U.S. patent application number 16/377604 was filed with the patent office on 2019-08-01 for expandable implant devices for filtering blood flow from atrial appendages.
This patent application is currently assigned to BOSTON SCIENTIFIC SCIMED, INC.. The applicant listed for this patent is BOSTON SCIENTIFIC SCIMED, INC.. Invention is credited to Thomas E. Borillo, Dean Peterson, Gregg S. Sutton, Jeffrey Welch.
Application Number | 20190231507 16/377604 |
Document ID | / |
Family ID | 27397622 |
Filed Date | 2019-08-01 |
United States Patent
Application |
20190231507 |
Kind Code |
A1 |
Borillo; Thomas E. ; et
al. |
August 1, 2019 |
EXPANDABLE IMPLANT DEVICES FOR FILTERING BLOOD FLOW FROM ATRIAL
APPENDAGES
Abstract
Implant devices for filtering blood flowing through the ostium
of an atrial appendage have component structures one or more of
which are expandable. Devices with component structures in their
unexpanded state have a compact size suitable for intra-cutaneous
delivery to an atrial appendage situs. The expandable component
structures are expanded in situ to deploy the devices. A device may
have sufficiently short axial length so that most or almost all of
the device length may fit within the ostium region.
Inventors: |
Borillo; Thomas E.;
(Plymouth, MN) ; Peterson; Dean; (Brooklyn Park,
MN) ; Sutton; Gregg S.; (Maple Grove, MN) ;
Welch; Jeffrey; (New Hope, MN) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
BOSTON SCIENTIFIC SCIMED, INC. |
MAPLE GROVE |
MN |
US |
|
|
Assignee: |
BOSTON SCIENTIFIC SCIMED,
INC.
MAPLE GROVE
MN
|
Family ID: |
27397622 |
Appl. No.: |
16/377604 |
Filed: |
April 8, 2019 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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14866017 |
Sep 25, 2015 |
10278805 |
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16377604 |
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14147149 |
Jan 3, 2014 |
9161830 |
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14866017 |
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13493730 |
Jun 11, 2012 |
8647361 |
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14147149 |
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11185425 |
Jul 19, 2005 |
8197527 |
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13493730 |
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09932512 |
Aug 17, 2001 |
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11185425 |
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60234113 |
Sep 21, 2000 |
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60234112 |
Sep 21, 2000 |
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60226461 |
Aug 18, 2000 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61F 2/01 20130101; A61F
2/013 20130101; A61F 2002/018 20130101; A61F 2002/015 20130101;
A61B 17/12122 20130101; A61F 2002/016 20130101; A61F 2230/008
20130101; A61B 2017/00575 20130101; A61F 2230/0006 20130101; A61F
2230/0069 20130101; A61B 17/12172 20130101; A61B 17/12136 20130101;
A61B 17/12022 20130101; A61B 17/12159 20130101 |
International
Class: |
A61F 2/01 20060101
A61F002/01; A61B 17/12 20060101 A61B017/12 |
Claims
1. An implant device deployable within an ostium of an atrial
appendage comprising: an expandable structure having an anterior
portion and a posterior portion, wherein the expandable structure
has a radially compact delivery configuration and an expanded
radial dimension greater than a radially compact dimension of the
radially compact delivery configuration; wherein the anterior
portion is configured to fit across the ostium of the atrial
appendage, and includes a filtering element; and wherein the
posterior portion is configured to extend within the atrial
appendage, and includes a plurality of anchors distributed over at
least a part of an exterior surface area of the posterior portion,
wherein the plurality of anchors is configured to engage a wall of
the atrial appendage.
2. The implant device of claim 1, wherein the posterior portion is
formed of a wire mesh.
3. The implant device of claim 1, wherein the posterior portion is
formed of a braided or woven fabric.
4. The implant device of claim 1, wherein the posterior portion is
flared with its diameter increasing along its axial length.
5. The implant device of claim 1, wherein the plurality of anchors
include barbs.
6. The implant device of claim 1, wherein its axial length is
slightly greater than a length of the ostium of the atrial
appendage.
7. The implant device of claim 1, wherein the expandable structure
is self-expanding.
8. The implant device of claim 1, wherein the filtering element
includes a plurality of holes, the plurality of holes has a size
distribution that remains constant when the expandable structure
expands.
9. The implant device of claim 1, wherein the posterior portion
includes elastic properties, wherein the elastic properties permit
the posterior portion to recoil to a smaller radial dimension than
that of the expanded radial dimension, but greater than the
radially compact dimension of the radially compact delivery
configuration.
10. The implant device of claim 9, wherein the plurality of anchors
engage the wall of the atrial appendage when in the expanded radial
dimension, and recoil of the posterior portion brings the wall of
the atrial appendage in an inward direction.
Description
[0001] This application is a continuation of U.S. application Ser.
No. 14/866,017, filed Sep. 9, 2015, which is a continuation of U.S.
application Ser. No. 14/147,149, filed Jan. 3, 2014, which is a
continuation of U.S. application Ser. No. 13/493,730, filed Jun.
11, 2012, now U.S. Pat. No. 8,647,361, which is a continuation of
U.S. application Ser. No. 11/185,425, filed Jul. 19, 2005, now U.S.
Pat. No. 8,197,527, which is a continuation of U.S. application
Ser. No. 09/932,512, filed Aug. 17, 2001, which claims the benefit
of U.S. provisional application No. 60/226,461, filed Aug. 18,
2000, U.S. provisional application No. 60/234,112, filed Sep. 21,
2000, and U.S. provisional application No. 60/234,113, filed Sep.
21, 2000, all of which are hereby incorporated by reference in
their entireties herein.
BACKGROUND OF THE INVENTION
1. Field of the Invention
[0002] The invention relates to implant devices that may be
implanted in an atrial appendage for filtering blood flowing
between the atrial appendage and an associated atrium of the heart
to prevent thrombi from escaping from the atrial appendage into the
body's blood circulation system.
2. Description of the Related Art
[0003] There are a number of heart diseases (e.g., coronary artery
disease, mitral valve disease) that have various adverse effects on
a patient's heart. An adverse effect of certain cardiac diseases,
such as mitral valve disease, is atrial (or auricular)
fibrillation. Atrial fibrillation leads to depressed cardiac
output. A high incidence of thromboembolic (i.e., blood clot
particulate) phenomena are associated with atrial fibrillation, and
the left atrial appendage (LAA) is frequently the source of the
emboli (particulates).
[0004] Thrombi (i.e., blood clots) formation in the LAA may be due
to stasis within the fibrillating and inadequately emptying LAA.
Blood pooling in the atrial appendage is conducive to the formation
blood clots. Blood clots may accumulate, build upon themselves.
Small or large fragments of the blood clots may break off and
propagate out from the atrial appendage into the atrium. The blood
clot fragments can then enter the body's blood circulation and
embolize distally into the blood stream.
[0005] Serious medical problems result from the migration of blood
clot fragments from the atrial appendage into the body's blood
stream. Blood from the left atrium and ventricle circulates to the
heart muscle, the brain, and other body organs, supplying them with
necessary oxygen and other nutrients. Emboli generated by blood
clots formed in the left atrial appendage may block the arteries
through which blood flows to a body organ.
[0006] The blockage deprives the organ tissues of their normal
blood flow and oxygen supply (ischemia), and depending on the body
organ involved leads to ischemic events such as heart attacks
(heart muscle ischemia) and strokes (brain tissue ischemia).
[0007] It is therefore important to find a means of preventing
blood clots from forming in the left atrial appendage. It is also
important to find a means to prevent fragments or emboli generated
by any blood clots that may have formed in the atrial appendages,
from propagating through the blood stream to the heart muscle,
brain or other body organs.
[0008] U.S. Pat. No. 5,865,791 (hereinafter, "the '791 patent")
relates to the reduction of regions of blood stasis in the heart
and ultimately reduction of thrombi formation in such regions,
particularly in the atrial appendages of patients with atrial
fibrillation. More specifically, the '791 patent relates to
procedures and devices for affixing the atrial appendages in an
orientation that prevents subsequent formation of thrombi. In the
'791 patent, the appendage is removed from the atrium by pulling
the appendage, placing a loop around the appendage to form a sack,
and then cutting it off from the rest of the heart.
[0009] U.S. Pat. No. 5,306,234 describes a method for surgically
closing the passage way between the atrium and the atrial
appendage, or alternatively severing the atrial appendage.
[0010] Some recently proposed methods of treatment are directed
toward implanting a plug-type device in an atrial appendage to
occlude the flow of blood therefrom.
[0011] A preventive treatment method for avoiding thromboembolic
events (e.g., heart attacks, strokes, and other ischemic events)
involves filtering out harmful emboli from the blood flowing out of
atrial appendages. Co-pending and co-owned U.S. patent application
Ser. No. 09/428,008, U.S. patent application Ser. No. 09/614,091,
U.S. patent application Ser. No. 09/642,291, and U.S. patent
application Ser. No. 09/697,628, all of which are hereby
incorporated by reference in their entireties herein, describe
filtering devices which may be implanted in an atrial appendage to
filter the blood flow therefrom. The devices may be delivered to
the atrial appendage using common cardiac catheterization methods.
These methods may include trans septal catheterization which
involves puncturing an atrial septum.
[0012] Catheters and implant devices that are large may require
large punctures in the septum. Large catheters and devices may
damage body tissue during delivery or implantation. Damage to body
tissue may cause trauma, increase recovery time, increase the risk
of complications, and increase the cost of patient care. Further
the atrial appendages may vary in shape and size from patient to
patient.
[0013] It would therefore be desirable to provide implant devices
which are small and which can be delivered by small-sized catheters
to the atrial appendages. It would therefore also be desirable to
provide implant devices whose size can be adjusted in situ to
conform to the size of the atrial appendages.
SUMMARY OF THE INVENTION
[0014] The invention provides implant devices and methods, which
may be used to filter blood flowing between atrial appendages and
atrial chambers. The devices are designed to prevent the release of
blood clots formed in the atrial appendages into the body's blood
circulation system.
[0015] All implant devices disclosed herein have adjustable sizes.
A compact or narrow size may be used for intra-cutaneous device
delivery to an atrial appendage, for example, by cardiac
catheterization. The devices include size-adjusting mechanisms that
allow the device size to be enlarged in situ to an expanded size
conforming to the dimensions of the atrial appendage.
[0016] It an embodiment of the implant device, an expanding inner
structure is disposed inside a membrane tube. The inner structure
has rigid components, which when the inner structure is expanded
press or push sides of the membrane tube outward. The inner
structure may be self-expanding or may, for example, be expanded by
an inflatable balloon. When the inner structure is in a collapsed
configuration, the device has a compact size suitable for delivery
to and insertion in an atrial appendage, for example, by cardiac
catheterization. When fully deployed for use, a closed end of the
membrane tube covers the ostium of the atrial appendage. Filter
elements or components built into the closed end of the membrane
tube filter out harmful-size emboli from the blood flowing out of
the atrial appendage. The device may be held in position by
expanding the inner structure to press sides of the membrane tube
against the interior walls of the atrial appendage.
[0017] Other embodiments of the implant devices may have other
kinds of inflatable or expandable structures which allow the
devices to have compact sizes for device delivery and which can
later be enlarged in situ to make the device size conform to the
dimensions of the atrial appendages.
[0018] The devices may have short axial lengths that are comparable
to or are a fraction of the length of an ostium. A short-axial
length device may have a thin expandable or inflatable structure.
The cross-sectional shape of a thin expandable structure may, for
example, resemble that of a mushroom cap, a pill box, or a
doughnut-shaped tube, etc. The structure may include suitable
blood-permeable filter elements for filtering harmful-size emboli
from the blood flow. The filter elements may be located centrally
or may be located off-center in the thin structure. When deployed
the thin structure covers the ostium of an atrial appendage and
directs all blood flow through the ostium to pass through the
filter elements. The structure may be suitably designed to prevent
unwanted flow channels (e.g., around the edges of the device)
through which unfiltered blood may flow between the appendage and
the atrium. The structure may have anchors attached to its outside
periphery. These anchors may be pins, hooks, barbs, atraumatic bulb
tips or other suitable structures for engaging wall tissue. The
anchors engage the interior walls of the ostium and thereby secure
the position of the deployed device. Some devices may have axial
lengths that may be slightly larger than the length of an ostium.
Such devices may have anchors disposed on posterior portions of the
expandable structure for engaging interior wall tissue of the neck
region of the atrial appendage leading to the ostium Other devices
with expandable or inflatable structures may have longer axial
lengths that are comparable to or are a substantial fraction of the
length of an atrial appendage. A longer-axial length device may
have a first structure designed to cover the ostium of an atrial
appendage and filter blood flow therethrough. This first structure
may optionally be expandable or non-expandable. In either case, an
expandable second structure in the device may be used to help
secure the device in its deployed position. The expandable second
structure is generally disposed in the lumen or interior cavity of
the atrial appendages. The expandable second structure may be
self-expanding or may, for example, be expandable by balloon
inflation. The expandable second structures may have components
such as attached anchors for engaging the interior walls of the
atrial appendages. These anchors may be pins, hooks, barbs,
atraumatic bulb tips or other suitable structures for engaging wall
tissue. The expandable second structure may additionally or
alternatively include inflatable anchors. These inflatable anchors
directly engage the interior walls of the atrial appendage when
inflated and provide resistance to changes in the position of the
deployed device.
[0019] Filter elements with predetermined hole size distributions
for filtering harmful-sized emboli from the blood flow may be
incorporated in the expandable implant devices. The filter elements
may be configured so that their hole size distributions do not
change significantly during the expansion of the device. In one
configuration the filter elements are embedded in elastic
membranes. These membranes are designed such that when the devices
are expanded concomitant stretching of the filter element
configurations due to the increase in device size is largely
accommodated by the elastic membranes. The sizes of filter elements
themselves and their predetermined hole size distributions remain
substantially unchanged.
[0020] Further features of the invention, its nature and various
advantages will be more apparent from the accompanying drawing and
the following detailed description.
BRIEF DESCRIPTION OF THE DRAWINGS
[0021] FIG. 1a is a cross sectional view showing an adjustable-size
implant device at its narrow compact size suitable for delivery by
cardiac catheterization in accordance with the principles of the
invention.
[0022] FIG. 1b is a cross sectional view showing the implant device
of FIG. 1a deployed in an atrial appendage. The implant device
shown has membrane tube having filter elements for filtering blood.
The device is retained in position by an expanded inner structure
in accordance with the principles of the invention.
[0023] FIG. 1c is a schematic perspective view showing an exemplary
expanded inner structure in its expanded configuration in
accordance with the principles of the invention.
[0024] FIG. 2 is a partial sectional view showing another implant
device deployed in an atrial appendage. The implant device shown
has filter elements for filtering blood and is retained in position
by a self-expanding inner structure in accordance with the
principles of the invention.
[0025] FIG. 3a is a schematic illustration of an as-delivered
implant device positioned within an ostium. The device has a thin
expandable structure which may be used to cover the ostium of an
atrial appendage so that blood flow between the appendage and the
atrium is constrained to pass through filter elements in the device
in accordance with the principles of the invention.
[0026] FIGS. 3b and 3c are cross-sectional views illustrating
exemplary shapes of the expandable structure of the implant device
of FIG. 3a.
[0027] FIG. 4 schematically illustrates the increase in size of the
implant device of FIG. 3a as its expandable structure is being
inflated in accordance with the principles of the invention.
[0028] FIG. 5a is a partial cross sectional view showing an implant
device with an expandable distal structure disposed in an atrial
appendage. The implant device shown has a proximal structure, which
may be used to cover the ostium of the atrial appendage to direct
blood flow to pass through filter elements. The device is retained
in position by the distal structure which has inflatable anchors in
accordance with the principles of the invention.
[0029] FIG. 5b is a side elevational view showing another implant
device with expandable structures in which a single expanding
structure provides the functions of both the proximal and distal
structures shown in FIG. 5b, in covering the ostium and in securing
the position of the device, in accordance with the principles of
the invention.
[0030] FIG. 5c is a plan view of the implant device shown in FIG.
5b.
[0031] FIG. 6 is a schematic illustration of a predetermined-size
filter element having holes impervious to harmful-size emboli, and
an elastic membrane attached the filter element in accordance with
the principles of the invention.
DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0032] Although atrial fibrillation may result in the pooling of
blood in the left atrial appendage and the majority of use of the
invention is anticipated to be for the left atrial appendage, the
invention may also be used for the right atrial appendage and in
general for placement across any aperture in the body in which
blood is permitted to flow therethrough or therefrom but in which
blood clots are substantially prevented from escaping from the
atrial appendage and entering into the bloodstream.
[0033] The implant devices disclosed herein have adjustable sizes.
A compact or narrow size is used for intra-cutaneous device
delivery to the atrial appendages, for example, by cardiac
catheterization. The devices include size-adjusting expansion
mechanisms that allow the device size to be enlarged in situ to an
expanded size. Controlled expansion may be desirable for the proper
functioning of an implant device. For example, the filter elements
of a device must be correctly centered or positioned across an
atrial appendage ostium for the device to properly intercept and
filter blood flowing out of the atrial appendage. The expansion
mechanisms allow for controlled expansion of the implanted device
size in situ to conform to the dimensions of the atrial appendage.
Further, the expansion mechanisms may allow for the expansion to be
at least partially reversed and thereby enable a physician to
optimize or adjust the deployment of the device in situ. The types
of implant devices disclosed herein add to variety of device types
disclosed in U.S. patent application Ser. No. 09/428,008, U.S.
patent application Ser. No. 09/614,091, U.S. patent application
Ser. No. 09/642,291, and U.S. patent application Ser. No.
09/697,628, all incorporated in by reference herein.
[0034] FIG. 1a shows device 101 at its compact size suitable for
delivery to atrial appendage 100 (FIG. 1b) by cardiac
catheterization. Device 101 has a membrane tube 120 in which an
expanding structure 130 is disposed. Membrane tube 120 may be made
of thin flexible materials. Expanding structure 130, in contrast,
may have components which are made of more rigid material such as
hard plastics or corrosion-resistant metal alloys including shape
memory alloys. Expanding structure 130 has a collapsed
configuration (FIG. 1a) and a larger expanded configuration (FIGS.
1b and 1c).
[0035] In both the collapsed and expanded configurations, structure
130 may have a generally cylindrical shape. Structure 130 may have
a design that allows it to expand radially without any significant
concomitant change in its axial length. The design of also may
allow for permanent deformation, or partially or completely
reversible deformation of structure 130 during its expansion. FIG.
1c schematically illustrates portions of an exemplary inner
structure 130 in its expanded configuration. Structure 130 shown in
FIG. 1c is similar to structures shown and described in greater
detail, for example, in U.S. application Ser. No. 09/642,291.
Structure 130 includes interconnected serpentine segments 131.
Adjacent serpentine segments 131 are interconnected by a plurality
of longitudinal struts 132. End serpentine segment 131 is connected
by radial members 133 to a central hollow cylindrical ring 134.
Some or all of components 130-134 may, for example, be fabricated
from shape memory alloys.
[0036] Externally-initiated means may be used to change the
configuration of structure 130 when it is placed in atrial
appendage 100. For example, balloon 140 (e.g., placed within
structure 130 through central hollow cylindrical ring 134) may be
inflated to change the configuration of structure 130 from its
collapsed configuration to its expanded configuration. Balloon 140
may be inflated or deflated conventionally, for example, by
injecting or withdrawing suitable fluids from the body of balloon
140, respectively, through suitable elastic sealed openings, for
example, valve structures 142. The elastic sealed openings such as
valve structures 142 prevent uncontrolled release of fluids
injected in to balloon 140.
[0037] FIG. 1b shows, for example, device 101 expanded to a
suitable expanded size for permanent deployment in atrial appendage
100. Device 101 may be used to filter blood flowing out from atrial
appendage 100. Device 101 has a membrane tube 120 in which an
expanding structure 130 is placed. Membrane tube 120 has a
generally cylindrical shape and may have one or both of its distal
and proximal ends closed. FIG. 1b shows membrane 120 having both
distal and proximal closed ends 124. The membrane tube 120 can be
made of bicompatible materials, such as, for example, ePFTE (e.g.,
Gortex.RTM.), polyester (e.g., Dacron.RTM.), PTFE (e.g.,
Teflon.RTM.), silicone, urethane, metal fibers, or other
biocompatible polymers.
[0038] In one embodiment of device 101 at least portions of closed
ends 124 serve as filter elements 125 for filtering harmful-size
emboli from blood flow. Filter elements 125 are made of
blood-permeable material. The remaining portions of membrane tube
125 (e.g., sides 126) may be made of blood-impervious material. The
materials used to fabricate membrane tube 125 components can be any
suitable bicompatible materials, such as, for example, ePFTE (e.g.,
Gortex.RTM.), polyester (e.g., Dacron.RTM.), PTFE (e.g.,
Teflon.RTM.), silicone, urethane, metal fibers, or other
biocompatible polymers.
[0039] The structure of the blood-permeable material used to
fabricate filter elements 125 is preferably a two-dimensional
screen, a cellular matrix, a woven or non-woven mesh, or the like.
The structure of the blood-permeable material may also be that of a
permeable metal or a mesh of fine metal fibers. Further, the
blood-permeable material in filter elements 125 may be coated or
covered with an anticoagulant, such as heparin, or another
compound, or treated to provide antithrombogenic properties to the
filter elements 125 to inhibit clogging of filter elements 125 by
an accumulation of blood clots.
[0040] Filter elements 125 have holes through them for blood flow.
As used herein, it will be understood that the term hole refers to
an opening in the structure of a filter element which provides a
continuous open channel or passageway from one side of the filter
element to the other. The term pore refers to a small cavity in the
material of a filter element. Cavities or pores do not provide a
continuous open channel or passageway through the filter element.
Partially opened surface pores, however, are an important component
of surface texture which is advantageous for cellular tissue
ingrowth.
[0041] The hole sizes in the blood-permeable material included in
filter elements 125 may be chosen to be sufficiently small so that
harmful-size emboli are filtered out from the blood flow between
appendage 100 and atrium 105 (shown partially in FIGS. 1b and 1c).
Yet the hole sizes may be chosen to be sufficiently large to
provide an adequate flow conductivity for emboli-free blood to pass
through device 101. Filter elements 125 may have hole sizes
ranging, for example, from about 50 to about 400 microns in
diameter. The distribution the hole sizes may be suitably chosen,
for example, with regard to individual circumstances, to be larger
or smaller than indicated, provided such holes substantially
inhibit harmful-size emboli from passing therethrough. The open
area of filter elements 125 is preferably at least 20% of the
overall surface area of the closed ends 124, although a range of
about 25-60% may be preferred.
[0042] The hole size distribution of the material used to make
filter elements 125, described above, allows blood to flow
therethrough while blocking or inhibiting the passage of thrombus,
clots, or emboli formed within the atrial appendage from entering
the atrium of the heart and, eventually, the patient's
bloodstream.
[0043] In an alternative embodiment, substantially all of membrane
tube 120 may be made of blood-permeable material suitable for
filtering harmful-size emboli. Use of a single material (or a fewer
number of different types of materials) in membrane tube 120 may
simplify its fabrication. In this case it may be sufficient to coat
or cover closed end 124 portions with an anticoagulant to prevent
clogging of blood flow between atrial appendage 100 and atrium 105.
Sides 126, for example, need not be coated with an anticoagulant as
they are likely to be sealed in any event by atrial appendage wall
tissue when device 101 is deployed in an atrial appendage, as
described below.
[0044] For all embodiments of device 101, for example, as described
above, when fully deployed, membrane tube 120 is held or retained
in position in atrial appendage 100 so that proximal closed end 124
extends across or covers ostium 110. After initial insertion of
device 101 in atrial appendage 100, expanding structure 130 is
expanded, for example, by inflating balloon 140, from its initial
compact size to an expanded size. Expanding structure 130 is
expanded to a suitable size to press membrane tube sides 126
directly against interior walls 100a of atrial appendage 100. The
direct engagement of sides 126 with interior wall tissue 100a
caused by the outward pressing by structure 130 holds device 101
provides a degree of resistance to movement of device 101 within
atrial appendage 100 and holds device 101 in a substantially fixed
position. However, this resistance to movement at least initially
during the implant procedure may be reversed to allow repositioning
of device 101 if necessary or desirable. The reversal may be
complete or partial corresponding to the elastic deformation
characteristics of structure 130. The reversal may be accomplished,
for example, by deflation of balloon 140. Later, regenerative
tissue growth, for example, of endothelial or endocardial tissue,
conforming to the outer surface textures of sides 126 may bind
sides 126 and provide additional securement of fully deployed
device 101. This tissue growth binding may, for example, involve
tissue ingrowth into partially-open surface pores of the material
of sides 126, or, for example, tissue ingrowth into holes in
blood-permeable material in the case where sides 126 are made of
blood-permeable material having holes. This tissue growth, in
conjunction with the outward pressure provided by inner structure
130, may provide additional means of reducing flow leakage about
the periphery of device 101.
[0045] In some implant procedures it may be desirable to leave
balloon 140 in situs, for example, in a deflated state. In other
implant procedures it may be desirable to physically remove balloon
140 after device 101 has been secured in appendage 100. As
necessary or desired, balloon 140 may be removed from the patient's
body using conventional catheterization techniques. Balloon 140 may
be withdrawn from tube 120 through suitable self-sealing openings
in closed ends 124. A suitable self-sealing opening may be of the
type formed by overlapping membrane flaps (e.g., flaps 124 FIG.
1b). Other types of conventional self-sealing openings such as
those formed by elastic O-ring structures (not shown) also may be
used.
[0046] In further embodiments of device 101, expanding inner
structure 130 may be a self-expanding structure. Structure 130 may
have suitable biasing means, for example, springs or other elastic
components, which change the configuration of structure 130 from
its as-implanted collapsed configuration to its expanded
configuration after device 101 has been implanted. Self-expanding
structure 130 also may, for example, have components made from
shape memory alloys (e.g., Nitinol.RTM.). The shape memory alloy
components may be preformed to have a shape corresponding to the
expanded configuration of structure 130. The performed components
may be bent or compressed to form structure 130 in its collapsed
configuration. After device implantation, heating or changing
temperature induces the bent or compressed the shape memory alloy
components to automatically revert to their performed shapes
corresponding to the expanded configuration of structure 130. FIG.
2 shows, for example, device 101 expanded by self-expanding
structure 200 to a suitable expanded size for permanent deployment
in an atrial appendage 100.
[0047] Other embodiments of the implant devices may have other
kinds of inflatable or expandable structures, which allow the
devices to have compact sizes for device delivery, and which can
later be enlarged in situ to make the device sizes conform to the
dimensions of the atrial appendages. An implant device of these
embodiments may have one or more component structures or
substructures. One or more of the component structures or
substructures in a device may be expandable or inflatable. A first
type of these component structures or substructures may include
blood-permeable filter elements, and, for example, serve to filter
harmful size emboli from the blood flow. A second type of the
component structures or substructures may include anchoring
elements, and, for example, serve to retain the deployed device in
position. It will be understood that neither component types are
contemplated within the invention as necessarily having mutually
exclusive functions. Neither type is restricted to having only
filter elements or only anchoring elements. A single component
structure may serve both to filter blood flow and to hold the
deployed device in position.
[0048] Different embodiments of devices having one or more of these
types of component structures or substructures may have
correspondingly different axial lengths spanning a wide range of
values. At the upper end of the range, devices may have axial
lengths that are comparable to or are a significant fraction of the
length of an atrial appendage. Toward the lower end of the range,
devices may have axial lengths that are comparable to or are a
fraction of the length of the ostium and the neck region of the
atrial appendage leading to the ostium.
[0049] A device embodiment having a short axial length suitable for
deployment fully within an ostium is illustrated in FIGS. 3a, 3b,
3c, and 4. Device 300 has a thin expandable or inflatable structure
310. FIG. 3a schematically shows device 300 as delivered for
deployment positioned within ostium 305. Structure 310 when
expanded may have a shape, for example, resembling a mushroom cap
(FIG. 3b), a pill box (FIG. 3c), a doughnut-shaped tube, or any
other shape suitable for engaging ostium 305.
[0050] Expandable structure 310 may be fabricated from membranes or
fabrics made of bicompatible materials, such as, for example, ePFTE
(e.g., Gortex.RTM.), polyester (e.g., Dacron.RTM.), PTFE (e.g.,
Teflon.RTM.), silicone, urethane, metal fibers, or other
biocompatible polymers. Expandable structure 310 includes filter
elements for filtering harmful-size emboli (not shown). Structure
310 may include non-expanding portions made of blood-permeable
membrane or fabric suitable for filtering harmful-size emboli (not
shown). The non-expanding portions may, for example, in the case
where structure 310 has an expandable doughnut shape extend across
the central region of the doughnut shape. Structure 310 may also
include access openings or fixtures for attaching catheters or
other delivery devices (not shown). Anchors 330 are attached to the
outer periphery of expandable structure 330. Anchors 330 may, for
example, be attached to an outer rim toward the posterior of
expandable structure 330. Anchors 330 may be pins, hooks, barbs,
wires with atraumatic bulb tips or other suitable structures for
engaging tissue. Device 300 is secured in position relative to
ostium 305 when anchors 330 engage surrounding ostium wall
tissue.
[0051] Device 300 may be suitably deployed to filter blood flowing
through ostium 305 by extending expandable structure 310 across
ostium 305. Expandable structure 320 may be self-expanding (e.g.,
like structure 130 FIG. 2). Alternatively, expandable structure 310
may include externally-initiated mechanical means for expansion
(e.g., like balloon 140 FIG. 1b). FIG. 4 schematically illustrates
the increase in size of device 300 as expandable structure 310 is
being inflated. FIG. 4 shows device 300 increasing from an initial
size a to an intermediate size b, and then to a size c. As device
300 size increases attached anchors 330 move radially outward
toward the interior walls of ostium 305.
[0052] When structure 310 is sufficiently expanded, anchors 330
engage surrounding interior wall tissue and secure device 300 in
position.
[0053] FIG. 5a shows an implant device 500 having an axial length
which is comparable or a significant fraction of the length of
atrial appendage 100. Device 500 has two component substructures,
i.e., proximal structure 510, and distal structure 520. Proximal
structure 510 may be used to cover ostium 110 of atrial appendage
100. Proximal structure 510 includes blood-permeable filter
elements which filter the blood flow through ostium 110. Proximal
structure 510 may be made of a suitable fabric made from
bicompatible materials, such as, for example, ePFTE (e.g.,
Gortex.RTM.), polyester (e.g., Dacron.RTM.), PTFE (e.g.,
Teflon.RTM.), silicone, urethane, metal fibers, or other
biocompatible polymers. Proximal structure 510 may be an expandable
structure, which may, for example, be similar to expandable
structure 310 described above with reference to FIGS. 3a, 3b and
3c. Alternatively, proximal structure 510 may be a structure which
is not expandable or inflatable. Non-inflatable structure 510 may,
for example, be any one of the structures for covering ostium 110
described in U.S. patent application Ser. No. 09/428,008, U.S.
patent application Ser. No. 09/614,091, U.S. patent application
Ser. No. 09/642,291, and U.S. patent application Ser. No.
09/697,628, all incorporated by reference herein.
[0054] In either case, structure 510 is retained in position
extending across ostium 110 by use of attached distal structure
520. Distal structure 520 is inflatable and has one or more anchor
sets 530 attached to an axial portion or shank 521. Each of the
anchor sets 530 has a suitable number of inflatable anchors 531
designed to engage the interior walls of atrial appendage 100.
Inflatable anchors 531 in a set 530 may be attached to axial
portion 521 along a radial circumference at a suitable distance
away from proximal cover 510 (not shown). Alternatively, inflatable
anchors 531 in a set 530 may be attached to axial portion 521 along
an axial length thereof, for example, as illustrated in FIG. 5a.
Other distributions of anchors 531 also may be used. For example,
anchors 531 may be attached to axial portion 521 in a spiral
pattern. Distal structure 520 including anchor sets 530 may be made
of a suitable fabric made of bicompatible materials, such as, for
example, ePFTE (e.g., Gortex.RTM.), polyester (e.g., Dacron.RTM.),
PTFE (e.g., Teflon.RTM.), silicone, urethane, metal fibers, or
other biocompatible polymers.
[0055] Device 500 is at its compact size suitable for
intra-cutaneous delivery when distal structure 520 is deflated, and
when proximal structure 510 deflated or suitably folded according
to whether proximal structure 510 is an expanding or a
non-expanding structure. In an implant procedure, device 500 in its
compact size may be delivered to atrial appendage 100, for example,
by cardiac catheterization. When fully deployed, device 500 is
positioned so that proximal structure 510 appropriately extends
across ostium 110. Distal structure 520 is disposed to the interior
of atrial appendage 100. Distal structure 520 is inflated by
suitable means so that inflated anchors 531 engage and press
against the interior walls of atrial appendage 100. The friction
between outwardly pressing anchors 531 and the atrial appendage
walls retains device 500 in its desired fully deployed position.
The suitable means for inflating structure 520 may, for example,
involve injection of fluids into structure 520 through suitable
openings (not shown). The openings may have suitable valved seals
preventing uncontrolled release or leakage of the inflating
fluids.
[0056] In another device embodiment, a single inflatable structure
may provide the functions of both the distal and proximal
structures described above. Such a device may have a sufficiently
short axial length so that all or almost all of the device may fit
within the ostium or ostium region of an atrial appendage Anterior
portions of the device may be used cover the ostium in order to
direct blood flow between the atrial appendage and the atrial
chamber through filter elements. Attached anchors may be
distributed on at least part of the exterior surface area of
posterior portions of the device. The anchors may be pins, hooks,
barbs, wires with atraumatic bulb tips or other suitable structures
for engaging tissue. The single inflatable structure may be
self-expanding or may expand in response to externally-initiated
means. When the device is expanded the anchors attached to its
posterior portions engage the rear walls of the ostium and/or
possibly the interior walls of the neck region of the atrial
appendage close to the ostium. The device may be fabricated using
suitable membranes or fabrics made of biocompatible materials, for
example, such as those mentioned earlier. Further, the
biocompatible materials may have, for example, any of the
structures mentioned earlier (e.g., cellular matrix, wire mesh,
etc.).
[0057] An exemplary implant device 550 most or almost all of which
may fit within the ostium of an atrial appendage is illustrated in
FIG. 5b and FIG. 5c. These two FIGS. show side elevational and top
plan views of device 550, respectively. Device 550 like device 300
(FIG. 3a) has a single component structure, i.e., expandable
structure 551. Expandable structure 551 includes anterior portion
560 and posterior portion 570. The axial length of device 550 may
be comparable to or slightly larger than the length of the ostium.
Device 550 with an axial length slightly larger than the length of
the ostium, when deployed, may extend into the neck region of the
atrial appendage close to the ostium.
[0058] FIG. 5b shows device 550 at an expanded size at which it may
be deployed in the ostium. Anterior portion 560 may be fabricated
from an elastic membrane and include suitable filter element 565
for filtering harmful-size emboli from the blood flow. Anterior
portion 560 may include suitable openings or fixtures for attaching
catheters or other delivery devices (not shown). Anterior portion
560 is used to cover the ostium to ensure that all blood flow
through the ostium passes through filter element 565. Posterior
portion 570 may, for example, be formed of a wire mesh (as shown),
a braided or woven fabric, or a short segment of sheet material
tube. Posterior portion 570 may have suitable radial dimensions
conforming to the ostium dimensions. FIG. 5c shows, for example, a
cylindrical posterior portion 570 having a substantially constant
diameter cross-section along its axial length. Alternatively,
cylindrical posterior portion 570 may be flared with its diameter
increasing along its axial length to match changes in the ostium
diameter, for example, as the ostium merges into the neck region of
the atrial appendage (not shown).
[0059] As shown in FIG. 5b, posterior portion 570 has barbs 575
distributed over a part of its exterior surface area close to
anterior portion 560. Alternatively, barbs 575 may be distributed
over all of the exterior surface area. When device 550 is
positioned and expanded in an ostium, barbs 575 engage the
surrounding ostium walls (and possibly neck region walls) to secure
device 550 in position.
[0060] Posterior portion 570 may optionally have suitable elastic
deformation properties that cause portion 570 to recoil slightly in
size from its largest expanded size. Such suitable deformation
properties may be obtained by design, for example, by choice of
fabrication materials with suitable elastic properties. The size
recoil of device 550 causes barbs 575 which have engaged the ostium
and/or neck region walls during the expansion of device 550 to pull
back and draw the walls closer to device 550. The expandable
structures in other device embodiments including those described
earlier (e.g., FIGS. 1-4, FIG. 5a) also may have similar size
recoil characteristics which cause attached anchors to engage and
draw surrounding wall tissue closer to the devices.
[0061] The various expandable implant devices (e.g., those
described above with reference to FIGS. 1-5) may have filter
elements for filtering harmful-size emboli out of the blood flowing
out from the atrial appendages into the atria. For effective
filtering, the filter elements should have appropriate hole size
distributions which filter out harmful-size emboli. Since the
implant devices are likely to be expanded to different sizes in
use, for example, to conform to the varying dimensions of
individual atrial appendages, the filter elements are configured so
that their hole size distributions do not change significantly
during the expansion of the device.
[0062] For example, FIG. 6 shows one configuration of filter
element 600 in which the size distribution of holes 610 does not
change significantly during device deployment. In the configuration
shown, filter element 600 is attached to elastic membrane 620.
Filter element 600 and elastic membrane 620 may, for example, be
made of a suitable membrane or fabric composed of bicompatible
materials, such as, for example, ePFTE (e.g., Gortex.RTM.),
polyester (e.g., Dacron.RTM.), PTFE (e.g., Teflon.RTM.), silicone,
urethane, metal fibers, or other biocompatible polymers. Filter 600
may have hole sizes ranging, for example, from about 50 to about
400 microns in diameter, suitable for filtering harmful-sized
emboli. This range of hole size distribution may be adequate to
make filter element 600 impervious to harmful-sized emboli, and yet
provide enough permeability for blood to flow through element 600.
The hole size distribution may be selected, for example, by
selecting the open weave density of the fabric used to make filter
600. Alternatively, for example, for filter elements made of solid
sheet material, other techniques such as laser drilling may be used
for making small diameter holes.
[0063] Filter element 600 and elastic membrane 620 are constructed
so that the former component is substantially less elastic than the
latter component. This difference in elasticity may be obtained,
for example, by using the same kind of material to make both
components, but by making filter element 600 substantially thicker
than elastic membrane 620. Alternatively, elastic membrane 620 and
filter 600 may be made of two different kinds of materials that
have different elastic properties. The two different material
components may be bonded or glued together.
[0064] Filter element 600 and elastic membrane 620 may be
incorporated in various types of implant device structures, for
example, membrane tube 120 FIG. 1a, expandable structure 310 FIG.
3a, proximal structure 510 FIG. 5a, and anterior portion 560 FIG.
5b. When the device incorporating these two components is expanded,
most of the concomitant stretching of the filter configuration due
to the increase in device size is accommodated by the stretching of
elastic membrane 620 leaving the size of filter element 600
substantially unchanged from its predetermined value.
[0065] It will be understood that the foregoing is only
illustrative of the principles of the invention, and that various
modifications can be made by those skilled in the art without
departing from the scope and spirit of the invention. It will be
understood that terms like "distal" and "proximal", anterior" and
"posterior", and other directional or orientational terms are used
herein only for convenience, and that no fixed or absolute
orientations are intended by the use of these terms.
* * * * *