U.S. patent application number 11/045026 was filed with the patent office on 2005-09-01 for devices, systems, and methods for closure of cardiac openings.
This patent application is currently assigned to NMT Medical, Inc.. Invention is credited to Carr, Robert M., Chanduszko, Andrzej J., Devellian, Carol A., Heneberry, Eileen M., Widomski, David R..
Application Number | 20050192626 11/045026 |
Document ID | / |
Family ID | 34891267 |
Filed Date | 2005-09-01 |
United States Patent
Application |
20050192626 |
Kind Code |
A1 |
Widomski, David R. ; et
al. |
September 1, 2005 |
Devices, systems, and methods for closure of cardiac openings
Abstract
The invention generally relates to devices, systems, and methods
for percutaneous closure of cardiac openings and obliteration of
the cardiac cul-de-sacs. In one embodiment, a closure device
includes a patch with an adhesive and/or a removable frame. The
patch may be placed across a cardiac opening, such as a patent
foramen ovale, or across a cardiac cul-de-sac, such as a left
atrial appendage. In another embodiment, a closure device includes
a balloon together with adhesives and/or substances for stimulating
tissue growth coated on, or contained within, the balloon. The
balloon may be inserted into a cardiac opening, such as the patent
foramen ovale, or into a cardiac cul-de-sac, such as a left atrial
appendage.
Inventors: |
Widomski, David R.;
(Wakefield, MA) ; Devellian, Carol A.; (Topsfield,
MA) ; Heneberry, Eileen M.; (Boston, MA) ;
Chanduszko, Andrzej J.; (Chandler, AZ) ; Carr, Robert
M.; (Paradise Valley, AZ) |
Correspondence
Address: |
KIRKPATRICK & LOCKHART NICHOLSON GRAHAM LLP
(FORMERLY KIRKPATRICK & LOCKHART LLP)
75 STATE STREET
BOSTON
MA
02109-1808
US
|
Assignee: |
NMT Medical, Inc.
Boston
MA
|
Family ID: |
34891267 |
Appl. No.: |
11/045026 |
Filed: |
January 27, 2005 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
60540474 |
Jan 30, 2004 |
|
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|
60540821 |
Jan 30, 2004 |
|
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|
60540827 |
Jan 30, 2004 |
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Current U.S.
Class: |
606/213 |
Current CPC
Class: |
A61B 2017/00606
20130101; A61B 2017/00592 20130101; A61B 17/12186 20130101; A61B
17/00491 20130101; A61B 17/1219 20130101; A61B 17/12122 20130101;
A61B 2017/00632 20130101; A61B 17/12136 20130101; A61B 17/0057
20130101; A61B 17/12195 20130101; A61B 2017/00575 20130101 |
Class at
Publication: |
606/213 |
International
Class: |
A61D 001/00 |
Claims
What is claimed is:
1. A system for percutaneous transluminal closure of a cardiac
opening, comprising: a balloon for application of an adhesive
comprising an outer surface, the balloon transitionable between a
deflated state and an inflated state; a catheter comprising a
length between a proximal end and a distal end, wherein said
balloon is joined to the distal end of the catheter; and a first
locator joined to said catheter, wherein said locator positions
said balloon in said cardiac opening.
2. The system of claim 1, wherein the first locator comprises a
disk.
3. The system of claim 1, wherein the first locator comprises a
plurality of arms.
4. The system of claim 1, wherein the first locator comprises a
rod.
5. The system of claim 1, wherein the first locator comprises a
locator balloon.
6-7. (canceled)
8. The system of claim 1 further comprising a second locator
coupled to at least one of the catheter and the balloon, the second
locator for positioning the closure device in the cardiac
opening.
9. The system of claim 1 further comprising an adhesive coated on
the first locator.
10. (canceled)
11. The system of claim 1, wherein the adhesive comprises a
cyanoacrylate.
12. The system of claim 1, wherein the adhesive comprises a fibrin
based adhesive.
13. The system of claim 1, wherein the adhesive comprises an
albumin gluteraldehyde type adhesive.
14. (canceled)
15. The system of claim 8 further comprising an adhesive coated on
the second locator.
16-18. (canceled)
19. The system of claim 1, wherein the adhesive comprises a light
activated adhesive.
20. The system of claim 1 further comprising a light source coupled
to the catheter for activating the light activated adhesive.
21. The system of claim 1 further comprising an adhesive coated on
an outer surface of the balloon.
22. (canceled)
23. The system of claim 1, wherein the balloon is
tubular-shaped.
24. The system of claim 1, wherein the balloon comprises a
plurality of holes.
25. (canceled)
26. The system of claim 24, wherein the adhesive is contained
within the balloon.
27. (canceled)
28. The system of claim 1, wherein the surface of the balloon is
involuted.
29. The system of claim 1, wherein the balloon is adapted to
deliver the adhesive from the inner lumen of the balloon to the
exterior surface of the balloon by capillary action.
30. The system of claim 1, wherein the balloon is detachable from
the distal end of the catheter.
31. The system of claim 30, wherein the first locator is attached
to the balloon.
32. The system of claim 1, wherein the adhesive comprises an
irritant.
33. The system of claim 1, wherein the adhesive comprises a tissue
growth stimulator.
34-226. (canceled)
Description
CROSS REFERENCE TO RELATED APPLICATIONS
[0001] This application incorporates by reference, and claims
priority to and the benefits of, U.S. Provisional Patent
Applications Ser. Nos. 60/540,474, 60/540,827, and 60/540,821, each
of which were filed on Jan. 30, 2004.
TECHNICAL FIELD
[0002] The invention generally relates to devices, systems, and
related methods for closing cardiac openings. More particularly,
the invention. features devices, systems, and related methods for
the percutaneous transluminal closure of patent foramen ovales and
left atrial appendages.
BACKGROUND
[0003] The human heart is divided into four compartments or
chambers. The left and right atria are located in the upper portion
of the heart and the left and right ventricles are located in the
lower portion of the heart. The left and right atria are separated
from each other by a muscular wall, the intraatrial septum, while
the ventricles are separated by the intraventricular septum.
[0004] Either congenitally or by acquisition, abnormal openings,
holes, or shunts can occur between the chambers of the heart or the
great vessels, causing blood to inappropriately flow therethrough.
Such deformities are usually congenital and originate during fetal
life when the heart forms from a folded tube into a four chambered,
two-unit system. The septal deformities result from the incomplete
formation of the septum, or muscular wall, between the chambers of
the heart and can cause significant problems.
[0005] One such septal deformity or defect, a patent foramen ovale,
is a persistent, one-way, usually flap-like opening in the wall
between the right atrium and left atrium of the heart. Since left
atrial pressure is normally higher than right atrial pressure, the
flap typically stays closed. Under certain conditions, however,
right atrial pressure exceeds left atrial pressure, creating the
possibility for right to left shunting that can allow blood clots
to enter the systemic circulation. This is particularly problematic
for patients who are prone to forming venous thrombus, such as
those with deep vein thrombosis or clotting abnormalities.
[0006] Moreover, certain patients are prone to atrial arrhythmias
(i.e., abnormal heart rhythms which can cause the heart to pump
less effectively). In a common such abnormality, atrial
fibrillation, the two upper chambers of the heart (i.e., the left
atria and the right atria), quiver instead of beating effectively.
Because the atria do not beat and empty cleanly during atrial
fibrillation, blood can stagnate on the walls and form clots that
can then pass through the heart and into the brain, causing a
stroke or a transient ischemic attack. These clots typically form
in a cul-de-sac in the heart called the left atrial appendage due
to its tendency to have low or stagnant flow.
[0007] Nonsurgical (i.e., percutaneous) closure of a patent foramen
ovale and similar cardiac openings such as an atrial septal defect
or a ventricular septal defect, and obliteration of a left atrial
appendage can be achieved using a variety of mechanical closure
devices. These closure devices typically consist of a metallic
structural framework with a scaffold material attached thereto.
Currently available closure devices, however, are often complex to
manufacture, are inconsistent in performance, require a technically
complex implantation procedure, lack anatomic conformability, and
lead to complications (e.g., thrombus formation, chronic
inflammation, residual leaks, perforations, fractures, and
conduction system disturbances).
[0008] Improved devices, systems, and related methods for closing
cardiac openings, such as, for example, a patent foramen ovale, and
for obliterating cardiac cul-de-sacs, such as, for example, a left
atrial appendage, are, therefore, needed.
SUMMARY OF THE INVENTION
[0009] The present invention provides devices, compounds, systems,
and related methods for closing cardiac openings. A device of the
invention may include, for example, a patch with an adhesive and/or
a removable frame. The patch can be placed across a cardiac
opening, such as a patent foramen ovale or a left atrial appendage,
to substantially occlude the cardiac opening. Alternatively, in
another aspect, the device includes a U-shaped patch, together with
an adhesive, that is specifically configured for attachment to a
septum secundum and closure of a patent foramen ovale.
[0010] Moreover, in another aspect, a compound may be used to
assist the device in closing, or may be used on its own to close, a
cardiac opening. For example, a compound that includes an adhesive
and a plurality of composite particles disposed within the adhesive
may be used in that regard. In one embodiment, the plurality of
composite particles disposed within the adhesive expand upon
contact with blood and/or water, thereby locking the compound into
place in the cardiac opening to substantially occlude the cardiac
opening.
[0011] In using the devices and compounds of the invention to close
cardiac openings, the aforementioned disadvantages associated with
the closure devices known in the art are minimized or
eliminated.
[0012] In one aspect, the invention provides a closure device for
percutaneous transvascular closure of a cardiac opening. The
closure device includes a patch, an adhesive coated on the patch,
and at least one hollow channel enclosed within the patch.
[0013] Various embodiments of this aspect of the invention include
the following features. The patch may include a bioresorbable
material and the adhesive may be a light activated adhesive, such
as, for example, an adhesive curable with ultraviolet light. The
hollow channel enclosed within the patch may, for its part, be a
conduit for light. The closure device may further include a fiber
optic cable, and/or a removable frame, enclosed within the hollow
channel. In another embodiment, the closure device includes a
divider that has first and second surfaces. The first surface is
coupled to the adhesive and the second surface is coated with a
primer.
[0014] In another aspect, the invention relates to a method for
percutaneous transluminal closure of a cardiac opening in a
patient. The method includes inserting a closure device as
described above into a heart of the patient and positioning the
closure device across the cardiac opening to substantially occlude
the cardiac opening.
[0015] In various embodiments of this aspect of the invention,
positioning the closure device across the cardiac opening includes
coupling the closure device to a tissue surface of the patient
proximate the cardiac opening. The cardiac opening may be, for
example, a patent foramen ovale or a left atrial appendage.
Coupling the closure device to the tissue surface may include
providing light to the hollow channel enclosed within the patch and
activating the adhesive coated on the patch with the provided
light. In another embodiment, coupling the closure device to the
tissue surface includes applying a primer to the tissue
surface.
[0016] In yet another aspect, the invention provides a closure
device for percutaneous transluminal closure of a cardiac opening.
The closure device includes a patch, at least one hollow channel
enclosed within the patch, and a removable frame enclosed within
the hollow channel.
[0017] In one embodiment of this aspect of the invention, the patch
is made from a collagen material. In another embodiment, the frame
is constructed from a shape memory alloy, such as, for example,
nitinol.
[0018] In still another aspect, the invention relates to a method
for percutaneous transluminal closure of a cardiac opening in a
patient. The method includes inserting a closure device as
immediately described above into a heart of the patient and
positioning the closure device across the cardiac opening to
substantially occlude the cardiac opening.
[0019] In various embodiments of this aspect of the invention,
positioning the closure device across the cardiac opening includes
coupling the closure device to a tissue surface of the patient
proximate the cardiac opening. The cardiac opening may be, for
example, a patent foramen ovale or a left atrial appendage. In one
embodiment, coupling the closure device to the tissue surface
includes thermally welding the closure device to the tissue
surface. In another embodiment, the frame of the closure device is
removed from within the hollow channel after the closure device is
thermally welded to the tissue surface.
[0020] In another aspect, the invention provides a closure device
for percutaneous transluminal closure of a cardiac opening. The
closure device includes a housing, a releasable patch coupled to
the housing, and an adhesive coated on the releasable patch.
[0021] In one embodiment of this aspect of the invention, the
housing is substantially conically shaped. In another embodiment,
the releasable patch includes a bioresorbable material. The
adhesive may be a light activated adhesive, such as, for example,
an adhesive curable with ultraviolet light. In yet another
embodiment, the closure device includes a light source enclosed
within the housing. The light source may be, for example, a light
bulb or a fiber optic cable. In still another embodiment, the
closure device includes a divider that has first and second
surfaces. The first surface is coupled to the adhesive and the
second surface is coated with a primer.
[0022] In yet another aspect, the invention relates to a method for
percutaneous transluminal closure of a cardiac opening in a
patient. The method includes inserting a closure device as
immediately described above into a heart of the patient and
positioning the releasable patch of the closure device across the
cardiac opening to substantially occlude the cardiac opening.
[0023] In various embodiments of this aspect of the invention,
positioning the releasable patch of the closure device across the
cardiac opening includes coupling the releasable patch to a tissue
surface of the patient proximate the cardiac opening. The cardiac
opening may be, for example, a patent foramen ovale or a left
atrial appendage. Coupling the releasable patch of the closure
device to the tissue surface may include providing a light source
emitting light within the housing and activating the adhesive
coated on the releasable patch with the emitted light. In another
embodiment, coupling the releasable patch to the tissue surface
includes applying a primer to the tissue surface. In yet another
embodiment, coupling the releasable patch to the tissue surface
includes separating the releasable patch from the housing.
[0024] Additionally, in another aspect, the invention provides a
closure device for percutaneous transvascular closure of a patent
foramen ovale. The closure device includes a U-shaped patch
configured for attachment to a septum secundum and an adhesive
coated on the U-shaped patch.
[0025] In one embodiment of this aspect of the invention, a
substance for stimulating tissue in-growth into the closure device
is coated on the U-shaped patch. The substance may be, for example,
a growth factor, a pharmacological agent to stimulate tissue
growth, an irritant to encourage an inflammatory response, cells,
or genes. In another embodiment, a substance for increasing
endothelization, or, alternatively, a substance for decreasing
thrombogenicity, such as, for example, heparin, is coated on the
U-shaped patch. In yet another embodiment, the closure device
includes at least one barrier coupled to the U-shaped patch. The
barrier may be a right atrial barrier for blocking an opening to
the patent foramen ovale from the right atrium, or, alternatively,
the barrier may be a left atrial barrier for blocking an opening to
the patent foramen ovale from the left atrium.
[0026] The U-shaped patch may include a biological material, a
bioresorable material, a synthetic material, a polymeric material,
a shape memory material, and/or a metallic mesh material. The
adhesive may be, for example, cyanoacrylate and/or a fibrin based
adhesive.
[0027] In a further aspect, the invention provides a method for
percutaneous transluminal closure of a patent foramen ovale in a
patient. The method includes inserting a closure device into a
heart of the patient and coupling the closure device to the septum
secundum to substantially occlude the patent foramen ovale. The
closure device includes a U-shaped patch configured for attachment
to a septum secundum and an adhesive coated on the U-shaped
patch.
[0028] In one embodiment of this aspect of the invention, coupling
the closure device to the septum secundum includes gluing the
closure device to the septum secundum.
[0029] In another aspect, the invention relates to a compound for
percutaneous transluminal closure of a cardiac opening. The
compound includes an adhesive and a plurality of composite
particles disposed within the adhesive. The composite particles are
capable of expansion upon contact with blood and/or water.
[0030] In various embodiments of this aspect of the invention, the
adhesive is a fibrin based adhesive. The composite particles may
be, for example, gelatin particles, biological particles,
bioresorbable particles, and/or foam particles.
[0031] In yet another aspect, the invention provides a method for
percutaneous transluminal closure of a cardiac opening in a
patient. The method includes providing a compound as described
above and injecting the compound into the cardiac opening to
substantially occlude the cardiac opening.
[0032] In one embodiment of this aspect of the invention, the
method further includes positioning a patch or a barrier across an
end of the cardiac opening, which may be, for example, a patent
foramen ovale or a left atrial appendage.
[0033] A device of the invention may further include specially
designed balloons together with adhesives and/or substances for
stimulating tissue growth coated on, or contained within, the
specially designed balloons. According to one feature of the
invention, the specially designed balloons ensure that the
adhesives are only exposed once the balloons are located within the
cardiac openings. Advantageously, the adhesives are exposed only to
the tissue surface of the cardiac openings and not to a patient's
blood prior to locating the balloons within the cardiac openings.
By minimizing the exposure of the adhesives to blood, the risk of
thrombus formation is reduced.
[0034] According to another feature of the invention, closure
systems employ one or more locators for initially locating the
cardiac openings and then properly positioning the balloons of the
invention within the cardiac openings. Knowing that a balloon is
properly positioned within a cardiac opening allows a physician to
release the adhesive contained within the balloon at the
appropriate time. As such, the risk of exposing the adhesive prior
to locating the balloon within the cardiac opening, and the
consequent risk of thrombus formation, is again reduced.
[0035] In one aspect, the invention provides a closure device for
percutaneous transluminal closure of a cardiac opening. The closure
device includes a balloon, which has an outer surface, and an
adhesive. The balloon is inflatable between a deflated state and an
inflated state. In the deflated state, the outer surface of the
balloon involutes to form a cavity and the adhesive is coated on a
surface of the cavity. In the inflated state, the cavity unfolds to
form the outer surface of the balloon and the adhesive is coated on
the outer surface of the balloon.
[0036] In one embodiment of this aspect of the invention, the
cavity is formed around a mid-portion of the balloon, which may be
tubularly-shaped. In another embodiment, the closure device further
includes a substance for stimulating tissue growth. In the deflated
state of the balloon, the growth substance is coated on the surface
of the cavity. In the inflated state of the balloon, the growth
substance is coated on the outer surface of the balloon.
[0037] In another aspect, the invention relates to a method for
percutaneous transluminal closure of a cardiac opening in a
patient. The method includes inserting a closure device as
described above into a heart of the patient, positioning the
closure device within the cardiac opening with the balloon of the
closure device deflated, and inflating the balloon to expose the
adhesive coated on the outer surface of the balloon to the cardiac
opening. In one embodiment of this aspect of the invention, the
balloon of the closure device is removed from the patient after the
adhesive is exposed to the cardiac opening.
[0038] In yet another aspect, the invention provides a closure
device that includes a balloon having an outer surface, a porous
band encircling only a portion of the outer surface of the balloon,
and an adhesive disposed between the outer surface of the balloon
and the porous band. The porous band has a plurality of
openings.
[0039] In one embodiment of this aspect of the invention, the
porous band encircles a center portion of the balloon, which may
be, for example, tubularly-shaped. In another embodiment, a
substance for stimulating tissue growth is disposed between the
outer surface of the balloon and the porous band.
[0040] In still another aspect, the invention relates to a method
that includes inserting a closure device as just described into a
heart of the patient, positioning the closure device within the
cardiac opening, and applying a pressure to the balloon of the
closure device to expose the adhesive through the plurality of
openings of the porous band to the cardiac opening. In one
embodiment of this aspect of the invention, the balloon and the
porous band of the closure device are removed from the patient
after the adhesive is exposed through the plurality of openings of
the porous band to the cardiac opening.
[0041] Additionally, in another aspect, the closure device includes
an outer balloon that has a plurality of first holes, an inner
balloon that has a plurality of second holes, and an adhesive. The
adhesive is contained within the inner balloon, which is itself
contained within the outer balloon.
[0042] In various embodiments of this aspect of the invention, at
least one of the plurality of first holes and the plurality of
second holes includes pores. Alternatively, in another embodiment,
at least one of the plurality of first holes and the plurality of
second holes includes slits. In yet another embodiment, at least
one of the inner balloon and the outer balloon is tubularly-shaped.
In another embodiment, a substance for stimulating tissue growth is
contained within the inner balloon.
[0043] In a further aspect, the invention relates to a method that
includes inserting a closure device as just described into a heart
of the patient, positioning the closure device within the cardiac
opening, applying a first pressure to the inner balloon to express
the adhesive through the plurality of second holes, and applying a
second pressure to the outer balloon to express the adhesive
through the plurality of first holes to the cardiac opening. In one
embodiment of this aspect of the invention, the outer balloon and
the inner balloon of the closure device are removed from the
patient after the adhesive is expressed through the plurality of
first holes to the cardiac opening.
[0044] In another aspect, the closure device includes a balloon and
an adhesive. The balloon has a membrane constructed from a wicking
material and the adhesive is contained within the membrane of the
balloon.
[0045] In one embodiment of this aspect of the invention, the
balloon is tubularly-shaped. In another embodiment, a substance for
stimulating tissue growth is contained within the membrane of the
balloon. At least a portion of the adhesive and/or the substance
for stimulating tissue growth may be absorbed within the membrane
of the balloon.
[0046] In yet another aspect, the invention relates to a method
that includes inserting a closure device as just described into a
heart of the patient, positioning the closure device within the
cardiac opening, and contacting a tissue surface of the cardiac
opening with the membrane of the balloon to apply the adhesive to
the tissue surface of the cardiac opening. In one embodiment of
this aspect of the invention, the balloon of the closure device is
removed from the patient after the adhesive is applied to the
tissue surface of the cardiac opening.
[0047] In various embodiments of the foregoing aspects of the
invention, the adhesives are cyanoacrylates, fibrin based
adhesives, albumin gluteraldehyde type adhesives, or light
activated adhesives. Moreover, the substances for stimulating
tissue growth may be, for example, growth factors, pharmacological
agents for stimulating tissue growth, irritants for encouraging an
inflammatory response, cells, or genes. The cardiac opening is, for
example, a patent foramen ovale or a left atrial appendage.
[0048] In still another aspect, the invention relates to a method
for percutaneous transluminal closure of a left atrial appendage in
a patient. The method includes inserting a closure device into a
heart of the patient and positioning the closure device within the
left atrial appendage. The closure device includes a balloon having
a plurality of holes and an adhesive contained within the balloon.
The method further includes applying a pressure to the balloon to
separate the plurality of holes and to expose the adhesive to the
left atrial appendage. The method also includes coupling the
balloon of the closure device to the left atrial appendage with the
exposed adhesive.
[0049] Additionally, in another aspect, the invention provides a
closure device that includes a balloon with an outer surface, a
first adhesive coated on the outer surface of the balloon, and a
light source located within the balloon.
[0050] In one embodiment of this aspect of the invention, the
closure device further includes a second adhesive coated on an
inner surface of the balloon. At least one of the first adhesive
and the second adhesive may be a light activated adhesive. In
another embodiment, the closure device further includes a divider
having first and second surfaces. The first surface of the divider
may be coupled to the first adhesive and the second surface of the
divider may be coated with a primer. The balloon may be made of an
elastomer, or, alternatively, a biological material, which may be,
for example, a collagen or a bioresorbable polymer. The balloon may
be tubularly-shaped.
[0051] In a further aspect, the invention relates to a method that
includes inserting a closure device as just described into a heart
of the patient, positioning the closure device within the cardiac
opening, and coupling the closure device to the cardiac opening to
substantially occlude the cardiac opening.
[0052] In various embodiments of this aspect of the invention,
coupling the closure device to the cardiac opening includes
inflating the balloon, emitting light from the light source located
within the balloon, and activating the adhesive coated on the outer
surface of the inflated balloon with the emitted light. The
inflated balloon may then be deflated and left behind in the
cardiac opening. Coupling the closure device to the cardiac opening
may also include applying a primer to a tissue surface of the
cardiac opening. The cardiac opening may be, for example, a patent
foramen ovale or a left atrial appendage.
[0053] In another aspect, the invention provides a percutaneous
transluminal system for positioning a closure device in a cardiac
opening. The system includes a catheter, a closure device coupled
to the catheter, and a first locator coupled to at least one of the
catheter and the closure device. The first locator is for
positioning the closure device within the cardiac opening.
[0054] In various embodiments of this aspect of the invention, the
first locator is a disk, a plurality of arms, a rod, or a balloon.
The first locator may be, for example, a right atrial locator or a
left atrial locator. In one embodiment, an adhesive, such as, for
example, a cyanoacrylate, a fibrin based adhesive, or an albumin
gluteraldehyde type adhesive, is coated on the first locator. In
another embodiment, the system further includes a second locator
coupled to at least one of the catheter and the closure device. The
second locator is also for positioning the closure device within
the cardiac opening.
[0055] In one embodiment, the system further includes an adhesive
coupled to the closure device. Again, the adhesive may be, for
example, a cyanoacrylate, a fibrin based adhesive, or an albumin
gluteraldehyde type adhesive. The adhesive coupled to the closure
device may alternatively be a light activated adhesive and the
system may further include a light source coupled to the catheter
for activating the light activated adhesive.
[0056] In another embodiment, the closure device is a balloon,
which may be, for example, tubularly-shaped. In one embodiment, the
balloon includes a first end, a second end, and a lumen extending
from the first end to the second end. In another embodiment, the
balloon includes a first opening at the first end of the balloon
and a second opening at the second end of the balloon. In yet
another embodiment, the balloon comprises a plurality of holes. An
adhesive may be coated on an outer surface of the balloon, coated
on an inner surface of the balloon, or simply contained within the
lumen of the balloon.
[0057] In still another aspect, the invention relates to a method
for delivering a closure device to a cardiac opening in a patient.
The method includes inserting, into a heart of the patient, a
system for positioning the closure device within the cardiac
opening. The system is as just described. The first locator of the
system is used to locate the cardiac opening and also to position
the closure device within the cardiac opening.
[0058] In various embodiments of this aspect of the invention, the
method further includes coupling the closure device to the cardiac
opening to substantially occlude the cardiac opening. The method
may also include coupling the first locator to a tissue surface of
the patient that is proximate the cardiac opening. The cardiac
opening may be, for example, a patent foramen ovale or a left
atrial appendage.
[0059] Additionally, in another aspect, the invention provides a
percutaneous transluminal system for closing a cardiac opening. The
system includes a first catheter having a proximal end, a distal
end, and a lumen extending from the proximal end to the distal end,
a second catheter at least partially enclosed within the lumen of
the first catheter, and a lining coupled to the first and second
catheters. The second catheter is movable between a retracted state
and a deployed state. In the retracted state of the second
catheter, the lining is positioned within the lumen of the first
catheter. In the deployed state of the second catheter, the lining
inverts and is positioned outside the lumen of the first
catheter.
[0060] In various embodiments of this aspect of the invention, the
lining is sock-shaped. Moreover, adhesives and/or substances for
stimulating tissue growth, of the types described above, may be
coated on a surface of the lining and/or contained within the
lining itself.
[0061] In a further aspect, the invention relates to a method for
percutaneous transluminal closure of a cardiac opening in a
patient. The method includes inserting a system as just described
into a heart of the patient, positioning the system proximate the
cardiac opening with the second catheter in a retracted state, and
deploying the second catheter to invert the lining and position the
lining within the cardiac opening.
[0062] In one embodiment of this aspect of the invention, the
system further includes an adhesive coated on a surface of the
lining and the adhesive is exposed to the cardiac opening when the
second catheter is deployed. In another embodiment, the lining
includes a plurality of holes and the system further includes an
adhesive contained within the lining. In such an embodiment, the
adhesive is exposed through the plurality of holes to the cardiac
opening when the second catheter is deployed. In yet another
embodiment, the system is removed from the patient after the
adhesive is exposed to the cardiac opening, which may be, for
example, a patent foramen ovale.
[0063] The foregoing and other aspects, features, and advantages of
the invention will become more apparent from the following
description taken in conjunction with the accompanying
drawings.
BRIEF DESCRIPTION OF THE DRAWINGS
[0064] In the drawings, like reference characters generally refer
to the same parts throughout the different views. Also, the
drawings are not necessarily to scale, emphasis instead generally
being placed upon illustrating the principles of the invention.
[0065] FIG. 1 is a cutaway view of a heart illustrating a patent
foramen ovale.
[0066] FIG. 2 is a partial cross-sectional view of another heart
illustrating a left atrial appendage.
[0067] FIG. 3 is a schematic perspective view of a system,
including a delivery catheter and a closure device, for the
percutaneous transluminal closure of a cardiac opening according to
an illustrative embodiment of the invention.
[0068] FIGS. 4A-4B illustrate extended and folded configurations of
a frame for the closure device illustrated in FIG. 3, according to
an illustrative embodiment of the invention.
[0069] FIG. 5 is a schematic perspective view of a system,
including a delivery catheter and a closure device, for the
percutaneous transluminal closure of a cardiac opening according to
another illustrative embodiment of the invention.
[0070] FIG. 6 is a schematic cross-sectional view of a system,
including a delivery catheter and a closure device, for the
percutaneous transluminal closure of a cardiac opening according to
another illustrative embodiment of the invention.
[0071] FIG. 7 is a schematic side view of a closure device for the
percutaneous transluminal closure of a cardiac opening according to
another illustrative embodiment of the invention.
[0072] FIG. 8 is a schematic side view of a closure device,
according to another illustrative embodiment of the invention,
coupled to the septum secundum and the septum primum of a patent
foramen ovale.
[0073] FIG. 9 is a schematic side view of a closure device,
according to another illustrative embodiment of the invention,
coupled to the septum secundum and the septum primum of a patent
foramen ovate.
[0074] FIG. 10 is a schematic side view of a closure device,
according to another illustrative embodiment of the invention,
coupled to the septum secundum and the septum primum of a patent
foramen ovale.
[0075] FIGS. 11A-11C illustrate the stages, according to an
illustrative embodiment of the invention, for closing a patent
foramen ovale in a patient.
[0076] FIG. 11D illustrates a left atrial appendage closed
according to an illustrative embodiment of the invention.
[0077] FIG. 11E-11F illustrates the stages, according to another
illustrative embodiment of the invention, for closing a patent
foramen ovale in a patient.
[0078] FIG. 12 is a schematic side view of the illustrative closure
device of FIG. 7 coupled to the septum secundum of a patent foramen
ovale.
[0079] FIG. 13 illustrates a compound for the percutaneous
transluminal closure of a cardiac opening according to an
illustrative embodiment of the invention.
[0080] FIG. 14 is a schematic side view of a closure system
according to an illustrative embodiment of the invention.
[0081] FIG. 15 is a schematic perspective view of a closure system
according to another illustrative embodiment of the invention.
[0082] FIG. 16 is a schematic side view of a closure system
according to another illustrative embodiment of the invention.
[0083] FIG. 17 is a schematic side view of a closure system
according to another illustrative embodiment of the invention.
[0084] FIG. 18 is a schematic perspective view of an inflated
balloon according to an illustrative embodiment of the
invention.
[0085] FIG. 19 is a schematic perspective view of the illustrative
balloon of FIG. 17 deflated according to an illustrative embodiment
of the invention.
[0086] FIG. 20 is a schematic cross-sectional view of the
illustrative balloon of FIG. 19 taken along the line 19-19.
[0087] FIG. 21 is a schematic cross-sectional view of the
illustrative balloon of FIG. 20 inflated according to an
illustrative embodiment of the invention.
[0088] FIG. 22 is a schematic perspective view of a deflated
balloon according to another illustrative embodiment of the
invention.
[0089] FIG. 23 is a schematic perspective view of a balloon
according to another illustrative embodiment of the invention.
[0090] FIG. 24 is a schematic cross-sectional view of the
illustrative balloon of FIG. 23 taken along the line 23-23.
[0091] FIG. 25 is a schematic cross-sectional view of a balloon
according to another illustrative embodiment of the invention.
[0092] FIG. 26 is a schematic cross-sectional view of concentric
balloons according to another illustrative embodiment of the
invention.
[0093] FIG. 27 is a schematic cross-sectional view of a balloon
according to another illustrative embodiment of the invention.
[0094] FIG. 28 is a schematic cross-sectional view of a balloon
according to another illustrative embodiment of the invention.
[0095] FIG. 29 is a schematic cross-sectional view of the
illustrative balloon of FIG. 28 taken along the line 28-28.
[0096] FIG. 30 is a schematic side view of a closure system,
including a retracted sock catheter, according to another
illustrative embodiment of the invention.
[0097] FIG. 31 is a schematic side view of the illustrative closure
system of FIG. 30, including a deployed sock catheter.
[0098] FIGS. 32A-32D illustrate the stages, according to an
illustrative embodiment of the invention, for closing a patent
foramen ovale in a patient.
[0099] FIGS. 33A-33E illustrate the stages, according to another
illustrative embodiment of the invention, for closing a patent
foramen ovale in a patient.
[0100] FIGS. 34A-34B illustrate the stages, according to another
illustrative embodiment of the invention, for closing a patent
foramen ovale in a patient.
DESCRIPTION
[0101] The present invention features devices, systems, and related
methods for closing cardiac openings, such as, for example, the
patent foramen ovale described below, and for obliterating cardiac
cul-de-sacs, such as, for example, the left atrial appendage
described below.
[0102] FIG. 1 depicts a cutaway view of a heart 20. The heart 20
includes a septum 24 that divides a right atrium 26 from a left
atrium 32. The septum 24 includes a septum secundum 36 and a septum
primum 40. An exemplary cardiac opening, a patent foramen ovale 44,
that is to be corrected by the devices, systems, and related
methods of the present invention is located between the septum
secundum 36 and the septum primum 40. The patent foramen ovale 44
provides an undesirable fluid communication between the right
atrium 26 and the left atrium 32 and, under certain conditions,
allows for the shunting of blood between the right atrium 26 and
the left atrium 32. If the patent foramen ovale 44 is not closed or
obstructed in some manner, a patient is placed at a higher risk for
an embolic stroke in addition to other circulatory
abnormalities.
[0103] FIG. 2 depicts a partial cross-sectional view of another
heart 60. The heart 60 includes an aorta 64, a left ventricle 68, a
left atrium 72, and a fossa ovalis 76. The heart 60 also includes
an exemplary cardiac cul-de-sac, a left atrial appendage 80, that
is to be obliterated by the devices, systems, and related methods
of the present invention. Under certain conditions, blood clots may
form in the left atrial appendage 80. If the left atrial appendage
80 is not closed or obstructed in some manner, a patient is placed
at a higher risk of having the blood clots pass from the heart 60
and into the vasculature of the brain, causing a stroke or a
transient ischemic attack.
[0104] In broad overview, embodiments of the devices of the
invention typically include a patch or a balloon. Referring to
embodiments that include a patch, an adhesive may be coated on the
patch and the adhesive may require activation (e.g., light
activation) to bond the patch to a patient's tissue surface. In one
embodiment, to close a patient's cardiac opening, the patch is
placed across the cardiac opening and the adhesive activated to
bond the patch to the patient's tissue. The cardiac opening is
thereby substantially occluded.
[0105] In another embodiment, a removable frame is enclosed within
the patch. In one such embodiment, to substantially occlude the
cardiac opening, the patch is placed across the cardiac opening and
thermally welded to the patient's tissue. The frame is then removed
from the patch.
[0106] In yet another embodiment, the patch is a U-shaped patch
that is bonded to a septum secundum of a patent foramen ovale. The
U-shaped patch includes, for example, a barrier that is attached to
a septum primum to substantially occlude the patent foramen ovale.
Alternatively, the U-shaped patch includes, for example, a
substance that stimulates tissue growth from the septum secundum
and/or the septum primum. In such a case, the patent foramen ovale
is encouraged to heal itself.
[0107] Compounds of the invention may be employed on their own, or
in conjunction with the devices of the invention, to occlude the
cardiac openings described herein. Typically, the compounds are
first physically injected or otherwise applied into the cardiac
openings and thereafter expand to substantially occlude the cardiac
openings.
[0108] FIG. 3 depicts a system 100, capable of being used for the
percutaneous transluminal closure of a cardiac opening, according
to an illustrative embodiment of the invention. The system 100
includes a closure device 104 and a delivery catheter 108 that is
used to deliver the closure device 104 to the cardiac opening in a
patient's heart. In one embodiment, the delivery catheter 108
includes a proximal end 112 (i.e., an end that is closest to a
physician when the physician is using the system 100), an opposite,
distal end 116, and a lumen 120 that extends from the proximal end
112 to the distal end 116.
[0109] For its part, in one embodiment, the closure device 104
includes a patch 124 and at least one hollow channel 136 enclosed
within the patch 124. For example, as illustrated, the patch 124
includes a plurality of hollow channels 136 extending from a common
center similar to spokes of a wheel. The closure device 104 is
coupled to the distal end 116 of the delivery catheter 108 such
that the lumen 120 of the delivery catheter 108 is contiguous with
the hollow channels 136 enclosed within patch 124. In one
embodiment, the closure device 104 is releasably coupled to the
distal end 116 of the delivery catheter 108. For example, the
closure device 104 is coupled to the distal end 116 of the delivery
catheter 108 so that it may be separated from the delivery catheter
108 through the application of a force, such as a torsional force
applied by the physician to the proximal end 112 of the delivery
catheter 108 and transmitted along the delivery catheter 108 to the
point of coupling with the closure device 104.
[0110] The lumen 120 of the catheter 108 and the hollow channels
136 may be used, for example, as conduits to channel light through
the delivery catheter 108 and the patch 124. In one embodiment, for
example, a physician using the system 100 positions a light source
(not shown) proximal to the proximal end 112 of the delivery
catheter 108, or at some other point within the lumen 120 of the
delivery catheter 108, and projects light down the lumen 120 and
through the hollow channels 136 of the patch 124. Alternatively, in
another embodiment, the lumen 120 and the hollow channels 136
enclose one or more fiber optic cables for delivering light through
the delivery catheter 108 and the patch 124. In such a case, the
fiber optic cables are connected at their proximal ends to a source
of illumination. The light serves to activate adhesive 128 to bond
the patch 124 to a patient's tissue.
[0111] Referring to FIG. 4A, in yet another embodiment, the lumen
120 and the hollow channels 136 enclose a continuous frame 110. The
frame 110 may be constructed from a shape memory alloy, such as,
for example, from nitinol or, alternatively from a polymer,
stainless steel, or any combination of the above materials. In one
embodiment, the frame 110 is used as a means for expanding the
patch 124 of the closure device 104 and as a means for holding the
patch 124 flush against a patient's tissue surface proximate the
cardiac opening. In a further embodiment, the frame 110 may include
a plurality of arms having springs or resilient coils 113 that
cause the closure device 104 to expand. Referring to FIG. 4B, in
one embodiment, a physician advances a sheath 400 into a patient's
heart and positions the distal end 404 of the sheath proximate the
cardiac opening. This is described below with reference to FIGS.
11A and 11B. During advancement of the closure device 104 through
the sheath 400, the arms 111 of frame 110 may bend at the springs
or resilient coils 113 to facilitate passage of the closure device
through the sheath 400. The frame 110 may also be coupled at its
proximal end to a power supply and used to deliver radio frequency
energy to a tissue surface proximate the cardiac opening.
[0112] In a particular embodiment, the fiber optic cables and/or
the frame 110 may be removable from the patch 124 after the patch
124 is coupled to a patient's tissues proximate the cardiac
opening. For example, the fiber optic cables and/or the frame 110
may be retracted from the hollow channels 136 of the patch 124 into
the contiguous lumen 120 of the delivery catheter 108.
[0113] Referring again to FIG. 3, in one embodiment, an adhesive
128 is applied to the patch 124 as a coating. For example, the
adhesive 128 is coated on a distal side 132 of the patch 124, or,
alternatively, on a proximal side 130 of the patch 124 (not shown).
The adhesive 128 may be, for example, a light activated adhesive,
such as an adhesive curable with ultraviolet light. To bond the
patch 124 to a patient's tissue surface proximate the cardiac
opening, light may be delivered through the delivery catheter 108
and the patch 124 to the adhesive 128 and used to activate the
adhesive 128.
[0114] Alternatively in still other embodiments, the adhesive 128
may be a heat activated adhesive, a chemically activated adhesive,
or a bioreactive adhesive. In such alternative embodiments, the
lumen 120 and hollow channels 136 are used to deliver heat,
chemicals, or biological agents, respectively, to the adhesive 128.
For example, the lumen 120 and hollow channels 136 may enclose a
pipe to bidrectionally carry hot water proximate a heat activated
adhesive 128. Alternatively, radio frequency energy (delivered, for
example, by the frame 110 enclosed within the lumen 120 and the
hollow channels 136), electrical resistance, ultrasound energy,
laser energy, or chemical energy may be supplied to the heat
activated adhesive 128.
[0115] In yet another embodiment, the adhesive 128, rather than
being initially coated on the distal side 132 or on the proximal
side 130 of the patch 124, is introduced to the distal side 132 or
to the proximal side 130 of the patch 124 via the lumen 120 and the
hollow channels 136. For example, in one embodiment illustrated in
FIG. 3, holes 137, which pass from the hollow channels 136 to the
surface of the patch 124, are present on the distal side 132 or on
the proximal side 130 of the patch 124 in the region of the hollow
channels 136. When the physician is ready to adhere the patch 124
to the patient's tissues proximate the intracardiac defect, the
physician injects the adhesive 128 through the lumen 120, through
the hollow channels 136, and through the holes 137 to the surface
of the distal side 132 or the surface of the proximal side 130 of
the patch 124.
[0116] In embodiments where the patch 124 includes the adhesive
128, the patch 124 may be made, either entirely or in part, from a
biological material, a bioresorbable material (e.g., polylactide,
glycolide, or caprolactone), a synthetic material (e.g., polyester,
expanded polytetrafluoroethylene (ePTFE), or polyvinyl alcohol), a
polymeric material, a shape memory material (e.g., a shape memory
alloy), a metal mesh, or other suitable material for closing a
cardiac opening, such as combinations of these materials. Moreover,
portions of the patch 124 proximate the hollow channels 136 may be
made from a translucent material.
[0117] In some embodiments, the closure device 104 is devoid of the
adhesive 128. In such embodiments, radio frequency energy is
delivered via the frame 110 and the patch 124 is thermally welded
to a patient's tissue surface proximate the cardiac opening. In
such embodiments, the patch 124 is typically made from a biological
material. For example, the patch 124 is made from a collagen based
material derived from the intestine, stomach, skin, bladder, or
pericardium of a porcine animal, a bovine animal, and/or a
human.
[0118] Referring still to FIG. 3, the patch 124 may be disk-shaped
and have a circular cross-section. Alternatively, the patch 124 may
have a variety of other cross-sectional shapes suitable for closing
a cardiac opening, including, but not limited to, rectangular and
triangular. The patch 124 may also include one or more radio-opaque
markers or radio-opaque fillers to indicate its position within a
patient's body.
[0119] FIG. 5 depicts a system 100, capable of being used for the
percutaneous transluminal closure of a cardiac opening, according
to another illustrative embodiment of the invention. As shown, the
closure device 104 of the system 100 further includes a removable
divider 144, such as, for example, a non-reactive sheet 144, having
a first surface 148 and a second surface 152. In the context of
divider 144, non-reactive means that the divider does not
appreciably adhere to adhesive 128, nor interact with material,
such as a primer, that may be coated onto a surface of divider 144.
The first surface 148 of the removable divider 144 contacts the
adhesive 128 of the closure device 104. Coated on the second
surface 152 of the removable divider 144 is a primer 156. In one
embodiment, the primer 156 prepares the tissue surface of the
patient to which the closure device 104 will be adhered during the
process of closing the patient's cardiac opening. In another
embodiment, the primer 156 helps to activate the adhesive 128
and/or bond the adhesive 128 to the patient's tissue surface. After
application of the primer 156 to the tissue surface proximate the
cardiac opening, the removable divider 144 may be removed from the
rest of the closure device 104. In one embodiment, sutures 145,
illustrated in FIG. 5, are attached to the removable divider 144 at
a point 146 on the edge of the removable divider 144. The physician
may remove the removable divider 144 from the rest of the closure
device 104 by applying traction to the proximal end 147 of the
suture, and withdrawing the removable divider 144 through a
perforation 149 in the delivery catheter 108.
[0120] In one embodiment, illustrated in FIG. 5, the adhesive 128
is coated on a distal side 132 of the patch 124. The removable
divider 144 and the primer 156 are therefore also located distal to
the patch 124. Alternatively, in another embodiment, the adhesive
128 is coated on a proximal side 130 of the patch 124 (not shown).
In such an embodiment, the removable divider 144 and the primer 156
are located proximal to the patch 124.
[0121] FIG. 6 depicts a system 200, capable of being used for the
percutaneous transluminal closure of a cardiac opening, according
to another illustrative embodiment of the invention. The system 200
includes a closure device 204 and a delivery catheter 208 that is
used to deliver the closure device 204 to the cardiac opening in a
patient's heart. The delivery catheter 208 includes a proximal end
212 (i.e., an end that is closest to a physician when the physician
is using the system 200) and an opposite, distal end 216. In one
embodiment, the closure device 204 includes a housing 222, a
releasable patch 224 coupled to a distal surface 226 of the housing
222, and an adhesive 228 coated on a distal side 232 of the
releasable patch 224.
[0122] In one embodiment, as illustrated in FIG. 6, the housing 222
is conically shaped, with the distal surface 226 of the housing 222
forming the base of the cone and the apex 218 of the cone being
coupled to the distal end 216 of the delivery catheter 208.
Alternatively, the housing 222 may be otherwise shaped, for example
as a tetrahedron with the distal surface 226 of the housing 222
forming the triangular base of the tetrahedron and the apex 218 of
the tetrahedron being coupled to the distal end 216 of the delivery
catheter 208. Enclosed within the housing 222 is, in one
embodiment, a light source 236. The light source 236 may be, for
example, a light bulb or a fiber optic cable that is used to
deliver light to, for example, a light activated adhesive 228
located at the distal surface 226 of the housing 222.
[0123] As described above for the closure device 104, the
releasable patch 224 of the closure device 204 may be made, either
entirely or in part, from biological materials, bioresorbable
materials, synthetic materials, polymeric materials, shape memory
materials, and/or metal meshes. Moreover, portions of the
releasable patch 224 may be made from a translucent material and
may include one or more radio-opaque markers or radio-opaque
fillers to indicate the anatomical position of the releasable patch
224 within a patient's body.
[0124] Referring still to FIG. 6, the releasable patch 224 of the
closure device 204 may be disk-shaped and have a circular
cross-section to match the shape of the distal surface 226 of the
housing 222. Alternatively, the releasable patch 224 may have a
variety of other cross-sectional shapes suitable for closing a
cardiac opening. Where, for example, the housing 222 is shaped as a
triangular prism, the releasable patch 224 may have a triangular or
rectangular cross-section to match the shape of the distal surface
226 of the housing 222.
[0125] In one embodiment according to the invention, the adhesive
228, coated to the distal side 232 of the releasable patch 224, is
a light activated adhesive. For example, the adhesive 228 is an
adhesive curable with ultraviolet light. Alternatively, in other
embodiments, the adhesive 228 may be a heat activated adhesive, a
chemically activated adhesive, or a bioreactive adhesive. In such
alternative embodiments, the light source 236 is replaced by other
devices. For example, to deliver heat to a heat activated adhesive
228, a pipe may be used to bidirectionally carry hot water
proximate the heat activated adhesive 228. Alternatively,
electrical resistance, radio frequency energy, ultrasound energy,
laser energy, or chemical energy is delivered to a heat activated
adhesive 228. In still other embodiments, chemicals are delivered
to a chemically activated adhesive 228 or biological agents are
delivered to a bioreactive adhesive 228.
[0126] As described above with respect to FIG. 5 for the closure
device 104, the closure device 204 may similarly further include a
removable divider 244 having a primer 256 coated on its second
surface 252. As illustrated in FIG. 6, the removable divider 244
separates the adhesive 228 from the primer 256.
[0127] FIG. 7 depicts a closure device 304, capable of being used
for the percutaneous transluminal closure of a patent foramen
ovale, according to another illustrative embodiment of the
invention. As illustrated, the exemplary closure device 304
includes a U-shaped patch 324 and an adhesive 328. In one
embodiment, the U-shaped patch 324 includes an outer surface 306
and an inner surface 310 to which the adhesive 328 is coated. The
U-shaped patch is specifically configured for attachment to a
septum secundum 36 of a patent foramen ovale.
[0128] The U-shaped patch 324 may be made from the biological
materials, the bioresorbable materials, the synthetic materials,
the polymeric materials, the shape memory materials, and/or the
metal meshes described above, or from other suitable materials for
closing a patent foramen ovale, such as combinations of these
materials. For its part, the adhesive 328 may be, for example, a
cyanoacrylate, a fibrin based adhesive, and/or a light activated
adhesive.
[0129] In one embodiment, the U-shaped patch 324 further includes
on its outer surface 306, i.e., convex surface, and/or on its inner
surface 310, i.e., concave surface, a substance that stimulates
in-growth of the patient's tissue into the patent foramen ovale
following placement of the closure device 304 on the septum
secundum 36 of the patent foramen ovale. In one embodiment, the
growth substance is, for example, a growth factor, such as a
vascular endothelial growth factor, a basic fibro growth factor, or
an angiogenic growth factor. In another embodiment, the growth
substance is a pharmacological agent for stimulating tissue growth,
such as, for example, growth of cells or expression of genes.
Alternatively, in another embodiment, the growth substance is a
topical irritant for encouraging an inflammatory response, such as,
for example, cotton seed oil or alcohol.
[0130] In one embodiment, because the closure device 304 is placed
on the septum secundum 36, the growth substance is delivered to, or
impregnated within, the septum secundum 36 and the tissue in-growth
into the patent foramen ovale therefore occurs from the septum
secundum 36. In another embodiment, the natural hydraulic pressure
difference between the right atrium 26 and the left atrium 32
eventually causes the septum primum 40 to contact the closure
device 304 that has been coupled to the septum secundum 36. In such
a case, the growth substance coated on the outer surface 306 of the
closure device 304 would contact the septum primum 40 and be
delivered to, or impregnated within, the septum primum 40. Tissue
in-growth into the patent foramen ovale would therefore occur from
the septum primum 40. The newly grown tissue leads to the closure
of the patent foramen ovale.
[0131] In yet another embodiment, a substance for increasing
endothelization, or, alternatively, a substance for decreasing
thrombogenicity, such as, for example, heparin, is coated on the
outer surface 306 and/or on the inner surface 310 of the U-shaped
patch 324.
[0132] FIGS. 8, 9, and 10 depict, according to further illustrative
embodiments of the invention, the exemplary closure device 304 of
FIG. 7 coupled to the septum secundum 36 of a patent foramen ovale.
As shown in each of FIGS. 8, 9, and 10, the closure device 304 may
further include at least one barrier 314 coupled to the U-shaped
patch 324. For example, the closure device 304 may include a right
atrial barrier 314A, as shown in FIG. 8, for blocking an opening to
the patent foramen ovale from the right atrium 26, a left atrial
barrier 314B, as shown in FIG. 9, for blocking an opening to the
patent foramen ovale from the left atrium 32, or, alternatively,
both a right atrial barrier 314A and a left atrial barrier 314B, as
shown in FIG. 10. In one embodiment, the right atrial barrier 314A
and/or the left atrial barrier 314B include(s) an adhesive for
bonding the barrier 314 to the septum primum 40, as shown. In
another embodiment, the right atrial barrier 314A and/or the left
atrial barrier 314B include(s), as described above for the U-shaped
patch 324, a substance that stimulates tissue in-growth into the
closure device 304 following placement of the closure device 304 on
the septum secundum 36 of the patent foramen ovale.
[0133] In another aspect, the invention provides methods for
percutaneously closing a cardiac opening in a patient. FIGS.
11A-11C depict the steps of an illustrative method for closing a
cardiac opening in a patient using the closure device 104 of the
invention. Similar steps, with appropriate differences described
below, are also performed in closing a cardiac opening in a patient
using the closure device 204 of the invention. The cardiac opening
illustrated in FIGS. 11A-11C is a patent foramen ovale. However, as
described below, the methods of the invention may also be used to
close or obliterate a left atrial appendage.
[0134] Referring to FIG. 11A, in one embodiment, an operator such
as a physician advances a sheath 400 into the patient's heart and
positions a distal end 404 of the sheath 400 proximate the cardiac
opening. The physician then advances the system 100, including the
closure device 104 and the delivery catheter 108, into and through
a lumen 408 of the sheath 400. The physician continues to advance
the system 100 though the lumen 408 of the sheath 400 until the
closure device 104 exits the distal end 404 of the sheath 400 and
expands to a position proximate the cardiac opening, as illustrated
in FIG. 11B. The closure device 104 may be made to expand by any of
a variety of means. For example, the shape memory frame 110
described above may cause the closure device 104 to expand.
Alternatively, the patch 124 of the closure 104 may itself be made
from a shape memory material, such as a shape memory alloy.
[0135] Where the closure device 104 includes both the adhesive 128
and the removable divider 144 containing the primer 156 (see FIG.
5), in order to couple the closure device 104 to a tissue surface
of the patient proximate the cardiac opening, the physician first
applies the primer 156 to the tissue surface. In one embodiment,
the physician advances the closure device 104 distally to contact
the patient's tissue surface with the primer 156 contained on the
second surface 152 of the removable divider 144. The physician then
withdraws the closure device 104 proximally to separate it from the
patient's tissues and removes the removable divider 144 from about
the rest of the closure device 104.
[0136] After applying the primer 156 to the patient's tissues
proximate the cardiac opening and removing the removable divider
144, the physician advances the closure device 104 to contact the
patient's tissue proximate the cardiac opening with the distal side
132 of the patch 124. In one embodiment, the adhesive 128 is coated
on the surface of the distal side 132 of patch 124 and is therefore
immediately applied to the patient's tissues. In another
embodiment, after contacting the patient's tissues with the distal
side 132 of the patch 124, the physician injects the adhesive 128
through the lumen 120, through the hollow channels 136, and through
holes 137 on the distal side 132 of the patch 124 to apply the
adhesive 128 to the patient's tissue.
[0137] With the adhesive 128 of the closure device 104 in contact
with the patient's tissues proximate the cardiac opening, the
physician activates the adhesive 128 to cure the adhesive 128 to
the patient's tissues. Specifically, for a light activated adhesive
128, the physician provides light to the hollow channels 136
enclosed within the patch 124, thereby activating the adhesive 128.
In another embodiment, where the physician uses the closure device
204 to close the cardiac opening (see FIG. 6), the physician causes
the light source 236 enclosed within the housing 222 of the closure
device 204 to emit light. The housing 222 prevents the blood in the
area surrounding the closure device 204 from blocking, or otherwise
interfering with, the passage of emitted light. The housing 222
therefore ensures that the emitted light reaches the adhesive 228
to activate the adhesive 228.
[0138] Once the adhesive 128 has cured to the patient's tissue
proximate the cardiac opening, the physician separates the patch
124 of the closure device 104 from the delivery catheter 108 of the
system 100, or, alternatively, separates the releasable patch 224
of the closure device 204 from the housing 222 of the closure
device 204. For example, the physician causes the patch 124 or the
releasable patch 224 to break away from the delivery catheter 108
or the housing 222, respectively, by applying a torque.
Alternatively, a variety of other mechanical means may be used to
separate the patch 124 from the delivery catheter 108 or the
releasable patch 224 from the housing 222. Accordingly, the patch
124 of the closure device 104, or the releasable patch. 224 of the
closure device 204, is positioned across the cardiac opening to
substantially occlude the cardiac opening. For instance, as
illustrated in FIG. 11C, the patch 124 is positioned across a
patent foramen ovale. In another embodiment, steps similar to those
described above are performed to position the patch across a left
atrial appendage 80, as illustrated in FIG. 11D.
[0139] Alternatively, in another embodiment, as described above,
the hollow channels 136 of the patch 124 of the closure device 104
enclose the frame 110, but the closure device 104 does not also
include the adhesive 128 or the removable divider 144 containing
the primer 156. In such an embodiment, following the exit, and the
expansion, of the closure device 104 from the distal end 404 of the
sheath 400, as illustrated in FIG. 11B, the physician contacts the
patient's tissues proximate the cardiac opening with the patch 124
of the closure device 104 and thermally welds the patch 124 to the
patient's tissues. More specifically, in one embodiment, the
physician generates a radio frequency current through the frame 110
enclosed within the hollow channels 136 of the patch 124. The
resultant radio frequency energy applied to the patient's tissues
proximate the cardiac opening, and to the patch 124 itself, heats
the patient's tissues and the biological material from which the
patch 124 is made. By applying this heat, and by also pressing the
patch 124 against the patient's tissues proximate the cardiac
opening, the physician fuses the patch 124 to the patient's
tissues. Accordingly, the patch 124 of the closure device 104 is
positioned across the cardiac opening to substantially occlude the
cardiac opening. In one embodiment, the physician then retracts the
frame 110 from within the patch 124 and removes the frame 110,
along with the sheath 400 and the delivery catheter 108, from the
patient's body.
[0140] In accordance with the methods described above, where the
cardiac opening under repair is a patent foramen ovale, the closure
device 104 may be deployed in the right atrium 26, as illustrated
in FIG. 11B, and the patch 124 may be bonded to the right atrial
walls of the septum primum 40 and the septum secundum 36, as
illustrated in FIG. 11C. Alternatively, in another embodiment in
accordance with the methods described above, the sheath 400 is
advanced through the patent foramen ovale and the closure device
104 is deployed in the left atrium 32, as illustrated in FIG. 11E.
In such an embodiment, by proximally withdrawing the closure device
104 to contact the left atrial walls of the septum primum 40 and
the septum secundum 36, the patch 124 may be bonded thereto, as
illustrated in FIG. 11F, in any of the manners described above.
[0141] Alternatively, in yet another embodiment, to substantially
occlude a cardiac opening or to obliterate a left atrial appendage,
the physician places the patch 124 within the cardiac opening or
the left atrial appendage, and bonds it thereto.
[0142] To percutaneously close a patent foramen ovale using the
closure device 304 of the invention, the physician first performs
essentially the same steps as illustrated and described above with
respect to FIGS. 11A and 11B. More specifically, in one embodiment,
the physician positions the distal end 404 of the sheath 400
proximate the patent foramen ovale and advances the closure device
304, by means of a delivery catheter attached to the closure device
304, into and through the lumen 408 of the sheath 400 until the
closure device 304 exits the distal end 404 of the sheath 400 and
expands to a position proximate the patent foramen ovale.
[0143] Because the septum secundum 36 is rather thick in comparison
to the septum primum 40, the physician then couples the inner
surface 310 of the closure device 304, which contains the adhesive
328, to the septum secundum 36. Once the adhesive 328 has cured and
glued to the septum secundum 36, the physician removes the delivery
catheter from about the U-shaped patch 324 of the closure device
304, leaving the closure device 304 attached to the patient's
septum secundum 36, as illustrated in FIG. 12.
[0144] As described above, the U-shaped patch 324 may include a
substance that stimulates in-growth of the patient's tissue into
the closure device 304 from either the septum secundum 36, the
septum primum 40, or both the septum secundum 36 and the septum
primum 40. Following placement of the closure device 304 on the
septum secundum 36, as illustrated in FIG. 12, this tissue
in-growth may be relied upon to substantially occlude the patent
foramen ovale. Alternatively, as illustrated in FIGS. 8, 9, and 10,
the closure device 304 may be further provided with either a right
atrial barrier 314A, a left atrial barrier 314B, or both the right
atrial barrier 314A and the left atrial barrier 314B to assist in
closing the patent foramen ovale. The barriers 314A, 314B may
include adhesives and may be bonded to the septum primum 40, as
shown. Moreover, the barriers 314A, 314B may include substances
that stimulate tissue in-growth into the closure device 304 from
either the septum secundum 36, the septum primum 40, or both the
septum secundum 36 and the septum primum 40.
[0145] In yet another aspect, the invention provides a compound for
percutaneous transluminal closure of a cardiac opening, such as a
patent foramen ovale, or for percutaneous transluminal obliteration
of a cardiac cul-de-sac, such as a left atrial appendage. In one
embodiment, the compound is used alone to close the cardiac opening
or to obliterate the cardiac cul-de-sac. In another embodiment, the
compound is used together with a closure device 104, 204, or
304.
[0146] FIG. 13 depicts an exemplary compound 500 in accordance with
this aspect of the invention. As illustrated, the compound 500
includes an adhesive 504 and a plurality of composite particles 508
disposed within the adhesive 504. In one embodiment, the plurality
of composite particles 508 are capable of expansion upon contact
with blood and/or water. The composite particles 508 are, for
example, gelatin particles, biological particles, bioresorbable
particles, and/or foam particles that swell upon contact with blood
and/or water. In one embodiment, the adhesive 504 is a fibrin based
adhesive. Alternatively, in other embodiments, the compound 500
includes other types of adhesives 504. Moreover, the adhesive 504
may be a permanent adhesive in the sense that, following placement
of the adhesive 504 into the cardiac opening, the adhesive 504
permanently remains in the cardiac opening over time.
Alternatively, in another embodiment, the adhesive 504 is a
temporary adhesive that gradually disappears over time after having
been placed in the cardiac opening. Mixed into the adhesive 504 may
be a substance that promotes tissue in-growth into the cardiac
opening over time.
[0147] In one embodiment, a physician positions the distal end of
the sheath proximate the cardiac opening. The physician then
advances, for example, a delivery catheter containing the compound
500 through a lumen of the sheath, until the delivery catheter
exits the distal end of the sheath to lie within the cardiac
opening. The physician then injects the compound 500 into the
cardiac opening. Once injected into the cardiac opening and upon
contact with the surrounding blood and/or water, the plurality of
composite particles 508 disposed within the adhesive 504 of the
compound 500 expand. By expanding, the plurality of composite
particles 508 help to lock the adhesive 504 into place and to
prevent the adhesive 504 from being washed away by the surrounding
blood. More specifically, upon being injected into the cardiac
opening, the adhesive 504 of the compound 500 cures both to the
patient's surrounding tissue and to the plurality of expanding
composite particles 508. As a result, the compound 500
substantially occludes the cardiac opening such as a patent foramen
ovale. Similar steps may be performed to substantially obliterate
an intra-cardiac cul-de-sac, such as the left atrial appendage.
[0148] In addition to closing the cardiac opening or obliterating
the cardiac cul-de-sac on its own, the compound 500 may also be
used in conjunction with the closure devices 104, 204, and 304
described above. For instance, after the compound 500 is injected
into a patent foramen ovale or a left atrial appendage, or as the
compound 500 is being injected, the patch 124 of the closure device
104 or the releasable patch 224 of the closure device 204 may be
positioned across the cardiac opening, for example the patent
foramen ovale or across the intra-cardiac cul-de-sac such as the
left atrial appendage and coupled to the proximate tissue surface.
Alternatively, prior to injecting the compound 500 into a patent
foramen ovale, the closure device 304, including either or both the
right atrial barrier 314A and the left atrial barrier 314B,
described above, may be bonded to the septum secundum 36, as
described above. The above-described patch 124 of the closure
device 104, the releasable patch 224 of the closure device 204,
and/or the atrial barriers 314A, 314B of the closure device 304 can
thus be used to ensure that the adhesive 504 of the compound 500
remains in the cardiac opening and can also be used to aid the
compound 500 in occluding the cardiac opening or the cardiac
cul-de-sac, or in obliterating the cardiac cul-de-sac.
[0149] Referring now to embodiments of closure devices that include
a balloon, FIG. 14 depicts an exemplary percutaneous transluminal
system 600 for positioning a balloon 700 in, for example, the
patent foramen ovale 44 or the left atrial appendage 80 described
above. In one embodiment the closure system 600 includes the
balloon 700 coupled to a balloon catheter 612. In accordance with
the invention, either an adhesive, a substance for stimulating
tissue growth, or both an adhesive and a substance for stimulating
tissue growth is coated on, or contained within, the balloon 700.
In use, the balloon 700 may be placed within a cardiac opening,
such as a patent foramen ovale of the patient. Once placed within
the cardiac opening, the balloon 700 may be manipulated to deliver
the adhesive and/or the substance for stimulating tissue growth to
the tissue surface of the cardiac opening. In one embodiment, the
balloon 700 is then released from the balloon catheter 612 and left
behind in the cardiac opening, while the balloon catheter 612 is
removed from the patient. In such a case, the balloon 700 assists
in closing the cardiac opening. Similar steps may be performed to
close a cardiac cul-de-sec. Alternatively, in another embodiment,
the balloon 700 is, after having delivered the adhesive and/or the
substance for stimulating tissue growth to the tissue surface of a
cardiac opening, removed from the cardiac opening and withdrawn
from the patient along with the balloon catheter 612. In this case,
the cardiac opening is encouraged to heal itself.
[0150] Referring briefly to FIGS. 15-17, to help locate a cardiac
opening and properly position the balloon 700 within the cardiac
opening, the closure system 600 includes, in some embodiments, a
proximal locator 628 (i.e., a locator that is closest to a
physician when the physician is using the closure system 600), an
opposite, distal locator 630, or both the proximal locator 628 and
the distal locator 630. In use, the locator 628 locates a proximal
end of a cardiac opening. The locator 630 locates a distal end of
the cardiac opening.
[0151] Referring again to FIG. 14, the balloon 700 includes a
proximal end 614 and an opposite, distal end 616. In one
embodiment, the balloon 700 also includes a proximal opening 633 at
its proximal end 614, a distal opening 635 at its distal end 616,
and a lumen 631 extending from its proximal end 614 to its distal
end 616. For its part, the balloon catheter 612 includes a proximal
end 618, an opposite, distal end 620, and a lumen 619 extending
from the proximal end 618 to the distal end 620. In the
illustrative embodiment shown, the balloon catheter 612 extends
through the proximal opening 633, through the lumen 631, and
through the distal opening 635 of the balloon 700 so that the
entire balloon 700 is located between the proximal end 618 and the
distal end 620 of the balloon catheter 612. In such an embodiment,
the portion of balloon catheter 612 located within the balloon 700
includes a plurality of holes 611. Accordingly, the lumen 619 of
the balloon catheter 612 is in fluid communication with the lumen
631 of the balloon 700. In another embodiment, the distal end 620
of the balloon catheter 612 is coupled to the proximal end 614 of
the balloon 700 such that the lumen 619 of the balloon catheter 612
is contiguous with the lumen 631 of the balloon 700. Alternatively,
in yet another embodiment, the distal end 620 of the balloon
catheter 612 extends through the proximal opening 633 and is
located within the lumen 631 of the balloon 700.
[0152] In one embodiment, the balloon 700 is releasably coupled to
the balloon catheter 612. For example, the balloon 700 is coupled
to the balloon catheter 612 so that it may be separated from the
balloon catheter 612 by applying a force, such as compression,
tension, torsion, or any other type of force. In this embodiment,
the balloon 700 is left within the cardiac opening to assist in
closing the cardiac opening. In another embodiment, the balloon 700
is permanently coupled to the balloon catheter 612 for removal from
the patient's body along with balloon catheter 612.
[0153] FIG. 14 also depicts a delivery catheter 622 having a lumen
624. In one embodiment, to deliver the balloon 700 to a cardiac
opening in a patient, the physician first places a distal end 626
of the delivery catheter 622 in the patient's heart proximate the
cardiac opening. The physician then places the closure system 600
in the lumen 624 of the delivery catheter 622 and advances the
closure system 600 through the lumen 624 of the delivery catheter
622 until the closure system 600 exits the distal end 626 of the
delivery catheter 622, as shown. Methods of delivering the balloon
700 to the patient are described further below.
[0154] FIGS. 15-17 depict the percutaneous transluminal closure
system 600 for positioning the balloon 700 in a cardiac opening of
a patient according to alternative illustrative embodiments of the
invention. As depicted in FIG. 15, the closure system 600 includes,
in one embodiment, an expandable proximal locator 628 for locating
a proximal end of a cardiac opening. The locator 628 may be, as
shown, coupled to the balloon catheter 612, to the proximal end 614
of the balloon 700, or to both the balloon catheter 612 and the
balloon 700. In one embodiment, the locator 628 is a right atrial
locator for locating a patent foramen ovale 44 from the right
atrium 26. When expanded, the locator 628 is configured to abut the
tissue surfaces of the septum secundum 36 and the septum primum 30
from the right atrium 26 as the balloon 700 is placed within the
patent foramen ovale 44. Accordingly, the locator 628 locates the
patent foramen ovale 44. In another embodiment, the locator 628 is
used for locating an exterior tissue surface of a left atrial
appendage 80. In this case, the locator 628 is configured to abut
the exterior tissue surface of the left atrial appendage 80 as the
balloon 700 is placed within the left atrial appendage 80.
[0155] In another embodiment, as depicted in FIG. 16, the closure
system 600 includes an expandable distal locator 630 for locating a
distal end of a cardiac opening. More specifically, the locator 630
is a left atrial locator for locating a patent foramen ovale 44
from the left atrium 32. The locator 630 may be, as shown, coupled
to the balloon catheter 612, to the distal end 616 of the balloon
700, or to both the balloon catheter 612 and the balloon 700. In
use, a physician advances the balloon 700 from the right atrium 26,
through the patent foramen ovale 44, to the left atrium 32. The
physician then expands the locator 630 in the left atrium 32 and
withdraws the balloon 700 from the left atrium 32 back into the
patent foramen ovale 44. The locator 630 is configured to abut the
tissue surfaces of the septum secundum 36 and the septum primum 40
from the left atrium 32 as the balloon 700 is placed within the
patent foramen ovale 44. Accordingly, the locator 630 locates the
patent foramen ovale 44 and properly positions the balloon 700
within the patent foramen ovale 44.
[0156] In yet another embodiment, and with reference now to FIG.
17, the closure system 600 includes two locators, a proximal
locator 628 and a distal locator 630.
[0157] The locators 628, 630 may be made to expand by any of a
variety of means. For example, in one embodiment, the locators 628,
630 include a plurality of springs or resilient coils that cause
them to expand. In another embodiment, the locators 628, 630 are
balloons that are inflated. The locators 628, 630 may be made from
an elastomer material, such as a polyurethane or a silicone, from a
biological material, such as a collagen or a bioresorbable polymer,
or from other materials, such as synthetic materials. In yet
another embodiment, the locators 628, 630 are made from a metallic
material or a shape memory material, such as a shape memory
alloy.
[0158] A plurality of arms, as illustrated for the proximal locator
628 in FIG. 15, may form the locators 628, 630. Alternatively, the
locators 628, 630 may each be shaped as a disk, as illustrated for
the distal locator 630 in FIG. 16, as a balloon, as illustrated for
the distal locator 630 in FIG. 17, or as a rod, as illustrated for
the proximal locator 628 in FIG. 17. Any other geometry deemed
suitable by one skilled in the art, such as, for example, a spiral
wire, may also be used for the locators 628, 630. In one
embodiment, the locators 628, 630 are releasably coupled to the
balloon 700 and/or to the balloon catheter 612. For example, the
locators 628, 630 are coupled to the balloon 700 and/or to the
balloon catheter 612 so that they may be separated from the balloon
700 and/or the balloon catheter 612 by applying a force, such as
compression, tension, torsion, or any other type of force. In
another embodiment, the locators 628, 630 are permanently coupled
to the balloon 700 and/or to the balloon catheter 612 for removal
from the patient's body along with the balloon 700 and/or the
balloon catheter 612.
[0159] In another embodiment, an adhesive 632 is coated on the
locators 628, 630. The adhesive 632 may be used, for example, to
bond the locators 628, 630 to the wall of the septum secundum 36
and/or to the wall of the septum primum 40 when the balloon 700 is
used to close a patent foramen ovale 44. Alternatively, the
adhesive 632 may be used to bond the proximal locator 628 to a
tissue surface proximate a left atrial appendage 80 when the
balloon 700 is used to obliterate the left atrial appendage 80. The
adhesive 632 may be, for example, a cyanoacrylate, a fibrin based
adhesive, or an albumin gluteraldehyde type adhesive.
[0160] FIG. 18 depicts an inflated balloon, generally 700, having
an outer surface 648. In one embodiment, an adhesive 656 is coated
on the outer surface 648 of the balloon 700.sup.a. FIG. 19 depicts
the balloon 700.sup.a deflated or partially deflated and FIG. 20
depicts a schematic cross-sectional view of the balloon 700.sup.a
of FIG. 19 taken along the line 19-19. Typically, the balloon
700.sup.a of the invention is coupled to the balloon catheter 612,
as described previously, and is initially delivered to a cardiac
opening in a heart of a patient with the balloon 700.sup.a deflated
or partially deflated.
[0161] Referring to FIG. 20, the outer surface 648 of the deflated
or partially deflated balloon 700.sup.a is involuted to form a
cavity 660 around the circumference of the outer surface 648 of the
balloon 700.sup.a. In one embodiment, the midline 676 of the outer
surface 648 of the balloon 700.sup.a is pushed towards the inside
of the balloon 700.sup.a to form the cavity 660. The edges 664, 672
of the cavity 660 are folded to contact or overlap one another, as
illustrated. By folding the balloon 700.sup.a as such, the outer
surface 648 of the balloon 700.sup.a seals the cavity 660 from
exposure to an outside environment 684.
[0162] In one embodiment, adhesive 656 is coated on the surface of
the cavity 660 of the deflated or partially deflated balloon
700.sup.a. Accordingly, when the balloon 700.sup.a is deflated or
partially deflated, the adhesive 656 is also sealed from exposure
to the outside environment 684. By delivering the balloon 700.sup.a
to the patient's cardiac opening with the balloon 700.sup.a
deflated, the adhesive 656 is not exposed to the patient's blood
and, according to one advantage of the invention, the risk of
thrombus formation is thereby minimized. Once properly positioned
within a patient's cardiac opening, the balloon 700.sup.a may be
inflated, thereby causing the involuted cavity 660 to unfold, as
illustrated in FIG. 21, and exposing the adhesive 656 to the
patient's tissues within the cardiac opening. Although the cavity
660 has been shown encircling the mid-portion of the balloon
700.sup.a, the cavity 660 may encircle in any orientation any
portion of the outer surface 648 of the balloon 700.sup.a and in
fact may be restricted to being simply an involuted pocket in a
portion of the outer surface 648 of the balloon 700.sup.a, as
illustrated in FIG. 22.
[0163] FIG. 23 depicts an embodiment of a balloon 700.sup.b. The
balloon 700.sup.b has an outer surface 748. An expandable porous
band 752 (e.g., an elastic band 752), having a plurality of
openings 756, encircles, in one embodiment, only a portion of the
outer surface 748 of the balloon 700.sup.b, such as the center
portion 728 of the balloon 700.sup.b. In alternative embodiments,
the expandable porous band 752 encircles other portions of the
balloon 700.sup.b. In one embodiment, an adhesive 716 is disposed
between the outer surface 748 of the balloon 700.sup.b and the
expandable porous band 752. The expandable porous band 752 is
designed such that, until the balloon 700.sup.b is sufficiently
inflated, the openings 756 of the porous band 752 are too small to
allow any of the adhesive 716 to pass therethrough. By ensuring
that the balloon 700.sup.b is not sufficiently inflated, a
physician can prevent the adhesive 716 from being inadvertently
exposed to a patient's blood and can thereby avoid thrombus
formation.
[0164] FIG. 24 depicts a schematic cross-sectional view of the
balloon 700.sup.b of FIG. 23 taken along the line 23-23. When
nearly sufficiently inflated, a cross-sectional diameter 760 of the
center portion 728 of the balloon 700.sup.b is, in one embodiment,
slightly less than the inner circumference of the cardiac opening
or the cardiac cul-de-sac that the balloon 700.sup.b is to close.
For example, where the balloon 700.sup.b is used to close a patent
foramen ovale 44, the center portion 728 of the balloon 700.sup.b
is designed to have, when nearly sufficiently inflated, a
cross-sectional diameter 760 between approximately 1 millimeter and
approximately 25 millimeters. Alternatively, when the balloon
700.sup.b is used to close a left atrial appendage 80, the center
portion 728 of the balloon 700.sup.b is designed to have, when
nearly sufficiently inflated, a cross-sectional diameter 760
between approximately 5 millimeters and approximately 25
millimeters.
[0165] FIG. 25 depicts another embodiment of a balloon 700.sup.c.
Contained within the lumen 862 of the balloon 700.sup.c is an
adhesive 816. The balloon 700.sup.c has a plurality of holes 864.
In various embodiments, the holes 864 are pores or slits. Until
sufficiently inflated, the balloon 700.sup.c will not have expanded
and/or stretched to a point where the holes 864 are large enough to
allow the adhesive 816 to pass therethrough.
[0166] FIG. 26 depicts yet another illustrative embodiment of the
invention. This embodiment includes two concentric balloons
700.sup.dA, 700.sup.dB and an adhesive 916 located within the lumen
962B of the inner balloon 700.sup.dB. In one embodiment, the outer
balloon 700.sup.dA and the inner balloon 700.sup.dB each include a
plurality of holes (e.g., pores or slits) 964A and 964B,
respectively.
[0167] Once the balloon 700.sup.b, c, or d is placed within the
cardiac opening or the cardiac cul-de-sac of a patient and is
nearly sufficiently inflated, the further application of pressure
to the balloon 700.sup.b, c, or d enlarges the openings 756 of the
porous band 752, the holes 864, or the holes 964, respectively. The
adhesive is thereby forced through the openings 756, the holes 864,
or the holes 964 to the tissue surface of the cardiac opening or
the cardiac cul-de-sac. A physician may apply the further pressure
to the balloon 700.sup.b, c, or d by further inflating the lumen of
the balloon 700.sup.b, c or d. For example, to further inflate the
lumen 862 of the balloon 700.sup.c, the physician pumps additional
adhesive 816 through the lumen 619 of the balloon catheter 612 into
the lumen 862 of the balloon 700.sup.c. Alternatively, compression
of a part of the balloon 700.sup.b, c or d by, for example,
contacting the tissue surface of the cardiac opening or the cardiac
cul-de-sac with that part of the balloon 700.sup.b, c, or d, thus
further inflating the remaining portions of the balloon 700.sup.b,
c, or d, will also cause the adhesive to be exposed to the tissue
surface. In certain embodiments, the adhesive is only exposed to
the patient's tissues in the area where the balloon 700.sup.b, c,
or d contacts the patient's tissues. For example, in one
embodiment, the adhesive is only exposed in the area where the
patient's tissues compress the balloon 700.sup.b, c, or d.
[0168] FIG. 27 depicts a balloon 700.sup.e having a membrane 1088
constructed from a wicking material. The wicking material may be,
for example, a natural fiber, such as cotton. In one embodiment, an
adhesive 1016 is absorbed within the wicking material of the
balloon membrane 1088. The adhesive 1016 is naturally drawn, by
capillary action, to the outer surface 1008 of the balloon
700.sup.e. Additionally, as shown, the adhesive 1016 may also be
contained within a lumen 1062 of the balloon 700.sup.e.
[0169] Once the balloon 700.sup.e is placed within, for example,
the cardiac opening, contacting the tissue surface of the cardiac
opening with the membrane 1088 of the balloon 700.sup.e draws, by
capillary action, further adhesive 1016 absorbed within the
membrane 1088 to the outer surface 1008 of the balloon 700.sup.e.
The tissue surface of the cardiac opening is thereby coated with
the adhesive 1016.
[0170] FIG. 28 depicts still another embodiment of the invention.
As shown, a balloon 700.sup.f has a first adhesive 1116A coated on
an outer surface 1108 of the balloon 700.sup.f. A light source 1168
is located within the lumen 619 of the balloon catheter 612 and
within a lumen 1162 of the balloon 700.sup.f. The balloon catheter
612 may be translucent, or, alternatively, may includes holes in
the region of the light source 1168, to allow the light emitted by
the light source 1168 to propagate outside the balloon catheter
612. The light source 1168 is, in one embodiment, a light bulb
coupled through the balloon catheter 612 to a power supply. In
another embodiment, the light source 1168 is an optical fiber
connected at its other end to a source of illumination.
[0171] In yet another embodiment, a second adhesive 1116B is coated
on an inner surface 1112 of the balloon 700.sup.f. The first
adhesive 1116A and/or the second adhesive 1116B may each be, for
example, a light activated adhesive, such as an adhesive curable
with ultraviolet light. The first adhesive 1116A and the second
adhesive 1116B may cover only a portion of the outer surface 1108
of the balloon 700.sup.f and the inner surface 1112 of the balloon
700.sup.f, respectively, as shown, or they may cover the entire
outer surface 1108 and inner surface 1112, respectively. In one
embodiment, the balloon 700.sup.f is translucent.
[0172] depicts a schematic cross-sectional view of the balloon
700.sup.f of FIG. 28, taken along the line 28-28. As shown in FIGS.
28 and 29, the balloon 700.sup.f further includes, in one
embodiment, a first non-reactive removable divider 1172. The
divider 1172 is coupled to the balloon 700.sup.f so that one
surface 1176 of the divider 1172 contacts the first adhesive 1116A
coated on the outer surface 1108 of the balloon 700.sup.f. Coated
on the second surface 1108 of the divider 1172 is a primer 1184. In
one embodiment, the primer 1184 prepares the tissue surface of the
patient to which the adhesive 1116A will be applied. In another
embodiment, the primer 1184 helps to activate the adhesive 1116A
and/or bond the adhesive 1116A to the patient's tissue surface.
[0173] In another embodiment, a second removable divider or
temporary membrane (not shown) covers the primer 1184 to protect it
against premature exposure to blood. The second removable divider
or temporary membrane may have attached to it sutures that can be
pulled upon by the physician to remove it from the primer 1184 when
the physician is ready to apply the primer 1184 to the tissues of
the patient's cardiac opening. Similarly, in one embodiment, the
first removable divider 1172 has attached to it sutures that can be
pulled upon by the physician to remove it from the adhesive 1116A
when the physician is ready to apply the adhesive 1116A to the
tissues of the patient's cardiac opening.
[0174] The balloons 700 described above may be tubularly-shaped. In
alternative embodiments, the balloons 700 have other shapes, such
as, for example, circular or rectangular shapes. The adhesives
coated on, or contained within, the balloons 700 of the invention
may be, for example, cyanoacrylates, fibrin based adhesives,
albumin gluteraldehyde type adhesives, or light activated
adhesives. Alternatively, other adhesives, known to those skilled
in the art, may be used.
[0175] In some embodiments, the balloons 700 include a substance
for stimulating tissue growth. The growth substance may be combined
with the adhesives of the balloons 700 or be used independently. In
fact, the growth substance may be applied to, or be positioned
within, the balloons 700 in the same manner as described above for
the adhesives of the balloons 700. In one embodiment, the growth
substance is, for example, a growth factor, such as a vascular
endothelial growth factor, a basic fibro growth factor, or an
angiogenic growth factor. In another embodiment, the growth
substance is a pharmacological agent for stimulating tissue growth,
such as, for example, cells or genes. Alternatively, in another
embodiment, the growth substance is an irritant for encouraging an
inflammatory response, such as, for example, cotton seed oil or
alcohol.
[0176] The balloons 700.sup.a, b, c, d, and f described above are,
in one embodiment, made from an elastomer material, such as, for
example, a polyurethane or a silicone. In another embodiment, the
balloons 700.sup.a, b, c, d, and f are made from a biological
material, such as, for example, a collagen or a bioresorbable
polymer. Alternatively, the balloons 700.sup.a, b, c, d, and f are
made from other materials.
[0177] FIG. 30 depicts a closure system 600 according to still
another illustrative embodiment of the invention. As illustrated,
the exemplary closure system 600 includes the delivery catheter 622
described above, a sock catheter 612', and a sock-shaped lining
634. For its part, the lining 634 has an open end 636, a closed end
637, a first surface 638, and a second surface 629. In one
embodiment, the open end 636 of the lining 634 is coupled to the
distal end 626 of the delivery catheter 622 and the closed end 637
of the lining 634 is coupled to the distal end 620 of the sock
catheter 612'. When the sock catheter 612' is retracted, as
depicted in FIG. 30, the lining 634 is contained within the lumen
624 of the delivery catheter 622, the first surface 638 forms an
inner surface of the sock-shaped lining 634, and the second surface
629 forms an outer surface of the sock-shaped lining 634. When the
sock catheter 612' is deployed, as illustrated in FIG. 31, the
lining 634 inverts. Consequently, the first surface 638 now forms
an outer surface of the sock-shaped lining 634 and the second
surface 629 forms an inner surface of the sock-shaped lining
634.
[0178] In the illustrative embodiment shown in FIGS. 30 and 31, an
adhesive 639, similar to any of the adhesives used for the balloons
700 described above, is coated on the first surface 638 of the
lining 634. Typically, a physician advances the closure system 600
with the sock catheter 612' retracted, as illustrated in FIG. 30,
and, once the closure system 600 is proximate a cardiac opening,
the physician deploys the sock catheter 612' so that it exits the
distal end 626 of the delivery catheter 622, as illustrated in FIG.
31. In one embodiment, the physician deploys the sock catheter 612'
by advancing (e.g., pushing) it distally or by withdrawing (e.g.,
pulling) the delivery catheter 622 proximally. Alternatively, in
another embodiment, the sock catheter 612' is itself a balloon that
may be expanded to exit the distal end 626 of the delivery catheter
622. By deploying the sock catheter 612', the lining 634 inverts to
expose the first surface 638 and the adhesive 639 coated thereon to
the patient's tissues.
[0179] In another embodiment, the lining 634 includes a plurality
of holes (not shown). In one such embodiment, the adhesive 639 is
coated on the second surface 629 of the lining 634 and/or is
contained (e.g., absorbed) within the lining 634 itself. By
deploying the sock catheter 612' as shown in FIG. 21, the lining
634 inverts and stretches, thereby enlarging the plurality of
holes. Accordingly, the adhesive 639 may pass through the plurality
of holes to the first surface 638 of the lining 634 for application
to the patient's tissues.
[0180] In yet another embodiment, a substance for stimulating
tissue growth, as described above, is combined with the adhesive
639 or is used independently.
[0181] In another aspect, the invention features methods for
delivering a balloon 700 to a cardiac opening or a cardiac
cul-de-sac in a patient and also methods for percutaneously closing
the cardiac opening or obliterating the cardiac cul-de-sac using
the delivered balloon 700. FIGS. 32A-32D depict the steps of an
illustrative method for delivering a balloon 700 of the invention
to a cardiac opening in a patient. The cardiac opening illustrated
in FIGS. 32A-32D is a patent foramen ovale 44. However, as
described below, the methods of the invention may also be used to
obliterate a left atrial appendage 80.
[0182] Referring to FIG. 32A, in one embodiment, a physician
advances the delivery catheter 622 into the patient's heart and
positions the distal end 626 of the delivery catheter 622 proximate
the cardiac opening. The physician then advances the balloon 700
and the balloon catheter 612 into and through the lumen 624 of the
delivery catheter 622. The physician continues to advance the
balloon 700 until it and a distal portion of the balloon catheter
612 exit the distal end 626 of the delivery catheter 622 adjacent
the cardiac opening, as illustrated in FIG. 32B. In one embodiment,
a deflated balloon 700 exits the distal end 626 of the delivery
catheter 622 and is kept deflated until appropriately positioned
within the cardiac opening. The balloon 700 is then inflated. In
another embodiment, the balloon 700 (e.g., the balloon 700.sup.f
depicted in FIGS. 28 and 29) exits the distal end 626 of the
delivery catheter 622 inflated, or, alternatively, exits deflated
and is inflated by the physician prior to being positioned within
the cardiac opening.
[0183] Referring now to FIG. 32C, after the balloon 700 exits the
distal end 626 of the delivery catheter 622 and/or is inflated
adjacent the cardiac opening by the physician, the physician, in
one embodiment, expands the proximal locator 628 adjacent the
cardiac opening. In one embodiment, with the locator 628 expanded
as illustrated in FIG. 32C, the physician advances the balloon 700
into the cardiac opening. The physician continues to advance the
balloon 700 into the cardiac opening until the locator 628 abuts a
tissue surface proximate cardiac opening. For example, as depicted
in FIG. 32D, the physician advances the balloon 700 into the patent
foramen ovale 44 until the locator 628 abuts the proximal walls of
the septum secundum 36 and the septum primum 40. Alternatively,
where the left atrial appendage 80 is to be obliterated, the
physician advances the balloon 700 into the left atrial appendage
80 until the locator 628 abuts the tissue surface of the heart
proximate the left atrial appendage 80. Having used the locator 628
to locate the cardiac opening, the physician then uses the locator
628 to correctly position the balloon 700 within the cardiac
opening. In one embodiment, the balloon 700 is correctly positioned
within the cardiac opening when the locator 628 abuts the tissue
surface proximate the cardiac opening. In another embodiment, the
physician proximally withdraws the locator 628 by a fixed amount
from the tissue surface of the cardiac opening to correctly
position the balloon 700 within the cardiac opening.
[0184] The methods described above for positioning the balloon 700
within a cardiac opening apply equally to positioning the balloon
700 within a patent foramen ovale 44 or a left atrial appendage 80.
Alternatively, other illustrative methods, specific to positioning
a balloon 700 within a patent foramen ovale 44, are illustrated in
FIGS. 33A-33E.
[0185] Referring first to FIG. 33A, in one embodiment, the
physician advances the delivery catheter 622 into the patient's
heart and through the patent foramen ovale 44, thereby positioning
the distal end 626 of the delivery catheter 622 in the left atrium
32. The physician then advances the balloon 700 into and through
the lumen 624 of the delivery catheter 622 until the balloon 700
and a distal portion of the balloon catheter 612 exit the distal
end 626 of the delivery catheter 622 into the left atrium 32, as
illustrated in FIG. 33B. After the balloon 700 exits the delivery
catheter 622, the physician, in one embodiment, expands the distal
locator 630, as illustrated in FIG. 33C.
[0186] With the locator 630 expanded as illustrated in FIG. 33C,
the physician withdraws the delivery catheter 622 and the balloon
700 proximally into the patent foramen ovale 44. The physician
continues to withdraw the delivery catheter 622 and the balloon 700
into the patent foramen ovale 44 until the locator 630 abuts the
distal walls of the septum secundum 36 and the septum primum 40, as
illustrated in FIG. 33D.
[0187] Alternatively, in another embodiment, after the physician
positions the distal end 626 of the delivery catheter 622 in the
left atrium 32, as illustrated in FIG. 33A, rather than both
deploying the balloon 700 and expanding the distal locator 630 in
the left atrium 32, as illustrated in FIG. 33C, the physician only
expands the locator 630 in the left atrium 32. The physician then
positions the locator 630 to abut the distal walls of the septum
secundum 36 and the septum primum 40. Once the locator 630 is
positioned as such, the physician removes the delivery catheter 622
from about the balloon 700 to deploy the balloon 700 within the
patent foramen ovale 44, as illustrated in FIG. 33D.
[0188] Optionally, when the balloon 700 is deployed within the
patent foramen ovale 44 as illustrated in FIG. 33D, the physician
then expands the proximal locator 628 in the right atrium 26, as
illustrated in FIG. 33E. In one particular embodiment, the locators
628 and 630 are both balloons that are inflated in the right atrium
26 and the left atrium 32, respectively. Together, the locators 628
and 630 may be used to correctly locate and position the balloon
700 within the patent foramen ovale 44.
[0189] After the physician correctly positions the balloon 700
within the cardiac opening, as depicted in FIGS. 32D and 33E, the
physician exposes the adhesive of the balloon 700 to the cardiac
opening. As described above, the physician may accomplish this step
in a variety of manners, depending on the type of balloon 700 that
has been positioned within the cardiac opening.
[0190] In an exemplary embodiment, a deflated balloon 700.sup.f is
positioned within the cardiac opening and, subsequent to placement
within the cardiac opening, is inflated, as illustrated in FIG. 28.
Where the balloon 700.sup.f includes the divider 1172 containing
the primer 1184, the physician first applies the primer 1184 to the
patient's tissue surface within the cardiac opening. In one
embodiment, the physician does so by contacting the patient's
tissues within the cardiac opening with the primer 1184 contained
on the second surface 1180 of the divider 1172. The physician then
removes the divider 1172 from about the balloon 700.sup.f.
[0191] After applying the primer 1184 to the tissue surface of the
cardiac opening and removing the divider 1172, the physician
further inflates the balloon 700.sup.f to contact the tissue
surface of the cardiac opening with the adhesive 1116A.
Alternatively, where the balloon 700.sup.f does not include the
divider 1172 and the primer 1184, the physician simply inflates the
balloon 700.sup.f to contact the tissue surface of the cardiac
opening with the adhesive 1116A immediately following the placement
of the balloon 700.sup.f within the cardiac opening.
[0192] With the adhesive 1116A of the balloon 700.sup.f in contact
with the patient's tissues in the cardiac opening, the physician
activates the adhesive 1116A to cure the adhesive 1116A to the
patient's tissues. In one embodiment, the physician illuminates the
adhesive 1116A to activate the adhesive 1116A.
[0193] In various embodiments, once the adhesive is exposed to the
tissue surface of the cardiac opening or the cardiac cul-de-sac,
the physician allows the adhesive to cure and to thereby glue the
balloon 700 to the tissue surface within the cardiac opening or the
cardiac cul-de-sac. As such, the entire balloon 700 is coupled to
the cardiac opening or the cardiac cul-de-sac to substantially
occlude the cardiac opening or obliterate the cardiac cul-de-sac.
Where, for example, the cardiac cul-de-sac is the left atrial
appendage 80, the physician may couple the entire balloon 700 to
the tissue surface of the left atrial appendage 80 to substantially
obliterate the left atrial appendage 80. As another example, where
the physician has positioned the balloon 700.sup.f within a patent
foramen ovale 44 and activated the adhesive 1116A, the physician
allows the adhesive 1116A to cure and to thereby couple the entire
balloon 700.sup.f to the tissue surface of the patent foramen ovale
44. The physician may then separate and remove the balloon catheter
612 from the balloon 700.sup.f and deflate the balloon 700.sup.f to
draw the septum secundum 36 and the septum primum 40 together. Once
the balloon 700.sup.f is deflated, the adhesive 1116B, which is
coated on the inner surface 1112 of the balloon 700.sup.f, glues
portions of the inner surface 1112 of the balloon 700.sup.f
together.
[0194] Where the physician couples the entire balloon 700 to the
cardiac opening, the physician may also couple the locators 628,
630 to the tissue surface of the patient proximate the cardiac
opening. In one embodiment, for example, the physician uses the
adhesive 632 to glue the locators 628, 630 to the tissue surface of
the patient proximate the cardiac opening. The locators 628, 630
therefore also aid in closing the cardiac opening. Alternatively,
one or both locators 628, 630 may be removed from the patient's
body, even though the entire balloon 700 is coupled to the cardiac
opening. For example, in one embodiment, the physician collapses
the proximal locator 628 and removes it, along with the balloon
catheter 612, from the patient's body. In another embodiment, the
distal locator 630 is collapsed and proximally withdrawn, along
with the balloon catheter 612, through the distal opening 635,
through the lumen 631, and through the proximal opening 633 of the
balloon 700 for removal from the patient's body.
[0195] In another embodiment, where the cardiac opening being
closed is a patent foramen ovale 44, after the adhesive is exposed
to the tissue surface of the patent foramen ovale 44 and is applied
thereto, but before the adhesive has cured, the physician removes
the balloon 700, the balloon catheter 612, and the one or more
locators 628, 630 from the patent foramen ovale 44. In such a case,
the natural pressure difference between the right atrium 26 and the
left atrium 32 will eventually cause the septum secundum 36 to
contact the septum primum 40. Because the septum secundum 36 and
the septum primum 40 are coated with the adhesive, they will
eventually bond together, thereby permanently closing the patent
foramen ovale 44. Alternatively, in other embodiments, while
removing the balloon 700 from the patent foramen ovale 44, the
physician permanently glues one or both locators 628 and 630 to the
tissue surface of the patient proximate the patent foramen ovale
44. The locators 628, 630 therefore also aid in closing the patent
foramen ovale 44.
[0196] In yet another embodiment, the substance for stimulating
tissue growth is combined with the adhesive of the balloon 700, or
is used in place of the adhesive, and is delivered to, or
impregnated within, the tissue surface of the patient's cardiac
opening in a manner similar to that described above for the
adhesives. In one embodiment, for example, the balloon 700 is used
to deliver the growth substance to a patient's tissue surface
located within a patent foramen ovale 44. The balloon 700 is then
removed from the patent foramen ovale 44. The growth substance,
having been applied to the septum secundum 36 and the septum primum
40, then stimulates tissue growth within the patent foramen ovale
44. The newly grown tissue leads to the closure of the patent
foramen ovale 44.
[0197] In yet another aspect, the invention provides methods for
percutaneously closing a patent foramen ovale 44 using the
exemplary closure system 600 depicted in FIGS. 30 and 31. In one
embodiment, a physician advances the closure system 600 into the
patient's heart with the sock catheter 612' retracted, as
illustrated in FIG. 30. The physician then positions the distal end
626 of the delivery catheter 622 in the right atrium 26 proximate
the patent foramen ovale 44, as illustrated, for example, in FIG.
34A. With the closure system 600 positioned as such, the sock
catheter 612' is deployed to invert the lining 634 within the
patent foramen ovale 44. Accordingly, as described above, the
adhesive 639 and/or the substance for stimulating tissue growth is
exposed to the patient's tissue surface located within the patent
foramen ovale 44, as illustrated in FIG. 34B, and is applied
thereto. The physician then retracts the sock catheter 612' to
remove the lining 634 from the patent foramen ovale 44.
Accordingly, as described above, the natural pressure difference
between the right atrium 26 and the left atrium 32 causes the
septum primum 36 and the septum secundum 30 to bond together,
and/or natural tissue growth is stimulated within the patent
foramen ovale 44, thereby leading to closure of the patent foramen
ovale 44.
[0198] Variations, modifications, and other implementations of what
is described herein will occur to those of ordinary skill in the
art without departing from the spirit and the scope of the
invention. The invention is not to be defined only by the preceding
illustrative description.
* * * * *