, 2014 |
EMBOLI GUARDING DEVICE
Abstract
A device including a stent structure or frame to which a sheet
is attached for use in minimizing or preventing emboli, particles,
and/or air bubbles from migrating into certain areas of the
anatomy. The device can be placed in the blood stream in an area of
the heart, such as the aortic arch, to direct particles toward the
descending aorta rather than toward the brain. The sheet of the
device can be a thin film material, which may include multiple
fenestrations that are smaller in size than the particles that are
to be filtered.
Inventors: |
Shu; Mark C.S.; (Rancho
Santa Margarita, CA) ; Tabor; Charles Paul; (Medicine
Lake, MN) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Medtronic, Inc. |
Minneapolis |
MN |
US |
|
|
Family ID: |
42038430 |
Appl. No.: |
14/477353 |
Filed: |
September 4, 2014 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
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12567243 |
Sep 25, 2009 |
8852225 |
|
|
14477353 |
|
|
|
|
61099935 |
Sep 25, 2008 |
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Current U.S.
Class: |
606/200 |
Current CPC
Class: |
A61F 2/01 20130101; A61F
2/013 20130101; A61F 2/856 20130101; A61F 2002/016 20130101; A61F
2002/018 20130101; A61F 2230/0006 20130101; A61F 2230/0069
20130101; A61F 2/86 20130101; A61F 2230/008 20130101; A61F 2/011
20200501 |
Class at
Publication: |
606/200 |
International
Class: |
A61F 2/01 20060101
A61F002/01 |
Claims
1-17. (canceled)
18. A delivery system comprising a proximal end, a distal end, a
self-expanding mesh portion adjacent to the distal end, and a
moveable stability layer having an internal area within which the
mesh portion is containable, wherein the stability layer is
proximally moveable to release the mesh portion from the internal
area of the stability layer, and wherein the mesh portion in its
released condition comprises an outer diameter that is larger than
an outer diameter of the stability layer.
19. The delivery system of claim 18, wherein the mesh portion
comprises a filtration material.
20. The delivery system of claim 19, wherein the filtration
material comprises a thin film with fenestrations through its
thickness.
Description
CROSS-REFERENCE TO RELATED APPLICATION
[0001] This application claims the benefit under 35 U.S.C.
.sctn.119(e) of U.S. Provisional Patent Application No. 61/099,935,
filed Sep. 25, 2008, which is incorporated herein by reference in
its entirety.
TECHNICAL FIELD
[0002] The present invention relates to devices and delivery
systems that can he used in heart structures for the prevention of
strokes. More particularly, the invention relates to devices,
methods, and delivery systems for preventing undesirable movement
of emboli within a heart structure.
BACKGROUND
[0003] Large or small embolic particles or emboli can be formed for
a number of reasons in the left atrium or in other parts o f the
heart, such as can occur when surgically implanting prosthetic
devices into a patient's anatomy. When such particles or emboli are
present in the atrium, they have the potential to migrate toward
the brain at the arch of the aorta, and can thereby impose
potential risk of stroke. Thus, there is a need to provide devices
and delivery systems that can filter or guard against undesired
emboli migration within the heart or other bodily structures of a
patient.
SUMMARY
[0004] This invention provides devices, methods, and delivery
systems that can be used to prevent or minimize the possibilities
of a person having a stroke due to litigation of emboli, particles,
and/or air bubbles into undesired areas of the anatomy. The device
accomplishes this by directing particle flow in a bloodstream in
such a way that any particles within that bloodstream are directed
along a path where such particles will not be detrimental to the
health of the patient. One embodiment of the invention includes a
device that consists of a stem structure or frame to which a
Nitinol thin film or pericardial sheet is attached in at least one
area. The Nitinol thin film or pericardial sheet can be affixed
diametrically across the stent, diameter at a distal segment of the
stent, in one embodiment, although it is also possible that the
device includes different placement a the film or sheet and/or that
the device includes multiple areas having a film or sheet.
Fenestrations with various desired dimensions can be created on the
thin film to allow blood to flow through it. If necessary, side
channels between the film or pericardial sheet and the all of the
structure in which the device is located can also be created.
[0005] The stent structure or frame of the device can be used to
anchor the device into the arch of an aorta, for example. In this
way, when emboli flow through the aortic arch, the thin film or
pericardial, sheet of the device can block the flow of emboli
toward the carotid arteries or other cerebrovascular structures,
and instead allow their movement with the blood flow to carry
emboli toward the descending aorta. Thus, the use of the device of
the invention can help to prevent brain stroke for a patient.
[0006] The devices of the invention can be percutaneously delivered
using a transcatheter delivery system to a location in a patient,
such as aortic arch. These devices can also be retrieved using a
transcatheter retrieval device if needed. The emboli guarding
devices can be used as a permanent implantable device at the aortic
arch to prevent brain strokes, or as a temporary deice to prevent
brain stroke during any prosthetic device implantation or a
transcatheter valve deployment, for example.
[0007] In another aspect of the invention, a guide catheter is
provided, which includes an embolic filter positioned between its
proximal and distal ends. The filter can be positioned in a desired
location in a patient to provide particle filtration. In another
aspect of the invention, an embolic guard centering delivery system
is provided, which includes an expandable mesh portion that can
provide both embolic protection and a centering function. In yet
another aspect of the invention, a guide catheter with an
expandable mesh portion is provided. The mesh of the guide catheter
can provide both embolic protection and a centering function to a
device through which other devices, such as delivery systems, can
be advanced to a desired anatomical location.
BRIEF DESCRIPTION OF THE DRAWINGS
[0008] The present invention will be further explained with
reference to the appended Figures, wherein like structure is
referred to by like numerals throughout the several views, and
wherein:
[0009] FIG. 1 is a schematic cross-sectional front view of an
emboli guarding device of the invention positioned within a heart
structure;
[0010] FIG. 2 is a front view of an embodiment of an emboli
guarding device, including a film or sheet including small
fenestrations;
[0011] FIG. 3 is a front view of another embodiment of an emboli
guarding device, including another embodiment of a film or sheet
including small fenestrations;
[0012] FIG. 4 is a front view of another embodiment of an emboli
guarding device of the invention positioned within a schematic
heart structure;
[0013] FIG. 5 is a front view of another embodiment of an emboli
guarding device on a delivery system within a heart structure, with
a self-expanding mesh structure in a collapsed condition;
[0014] FIG. 6 is another front view of the emboli guarding device
of FIG. 5, with the self-expanding mesh structure in an expanded
condition within the heart structure;
[0015] FIG. 7 is a front view of another embodiment of an emboli
guarding device on a delivery system within a heart structure, with
a mesh structure in a collapsed condition; and
[0016] FIG. 8 is another front view of the emboli guarding device
of FIG. 7, with the mesh structure in an expanded condition within
the heart structure.
DETAILED DESCRIPTION
[0017] Referring now to the Figures, wherein the components are
labeled with like numerals throughout the several Figures, and
initially to FIG. 1, one embodiment of an emboli guarding device 10
is illustrated in an exemplary, position within the anatomy of a
patient. In particular, the device 10 is shown here as being
positioned within an aortic arch 12, between the ascending aorta 14
and the descending aorta 16. Multiple particles or emboli 20 are
illustrated as being randomly dispersed throughout the stream of
blood. These particles 20 tend to flow in the main flow stream,
which is indicated with arrow 22 in the area of the ascending aorta
14 and with the arrow 24, which is on the opposite side of the
device 10 and in the area of the descending aorta 16. The emboli
guarding device 10 alters the flow direction and guides emboli 20
and/or air bubbles carried by the flow stream toward the descending
aorta 16, rather than toward the head vessels 26 (i.e., the
brachiocephalic trunk, the left common carotid artery, and the left
subclavian artery) and in the direction of arrows 28, Such an
alternative flow of emboli 20 can thereby help to prevent potential
brain strokes and/or minimize the chances of migraines and other
health issues. It is noted that the emboli and/or air bubbles
within the blood stream can be created in, a variety of manners,
such as from atrial fibrillation (AF), from prosthetic heart
valves, from left ventricular assist devices (LVAD's), and/or from
any other sources of emboli.
[0018] Referring also to FIGS. 2 and 3, one embodiment of an emboli
guarding device 10 consists generally of a frame 30 and a sheet of
material 32 that is positioned generally across its upper portion.
The frame 30 may be made of a material that is capable of being
compressed and expanded, which can be advantageous for percutaneous
delivery of the frame 30 to its desired location within the heart.
In one example, the frame 30 is made of a material that is
expandable via the application of an outwardly directed internal
force, such as the force that can be applied with an expandable
balloon positioned within the internal opening or area of the frame
30. In another example, the frame 30 is made from a self-expanding
material, such as a Nitinol mesh material. In this way, the device
10 can be compressed, to a size that allows it to be delivered
percutaneously to the desired location via a delivery system, and
then allowed to expand by removing or retracting a compressive
sheath, for example.
[0019] The materials from which the frames 30 of the invention are
generally made include a series of wires arranged into, a generally
elongated tubular support structure. The structure can include one
or more linear portions and/or one or more curved, bent, or
otherwise shaped portions, in order to provide an optimal fit
within area of the heart. The support structure of the frame 30 may
either be made up of a number of individual struts or wire segments
arranged and secured to each other. Alternatively, the frame 30 may
instead be formed from a single piece of material (e.g., a tube of
material that is machined to provide, a desired structure
configuration). That is, in one exemplary embodiment, the frame 30
may be laser cut from a single piece of material or may be
assembled from a number of different components.
[0020] As described above, the frames 30 of the invention can be
compressible to a relatively small diameter for percutaneous
delivery to the heart of the patient, and then are expandable
either via removal of external compressive forces (e.g.,
self-expanding frames), or through application of an outward radial
force (e.g., balloon expandable frames). In a further alternative,
some portions of the frame 30 may be self-expanding while other
portions of the same frame are expandable through application of an
externally applied force. In yet another alternative, the frames of
the invention can be self-expandable from a contracted state to an
expanded state via the application of beat, energy, and the
like.
[0021] Methods for insertion of the emboli guarding devices of the
invention can include delivery systems that can maintain the frames
in their compressed state during their insertion and allow or cause
all or specific features of the flames to expand once they are in
their desired location. In addition, delivery methods of the
invention can further include features that allow the emboli
guarding devices to be retrieved for removal or relocation thereof
after they have been deployed from their delivery systems. The
methods of the invention may include implantation of the devices
using either an antegrade or retrograde approach. Further, in
certain approaches for delivering the devices 10 of the invention,
the devices can be rotatable in vivo to, allow the stent structure
to be positioned in a desired orientation. In one embodiment, a
portion of the device 10, such as the frame 30, can include a
radiopaque, echogenic, or MRI visible material to facilitate visual
confirmation of proper placement of the frame 30 relative to the
anatomy of the patient. Alternatively, other known surgical visual
aids can be incorporated into the frame 30, if desired.
[0022] In another alternative embodiment, the device 10 can be
delivered to the patient's anatomy via a minimally invasive
surgical incision (i.e., non-percutaneously). In yet another
alternative embodiment, the device 10 can be delivered via open
heart/chest surgery.
[0023] The frame 30 of the device 10 is generally tubular in shape,
defining an internal area that extends from a first end 34 to a
second end 36. The internal area is essentially surrounded by the
frame 30 and the sheet of material 32. The frame 30 can be
configured to have an arc portion 38 that is designed and/or chosen
to generally match the anatomy of the aortic arch of the patient in
order to keep it from being dislodged once it is in place. Thus,
the frames can be provided in various lengths and/or shapes to
accommodate the different sizes and/or shapes of different patient
anatomies. While the exemplary frames 30 of FIGS. 2 and 3 are
similarly configured, the frame 30 of FIG. 3 includes an extension
portion 39 at its second end 36 that, can provide additional
anchoring capability relative to the vessel in which it is
positioned. A frame, may include one or more extensions of this
type and/or other features that provide such an anchoring
capability.
[0024] The material or materials from which the sheet of material
32 is made can vary widely, but generally include a relatively thin
piece of material, such as pericardium or a polymer sheet, for
example. In another alternative, a thin piece of Nitinol material
can be used. With any of these materials, a number of fenestrations
or openings 40 can be provided across the area of the sheet 32, as
illustrated in FIGS. 1 and 2 These fenestrations 40 can be sized to
be smaller than approximately 60.mu., although the fenestrations
can be any size that allows some blood flow through the surface of
the sheet 32 while blocking the movement of the emboli 20 through
the sheet 32. Thus, the size of the fenestrations 40 can be
selected to effectively filter a size of emboli or particles 20
that would be detrimental to the health of a patient if they were
to move through the sheet 32 in the direction of the arrows 28.
[0025] One method of delivering the device to a desired location in
a patient is via percutaneous device insertion. In general terms
for this exemplary, delivery system, a transcatheter assembly can
be provided, including a delivery catheter, a balloon catheter, and
a guide wire. The delivery catheter can be of a type known in the
art that defines a lumen within which the balloon catheter is
received. The balloon catheter, in turn, can define a lumen within
which the guide wire is slidably disposed. Further, the balloon
catheter can include a balloon that is fluidly connected to an
inflation source. It is noted that if the frame being implanted is
a self-expanding type of frame, the balloon would not be needed and
a sheath or other restraining means would instead be used for
maintaining the frame in its compressed state until deployment of
the device. In any case, the transcatheter assembly is
appropriately sized for a desired percutaneous approach. For
example, the transcatheter assembly can be sized for delivery to
the heart via an opening at a carotid artery, a jugular vein, a
sub-clavian vein, femoral artery or vein, or the like. Essentially,
any percutaneous intercostals penetration can be made to facilitate
use of the transcatheter assembly.
[0026] In the case of a balloon-expandable frame, once the frame 30
is properly positioned relative to the anatomy of the patient, the
balloon catheter is operated to inflate the balloon, thereby
expanding the frame 30 to the expanded state shown in FIG. 1.
Alternatively, if the frame 30 is formed of a shape memory
material, the frame can be allowed to self-expand to the expanded
state of FIG. 1, such as by removing the external forces applied by
a sheath. In either case, the frame 30 is preferably expandable
within the internal region of the implantation area of the patient
with sufficient outward radial force against the anatomical
structure (e.g., the aortic arch area) that it cannot become
unintentionally dislodged from this area of the patient.
[0027] The techniques described above relative to placement of the
device 10 within the heart can be used both to monitor and correct
the placement of the device 10 in a longitudinal direction relative
to the length, shape, and the like of the anatomical structure in
which it is positioned and also to monitor and correct the
orientation of the device 10 relative to any other structures that
may also be implanted in this area.
[0028] It is noted that the emboli guarding devices 10 of the
invention may be designed for permanent placement within the
patient, or may alternatively be removable after a certain period
of time. In one embodiment, the device 10 can be removed
pertcutaneously, such as with the use of a system that can
recompress the frame 30 by a sufficient amount to remove it in this
minimally invasive manner. In another embodiment, the device 10 may
need to be removed in a more invasive manner, such as via more
conventional surgical techniques.
[0029] FIG. 4 illustrates an alternative embodiment of the
invention, which includes an embolic guard guide catheter 60 that
is shown as positioned within the aortic arch 66 of a patient. In
this embodiment, the guide catheter 60 includes an embolic filter
62 positioned between proximal and distal ends of the catheter 60.
The embolic filter 62 can be delivered to the desired location in
the patient in order to provide similar filtering features to those
described above relative to FIGS. 1-3. In this example, the
catheter 60 can localize the embolic filter 62 at the location of
the head vessels 64. The length of the filter 62 can be selected to
achieve certain performance characteristics, such as being
sufficiently long to span across the all of the head vessels 64.
The filter 62 may include one or more areas having a thin film,
which may or may not include fenestrations, as described above
relative to the films that can be used in accordance with the
invention.
[0030] FIGS. 5 and 6 illustrate another embodiment of the
invention, which includes an embolic guard centering delivery
system 80 that is shown as positioned within the aortic arch 82 of
a patient. In particular, FIG. 5 shows the system 80 with a
self-expanding mesh portion 84 in a compressed or collapsed
condition relative to a delivery system stability layer 86.
Further, FIG. 6 shows the system 80 with the mesh portion 84 in an
expanded condition. In order to expand in this way, the stability
layer 86 can be pulled proximally to release the mesh portion 84,
thereby allowing it to expand to the size and shape of the vessel
in which it is positioned. In this way, the mesh portion 84 can
provide embolic protection during delivery of a device. That is,
the, mesh portion 84 is made of a material or materials that allow
blood flow, yet that filter out emboli, particles, and/or air
bubbles that are undesirably large. Further, the mesh portion 84
may comprise wires and/or film materials that provide the desired
level of particle filtering. It is further noted that the expansion
of the mesh portion 84 provides a centering function for the
delivery system 80 within the ascending aorta. In this way, better
coaxial alignment can occur between a transcatheter valve that is
being delivered via the delivery system and the annulus during
positioning and release thereof, for example.
[0031] Another aspect of the emboli guarding features of the
invention is illustrated in FIGS. 7 and 8. In particular, a guide
catheter 100 is illustrated as being positioned within an aortic
arch 102 of a patient. FIG. 7 shows the guide catheter 100 with a
self-expanding mesh portion 104 adjacent to its distal end in a
compressed or collapsed condition. In this Figure, guide catheter
100 can be driven over a guidewire (not shown) to position the
device in a desired location above the aortic valve in the
ascending aorta. FIG. 8 illustrates the mesh portion 104 in an
expanded condition. In order to expand the mesh portion 104 in this
way, an outer sheath 110 is pulled proximally to expose and
therefore expand the mesh portion 104. A tip 108, which can be
collapsible, of the delivery system 100 can be pulled proximally
out of the guide catheter 100. This will provide an access channel
through which another device can be inserted. For example, a
delivery system can be advanced through the guide catheter 100 to a
position adjacent to the aortic valve.
[0032] The mesh portion 104 can expand to the size and shape of the
vessel in which it is positioned. In this way, the mesh portion 104
can provide embolic protection during delivery of a device (e.g., a
transcatheter valve) and/or during balloon valvuloplasty
procedures. That is, the mesh portion 104 is made of a material or
materials that allow blood flow, yet that filter out emboli,
particles, and/or an bubbles that are undesirably large during
other processes. Further, the mesh portion 104 may comprise wires
and/or film materials that provide a desired level of particle
filtering. It is further noted that the expansion of the mesh
portion 104 provides a centering function for the delivery system
100 within the ascending aorta. In this way, better coaxial
alignment can occur between a transcatheter valve that is being
delivered via the delivery system and the annulus during
positioning and release thereof for example. In this embodiment,
once any other processes are completed, such as transcatheter valve
delivery and deployment or balloon valvuloplasty, the outer sheath
110 can be advanced in a distal direction to collapse the mesh
portion 104 for removal of the device from the body.
[0033] The distal end of the guide catheter can also function to
align and/or direct a delivery system that is advanced within the
guide catheter to an anatomical target, such as the aortic valve,
for example. Providing these capabilities of being able to more
accurately align and direct the delivery system can help to
optimize the accuracy and reliability with which an implant or
therapy can be introduced.
[0034] With either of the mesh portions described above relative to
FIGS. 5 and 6 or FIGS. 7 and 8, the mesh portions preferably are
sufficiently sized so that they can expand to match the size and
shape of the vessel in which they are located. The mesh portions
are also preferably made of a material that provides sufficient
force against the walls of the vessel to prevent emboli from moving
between the mesh portion and the vessel. Further, the mesh portions
can additionally include one or more sections or areas, having a
thin film or material that may or may not include fenestrations,
such as is described above relative to FIGS. 1-3, for example.
[0035] The present invention has now been described with reference
to several embodiments thereof. The contents of any patents or
patent application cited herein are incorporated by reference in
their entireties. The foregoing detailed description and examples
have been, given for clarity of understanding only. No unnecessary
limitations are to be understood therefrom. It will be apparent to
those skilled in the art that many changes can be made in the
embodiments described without departing from the scope of the
invention. Thus, the scope of the present invention should not be
limited to the structures described herein.
* * * * *