U.S. patent application number 14/819724 was filed with the patent office on 2017-02-09 for left atrial appendage occluder device anchoring system, anchor, and method of attachment.
The applicant listed for this patent is Thomas J. Forbes. Invention is credited to Thomas J. Forbes.
Application Number | 20170035433 14/819724 |
Document ID | / |
Family ID | 57943483 |
Filed Date | 2017-02-09 |
United States Patent
Application |
20170035433 |
Kind Code |
A1 |
Forbes; Thomas J. |
February 9, 2017 |
LEFT ATRIAL APPENDAGE OCCLUDER DEVICE ANCHORING SYSTEM, ANCHOR, AND
METHOD OF ATTACHMENT
Abstract
The present invention relates in general to anchoring systems
for occluder devices, and more specifically, to an anchoring system
and method for implanting an occluder device within a left atrial
appendage ("LAA") of the heart. The anchoring system is configured
so that an anchor penetrates the inner endocardium layer, middle
myocardium layer, and outer epicardium layer of an LAA wall. The
purpose of the present invention is to provide an occluder device
anchor that has a low risk of embolization and/or causing injury to
neighboring valve structures. An additional purpose of the present
invention is to provide an anchoring system and method for
implanting an occluder device within the LAA that allows for the
occluder device to be retrievable after initial placement,
reusable, and repositionable for an optimal final placement within
the LAA.
Inventors: |
Forbes; Thomas J.; (Grosse
Pointe Park, MI) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Forbes; Thomas J. |
Grosse Pointe Park |
MI |
US |
|
|
Family ID: |
57943483 |
Appl. No.: |
14/819724 |
Filed: |
August 6, 2015 |
Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61M 29/00 20130101;
A61B 17/12031 20130101; A61B 2017/00243 20130101; A61B 2017/00623
20130101; A61B 2017/1205 20130101; A61B 17/0057 20130101; A61B
17/12122 20130101; A61B 17/1214 20130101; A61B 17/12172 20130101;
A61B 17/1219 20130101; A61B 2017/00615 20130101; A61B 2017/00349
20130101; A61B 2017/00606 20130101; A61B 2017/00592 20130101; A61B
2017/00575 20130101 |
International
Class: |
A61B 17/12 20060101
A61B017/12 |
Claims
1. An anchoring system for implanting an occluder device within a
left atrial appendage (LAA) of a heart, comprising: an outer
sheath; a pericardial catheter; an occluder device for a LAA; an
anchor; a contracted first position of the anchor; a deployed
second position of the anchor; the outer sheath inserted into the
LAA through a left atrium proper of the heart; the pericardial
catheter advanced through the outer sheath into the LAA; the
pericardial catheter perforates an inner endocardium layer, middle
myocardium layer, and outer epicardium layer of an LAA wall of the
heart; the pericardial catheter creates a small hole through the
LAA wall into a pericardial space; a delivery wire and/or a buddy
wire advanced through the pericardial catheter into the pericardial
space of the heart through the small hole; the pericardial catheter
removed from the LAA through the outer sheath; the occluder device
and the anchor advanced into the LAA using the delivery wire,
wherein the anchor is in the contracted first position; the anchor
in the contracted first position is advanced through the inner
endocardium layer, middle myocardium layer, and outer epicardium
layer of the LAA wall using the delivery wire; the anchor in the
contracted first position is advanced into the pericardial space
through the small hole in the LAA wall using the delivery wire; the
anchor is expanded in the pericardial space from the contracted
first position to the deployed second position; and the occluder
device is released from the outer sheath to occlude the LAA;
wherein the anchor moors the occluder device to the LAA wall.
2. The anchoring system of claim 1, further comprising: the
occluder device is detached from the anchor; the anchor is left
implanted in the LAA wall of the LAA; the occluder device is
retrieved; a new anchor is inserted into the LAA; the new anchor is
implanted at another location in the LAA wall, wherein the new
anchor is advanced through the inner endocardium layer, middle
myocardium layer, and outer epicardium layer of the LAA wall; the
occluder device is released from the outer sheath to occlude the
LAA; and wherein the occluder device is moored to the LAA wall via
the new anchor.
3. The anchoring system of claim 1, further comprising: the
occluder device is detached from the anchor; the anchor is left
implanted in the LAA wall of the LAA; the occluder device is
retrieved; a new occluder device is inserted into the LAA via the
outer sheath; the new occluder device is attached to the anchor
implanted in the LAA wall of the LAA; the new occluder device is
released from the outer sheath to occlude the LAA; and wherein the
occluder device is moored to the LAA wall via the new anchor.
4. The anchoring system of claim 1, wherein the anchor has a
diameter of approximately 1-5 mm in the contracted first position
and a diameter of approximately 2-20 mm in the deployed second
position.
5. The anchoring system of claim 1, wherein the anchor is
self-expanding.
6. The anchoring system of claim 1, wherein the anchor comprises a
sheave shape.
7. The anchoring system of claim 6, wherein the anchor comprises a
first half and a second half, wherein the first half is connected
to the second half by a shaft.
8. The anchoring system of claim 7, wherein the first half is
inside the LAA, the second half is inside the pericardial space,
and the shaft is through the inner endocardium layer, middle
myocardium layer, and outer epicardium layer of the LAA wall to
moor the occluder device within the LAA.
9. The anchoring system of claim 8, wherein the anchor comprises a
coil.
10. The anchoring system of claim 9, wherein the anchor comprises a
first coil and a second coil, wherein the first coil is connected
to the second coil by a shaft.
11. The anchoring system of claim 10, wherein the first coil is
inside the LAA, the second coil is inside the pericardial space,
and the shaft is through the inner endocardium layer, middle
myocardium layer, and outer epicardium layer of the LAA wall to
moor the occluder device within the LAA.
12. An anchor for implanting an occluder device within a left
atrial appendage (LAA) of a heart, comprising: an anchor comprising
a contracted first position and a deployed second position; wherein
the anchor penetrates an inner endocardium layer, a middle
myocardium layer, and an outer epicardium layer of a LAA wall;
wherein a portion of the anchor self-expands from a contracted
first position to a deployed second position within a pericardial
space of the heart; wherein the occluder device is moored to the
LAA wall via the anchor.
13. The anchor of claim 12, further comprising: wherein the
occluder device may be detached from the anchor; wherein the anchor
remains implanted through the LAA wall without harming the
patient.
14. The anchor of claim 12, further comprising: wherein the anchor
retracts from the deployed second position to the contracted first
position; wherein the anchor re-penetrates at a different location
of the LAA wall the inner endocardium layer, the middle myocardium
layer, and the outer epicardium layer of the LAA wall; wherein a
portion of the anchor self-expands from a contracted first position
to a deployed second position within the pericardial space of the
heart; and wherein the occluder device is moored to the LAA wall
via the anchor at a new location.
15. The anchor system of claim 12, wherein the anchor has a
diameter of approximately 1-5 mm in the contracted first position
and a diameter of approximately 2-20 mm in the deployed second
position.
16. The anchoring system of claim 15, wherein the anchor comprises
a sheave shape.
17. The anchoring system of claim 15, wherein the anchor comprises
a coil.
18. A method of anchoring an occluder device within a left atrial
appendage (LAA) of a heart, comprising: providing an anchoring
system for implanting the occluder device within the LAA, wherein
the anchoring system comprises: a) an outer sheath; b) a
pericardial catheter; c) an occluder device for a LAA; d) an
anchor; e) a plurality of self-expanding anchor tines or a sheave
shape or a coil; f) a contracted first position of the anchor; and
g) a deployed second position of the anchor; inserting the outer
sheath into the LAA through a left atrium proper of the heart;
advancing the pericardial catheter through the outer sheath into
the LAA; perforating an inner endocardium layer, a middle
myocardium layer, and an outer epicardium layer of an LAA wall of
the heart using the pericardial catheter; creating a small hole
through the LAA wall into a pericardial space using the pericardial
catheter; advancing a delivery wire and/or a buddy wire through the
pericardial catheter into the pericardial space of the heart
through the small hole; removing the pericardial catheter from the
LAA through the outer sheath; advancing the occluder device and
anchor into the LAA using the delivery wire, wherein the anchor is
in the contracted first position; advancing the anchor in the
contracted first position through the inner endocardium layer, the
middle myocardium layer, and the outer epicardium layer of the LAA
wall using the delivery wire; further advancing the anchor in the
contracted first position into the pericardial space through the
small hole in the LAA wall using the delivery wire; expanding the
anchor from the contracted first position to the deployed second
position; and releasing the occluder device from the outer sheath
to occlude the LAA; wherein the occluder device is moored to the
LAA wall via the anchor.
19. The method of claim 18, further comprising: detaching the
occluder device from the anchor; leaving the anchor implanted in
the LAA wall of the LAA; retrieving the occluder device inside the
outer sheath; inserting a new occluder device in the outer sheath;
implanting the new occluder device in the LAA using the anchor;
releasing the occluder device from the outer sheath to occlude the
LAA; and removing the delivery wire, buddy wire, and outer sheath
from the LAA.
20. The method of claim 18, further comprising: retrieving the
occluder device inside the outer sheath; removing the anchor from
the LAA wall, wherein the anchor retracts from the deployed second
position to the contracted first position; advancing the anchor
through the inner endocardium layer, the middle myocardium layer,
and the outer epicardium layer at a different location of the LAA
wall; and releasing the occluder device from the outer sheath to
occlude the LAA.
Description
FIELD OF THE INVENTION
[0001] The present invention relates in general to an anchoring
system and method of attaching and retrieving an occluder device in
the left atrial appendage of the heart. The purpose of the
invention is to provide an anchoring system and method of attaching
and retrieving an occluder device that ensures optimal placement
within the left atrial appendage of the heart. A further purpose of
the present invention is to provide an anchor for an occluder
device that has a low risk of embolization.
BACKGROUND OF THE INVENTION
[0002] Approximately 7 million Americans have what is known as
non-valvular atrial fibrillation involving complications with the
left atrial appendage of the heart (hereinafter, "LAA"). The LAA is
a small, windsock shaped sac in the muscle wall of the left atrium.
Though uncertain as to what function the LAA performs, if anything,
what is certain is that in patients with non-valvular atrial
fibrillation, 90% of the thrombus formation occurs in the body of
the LAA. In normal conditions, electrical impulses that control a
heartbeat travel in an orderly fashion throughout the heart. These
electrical impulses cause the heart to contract wherein blood in
the left atrium and LAA is driven into the left ventricle with each
heartbeat. However, in patients with atrial fibrillation the
electrical impulses are fast and chaotic, wherein many impulses
begin at the same time and spread throughout the atria. For
instance, a healthy atria contracts 60-80 times per minute, while a
fibrillating atria quivers at 300-400 times per minute. Problems
arise when the electrical impulses do not allow the atria enough
time to fully contract and efficiently displace blood into the left
ventricle from the left atrium and LAA. Consequently, blood pools
and collects in the LAA due to inefficient contraction of the atria
and the LAA's sac-like physiological structure, causing blood
clots. Strokes may ultimately occur in patients when the blood
clots are pumped out of the heart and embolize to the brain.
Notably, individuals with atrial fibrillation are five to seven
times more likely to have a stroke than the general population.
[0003] Treatment of atrial fibrillation typically involves oral
anticoagulant therapy. Patient's taking blood thinners have noted a
reduction in the risk of stroke by 65% as compared to patients
without medication. The oral anticoagulant warfarin (COUMADIN.RTM.)
has been traditionally utilized to minimize thrombus formation in
patients with atrial fibrillation. Due to the requirement of
frequent blood draws to monitor a patient's anticoagulation status,
frequent interactions of the medication with either dietary changes
or with other medications, and the high risk of encountering
serious bleeding events, Coumadin has recently fallen into disfavor
in the medical community. Newer medications including dabigatran
(PRADAXA.RTM.) and rivaroxaban (XARELTO.RTM.) are also being
utilized. The advantage of these newer medications are that they
have less interaction with dietary changes and do not require blood
draws to monitor a patient's anticoagulation status. However, these
medications continue to encounter serious gastrointestinal bleeding
events, are not reversible, and are extremely expensive.
[0004] Patients who cannot tolerate anticoagulants, or are not
eligible for anticoagulant treatment due to pregnancy or other
medical reasons, may elect to undertake various procedures to seal
off or remove the LAA. One particular procedure, known as LAA
occlusion, involves implanting a device into the heart that closes
the LAA. Currently, there are several different occluder devices on
the market or in current testing, including the WATCHMAN.RTM.,
ATRICLIP.RTM., PLAATO LAA Occlusion System.RTM., AMPLATZER.TM., and
the AMULET.TM.. In each of these devices, the major technical
difficulty encountered is to get the device to reliably fix itself
within the LAA without embolizing or migrating out of the LAA into
the systemic circulation. The reason for this is multifactorial,
although primarily being related to the LAA coming in many
different sizes and configurations. Some sizes and configurations
of the LAA are more amenable to device closure, whereas in others,
device closure can be extremely difficult--if not impossible--to
safely place an occluder device within the LAA.
[0005] The heart is comprised of three layers: (1) an inner
endocardium layer; (2) a middle myocardium layer; and (3) an outer
epicardium layer. The endocardium is a fragile, thin layer of
tissue that lines the heart's chambers and valves. The myocardium
is the thickest layer of the heart and is comprised of muscle
tissue. The epicardium is a thin layer of visceral tissue. Between
the heart and mediastinal space is the pericardium. The pericardium
is a visceral layer of endothelium. The pericardial space lies in
between the heart's epicardial surface and the pericardium. The
pericardial space is filled with clear fluid that minimizes
friction between the heart and other structures within the chest
wall.
[0006] Current LAA occluder devices such as the WATCHMAN.RTM. and
AMPLATZER.TM. have barbs on the outer edge of the device that latch
on circumferentially to the endocardium layer of the LAA. Using
barbs to fix the occluder device onto the endocardium layer of the
LAA has significant disadvantages. For example, successfully
"latching" an occluder device onto the endocardial layer of the LAA
may be extremely difficult and time consuming for the
interventional cardiologist. Problems are compounded if initial
placement of the occluder device within the LAA is less than ideal,
as the occluder device cannot be fully retrieved back within the
delivery system without permanently damaging the retention barbs
and/or the endocardium layer. Moreover, if the occluder device
embolizes out of the LAA, irreparable damage to neighboring
structures such as the mitral and/or aortic valves of the heart may
occur in part, due to the presence of the barbs on the occluder
device. Retrieval of an embolized occluder device is further
complicated by the presence of the retention barbs.
[0007] Therefore, what is needed is an anchoring system and method
for implanting an occluder device in the LAA that would allow for
complete retraction and removal of the occluder device without
permanently damaging the device. What is also needed is an
anchoring system and method for implanting an occluder device in
the LAA that provides a low risk of embolization and/or causing
injury to neighboring valve structures. What is further needed is
an anchoring system and method for implanting an occluder device
that allows the occluder device to be positioned in multiple
locations within the LAA, being able to be used in all types of LAA
anatomy, and still result in optimal final placement of the
occluder device within the LAA.
BRIEF SUMMARY OF THE INVENTION
[0008] Therefore, it is a principal object, feature, and/or
advantage of the present invention to overcome the aforementioned
deficiencies in the art and provide an anchoring system and method
for implanting and retrieving an occluder device in the LAA.
[0009] A further object, feature, and/or advantage of the present
invention is to provide an anchoring system and method for
implanting and retrieving an occluder device in the LAA that may be
used with a diverse range of LAA occluder devices.
[0010] Another object, feature, and/or advantage of the present
invention is to provide an anchoring system and method for
implanting and recapturing an occluder device in the LAA that
minimizes the risk of the occluder device embolizing or migrating
following release of the occluder device into the LAA.
[0011] Yet another object, feature, and/or advantage of the present
invention is to provide an anchoring system and method for
implanting an occluder device in the LAA that allows an
interventional cardiologist to anchor the occluder device in
multiple locations within the LAA.
[0012] A still further object, feature, and/or advantage of the
present invention is to provide an anchoring system and method for
implanting an occluder device in the LAA that allows the occluder
device to be retrieved and adjusted within the LAA to achieve an
optimal final position.
[0013] Another object, feature, and/or advantage of the present
invention is to provide an anchoring system and method for
implanting an occluder device in the LAA that causes minimal or no
bleeding into the pericardial space upon anchoring.
[0014] A further object, feature, and/or advantage of the present
invention is to provide an anchoring system and method for
implanting an occluder device in the LAA that is easy to implant
and retrieve by an interventional cardiologist.
[0015] A still further object, feature, and/or advantage of the
present invention is to provide an anchoring system and method for
implanting an occluder device in the LAA that allows the occluder
device to be retrieved and adjusted by a interventional
cardiologist within the LAA without damaging the occluder
device.
[0016] These and/or other objects, features, and/or advantages of
the present invention will be apparent to those skilled in the art.
The present invention is not to be limited to or by these objects,
features, and advantages. No single aspect need provide each and
every object, feature, or advantage.
[0017] According to one aspect of the present invention, an
anchoring system for implanting and retrieving an occluder device
into a LAA comprises an outer sheath and a pericardial catheter.
The pericardial catheter may be advanced through the outer sheath
into the LAA, wherein the pericardial catheter penetrates a wall of
the LAA and enters the pericardial space creating a small hole. A
buddy wire and/or a delivery wire are advanced through the
pericardial catheter to enter the pericardial space. The anchoring
system of the present invention further comprises an anchor, an
occluder device, and a flexible connector. The occluder device may
be attached to the anchor via the connector. After the pericardial
catheter is removed from the outer sheath, the anchor, the
connector, and the occluder device are advanced through the outer
sheath. The anchor is further advanced to penetrate the LAA wall
via the small hole and extend into the pericardial space.
Specifically, the anchor penetrates the inner endocardium layer,
middle myocardium layer, and outer epicardium layer of the LAA
wall. Once inside the pericardial space, the anchor self-expands to
implant the base in the LAA wall. The anchor is further configured
to prevent the occluder device from being pushed through the small
hole into the pericardial space. The outer sheath releases the
occluder device into the LAA, wherein it is held in position by the
anchor. By mooring the occluder device through all three layers of
the LAA wall via the anchor, the risk of embolization is reduced.
Another aspect of the present invention includes a method of
implanting and retrieving an occluder device into a LAA using the
anchoring system described above.
[0018] According to a further aspect of the present invention, an
anchoring system for implanting and retrieving an occluder device
into a LAA comprises an outer sheath, a pericardial catheter, an
occluder device, and an anchor. The pericardial catheter may be
advanced through the outer sheath into the LAA, wherein the
pericardial catheter penetrates a wall of the LAA and enters the
pericardial space creating a small hole. The anchor may comprise a
sheave shape with a first half and a second half connected by a
shaft. The anchor may further comprise a contracted first position
and a deployed second position. After the pericardial catheter is
removed from the outer sheath, the occluder device, anchor
catheter, and anchor are advanced through the outer sheath using
the delivery wire, wherein the anchor is in the contracted first
position. The anchor catheter is further advanced to penetrate the
LAA wall via the small hole and extend into the pericardial space.
Specifically, the anchor catheter delivers the anchor, wherein the
first half of the anchor remains inside the LAA and the shaft
portion and the second half of the anchor penetrates the inner
endocardium layer, middle myocardium layer, and outer epicardium
layer of the LAA wall. Once inside the pericardial space, the
second half of the anchor self-expands to the deployed second
position within the pericardial space to implant the anchor in the
LAA wall. The first half of the anchor remaining within the LAA
also self-expands to the deployed second position, pinning the
occluder device against the wall of the LAA. The outer sheath
releases the occluder device into the LAA, wherein it is held in
position by the anchor. By mooring the occluder device through all
three layers of the LAA wall via the anchor, the risk of
embolization is reduced. Another aspect of the present invention, a
method of implanting and retrieving an occluder device into a LAA
is provided. Another aspect of the present invention includes a
method of implanting and retrieving an occluder device into a LAA
using the anchoring system described above.
[0019] According to yet a further aspect of the present invention,
an anchoring system for implanting and retrieving an occluder
device into a LAA comprises an outer sheath, a pericardial
catheter, an occluder device, and an anchor. The pericardial
catheter may be advanced through the outer sheath into the LAA,
wherein the pericardial catheter penetrates a wall of the LAA and
enters the pericardial space creating a small hole. A buddy wire
and/or a delivery wire are advanced through the pericardial
catheter to enter the pericardial space. After the pericardial
catheter is removed from the outer sheath, an anchor catheter, the
occluder device, and the anchor are then advanced through the outer
sheath using the delivery wire. While in a straight-coil
configuration, the anchor penetrates the inner endocardium layer,
middle myocardium layer, and outer epicardium layer of the LAA wall
to extend into the pericardial space. When the delivery wire is
retrieved, the anchor self-expands into a two-disc shape, wherein a
first coil resides within the LAA and a second coil resides within
the pericardial space. The outer sheath releases the occluder
device into the LAA, wherein it is pinned against the LAA wall by
the anchor. By mooring the occluder device through all three layers
of the LAA wall via the anchor, the risk of embolization is
reduced. Another aspect of the present invention includes a method
of implanting and retrieving an occluder device into a LAA using
the anchoring system described above.
[0020] Different aspects may meet different objects of the
invention. Other objectives and advantages of this invention will
be more apparent in the following detailed description taken in
conjunction with the figures. The present invention is not to be
limited by or to these objects, aspects, or figures.
BRIEF DESCRIPTION OF THE DRAWINGS
[0021] FIGS. 1-26 represent examples of the anchoring system,
anchor, and method of the present invention.
[0022] FIG. 1 is a view of an outer sheath and pericardial catheter
of an anchoring system of the present invention and method for
implanting and retrieving an occluder device within a LAA.
[0023] FIG. 2 is a view of an anchor, connector, and occluder
device of the anchoring system and method of FIG. 1.
[0024] FIG. 3 is a view of an anchor of the anchoring system and
method of claim 1, wherein the anchor comprises anchor tines.
[0025] FIG. 3A is an end-view of the anchor of FIG. 3, wherein
anchor tines are in a contracted first position.
[0026] FIG. 3B is an end-view of the anchor of FIG. 3, wherein the
anchor tines are in a deployed second position.
[0027] FIG. 4 is a view of an anchor of the anchoring system and
method of FIG. 1, wherein the anchor comprises a coil-wire.
[0028] FIG. 4A is an end-view of the anchor of FIG. 4, wherein a
coil-wire is in a contracted first position constrained within an
inner sheath.
[0029] FIG. 4B is an end-view of the anchor of FIG. 4, wherein the
coil-wire is in a deployed second position within the pericardial
space.
[0030] FIG. 5 is a view of the anchoring system and method of FIG.
1, wherein the anchor and the occluder device are advanced into the
LAA.
[0031] FIG. 6 is a view of the anchoring system and method of FIG.
5, wherein the anchor is advanced through the LAA wall.
[0032] FIG. 7 is a view of the anchoring system and method of FIG.
6, wherein the occluder device is released from the inner sheath
and positioned within the LAA.
[0033] FIG. 8 is a view of the anchoring system and method of FIG.
7, wherein the occluder device is retrieved inside the inner sheath
and the anchor is left implanted in the LAA wall, sealing up the
small hole created by the pericardial catheter.
[0034] FIG. 9 is a view of the anchoring system and method of FIG.
8, wherein the anchor is retracted from the LAA wall and the anchor
and the occluder device are retrieved inside the inner sheath.
[0035] FIG. 10 is a view of an outer sheath and a pericardial
catheter of another aspect of an anchoring system of the present
invention and method for implanting and retrieving an occluder
device within a LAA.
[0036] FIG. 11 is a view of an outer sheath, anchor catheter, and
inner dilator of the anchoring system and method of FIG. 10,
wherein the inner dilator and anchor catheter penetrate the LAA
wall.
[0037] FIG. 12 is a view the anchoring system and method of FIG.
10, wherein an occluder device and an anchor are advanced through
the outer sheath and anchor catheter, respectively.
[0038] FIG. 13 is a frontal-side view of the anchor of the
anchoring system and method of FIG. 10, wherein the anchor
comprises a sheave shape with a first half, a second half, and a
shaft connecting the two halves.
[0039] FIG. 13A is a side-view of the anchor of FIG. 13, wherein
the anchor is in a contracted first position.
[0040] FIG. 13B is a side-view of the anchor of FIG. 13, wherein
the anchor is in a deployed second position.
[0041] FIG. 14 is a view of the anchoring system and method of FIG.
1, wherein the second half of the anchor is deployed in the
pericardial space.
[0042] FIG. 15 is a view of the anchoring system and method of FIG.
1, wherein the first half of the anchor is partially deployed in
the occluder device.
[0043] FIG. 16 is a view of the anchoring system and method of FIG.
1, wherein the occluder device is released from the outer sheath
and the second half of the anchor fully deployed to pin the
occluder device against the LAA wall.
[0044] FIG. 17 is a view of the anchoring system and method of FIG.
1 if problems arise after deployment of the occluder device,
wherein the occluder device is retracted inside the outer sheath
and the first half of the anchor is retracted inside the anchor
catheter.
[0045] FIG. 18 is a view of the anchoring system and method of FIG.
1 if problems arise after deployment of the occluder device,
wherein the anchor is left implanted in the LAA wall.
[0046] FIG. 19 is a view of an outer sheath and pericardial
catheter of another aspect of an anchoring system of the present
invention and method for implanting and retrieving an occluder
device within a LAA.
[0047] FIG. 20 is a view the anchoring system and method of FIG.
19, wherein an occluder device is advanced through the outer sheath
and an anchor is advanced through the anchor catheter.
[0048] FIG. 21A is a side-view of the anchor of FIG. 20, wherein
the anchor is in a contracted first position.
[0049] FIG. 21B is a side-view of the anchor of FIG. 20, wherein
the anchor is in a deployed second position comprising a
double-coiled shape with a first half, a second half, and a shaft
connecting the two halves.
[0050] FIG. 22 is a view of the anchoring system and method of FIG.
19, wherein the second half of the anchor is deployed in the
pericardial space.
[0051] FIG. 23 is a view of the anchoring system and method of FIG.
19, wherein the first half of the anchor is partially deployed in
the occluder device.
[0052] FIG. 24 is a view of the anchoring system and method of FIG.
19, wherein the occluder device is released from the outer sheath
and the first half of the anchor is fully deployed to pin the
occluder device against the LAA wall.
[0053] FIG. 25 is a view of the anchoring system and method of FIG.
19 if problems arise after deployment of the occluder device,
wherein the occluder device is retracted inside the outer sheath
and the first half of the anchor is retracted inside the anchor
catheter.
[0054] FIG. 26 is a view of the anchoring system and method of FIG.
19 if problems arise after deployment of the occluder device,
wherein the anchor is left implanted in the LAA wall.
DETAILED DESCRIPTION OF THE INVENTION
[0055] FIG. 1 illustrates one aspect of the present invention, an
anchoring system 10 for implanting and retrieving an occluder
device within a LAA. The anchoring system 10 may comprise a
pericardial catheter 14, wherein the pericardial catheter 14 may be
a single or double-lumen pericardial catheter. The anchoring system
10 may further comprise an outer sheath 16 and an inner sheath 18.
A balloon-occlusion catheter may also be utilized by the present
invention. However, it is intended that other catheters standard in
the industry may also be utilized. The single or double-lumen
pericardial catheter 14 may be configured to fit a delivery wire 20
and/or a buddy wire 22, also standardly used in the industry. A
diameter of the delivery wire 20 may range between approximately
0.025-0.052 inches and a diameter of the buddy wire 22 may range
between approximately 0.008 0.025 inches.
[0056] Further illustrated in FIG. 1, the outer sheath 16 may be
inserted into LAA 24 via the left atrium proper of the heart by
crossing the atrial septum using a transeptal procedure. If a
balloon-occlusion catheter has been utilized, the balloon occlusion
may be expanded to occlude the LAA 24 from the left atrium proper.
Expanding the balloon occlusion may improve stabilization of the
outer sheath 16 within the LAA 24 and allow for better imaging of
the LAA 24 by an interventional cardiologist. The pericardial
catheter 14 may be advanced through the outer sheath 16, wherein
the pericardial catheter 14 penetrates LAA wall 26 and enters
pericardial space 28. Specifically, the pericardial catheter 14
penetrates the inner endocardium layer, middle myocardium layer,
and outer epicardium layer of the LAA wall 26. Thus, the
pericardial catheter 14 creates a small hole 30 through the LAA
wall 26 of the heart. If utilized, the expanded balloon occlusion
of the balloon-occlusion catheter decreases the likelihood of
bleeding and fluid accumulating within the pericardial space 28 via
the small hole 30. While the pericardial catheter 14 remains inside
the pericardial space 28 via the small hole 30, the delivery wire
20 and/or the buddy wire 22 may be advanced through the pericardial
catheter 14, wherein the delivery wire 20 and/or the buddy wire 22
enter the pericardial space 28. The buddy wire 22 remains inside
the pericardial space 28 and is a safety feature in case of
emergencies. The buddy wire 22 allows a interventional cardiologist
to advance another catheter through the LAA wall 26 and place a
plug within the small hole 30 if a malfunction is observed with the
anchor 32 or the occluder device 36. The pericardial catheter 14
may then be removed from the outer sheath 16, leaving the delivery
wire 20 and/or the buddy wire 22 inside the pericardial space 28
via the small hole 30 in the LAA wall 26.
[0057] Illustrated in FIG. 2, the anchoring system 10 of the
present invention further comprises an anchor 32, an occluder
device 36, and a connector 38. It is contemplated that the
anchoring system 10 of the present invention may be used with a
diverse range of LAA occluder devices such as coil implants, foam
plugs, expandable frames, combinations thereof, and other occluder
devices currently used in the industry and/or to be developed in
the future. Specific examples of occluder devices that may be used
by the present invention include, but are not limited to,
WATCHMAN.RTM., ATRICLIP.RTM., PLAATO LAA Occlusion System.RTM.,
AMPLATZER.TM., and AMULET.TM..
[0058] Further illustrated in FIG. 2, the occluder device 36 is
connected to the anchor 32 via the connector 38. The connector 38
may be comprised of stainless steel, platinum, Nitinol, Elgiloy, or
other materials standardly used in the industry. The connector 38
may be square, flat, rectangular, round, spherical, coiled, ovular,
a combination thereof, or any other shape. The connector 38 may be
approximately 0.5 mm-10 mm in length and approximately 0.5 mm-10 mm
in width. It is intended that the connector 38 provide flexibility
between the anchor 32 and the occluder device 36. This flexibility
may be achieved via an articulating joint, such as a
ball-and-socket joint 44, shown in FIG. 2. The ball-and-socket
joint 44 of FIG. 2 is illustrated for example purposes only. It is
not intended that the connector 38 of the present invention be
limited to a ball-and-socket joint 44. Rather, it is intended that
other articulating connectors standardly used in the industry may
also be utilized, such as hinge joints, pivot joints, ellipsoid
joints, gliding joints, saddle joints, and others. It is important
that the connector 38 provide flexibility between the occluder
device 36 and the anchor 32 to allow for multiple insertion sites
within the LAA 24, thus, ensuring the occluder device 36 is
properly positioned within the LAA 24 once deployed. Furthermore,
the connector 38 may allow an interventional cardiologist via a
cable (not shown) to conveniently attach the occluder device 36 to
the anchor 32, release the occluder device 36 from the anchor 32,
and reattach the occluder device 36 to the anchor 32 without
damaging the occluder device 36.
[0059] Illustrated in FIG. 3, the anchor 32 may be comprised of a
square, rectangle, flat, sphere, circle, oval, pentagon, octagon,
or any other shape. The length of the anchor 32 may be
approximately 1-10 mm, wherein the width of the anchor 32 may be
approximately 1-20 mm. The anchor 32 may be comprised of stainless
steel, platinum, Nitinol, Elgiloy or other materials standardly
used in the industry. The anchor 32 may also comprise antibiotics,
drugs that prevent the LAA pericardium wall from bleeding, ePTFE,
any variety of materials which facilitate cellular in-growth,
hydrogel, anticoagulants, fibrin hairs and/or other
pharmaceuticals.
[0060] Further illustrated in FIG. 3, the anchor 32 may comprise a
plurality of self-expanding anchor tines 39, wherein the plurality
may comprise 2-10 tines. The anchor tines 39 may be approximately
5-20 mm in length and approximately 0.01-1.5 mm in width. The
anchor tines 39 may be circular in cross-section, however, it is
contemplated that other cross-sectional shapes may also be
utilized, including but not limited to, square, rectangular,
triangular, pentagonal, and octagonal depending on the
manufacturing technique. The anchor tines 39 may further include
barbs, points, bristles, spurs, screws, hooks, pins, sutures,
adhesives, pledgets, or other means of attachment. The anchor tines
39 may be comprised of stainless steel, platinum, Nitinol, Elgiloy
or other materials standardly used in the industry. It is also
contemplated that the anchor tines 39 may comprise antibiotics,
drugs that prevent the LAA pericardium wall from bleeding, ePTFE,
any variety of materials which facilitate cellular in-growth,
hydrogel, anticoagulants, fibrin hairs and/or other
pharmaceuticals.
[0061] Alternatively, the anchor 32 of the present invention may
comprise a self-expanding coil-wire 40 instead of the anchor tines
39 as illustrated in FIG. 4. The coil-wire 40 may be approximately
5-25 mm in length and 0.01-1.5 mm in width. The coil-wire 40 may be
circular in cross-section, however, it is contemplated that other
cross-sectional shapes may also be utilized, including but not
limited to, square, rectangular, triangular, pentagonal, and
octagonal depending on the manufacturing technique. The coil-wire
40 may further include barbs, points, bristles, spurs, screws,
hooks, pins, sutures, adhesives, pledgets, or other means of
attachment. The coil-wire 40 may be comprised of stainless steel,
platinum, Nitinol, Elgiloy or other materials standardly used in
the industry. It is also contemplated that the coil-wire 40 may
comprise antibiotics, drugs that prevent the LAA pericardium wall
from bleeding, ePTFE, any variety of materials which facilitate
cellular in-growth, hydrogel, anticoagulants, fibrin hairs and/or
other pharmaceuticals.
[0062] The anchor 32 may have a contracted first position (FIGS.
3A, 4A) and a deployed second position (FIGS. 3B, 4B). When the
anchor tines 39 are utilized, the anchor tines 39 may expand
outwards a distance of approximately 2-20 mm in diameter in the
deployed second position (FIG. 3B). Alternatively when the
coil-wire 40 is utilized, the coil-wire may have a circular
diameter of 0.01-1.5 mm in the contracted first position (FIG. 4A),
and may have a circular diameter of approximately 5-20 mm in the
deployed second position (FIG. 4B). However, it is contemplated
that the diameter of the contracted first position and deployed
second position of the coil-wire 40 may have any shape compatible
with the LAA 24.
[0063] Illustrated in FIG. 5, the inner sheath 18 is advanced up to
and adjacent the LAA wall 26. The anchor 32, the connector 38, and
the occluder device 36 are next advanced through the inner sheath
18 using the delivery wire 20, wherein the anchor 32 resides
adjacent the small hole 30 in the LAA wall 26.
[0064] Illustrated in FIG. 6, the anchor 32, the connector 38, and
the occluder device 36 are further advanced through the inner
sheath 18 using the delivery wire 20, wherein the anchor 32
penetrates the LAA wall 26 via the small hole 30 and extends into
the pericardial space 28. Specifically, the anchor 32 penetrates
the inner endocardium layer, middle myocardium layer, and outer
epicardium layer of the LAA wall 26. Once inside the pericardial
space 28, the anchor 32 self-expands from the contracted first
position (FIGS. 3A, 4A) to the deployed second position (FIGS. 3B,
4B).
[0065] Illustrated in FIG. 7, the inner sheath 18 is retracted
inside the outer sheath 16 after the anchor 32 has been implanted
in the LAA wall 26. This effectively releases the occluder device
36 into the LAA 24. The expanded anchor 32 in the deployed second
position (FIGS. 3B, 4B) covers a large surface area and therefore
retains the occluder device 36 in an implanted position within the
LAA 24. Moreover, by anchoring the occluder device 36 via the
anchor 32 through all three layers of the LAA wall 26--instead of
merely latching onto the thin endocardium layer--the anchoring
system 10 of the present invention lowers the risk of
embolization.
[0066] FIGS. 8-9 illustrate the anchoring system 10 of the present
invention if problems arise after deployment of the occluder device
36. For instance, it may be determined that the occluder device 36
is not placed in an optimal location of the LAA 24 after deployment
to achieve maximum occlusion. The anchoring system 10 of the
present invention offers two solutions to overcome these
problems.
[0067] The first solution is illustrated in FIG. 8, wherein an
interventional cardiologist may use a cable (not shown) to detach
42 the occluder device 36 from the anchor 32 via connector 38. The
occluder device 36 is then retrieved inside the inner sheath 18 via
the cable. The anchor 32 is expendable and may be left implanted in
the LAA wall 26 where it causes no harm to the patient. A new
anchor 32 is then connected to the occluder device 36 via the
connector 38, and the anchoring steps repeated until optimal
placement of the occluder device 36 within the LAA 24 is
achieved.
[0068] The second solution is illustrated in FIG. 9, wherein the
occluder device 36 is retrieved inside the inner sheath 18 via a
cable (not shown). The inner sheath 18 is then advanced to envelope
the anchor 32 and press up against the LAA wall 26. While the inner
sheath 18 is pressed up against the LAA wall 26, the anchor 32 is
pulled back through the LAA wall 26, into the LAA 24, and retrieved
46 inside the inner sheath 18 via the cable. The anchor 32 is
designed to retract from the deployed second position (FIGS. 3B,
4B) into the contracted first position (FIGS. 3A, 4A) without
tearing or ripping the LAA wall 26 as the anchor 32 is retrieved
inside the inner sheath 18. Thus, the anchoring system 10 of the
present invention allows an interventional cardiologist to quickly
and cost-effectively implant the occluder device 36 into the LAA 24
using anchor 32, safely retrieve the occluder device 36 and anchor
32 if initial placement was improper or if complications arise, and
then reuse and re-implant the occluder device 36 and anchor 32 in
an optimal location of the LAA 24. Ultimately after optimal
placement of the occluder device within the LAA is achieved, the
delivery wire 20 and buddy wire 22 are removed from the LAA via the
outer 16 sheath. The outer sheath 16 may be subsequently removed
from the LAA 24 via the left atrium proper of the heart.
[0069] In another aspect of the present invention, an anchor 32 is
provided for anchoring an occluder device 36 within the LAA 24. As
illustrated in FIG. 3, the anchor 32 may be comprised of a square,
rectangle, flat, sphere, circle, oval, pentagon, octagon, or any
other shape. The length of the anchor 32 may be approximately 1-10
mm, wherein the width of the anchor 32 may be approximately 1-20
mm. The anchor 32 may be comprised of stainless steel, platinum,
Nitinol, Elgiloy or other materials standardly used in the
industry. The anchor 32 may also comprise antibiotics, drugs that
prevent the LAA pericardium wall from bleeding, ePTFE, any variety
of materials which facilitate cellular in-growth, hydrogel,
anticoagulants, fibrin hairs and/or other pharmaceuticals.
[0070] Illustrated in FIG. 2, the anchor 32 is further configured
to connect to an occluder device 36 via a connector 38. The
connector 38 may be comprised of stainless steel, platinum,
Nitinol, Elgiloy, or other materials standardly used in the
industry. The connector 38 may be square, flat, rectangular, round,
spherical, coiled, ovular, a combination thereof, or any other
shape. The connector 38 may be approximately 0.5 mm-10 mm in length
and approximately 0.5 mm-10 mm in width. It is intended that the
connector 38 provide flexibility between the anchor 32 and the
occluder device 36. This flexibility may be achieved via an
articulating joint, such as a ball-and-socket joint 44, shown in
FIG. 2. The ball-and-socket joint 44 of FIG. 2 is illustrated for
example purposes only. It is not intended that the connector 38 of
the present invention be limited to a ball-and-socket joint 44.
Rather, it is intended that other articulating connectors
standardly used in the industry may also be utilized, such as hinge
joints, pivot joints, ellipsoid joints, gliding joints, saddle
joints, and others. It is important that the connector 38 provide
flexibility between the occluder device 36 and the anchor 32 to
allow for multiple insertion sites within the LAA 24, thus,
ensuring the occluder device 36 is properly positioned within the
LAA 24 once deployed. Furthermore, the connector 38 may allow an
interventional cardiologist via a cable (not shown) to conveniently
attach the occluder device 36 to the anchor 32, release the
occluder device 36 from the anchor 32, and reattach the occluder
device 36 to the anchor 32 without damaging the occluder device
36.
[0071] Further illustrated in FIG. 3, the anchor 32 may comprise a
plurality of self-expanding anchor tines 39, wherein the plurality
may comprise 2-10 tines. The anchor tines 39 may be approximately
5-20 mm in length and approximately 0.01-1.5 mm in width. The
anchor tines 39 may be circular in cross-section, however, it is
contemplated that other cross-sectional shapes may also be
utilized, including but not limited to, square, rectangular,
triangular, pentagonal, and octagonal depending on the
manufacturing technique. The anchor tines 39 may further include
barbs, points, bristles, spurs, screws, hooks, pins, sutures,
adhesives, pledgets, or other means of attachment. The anchor tines
39 may be comprised of stainless steel, platinum, Nitinol, Elgiloy
or other materials standardly used in the industry. It is also
contemplated that the anchor tines 39 may comprise antibiotics,
drugs that prevent the LAA pericardium wall from bleeding, ePTFE,
any variety of materials which facilitate cellular in-growth,
hydrogel, anticoagulants, fibrin hairs and/or other
pharmaceuticals.
[0072] Alternatively, the anchor 32 of the present invention may
comprise a self-expanding coil-wire 40 instead of the anchor tines
39 as illustrated in FIG. 4. The coil-wire 40 may be approximately
5-25 mm in length and 0.01-1.5 mm in width. The coil-wire 40 may be
circular in cross-section, however, it is contemplated that other
cross-sectional shapes may also be utilized, including but not
limited to, square, rectangular, triangular, pentagonal, and
octagonal depending on the manufacturing technique. The coil-wire
40 may further include barbs, points, bristles, spurs, screws,
hooks, pins, sutures, adhesives, pledgets, or other means of
attachment. The coil-wire 40 may be comprised of stainless steel,
platinum, Nitinol, Elgiloy or other materials standardly used in
the industry. It is also contemplated that the coil-wire 40 may
comprise antibiotics, drugs that prevent the LAA pericardium wall
from bleeding, ePTFE, any variety of materials which facilitate
cellular in-growth, hydrogel, anticoagulants, fibrin hairs and/or
other pharmaceuticals.
[0073] The anchor 32 may have a contracted first position (FIGS.
3A, 4A) and a deployed second position (FIGS. 3B, 4B). When the
anchor tines 39 are utilized, the anchor tines 39 may expand
outwards a distance of approximately 2-20 mm in diameter in the
deployed second position (FIG. 3B). Alternatively when the
coil-wire 40 is utilized, the coil-wire may have a circular
diameter of 0.01-1.5 mm in the contracted first position (FIG. 4A),
and may have a circular diameter of approximately 5-20 mm in the
deployed second position (FIG. 4B). However, it is contemplated
that the diameter of the contracted first position and deployed
second position of the coil-wire 40 may have any shape compatible
with the LAA 24.
[0074] Illustrated in FIG. 6, the anchor 32 is configured to
penetrate the LAA wall 26 via a pre-made small hole 30 through the
LAA wall. Specifically, the anchor 32 penetrates the inner
endocardium layer, middle myocardium layer, and outer epicardium
layer of the LAA wall 26. The anchor 32 extends into the
pericardial space 28, wherein the anchor 32 self-expands from the
contracted first position (FIGS. 3A, 4A) to the deployed second
position (FIGS. 3B, 4B). The expanded anchor 32 in the deployed
second position (FIGS. 3B, 4B) covers a large surface area and
therefore retains the occluder device 36 in an implanted position
within the LAA 24. Moreover, by anchoring the occluder device 36
via the anchor 32 through all three layers of the LAA wall
26--instead of merely latching onto the thin endocardium layer--the
anchor 32 of the present invention lowers the risk of
embolization.
[0075] In yet another aspect of the present invention, a method of
implanting and retrieving an occluder device within a LAA is
illustrated in FIG. 1. The method of the present invention
comprises providing an anchoring system 10. The anchoring system 10
comprises a pericardial catheter 14, wherein the pericardial
catheter 14 may be a single or double-lumen pericardial catheter.
The anchoring system 10 may further comprise an outer sheath 16 and
an inner sheath 18. A balloon-occlusion catheter may also be
utilized in the present invention. However, it is intended that
other catheters standard in the industry may also be utilized. The
pericardial catheter 14 may be configured to fit a delivery wire 20
and/or a buddy wire 22, also standardly used in the industry. A
diameter of the delivery wire 20 may range between approximately
0.025-0.052 inches and a diameter of the buddy wire 22 may range
between approximately 0.008-0.025 inches.
[0076] Further illustrated in FIG. 1, the method of the present
invention comprises inserting the outer sheath 16 into LAA 24 via
the left atrium proper of the heart. If a balloon-occlusion
catheter has been utilized, the balloon occlusion may be expanded
to occlude the LAA 24 from the left atrium proper. Next, the
pericardial catheter 14 may be advanced through the outer sheath
16, wherein the pericardial catheter 14 penetrates LAA wall 26 and
enters pericardial space 28. Specifically, the pericardial catheter
14 penetrates the inner endocardium layer, middle myocardium layer,
and outer epicardium layer of the LAA wall 26. Thus, the
pericardial catheter 14 creates a small hole 30 through the LAA
wall 26 of the heart. If utilized, the expanded balloon occlusion
of the balloon-occlusion catheter decreases the likelihood of fluid
accumulating within the pericardial space 28 via the small hole 30.
While the pericardial catheter 14 remains inside the pericardial
space 28 via the small hole 30, the delivery wire 20 and the buddy
wire 22 may be advanced through the pericardial catheter 14,
wherein the delivery wire 20 and the buddy wire 22 enter the
pericardial space 28. The buddy wire 22 remains inside the
pericardial space 28 and is a safety feature in case of
emergencies. The buddy wire 22 allows an interventional
cardiologist to advance another catheter through the LAA wall 26
and place a plug within the small hole 30 if a malfunction is
observed with the anchor 32 or the occluder device 36. The
pericardial catheter 14 may then be removed from the outer sheath
16, leaving the delivery wire 20 and the buddy wire 22 inside the
pericardial space 28 via the small hole 30 in the LAA wall 26.
[0077] Illustrated in FIG. 2, the method of the present invention
further comprises providing an anchor 32, an occluder device 36,
and a connector 38. It is contemplated that the method of the
present invention may be used with a diverse range of LAA occluder
devices such as coil implants, foam plugs, expandable frames,
combinations thereof, and other occluder devices currently used in
the industry and/or to be developed in the future. Specific
examples of occluder devices that may be used by the present
invention include, but are not limited to, WATCHMAN.RTM.,
ATRICLIP.RTM., PLAATO LAA Occlusion System.RTM., AMPLATZER.TM., and
AMULET.TM..
[0078] Further illustrated in FIG. 2, the method of the present
invention comprises connecting the occluder device 36 to the anchor
32 via the connector 38. The connector 38 may be comprised of
stainless steel, platinum, Nitinol, Elgiloy, or other materials
standardly used in the industry. The connector 38 may be square,
flat, rectangular, round, spherical, coiled, ovular, a combination
thereof, or any other shape. The connector 38 may be approximately
0.5 mm-10 mm in length and approximately 0.5 mm-10 mm in width. It
is intended that the connector 38 provide flexibility between the
anchor 32 and the occluder device 36. This flexibility may be
achieved via an articulating joint, such as a ball-and-socket joint
44, shown in FIG. 2. The ball-and-socket joint 44 of FIG. 2 is
illustrated for example purposes only. It is not intended that the
connector 38 of the present invention be limited to a
ball-and-socket joint 44. Rather, it is intended that other
articulating connectors standardly used in the industry may also be
utilized, such as hinge joints, pivot joints, ellipsoid joints,
gliding joints, saddle joints, and others. It is important that the
connector 38 provide flexibility between the occluder device 36 and
the anchor 32 to allow for multiple insertion sites within the LAA
24, thus, ensuring the occluder device 36 is properly positioned
within the LAA 24 once deployed. Furthermore, the connector 38 may
allow an interventional cardiologist via a cable (not shown) to
conveniently attach the occluder device 36 to the anchor 32,
release the occluder device 36 from the anchor 32, and reattach the
occluder device 36 to the anchor 32 without damaging the occluder
device 36.
[0079] Illustrated in FIG. 3, the anchor 32 may be comprised of a
square, rectangle, flat, sphere, circle, oval, pentagon, octagon,
or any other shape. The length of the anchor 32 may be
approximately 1-10 mm, wherein the width of the anchor 32 may be
approximately 1-20 mm. The anchor 32 may be comprised of stainless
steel, platinum, Nitinol, Elgiloy or other materials standardly
used in the industry. The anchor 32 may also comprise antibiotics,
drugs that prevent the LAA pericardium wall from bleeding, ePTFE,
any variety of materials which facilitate cellular in-growth,
hydrogel, anticoagulants, fibrin hairs and/or other
pharmaceuticals.
[0080] Further illustrated in FIG. 3, the anchor 32 may comprise a
plurality of self-expanding anchor tines 39, wherein the plurality
may comprise 2-10 tines. The anchor tines 39 may be approximately
5-20 mm in length and approximately 0.01-1.5 mm in width. The
anchor tines 39 may be circular in cross-section, however, it is
contemplated that other cross-sectional shapes may also be
utilized, including but not limited to, square, rectangular,
triangular, pentagonal, and octagonal depending on the
manufacturing technique. The anchor tines 39 may further include
barbs, points, bristles, spurs, screws, hooks, pins, sutures,
adhesives, pledgets, or other means of attachment. The anchor tines
39 may be comprised of stainless steel, platinum, Nitinol, Elgiloy
or other materials standardly used in the industry. It is also
contemplated that the anchor tines 39 may comprise antibiotics,
drugs that prevent the LAA pericardium wall from bleeding, ePTFE,
any variety of materials which facilitate cellular in-growth,
hydrogel, anticoagulants, fibrin hairs and/or other
pharmaceuticals.
[0081] Alternatively, the anchor 32 of the present invention may
comprise a self-expanding coil-wire 40 instead of the anchor tines
39 as illustrated in FIG. 4. The coil-wire 40 may be approximately
5-25 mm in length and 0.01-1.5 mm in width. The coil-wire 40 may be
circular in cross-section, however, it is contemplated that other
cross-sectional shapes may also be utilized, including but not
limited to, square, rectangular, triangular, pentagonal, and
octagonal depending on the manufacturing technique. The coil-wire
40 may further include barbs, points, bristles, spurs, screws,
hooks, pins, sutures, adhesives, pledgets, or other means of
attachment. The coil-wire 40 may be comprised of stainless steel,
platinum, Nitinol, Elgiloy or other materials standardly used in
the industry. It is also contemplated that the coil-wire 40 may
comprise antibiotics, drugs that prevent the LAA pericardium wall
from bleeding, ePTFE, any variety of materials which facilitate
cellular in-growth, hydrogel, anticoagulants, fibrin hairs and/or
other pharmaceuticals.
[0082] The anchor 32 may have a contracted first position (FIGS.
3A, 4A) and a deployed second position (FIGS. 3B, 4B). When the
anchor tines 39 are utilized, the anchor tines 39 may expand
outwards a distance of approximately 2-20 mm in diameter in the
deployed second position (FIG. 3B). Alternatively when the
coil-wire 40 is utilized, the coil-wire may have a circular
diameter of 0.01-1.5 mm in the contracted first position (FIG. 4A),
and may have a circular diameter of approximately 5-20 mm in the
deployed second position (FIG. 4B). However, it is contemplated
that the diameter of the contracted first position and deployed
second position of the coil-wire 40 may have any shape compatible
with the LAA 24.
[0083] Illustrated in FIG. 5, the method of the present invention
further comprises advancing the inner sheath 18 up to and adjacent
the LAA wall 26. The anchor 32, the connector 38, and the occluder
device 36 are next advanced through the inner sheath 18 using the
delivery wire 20, wherein the anchor 32 resides adjacent the small
hole 30 in the LAA wall 26.
[0084] Illustrated in FIG. 6, the method of the present invention
comprises further advancing the anchor 32, the anchor tines 39, the
connector 38, and the occluder device 36 through the inner sheath
18 using the delivery wire 20, wherein the anchor 32 penetrates the
LAA wall 26 via the small hole 30 and extends into the pericardial
space 28. Specifically, the anchor 32 penetrates the inner
endocardium layer, middle myocardium layer, and outer epicardium
layer of the LAA wall 26. Once inside the pericardial space 28, the
anchor 32 self-expands from the contracted first position (FIGS.
3A, 4A) to the deployed second position (FIGS. 3B, 4B).
[0085] Illustrated in FIG. 7, the method of the present invention
further comprises retracting the inner sheath 18 inside the outer
sheath 16 after the anchor 32 has been implanted in the LAA wall
26. This effectively releases the occluder device 36 into the LAA
24. The expanded anchor 32 in the deployed second position (FIGS.
3B, 4B) covers a large surface area and therefore retains the
occluder device 36 in an implanted position within the LAA 24.
Moreover, by anchoring the occluder device 36 via the anchor 32
through all three layers of the LAA wall 26--instead of merely
latching onto the thin endocardium layer--the anchoring system 10
of the present invention lowers the risk of embolization.
[0086] FIGS. 8-9 illustrate the method of the present invention,
further comprising making a determination whether a problem has
arisen after deployment of the occluder device 36. For example, it
may be determined that the occluder device 36 is not placed in an
optimal location of the LAA 24 after deployment to achieve maximum
occlusion. The method of the present invention offers two
alternative solutions to overcome these problems.
[0087] The first solution is illustrated in FIG. 8, wherein an
interventional cardiologist may use a cable (not shown) to detach
42 the occluder device 36 from the anchor 32 via connector 38. The
occluder device 36 is then retrieved inside the inner sheath 18 via
the cable. The anchor 32 is expendable and may be left implanted in
the LAA wall 26 where it causes no harm to the patient. A new
anchor 32 is then connected to the occluder device 36 via the
connector 38, and the anchoring steps repeated until optimal
placement of the occluder device 36 within the LAA 24 is
achieved.
[0088] The second solution is illustrated in FIG. 9, wherein the
occluder device 36 is retrieved inside the inner sheath 18 via a
cable (not shown). The inner sheath 18 is then advanced to envelope
the anchor 32 and press up against the LAA wall 26. While the inner
sheath 18 is pressed up against the LAA wall 26, the anchor 32 is
pulled back through the LAA wall 26, into the LAA 24, and retrieved
46 inside the inner sheath 18 via the cable. The anchor 32 is
designed to retract from the deployed second position (FIGS. 3B,
4B) into the contracted first position (FIGS. 3A, 4A) without
tearing or ripping the LAA wall 26 as the anchor 32 is retrieved
inside the inner sheath 18. Thus, the method of the present
invention allows an interventional cardiologist to quickly and
cost-effectively implant the occluder device 36 into the LAA 24
using anchor 32, safely retrieve the occluder device 36 and anchor
32 if initial placement was improper or if complications arise, and
then reuse and re-implant the same occluder device 36 and anchor 32
in an optimal location of the LAA 24. Ultimately after optimal
placement of the occluder device within the LAA is achieved, the
delivery wire 20 and buddy wire 22 are removed from the LAA via the
outer sheath 16. The outer sheath 16 may be subsequently removed
from the LAA 24 via the left atrium proper of the heart.
[0089] FIG. 10 illustrates a further aspect of the present
invention, an anchoring system 50 for implanting and retrieving an
occluder device within a LAA. The anchoring system 50 may comprise
a pericardial catheter 54, wherein the pericardial catheter 54 may
be a single or double-lumen pericardial catheter. The anchoring
system 50 may further comprise an outer sheath 56. A
balloon-occlusion catheter may also be utilized by the present
invention. However, it is intended that other catheters standard in
the industry may also be utilized. The pericardial catheter 54 may
be configured to fit a delivery wire 60 and/or a buddy wire 62,
also standardly used in the industry. A diameter of the delivery
wire 60 may range between approximately 0.025-0.052 inches and a
diameter of the buddy wire 62 may range between approximately
0.008-0.025 inches.
[0090] Further illustrated in FIG. 10, the outer sheath 56 may be
inserted into LAA 64 via the left atrium proper of the heart by
crossing the atrial septum using a transeptal procedure. If a
balloon-occlusion catheter has been utilized, the balloon occlusion
may be expanded to occlude the LAA 64 from the left atrium proper.
Expanding the balloon occlusion may improve stabilization of the
outer sheath 56 within the LAA 64 and allow for better imaging of
the LAA 64 by an interventional cardiologist. The pericardial
catheter 54 may be advanced through the outer sheath 56 to the LAA
wall 66. The buddy wire 62 is next advanced through the pericardial
catheter 54 and the adjacent LAA wall 66, wherein the buddy wire 62
penetrates the inner endocardium layer, middle myocardium layer,
and outer epicardium layer of the LAA wall 26 to extend into the
pericardial space 68. The pericardial catheter 54 is next advanced
over the buddy wire 62 and through the LAA wall 66, penetrating the
inner endocardium layer, middle myocardium layer, and outer
epicardium layer of the LAA wall 66 to extend into the pericardial
space 68. Thus, the pericardial catheter 54 creates a small hole 70
through the LAA wall 66 of the heart. If utilized, the expanded
balloon occlusion of the balloon-occlusion catheter decreases the
likelihood of fluid accumulating within the pericardial space 68
via the small hole 70. While the pericardial catheter 54 remains
inside the pericardial space 68 via the small hole 70, the delivery
wire 60 may then be advanced through the pericardial catheter 54,
wherein the delivery wire 60 enters the pericardial space 68. The
pericardial catheter 54 may then be removed from the outer sheath
56, leaving the delivery wire 60 and the buddy wire 62 inside the
pericardial space 68 via the small hole 70 in the LAA wall 66.
[0091] Illustrated in FIG. 11, the anchoring system 50 of the
present invention further comprises an anchor catheter 58 and an
inner dilator 86, wherein the inner dilator 86 includes a pointed
distal end 88. The inner dilator 86 may be configured to encompass
the delivery wire 60, wherein the delivery wire 60 may traverse
through an inner lumen of the inner dilator 86. The anchor catheter
58 and the inner dilator 86 may be advanced through the outer
sheath 56 to the LAA wall 66 adjacent the small hole 70.
Particularly, the delivery wire 60 may traverse through the anchor
catheter 52 and the inner dilator 86. The buddy wire 62 may reside
outside the anchor catheter 58 and yet inside the outer sheath 56.
Using the pointed distal end 88 of the inner dilator 86, the inner
dilator 86 and the anchor catheter 52 may be further advanced
through the small hole 70 to penetrate the inner endocardium layer,
middle myocardium layer, and outer epicardium layer of the LAA wall
66. Thus, the pointed distal end 88 of the inner dilator 86, along
with a distal end of the anchor catheter 52, extends into the
pericardial space 68. The inner dilator 86 may be subsequently
removed from the anchor catheter 58, wherein the distal end of the
anchor catheter 58 remains extending into the pericardial space
68.
[0092] Illustrated in FIG. 12, the anchoring system 50 of the
present invention further comprises an occluder device 80 and an
occluder cable 84. It is contemplated that the anchoring system 50
of the present invention may be used with a diverse range of LAA
occluder devices 80 such as coil implants, foam plugs, expandable
frames, combinations thereof, and other occluder devices currently
used in the industry and/or to be developed in the future. Specific
examples of occluder devices 80 that may be used by the present
invention include, but are not limited to, WATCHMAN.RTM.,
ATRICLIP.RTM., PLAATO LAA Occlusion System.RTM., AMPLATZER.TM., and
AMULET.TM.. In the present invention, the occluder device 80 may
have a distal end with a hole approximately 1-5 mm in diameter. As
shown in FIG. 12, the occluder cable 84 may be a hollow coaxial
cable standardly used in the industry. The occluder cable 84 may be
attached to the occluder device 80, wherein the occluder cable 84
may be used for deploying and retrieving the occluder device 80
within the LAA 64. The occluder device 80 and the occluder cable 84
may encompass the anchor catheter 58, wherein the anchor catheter
58 may traverse through an inner lumen of the occluder device 80
and an inner lumen of the occluder cable 84. The occluder device 80
may reside between the anchor catheter 58 and the outer sheath
56.
[0093] As further shown in FIG. 12, the anchoring catheter 58 may
comprise an anchor 72 and an anchor cable 82. The anchor cable 82
may be attached to the anchor 72, wherein the anchor cable 82 may
be used for deploying the anchor 72 within the LAA wall 66. The
anchor cable 82 may be a hollow coaxial cable standardly used in
the industry. The anchor cable 82 and anchor 72 may encompass the
delivery wire 60, wherein the delivery wire 60 may traverse through
an inner lumen of the anchor 72 and an inner lumen of the anchor
cable 82. The delivery wire 60 may be used to navigate the
anchoring system 50 through the LAA 64. Alternatively, the anchor
72 and anchor cable 82 may be advanced through the anchor catheter
58 into the pericardial space 68 without using the delivery wire
60. The buddy wire 62 may remain inside the pericardial space 68
and is a safety feature in case of emergencies. The buddy wire 62
allows an interventional cardiologist to advance another catheter
through the LAA wall 66 and place a plug within the small hole 70
if a malfunction is observed with the anchor 72 or the occluder
device 80.
[0094] Illustrated in FIG. 13, the anchor 72 may be shaped like a
sheave, comprising a first half 74, a second half 76, and a shaft
78 connecting the first half 74 to the second half 76, although it
is contemplated that other anchor shapes may also be utilized in
the present invention. The anchor 72 may be comprised of wire,
wherein the first half 74 and second half 76 of the anchor 72
comprise wire mesh, further wherein the shaft 78 may comprise a
single wire connecting the first half 75 wire mesh and the second
half 76 wire mesh. The anchor 72 may be comprised of a square,
rectangle, flat, sphere, circle, oval, pentagon, octagon, or any
other shape, and may be comprised of single or multiple wires. The
anchor 72 may be circular in diameter, however, it is contemplated
that other cross-sectional shapes may also be utilized, including
but not limited to, square, rectangular, triangular, pentagonal,
and octagonal depending on the manufacturing technique. The anchor
72 may be comprised of stainless steel, platinum, Nitinol, Elgiloy
or other materials standardly used in the industry. The anchor 72
may also comprise antibiotics, drugs that prevent the LAA
pericardium wall from bleeding, ePTFE, any variety of materials
which facilitate cellular in-growth, hydrogel, anticoagulants,
fibrin hairs and/or other pharmaceuticals. The anchor 72 may have a
lumen wherein the delivery wire 60 traverses therein,
alternatively, the anchor 72 may not have a lumen. The anchor 72
may further include barbs, points, bristles, spurs, screws, hooks,
pins, sutures, adhesives, pledgets, or other means of
attachment.
[0095] Illustrated in FIGS. 13A-B, the anchor 72 may have a
contracted first position (FIG. 13A) and a deployed second position
(FIG. 13B). In the contracted first position (FIG. 13A), the first
half 74, second half 76, and shaft 78 of the anchor 72 have a
diameter of approximately 1-5 mm and a length of approximately 5-55
mm. In the deployed second position (FIG. 13B), the first half 74
and second half 76 of the anchor 72 may expand outwards a distance
of approximately 5-25 mm in diameter, wherein the shaft 78 remains
approximately 1-5 mm in diameter. The anchor 72 may self-expand
from the contracted first position (FIG. 13A) to the deployed
second position (FIG. 13B).
[0096] Illustrated in FIG. 14, the anchor 72 in the contracted
first position (FIG. 13A) may be advanced through the anchor
catheter 58 using the anchor cable 82 and the delivery wire 60,
wherein the anchor 72 extends into the pericardial space 68. The
anchor catheter 58 may then be retracted, allowing the second half
76 of the anchor 72 to self-expand from the contracted first
position to the deployed second position within the pericardial
space 68. While the second half 76 of the anchor 72 is in the
deployed second position, the shaft 78 and the first half 74 of the
anchor 72 remain temporarily inside the anchor catheter 58.
[0097] Illustrated in FIG. 15, the anchor catheter 58 may be
further retracted, allowing the first half 74 of the anchor 72 to
self-expand from the contracted first position to a partially
deployed second position within the occluder device 80, wherein the
occluder device 80 remains inside the outer sheath 56. The shaft 78
resides inside the inner endocardium layer, middle myocardium
layer, and outer epicardium layer of the LAA wall 66. The second
half 76 of the anchor 72 remains in the deployed second position
within the pericardial space 68, wherein the first half 74 of the
anchor 72 is in the partially deployed second position within the
occluder device 80. Alternatively, the anchor 72 and occluder
device 80 may be integral, wherein the occluder device 80 may be a
coil occluder device. Thus, the integral anchor 72 and occluder
device 80 may be advanced together through the anchor catheter 58,
wherein the anchor 72 is implanted in the LAA wall 66 using the
system 50 of the present invention described above.
[0098] Illustrated in FIG. 16, the outer sheath 56 may be retracted
to allow the occluder device 80 to expand inside the LAA 64.
Moreover, retracting the outer sheath 56 allows the first half 74
of the anchor 72 to fully expand into the deployed second position
within the occluder device 80. Thus, the shaft 78 of the anchor 72
may extend through the hole in the distal end of the occluder
device 80, wherein the distal end of the occluder device 80 pinches
down on the shaft 78. Furthermore, the first half of the anchor 74
in the deployed second position may pin the occluder device 80
against the LAA wall 66, wherein the anchor 72 effectively moors
the occluder device 80 inside the LAA 64. At this time the expanded
anchor 72 in the deployed second position covers a large surface
area and therefore retains the occluder device 80 in an implanted
position within the LAA 64. Moreover, by anchoring the occluder
device 80 via the anchor 72 through all three layers of the LAA
wall 66--instead of merely latching onto the thin endocardium
layer--the anchoring system 50 of the present invention lowers the
risk of embolization. Here, the anchor cable 82 remains attached to
the anchor 72 and the occluder cable 84 remains attached to the
occluder device 80 in case problems arise after deployment of the
occluder device 80. If no problems arise and it is determined that
the occluder device 80 is in an optimal location of the LAA 64, the
occluder cable 84 may be detached from the occluder device 80 and
removed from the LAA 64. Furthermore, the anchor cable 82 may be
detached from the anchor 72 and removed from the LAA 64. The buddy
wire 62 and delivery wire 60 may also be withdrawn from the LAA 64,
leaving the occluder device 80 anchored securely in the LAA 64 by
the anchoring system 50 of the present invention.
[0099] FIG. 17 illustrates the anchoring system 50 of the present
invention if problems arise after deployment of the occluder device
80. For instance, it may be determined that the occluder device 80
is not placed in an optimal location of the LAA 64 after deployment
to achieve maximum occlusion. In this situation--prior to release
of the occluder cable 84 from the occluder device 80 and the anchor
cable 82 from the anchor 72--the outer sheath 56 may be advanced
over the occluder device 80 to the LAA wall 66, wherein the
occluder device 80 is retracted inside the outer sheath 56 using
the occluder cable 82. The anchor catheter 58 may then be advanced
to the LAA wall 66, wherein the first half 74 of the anchor 72 is
retracted inside the anchor catheter 58 using the anchor cable 82.
Thus, using the anchor cable 82, the first half 74 of the anchor 72
retracts from the deployed second position to the contracted first
position to fit inside the anchor catheter 58. The outer sheath 56
containing the occluder device 80 may then be removed from the LAA
64, or the occluder device 80 may be re-deployed in a more optimal
location of the LAA 64. If the occluder device 80 is removed from
the LAA 64, the anchor catheter 58 may be retrieved thereafter,
allowing the first half 74 of the anchor 72 to expand from the
contracted first position to the deployed second position within
the LAA 64. Thus, the deployed anchor 72 remains inside the LAA 64
and allows for occlusion of the small hole 70 that was created by
the pericardial catheter 54 through the inner endocardium layer,
middle myocardium layer, and outer epicardium layer of the LAA wall
66.
[0100] Illustrated in FIG. 18, if optimal placement of the occluder
device 80 was not achieved the anchor 72 may be released from the
anchor cable 82 and deployed alone within the LAA wall 66 to plug
the small hole 70 and prevent fluids from entering the pericardial
space 68. The delivery wire 60 and buddy wire 62 may be
subsequently removed from the LAA 64. This allows for a new anchor
72 to be placed within the LAA wall 66 using the anchoring system
50 cited above for achieving optimal placement of the occluder
device 80 within the LAA 64. On the other hand, if the anchor 72 is
initially placed in an optimal location within the LAA wall 66 but
there are problems with the occluder device 80, a second occluder
device may be advanced over the inner sheath 58 and deployed within
the LAA 64 using the anchoring system 50 cited above. Thus, the
anchoring system 50 of the present invention allows an
interventional cardiologist to quickly and cost-effectively implant
the occluder device 80 into the LAA 64 using anchor 72, safely
retrieve or re-deploy the occluder device 80 if initial placement
was improper or if complications arise, with an option to
re-implant a new occluder device and new anchor in an optimal
location of the LAA 24. After optimal placement of the occluder
device 80 within the LAA 64 is achieved, the delivery wire 60 and
buddy wire 62 may be removed from the LAA 64.
[0101] In another aspect of the present invention, an anchor 72 is
provided for anchoring an occluder device 80 within a LAA 64. As
illustrated in FIG. 13, the anchor 72 may be shaped like a sheave,
comprising a first half 74, a second half 76, and a shaft 78
connecting the first half 74 to the second half 76, although it is
contemplated that other anchor shapes may also be utilized in the
present invention. The anchor 72 may be comprised of wire, wherein
the first half 74 and second half 76 of the anchor 72 comprise wire
mesh, further wherein the shaft 78 may comprise a single wire
connecting the first half 75 wire mesh and the second half 76 wire
mesh. The anchor 72 may further be comprised of a square,
rectangle, flat, sphere, circle, oval, pentagon, octagon, or any
other shape, and may be comprised of single or multiple wires. The
anchor 72 may be circular in diameter, however, it is contemplated
that other cross-sectional shapes may also be utilized, including
but not limited to, square, rectangular, triangular, pentagonal,
and octagonal depending on the manufacturing technique. The anchor
72 may be comprised of stainless steel, platinum, Nitinol, Elgiloy
or other materials standardly used in the industry. The anchor 72
may also comprise antibiotics, drugs that prevent the LAA
pericardium wall from bleeding, ePTFE, any variety of materials
which facilitate cellular in-growth, hydrogel, anticoagulants,
fibrin hairs and/or other pharmaceuticals. The anchor 72 may
further include barbs, points, bristles, spurs, screws, hooks,
pins, sutures, adhesives, pledgets, or other means of
attachment.
[0102] Illustrated in FIGS. 13A-B, the anchor 72 may have a
contracted first position (FIG. 13A) and a deployed second position
(FIG. 13B). In the contracted first position (FIG. 13A), the first
half 74, second half 76, and shaft 78 of the anchor 72 have a
diameter of approximately 1-5 mm and a length of approximately 5-55
mm. In the deployed second position (FIG. 13B), the first half 74
and second half 76 of the anchor 72 may expand outwards a distance
of approximately 5-25 mm in diameter, wherein the shaft 78 remains
approximately 1-5 mm in diameter. The anchor 72 may self-expand
from the contracted first position (FIG. 13A) to the deployed
second position (FIG. 13B).
[0103] It is contemplated that the anchor 72 of the present
invention may be used with a diverse range of LAA occluder devices
80 such as coil implants, foam plugs, expandable frames,
combinations thereof, and other occluder devices currently used in
the industry and/or to be developed in the future. Specific
examples of occluder devices 80 that may be used by the present
invention include, but are not limited to, WATCHMAN.RTM.,
ATRICLIP.RTM., PLAATO LAA Occlusion System.RTM., AMPLATZER.TM., and
AMULET.TM.. In the present invention, the occluder device 80 may
have a distal end with a hole approximately 1-5 mm in diameter.
[0104] Illustrated in FIG. 14, the anchor 72 in the contracted
first position (FIG. 13A) may be advanced through an anchor
catheter 58 using an anchor cable 82 and a delivery wire 60,
wherein the anchor 72 extends into pericardial space 68. The anchor
catheter 58 may then be retracted, allowing the second half 76 of
the anchor 72 to self-expand from the contracted first position to
the deployed second position within the pericardial space 68. While
the second half 76 of the anchor 72 is in the deployed second
position, the shaft 72 and the first half 74 of the anchor 72
remain temporarily inside the anchor catheter 58.
[0105] Illustrated in FIG. 15, the anchor catheter 58 may be
further retracted, allowing the first half 74 of the anchor 72 to
self-expand from the contracted first position to a partially
deployed second position within the occluder device 80, wherein the
occluder device 80 remains inside the outer sheath 56. The shaft 78
resides inside the inner endocardium layer, middle myocardium
layer, and outer epicardium layer of the LAA wall 26. The second
half 76 of the anchor 72 remains in the deployed second position
within the pericardial space 68, wherein the first half 74 of the
anchor 72 is in the partially deployed second position within the
occluder device 80. Alternatively, the anchor 72 and occluder
device 80 may be integral, wherein the occluder device 80 may be a
coil occluder device. Thus, the integral anchor 72 and occluder
device 80 may be advanced together through the anchor catheter 58,
wherein the anchor 72 is implanted in the LAA wall 26 using the
system 50 of the present invention described above.
[0106] Illustrated in FIG. 16, the outer sheath 56 may be retracted
to allow the occluder device 80 to expand inside the LAA 64.
Moreover, retracting the outer sheath 56 allows the first half 74
of the anchor 72 to fully expand into the deployed second position
within the occluder device 80. Thus, the shaft 78 of the anchor 72
may extend through the hole in the distal end of the occluder
device 80, wherein the distal end of the occluder device 80 pinches
down on the shaft 78. Furthermore, the first half of the anchor 74
in the deployed second position may pin the occluder device 80
against the LAA wall 66, wherein the anchor 72 effectively moors
the occluder device 80 inside the LAA 64. At this time the expanded
anchor 72 in the deployed second position covers a large surface
area and therefore retains the occluder device 80 in an implanted
position within the LAA 64. Moreover, by anchoring the occluder
device 80 via the anchor 72 through all three layers of the LAA
wall 66--instead of merely latching onto the thin endocardium
layer--the anchoring system 50 of the present invention lowers the
risk of embolization. Here, the anchor cable 82 remains attached to
the anchor 72 and an occluder cable 84 remains attached to the
occluder device 80 in case problems arise after deployment of the
occluder device 80. If no problems arise and it is determined that
the occluder device 80 is in an optimal location of the LAA 64, the
occluder cable 84 may be detached from the occluder device 80 and
removed from the LAA 64. Furthermore, the anchor cable 82 may be
detached from the anchor 72 and removed from the LAA 64. The
delivery wire 60 and/or a buddy wire 62 may also be withdrawn from
the LAA 64, leaving the occluder device 80 anchored securely in the
LAA 64 by the anchor 72 of the present invention.
[0107] In yet another aspect of the present invention, a method of
implanting and retrieving an occluder device within a LAA is
illustrated in FIG. 10. The method of the present invention
comprises providing an anchoring system 50. The anchoring system 50
may comprise a pericardial catheter 54, wherein the pericardial
catheter 54 may be a single or double-lumen pericardial catheter.
The anchoring system 50 may further comprise an outer sheath 56. A
balloon-occlusion catheter may also be utilized by the present
invention. However, it is intended that other catheters standard in
the industry may also be utilized. The pericardial catheter 54 may
be configured to fit a delivery wire 60 and/or a buddy wire 62,
also standardly used in the industry. A diameter of the delivery
wire 60 may range between approximately 0.025-0.052 inches and a
diameter of the buddy wire 62 may range between approximately
0.008-0.025 inches.
[0108] Further illustrated in FIG. 10, the method of the present
invention further comprises inserting the outer sheath 56 into the
LAA 64 via the left atrium proper of the heart by crossing the
atrial septum using a transeptal procedure. If a balloon-occlusion
catheter has been utilized, the balloon occlusion may be expanded
to occlude the LAA 64 from the left atrium proper. Expanding the
balloon occlusion may improve stabilization of the outer sheath 56
within the LAA 64 and allow for better imaging of the LAA 64 by an
interventional cardiologist. The pericardial catheter 54 may be
advanced through the outer sheath 56 to the LAA wall 66. The buddy
wire 62 is next advanced through the pericardial catheter 54 and
the adjacent LAA wall 66, wherein the buddy wire 62 penetrates the
inner endocardium layer, middle myocardium layer, and outer
epicardium layer of the LAA wall 26 to extend into the pericardial
space 68. The pericardial catheter 54 is advanced over the buddy
wire 62 and through the LAA wall 66, penetrating the inner
endocardium layer, middle myocardium layer, and outer epicardium
layer of the LAA wall 66 to extend into the pericardial space 68.
Thus, the pericardial catheter 54 creates a small hole 70 through
the LAA wall 66 of the heart. If utilized, the expanded balloon
occlusion of the balloon-occlusion catheter decreases the
likelihood of fluid accumulating within the pericardial space 68
via the small hole 70. While the pericardial catheter 54 remains
inside the pericardial space 68 via the small hole 70, the delivery
wire 60 may then be advanced through the pericardial catheter 54,
wherein the delivery wire 60 enters the pericardial space 68. The
pericardial catheter 54 may then be removed from the outer sheath
56, leaving the delivery wire 60 and the buddy wire 62 inside the
pericardial space 68 via the small hole 70 in the LAA wall 66.
[0109] Illustrated in FIG. 11, the method of the present invention
further comprises providing an anchor catheter 58 and an inner
dilator 86, wherein the inner dilator 86 includes a pointed distal
end 88. The inner dilator 86 may be configured to encompass the
delivery wire 60, wherein the delivery wire 60 may traverse through
an inner lumen of the inner dilator 86. The anchor catheter 58 and
the inner dilator 86 may be advanced through the outer sheath 56 to
the LAA wall 66 adjacent the small hole 70. Particularly, the
delivery wire 60 may traverse through the anchor catheter 52 and
the inner dilator 86. The buddy wire 62 may reside outside the
anchor catheter 58 and yet inside the outer sheath 56. Using the
pointed distal end 88 of the inner dilator 86, the inner dilator 86
and the anchor catheter 52 may be further advanced through the
small hole 70 to penetrate the inner endocardium layer, middle
myocardium layer, and outer epicardium layer of the LAA wall 66.
Thus, the pointed distal end 88 of the inner dilator 86, along with
a distal end of the anchor catheter 52, extends into the
pericardial space 68. The inner dilator 86 may be subsequently
removed from the anchor catheter 58, wherein the distal end of the
anchor catheter 58 remains extending into the pericardial space
68.
[0110] Illustrated in FIG. 12, the method of the present invention
further comprises providing an occluder device 80 and an occluder
cable 84. It is contemplated that the method of the present
invention may be used with a diverse range of LAA occluder devices
80 such as coil implants, foam plugs, expandable frames,
combinations thereof, and other occluder devices currently used in
the industry and/or to be developed in the future. Specific
examples of occluder devices 80 that may be used by the present
invention include, but are not limited to, WATCHMAN.RTM.,
ATRICLIP.RTM., PLAATO LAA Occlusion System.RTM., AMPLATZER.TM., and
AMULET.TM.. In the present invention, the occluder device 80 may
have a distal end with a hole approximately 1-5 mm in diameter. As
shown in FIG. 12, the occluder cable 84 may be a hollow coaxial
cable standardly used in the industry. The occluder cable 84 may be
attached to the occluder device 80, wherein the occluder cable 84
may be used for deploying and retrieving the occluder device 80
within the LAA 64. The occluder device 80 and the occluder cable 84
may encompass the anchor catheter 58, wherein the anchor catheter
58 may traverse through an inner lumen of the occluder device 80
and an inner lumen of the occluder cable 84. The occluder device 80
may reside between the anchor catheter 58 and the outer sheath
56.
[0111] As further shown in FIG. 12, the method of the present
invention further comprises providing an anchor 72 and an anchor
cable 82, wherein the anchor 72 and anchor cable 82 are inserted in
the anchor catheter 58. The anchor cable 82 may be attached to the
anchor 72, wherein the anchor cable 82 may be used for deploying
the anchor 72 within the LAA wall 66. The anchor cable 82 may be a
hollow coaxial cable standardly used in the industry. The anchor
cable 82 and anchor 72 may encompass the delivery wire 60, wherein
the delivery wire 60 may traverse through an inner lumen of the
anchor 72 and an inner lumen of the anchor cable 82. The delivery
wire 60 may be used to navigate the anchoring system 50 through the
LAA 64. Alternatively, the anchor 72 and anchor cable 82 may be
advanced through the anchor catheter 58 into the pericardial space
68 without using the delivery wire 60. The buddy wire 62 may remain
inside the pericardial space 68 and is a safety feature in case of
emergencies. The buddy wire 62 allows an interventional
cardiologist to advance another catheter through the LAA wall 66
and place a plug within the small hole 70 if a malfunction is
observed with the anchor 72 or the occluder device 80.
[0112] Illustrated in FIG. 13, the anchor 72 may be shaped like a
sheave, comprising a first half 74, a second half 76, and a shaft
78 connecting the first half 74 to the second half 76, although it
is contemplated that other anchor shapes may also be utilized in
the present invention. The anchor 72 may be comprised of wire,
wherein the first half 74 and second half 76 of the anchor 72
comprise wire mesh, further wherein the shaft 78 may comprise a
single wire connecting the first half 75 wire mesh and the second
half 76 wire mesh. The anchor 72 may be comprised of a square,
rectangle, flat, sphere, circle, oval, pentagon, octagon, or any
other shape, and may be comprised of single or multiple wires. The
anchor 72 may be circular in diameter, however, it is contemplated
that other cross-sectional shapes may also be utilized, including
but not limited to, square, rectangular, triangular, pentagonal,
and octagonal depending on the manufacturing technique. The anchor
72 may be comprised of stainless steel, platinum, Nitinol, Elgiloy
or other materials standardly used in the industry. The anchor 72
may also comprise antibiotics, drugs that prevent the LAA
pericardium wall from bleeding, ePTFE, any variety of materials
which facilitate cellular in-growth, hydrogel, anticoagulants,
fibrin hairs and/or other pharmaceuticals. The anchor 72 may have a
lumen wherein the delivery wire 60 traverses therein,
alternatively, the anchor 72 may not have a lumen. The anchor 72
may further include barbs, points, bristles, spurs, screws, hooks,
pins, sutures, adhesives, pledgets, or other means of
attachment.
[0113] Illustrated in FIGS. 13A-B, the anchor 72 may have a
contracted first position (FIG. 13A) and a deployed second position
(FIG. 13B). In the contracted first position (FIG. 13A), the first
half 74, second half 76, and shaft 78 of the anchor 72 have a
diameter of approximately 1-5 mm and a length of approximately 5-55
mm. In the deployed second position (FIG. 13B), the first half 74
and second half 76 of the anchor 72 may expand outwards a distance
of approximately 5-25 mm in diameter, wherein the shaft 78 remains
approximately 1-5 mm in diameter. The anchor 72 may self-expand
from the contracted first position (FIG. 13A) to the deployed
second position (FIG. 13B).
[0114] Illustrated in FIG. 14, the method of the present invention
comprises advancing the anchor 72 in the contracted first position
(FIG. 13A) through the anchor catheter 58 using the anchor cable 82
and the delivery wire 60, wherein the anchor 72 extends into the
pericardial space 68. The anchor catheter 58 may then be retracted,
allowing the second half 76 of the anchor 72 to self-expand from
the contracted first position to the deployed second position
within the pericardial space 68. While the second half 76 of the
anchor 72 is in the deployed second position, the shaft 78 and the
first half 74 of the anchor 72 remain temporarily inside the anchor
catheter 58.
[0115] Illustrated in FIG. 15, the method of the present invention
further comprises retracting the anchor catheter 58, allowing the
first half 74 of the anchor 72 to self-expand from the contracted
first position to a partially deployed second position within the
occluder device 80, wherein the occluder device 80 remains inside
the outer sheath 56. The shaft 78 resides inside the inner
endocardium layer, middle myocardium layer, and outer epicardium
layer of the LAA wall 66. The second half 76 of the anchor 72
remains in the deployed second position within the pericardial
space 68, wherein the first half 74 of the anchor 72 is in the
partially deployed second position within the occluder device 80.
Alternatively, the anchor 72 and occluder device 80 may be
integral, wherein the occluder device 80 may be a coil occluder
device. Thus, the integral anchor 72 and occluder device 80 may be
advanced together through the anchor catheter 58, wherein the
anchor 72 is implanted in the LAA wall 66 using the system 50 of
the present invention described above.
[0116] Illustrated in FIG. 16, the method of the present invention
comprises retracting the outer sheath 56 to allow the occluder
device 80 to expand inside the LAA 64. Moreover, retracting the
outer sheath 56 allows the first half 74 of the anchor 72 to fully
expand into the deployed second position within the occluder device
80. Thus, the shaft 78 of the anchor 72 may extend through the hole
in the distal end of the occluder device 80, wherein the distal end
of the occluder device 80 pinches down on the shaft 78.
Furthermore, the first half of the anchor 74 in the deployed second
position may pin the occluder device 80 against the LAA wall 66,
wherein the anchor 72 effectively moors the occluder device 80
inside the LAA 64. At this time the expanded anchor 72 in the
deployed second position covers a large surface area and therefore
retains the occluder device 80 in an implanted position within the
LAA 64. Moreover, by anchoring the occluder device 80 via the
anchor 72 through all three layers of the LAA wall 66--instead of
merely latching onto the thin endocardium layer--the method of the
present invention lowers the risk of embolization. Here, the anchor
cable 82 remains attached to the anchor 72 and the occluder cable
84 remains attached to the occluder device 80 in case problems
arise after deployment of the occluder device 80. If no problems
arise and it is determined that the occluder device 80 is in an
optimal location of the LAA 64, the occluder cable 84 may be
detached from the occluder device 80 and removed from the LAA 64.
Furthermore, the anchor cable 82 may be detached from the anchor 72
and removed from the LAA 64. The buddy wire 62 and delivery wire 60
may also be withdrawn from the LAA 64, leaving the occluder device
80 anchored securely in the LAA 64 by the method of the present
invention.
[0117] FIG. 17 illustrates the method of the present invention if
problems arise after deployment of the occluder device 80. For
instance, the method comprises making a determination that the
occluder device 80 is not placed in an optimal location of the LAA
64 after deployment to achieve maximum occlusion. In this
situation--prior to release of the occluder cable 84 from the
occluder device 80 and the anchor cable 82 from the anchor 72--the
outer sheath 56 may be advanced over the occluder device 80 to the
LAA wall 66, wherein the occluder device 80 is retracted inside the
outer sheath 56 using the occluder cable 82. The anchor catheter 58
may then be advanced to the LAA wall 66, wherein the first half 74
of the anchor 72 is retracted inside the anchor catheter 58 using
the anchor cable 82. Thus, using the anchor cable 82, the first
half 74 of the anchor 72 retracts from the deployed second position
to the contracted first position to fit inside the anchor catheter
58. The outer sheath 56 containing the occluder device 80 may then
be removed from the LAA 64, or the occluder device 80 may be
re-deployed in a more optimal location of the LAA 64. If the
occluder device 80 is removed from the LAA 64, the anchor catheter
58 may be retrieved thereafter, allowing the first half 74 of the
anchor 72 to expand from the contracted first position to the
deployed second position within the LAA 64. Thus, the deployed
anchor 72 remains inside the LAA 64 and allows for occlusion of the
small hole 70 that was created by the pericardial catheter 54
through the inner endocardium layer, middle myocardium layer, and
outer epicardium layer of the LAA wall 66.
[0118] Illustrated in FIG. 18, if a determination is made that
optimal placement of the anchor 72 was not achieved, the anchor 72
may be released from the anchor cable 82 and deployed alone within
the LAA wall 66 to plug the small hole 70 and prevent fluids from
entering the pericardial space 68. The delivery wire 60 and buddy
wire 62 may be subsequently removed from the LAA 64. This allows
for a new anchor 72 to be placed within the LAA wall 66 using the
method cited above for achieving optimal placement of the occluder
device 80 within the LAA 64. On the other hand, if a determination
is made that the anchor 72 is initially placed in an optimal
location within the LAA wall 66 but there are problems with the
occluder device 80, a second occluder device may be advanced over
the inner sheath 58 and deployed within the LAA 64 using the method
cited above. Thus, the method of the present invention allows an
interventional cardiologist to quickly and cost-effectively implant
the occluder device 80 into the LAA 64 using anchor 72, safely
retrieve or re-deploy the occluder device 80 if initial placement
was improper or if complications arise, with an option to
re-implant a new occluder device and new anchor in an optimal
location of the LAA 24. After optimal placement of the occluder
device 80 within the LAA 64 is achieved, the delivery wire 60 and
buddy wire 62 may be removed from the LAA 64.
[0119] FIG. 19 illustrates yet a further aspect of the present
invention, an anchoring system 90 for implanting and retrieving an
occluder device within a LAA. The anchoring system 90 may comprise
a pericardial catheter 94, wherein the pericardial catheter 94 may
be a single or double-lumen pericardial catheter. The anchoring
system 90 may further comprise an outer sheath 96 and an inner
sheath 98. A balloon-occlusion catheter may also be utilized by the
present invention. However, it is intended that other catheters
standard in the industry may also be utilized. The pericardial
catheter 94 may be configured to fit a delivery wire 100 and/or a
buddy wire 102, also standardly used in the industry. A diameter of
the delivery wire 100 may range between approximately 0.025-0.052
inches and a diameter of the buddy wire 102 may range between
approximately 0.008-0.025 inches.
[0120] Further shown in FIG. 19, the outer sheath 96 may be
inserted into LAA 104 via the left atrium proper of the heart by
crossing the atrial septum using a transeptal procedure to a LAA
wall 106. If a balloon-occlusion catheter has been utilized, the
balloon occlusion may be expanded to occlude the LAA 104 from the
left atrium proper. Expanding the balloon occlusion may improve
stabilization of the outer sheath 96 within the LAA 104 and allow
for better imaging of the LAA 104 by an interventional
cardiologist. The pericardial catheter 94 may be advanced through
the outer sheath 96 to the LAA wall 106. The buddy wire 102 is next
advanced through the pericardial catheter 94 and the adjacent LAA
wall 106, wherein the buddy wire 102 penetrates the inner
endocardium layer, middle myocardium layer, and outer epicardium
layer of the LAA wall 106 to extend into the pericardial space 108.
The pericardial catheter 94 is next advanced over the buddy wire
104 and through the LAA wall 106, penetrating the inner endocardium
layer, middle myocardium layer, and outer epicardium layer of the
LAA wall 106 to extend into the pericardial space 108. Thus, the
pericardial catheter 94 creates a small hole 110 through the LAA
wall 106 of the heart. If utilized, the expanded balloon occlusion
of the balloon-occlusion catheter decreases the likelihood of fluid
accumulating within the pericardial space 108 via the small hole
110. While the pericardial catheter 94 remains inside the
pericardial space 108 via the small hole 110, the delivery wire 100
may then be advanced through the pericardial catheter 94, wherein
the delivery wire 100 enters the pericardial space 108. The
pericardial catheter 94 may then be removed from the outer sheath
96, leaving the delivery wire 100 and the buddy wire 102 inside the
pericardial space 108 via the small hole 110 in the LAA wall
106.
[0121] Illustrated in FIG. 20, the anchoring system 90 of the
present invention further comprises an occluder device 120 and an
occluder cable 124. It is contemplated that the anchoring system 90
of the present invention may be used with a diverse range of LAA
occluder devices 120 such as coil implants, foam plugs, expandable
frames, combinations thereof, and other occluder devices currently
used in the industry and/or to be developed in the future. Specific
examples of occluder devices 120 that may be used by the present
invention include, but are not limited to, WATCHMAN.RTM.,
ATRICLIP.RTM., PLAATO LAA Occlusion System.RTM., AMPLATZER.TM., and
AMULET.TM.. In the present invention, the occluder device 120 may
have a distal end with a hole approximately 1-5 mm in diameter.
[0122] As shown in FIG. 20, the occluder cable 124 may be a hollow
coaxial cable standardly used in the industry. The occluder cable
124 may be attached to the occluder device 120, wherein the
occluder cable 124 may be used for deploying and retrieving the
occluder device 120 within the LAA 104. The occluder device 120 and
the occluder cable 124 may encompass the inner sheath 98, wherein
the inner sheath 98 may traverse through an inner lumen of the
occluder device 120 and an inner lumen of the occluder cable 124.
The occluder device 120 may reside between the inner sheath 98 and
the outer sheath 96.
[0123] As further shown in FIG. 20, the inner sheath 98 may be
advanced through the outer sheath 96 to the LAA wall 106 adjacent
the small hole 110. Particularly, the delivery wire 100 may
traverse through the inner sheath 98, the occluder device 120, and
the occluder cable 124. The buddy wire 102 may reside outside the
inner sheath 98 and yet inside the outer sheath 96.
[0124] As also shown in FIG. 20, the inner sheath 98 may comprise
an anchor 112 and an anchor cable 122. The anchor cable 122 may be
attached to the anchor 112, wherein the anchor cable 122 may be
used for deploying the anchor 112 within the LAA wall 106. The
anchor cable 122 may be a hollow coaxial cable standardly used in
the industry. The anchor cable 122 and anchor 112 may encompass the
delivery wire 100, wherein the delivery wire 100 may traverse
through an inner lumen of the anchor 112 and an inner lumen of the
anchor cable 122. The delivery wire 100 may be used to navigate the
anchoring system 90 through the LAA 104. Alternatively, the anchor
112 and anchor cable 122 may be advanced through the inner sheath
98 into the pericardial space 108 without using the delivery wire
100. The buddy wire 102 may remain inside the pericardial space 108
and is a safety feature in case of emergencies. The buddy wire 102
allows an interventional cardiologist to advance another catheter
through the LAA wall 106 and place a plug within the small hole 110
if a malfunction is observed with the anchor 112 or the occluder
device 120.
[0125] Illustrated in FIGS. 21A and 21B, the anchor 112 may have an
elongate contracted first position (FIG. 21A) (e.g.,
straight--coil) when the delivery wire 100 is traversing the inner
lumen of the anchor 112, and a deployed second position (FIG. 21B)
(e.g., double-coil) when the delivery wire 100 has been removed
from the inner lumen of the anchor 112. The delivery wire 100 when
inside the inner lumen of the anchor 112 straightens the anchor 112
from its natural coiled state (deployed second position) into the
elongated straight-coil (contracted first position). In the
contracted first position (FIG. 21A), the anchor 112 has a diameter
of approximately 0.5-2 mm and a length of approximately 2-40 mm. In
the deployed second position (FIG. 21B), the anchor 112 may
comprise a first coil 114, a second coil 116, wherein the first
coil 114 and second coil 116 are connected together by a shaft 118.
In the deployed second position (FIG. 21B), the first coil 114 and
second coil 116 expand outwards a distance of approximately 5-15 mm
in diameter, the shaft 118 remains approximately 0.5-2 mm in
diameter, wherein the total length of the anchor 112 is
approximately 1-10 mm. The anchor 112 may self-expand from the
contracted first position (FIG. 21A) to the deployed second
position (FIG. 21B).
[0126] Illustrated in FIG. 21B, the first coil 114 and second coil
116 of the anchor 112 may be shaped like circular disks, although
it is contemplated that other anchor shapes may also be utilized in
the present invention. For instance, the anchor coils 114, 116 may
comprise a square, rectangle, flat, sphere, circle, oval, pentagon,
octagon, or any other shape. The anchor 112 may be circular in
diameter, however, it is contemplated that other cross-sectional
shapes may also be utilized, including but not limited to, square,
rectangular, triangular, pentagonal, and octagonal depending on the
manufacturing technique. The anchor 112 may be comprised of
stainless steel, platinum, Nitinol, Elgiloy or other materials
standardly used in the industry. The anchor 112 may also comprise
antibiotics, drugs that prevent the LAA pericardium wall from
bleeding, ePTFE, any variety of materials which facilitate cellular
in-growth, hydrogel, anticoagulants, fibrin hairs and/or other
pharmaceuticals. The anchor 112 may further include barbs, points,
bristles, spurs, screws, hooks, pins, sutures, adhesives, pledgets,
or other means of attachment.
[0127] Illustrated in FIG. 22, the anchor 112 in the contracted
first position (FIG. 21A) may be advanced through the inner sheath
98 using the anchor cable 122 and the delivery wire 100, wherein
the anchor 112 is further advanced through the small hole 110 to
penetrate the inner endocardium layer, middle myocardium layer, and
outer epicardium layer of the LAA wall 106 to extend into the
pericardial space 68. The delivery wire 100 may then be retracted,
allowing the second coil 116 of the anchor 112 to self-expand from
the contracted first position to the deployed second position
within the pericardial space 108. While the second coil 116 of the
anchor 112 is in the deployed second position, the shaft 118 and
the first coil 114 of the anchor 112 remain temporarily in the
contracted first position.
[0128] Illustrated in FIG. 23, the inner sheath 98 adjacent the LAA
wall 106 may be retracted along with the delivery wire 100,
allowing the first coil 114 of the anchor 112 to self-expand from
the contracted first position to a partially deployed second
position within the occluder device 120. The occluder device 120
remains inside the outer sheath 96 adjacent the LAA wall 106. The
shaft 118 resides inside the inner endocardium layer, middle
myocardium layer, and outer epicardium layer of the LAA wall 106.
The second coil 116 of the anchor 112 remains in the deployed
second position within the pericardial space 108, wherein the first
coil 114 of the anchor 112 is in the partially deployed second
position within the occluder device 120. Alternatively, the anchor
112 and occluder device 120 may be integral, wherein the occluder
device 120 may be a coil occluder device. Thus, the integral anchor
112 and occluder device 120 may be advanced together through the
inner sheath 98, wherein the anchor 112 is implanted in the LAA
wall 106 using the system 90 of the present invention described
above.
[0129] Illustrated in FIG. 24, the outer sheath 96 may be retracted
to allow the occluder device 120 to expand inside the LAA 104.
Moreover, retracting the outer sheath 96 allows the first coil 114
of the anchor 112 to fully expand into the deployed second position
within the occluder device 120. Thus, the shaft 118 of the anchor
112 may extend through the hole in the distal end of the occluder
device 120, wherein the distal end of the occluder device 120
pinches down on the shaft 118. Furthermore, the first coil 114 of
the anchor 112 in the deployed second position may pin the occluder
device 120 against the LAA wall 106, wherein the anchor 112
effectively moors the occluder device 120 inside the LAA 104. At
this time the expanded anchor 112 in the deployed second position
covers a large surface area and therefore retains the occluder
device 120 in an implanted position within the LAA 104. Moreover,
by anchoring the occluder device 120 via the anchor 112 through all
three layers of the LAA wall 106--instead of merely latching onto
the thin endocardium layer--the anchoring system 90 of the present
invention lowers the risk of embolization. The second coil 116
located within the pericardial space 108 may unwind in a clockwise
fashion, while the first coil 114 located in the LAA 104 may unwind
in an reverse-clockwise fashion. Thus, there would be
counter-forces acting on the coils, wherein the second coil 116
exerts proximal traction and the first coil 114 exerts distal
traction against opposite sides of the LAA wall 106. Such
counter-forces discourage the anchor 112 from unraveling while in
the deployed second position within the LAA wall 106.
[0130] The anchor cable 122 remains attached to the anchor 112 and
the occluder cable 124 remains attached to the occluder device 120
in case problems arise after deployment of the occluder device 120.
If no problems arise and it is determined that the occluder device
120 is in an optimal location of the LAA 104, the occluder cable
124 may be detached from the occluder device 120 and removed from
the LAA 104. Furthermore, the anchor cable 122 may be detached from
the anchor 112 and removed from the LAA 104. The buddy wire 102 and
delivery wire 100 may also be withdrawn from the LAA 106, leaving
the occluder device 120 anchored securely in the LAA 104 by the
anchoring system 90 of the present invention.
[0131] FIG. 25 illustrates the anchoring system 90 of the present
invention if problems arise after deployment of the occluder device
120. For instance, it may be determined that the occluder device
120 is not placed in an optimal location of the LAA 104 after
deployment to achieve maximum occlusion. In this situation--prior
to release of the occluder cable 124 from the occluder device 120
and the anchor cable 122 from the anchor 112--the outer sheath 96
may be advanced over the occluder device 120, wherein the occluder
device 120 is retracted inside the outer sheath 96 using the
occluder cable 124. The delivery wire 100 may be further advanced
through the anchor cable 112 and first coil 114 of the anchor 112,
wherein the first coil 114 retracts from the deployed second
position to the contracted first position and may be retrieved
inside the inner sheath 98. The outer sheath 96 containing the
occluder device 120 may then be removed from the LAA 104, or the
occluder device 120 may be re-deployed in a more optimal location
of the LAA 104. If the occluder device 120 is removed from the LAA
104, the delivery wire 100 may be retrieved thereafter, allowing
the first coil 114 of the anchor 112 to re-expand from the
contracted first position to the deployed second position within
the LAA 104. Thus, the deployed anchor 112 remains inside the LAA
104 and allows for occlusion of the small hole 110 that was created
by the pericardial catheter 94 through the inner endocardium layer,
middle myocardium layer, and outer epicardium layer of the LAA wall
106.
[0132] Illustrated in FIG. 26, if optimal placement of the occluder
device 120 was not achieved the anchor 112 may be released from the
anchor cable 122 and deployed alone within the LAA wall 106. This
allows for a new anchor 112 to be placed within the LAA wall 106
using the anchoring system 90 cited above for achieving optimal
placement of the occluder device 120 within the LAA 104. On the
other hand, if the anchor 112 is initially placed in an optimal
location within the LAA wall 106 but there are problems with the
occluder device 120, a second occluder device may be advanced using
the inner sheath 98 and deployed within the LAA 104 using the
anchoring system 90 cited above. Thus, the anchoring system 90 of
the present invention allows an interventional cardiologist to
quickly and cost-effectively implant the occluder device 120 into
the LAA 104 using anchor 112, safely retrieve or re-deploy the
occluder device 120 if initial placement was improper or if
complications arise, with an option to re-implant a new occluder
device and new anchor in an optimal location of the LAA 104. After
optimal placement of the occluder device 120 within the LAA 104 is
achieved, the delivery wire 100 and the buddy wire 102 may be
removed from the LAA 104.
[0133] In another aspect of the present invention, an anchor 112 is
provided for anchoring an occluder device 120 within a LAA 104. As
illustrated in FIGS. 21A and 21B, the anchor 112 may have an
elongate contracted first position (FIG. 21A) (e.g.,
straight--coil) when a delivery wire 100 is traversing an inner
lumen of the anchor 112, and a deployed second position (FIG. 21B)
(e.g., double-coil) when the delivery wire 100 has been removed
from the inner lumen of the anchor 112. The delivery wire 100 when
inside the inner lumen of the anchor 112 straightens the anchor 112
from its natural coiled state (deployed second position) into the
elongated straight-coil (contracted first position). In the
contracted first position (FIG. 21A), the anchor 112 has a diameter
of approximately 0.5-2 mm and a length of approximately 2-40 mm. In
the deployed second position (FIG. 21B), the anchor 112 may
comprise a first coil 114, a second coil 116, wherein the first
coil 114 and second coil 116 are connected together by a shaft 118.
In the deployed second position (FIG. 21B), the first coil 114 and
second coil 116 expand outwards a distance of approximately 5-15 mm
in diameter, the shaft 118 remains approximately 0.5-2 mm in
diameter, wherein the total length of the anchor 112 is
approximately 1-10 mm. The anchor 112 may self-expand from the
contracted first position (FIG. 21A) to the deployed second
position (FIG. 21B).
[0134] Illustrated in FIG. 21B, the first coil 114 and second coil
116 of the anchor 112 may be shaped like circular disks, although
it is contemplated that other anchor shapes may also be utilized in
the present invention. For instance, the anchor coils 114, 116 may
comprise a square, rectangle, flat, sphere, circle, oval, pentagon,
octagon, or any other shape. The anchor 112 may be circular in
diameter, however, it is contemplated that other cross-sectional
shapes may also be utilized, including but not limited to, square,
rectangular, triangular, pentagonal, and octagonal depending on the
manufacturing technique. The anchor 112 may be comprised of
stainless steel, platinum, Nitinol, Elgiloy or other materials
standardly used in the industry. The anchor 112 may also comprise
antibiotics, drugs that prevent the LAA pericardium wall from
bleeding, ePTFE, any variety of materials which facilitate cellular
in-growth, hydrogel, anticoagulants, fibrin hairs and/or other
pharmaceuticals. The anchor 112 may further include barbs, points,
bristles, spurs, screws, hooks, pins, sutures, adhesives, pledgets,
or other means of attachment.
[0135] It is contemplated that the anchor 112 of the present
invention may be used with a diverse range of LAA occluder devices
120 such as coil implants, foam plugs, expandable frames,
combinations thereof, and other occluder devices currently used in
the industry and/or to be developed in the future. Specific
examples of occluder devices 120 that may be used by the present
invention include, but are not limited to, WATCHMAN.RTM.,
ATRICLIP.RTM., PLAATO LAA Occlusion System.RTM., AMPLATZER.TM., and
AMULET.TM.. In the present invention, the occluder device 120 may
have a distal end with a hole approximately 1-5 mm in diameter.
[0136] Illustrated in FIG. 22, the anchor 112 in the contracted
first position (FIG. 21A) may be advanced through an inner sheath
98 using an anchor cable 122 and the delivery wire 100, wherein the
anchor 112 is further advanced through a small hole 110 in an LAA
wall 106 to penetrate the inner endocardium layer, middle
myocardium layer, and outer epicardium layer of the LAA wall 106 to
extend into pericardial space 68. The delivery wire 100 may then be
retracted, allowing the second coil 116 of the anchor 112 to
self-expand from the contracted first position to the deployed
second position within the pericardial space 108. While the second
coil 116 of the anchor 112 is in the deployed second position, the
shaft 118 and the first coil 114 of the anchor 112 remain
temporarily in the contracted first position.
[0137] Illustrated in FIG. 23, the inner sheath 98 adjacent the LAA
wall 106 may be retracted along with the delivery wire 100,
allowing the first coil 114 of the anchor 112 to self-expand from
the contracted first position to a partially deployed second
position within the occluder device 120. The occluder device 120
remains inside an outer sheath 96 adjacent the LAA wall 106. The
shaft 118 resides inside the inner endocardium layer, middle
myocardium layer, and outer epicardium layer of the LAA wall 106.
The second coil 116 of the anchor 112 remains in the deployed
second position within the pericardial space 108, wherein the first
coil 114 of the anchor 112 is in the partially deployed second
position within the occluder device 120. Alternatively, the anchor
112 and occluder device 120 may be integral, wherein the occluder
device 120 may be a coil occluder device. Thus, the integral anchor
112 and occluder device 120 may be advanced together through the
inner sheath 98, wherein the anchor 112 is implanted in the LAA
wall 106 using the system 90 of the present invention described
above.
[0138] Illustrated in FIG. 24, the outer sheath 96 may be retracted
to allow the occluder device 120 to expand inside the LAA 104.
Moreover, retracting the outer sheath 96 allows the first coil 114
of the anchor 112 to fully expand into the deployed second position
within the occluder device 120. Thus, the shaft 118 of the anchor
112 may extend through the hole in the distal end of the occluder
device 120, wherein the distal end of the occluder device 120
pinches down on the shaft 118. Furthermore, the first coil 114 of
the anchor 112 in the deployed second position may pin the occluder
device 120 against the LAA wall 106, wherein the anchor 112
effectively moors the occluder device 120 inside the LAA 104. At
this time the expanded anchor 112 in the deployed second position
covers a large surface area and therefore retains the occluder
device 120 in an implanted position within the LAA 104. Moreover,
by anchoring the occluder device 120 via the anchor 112 through all
three layers of the LAA wall 106--instead of merely latching onto
the thin endocardium layer--the anchoring system 90 of the present
invention lowers the risk of embolization. The second coil 116
located within the pericardial space 108 may unwind in a clockwise
fashion, while the first coil 114 located in the LAA 104 may unwind
in an reverse-clockwise fashion. Thus, there would be
counter-forces acting on the coils, wherein the second coil 116
exerts proximal traction and the first coil 114 exerts distal
traction against opposite sides of the LAA wall 106. Such
counter-forces discourage the anchor 112 from unraveling while in
the deployed second position within the LAA wall 106.
[0139] The anchor cable 122 remains attached to the anchor 112 and
an occluder cable 124 remains attached to the occluder device 120
in case problems arise after deployment of the occluder device 120.
If no problems arise and it is determined that the occluder device
120 is in an optimal location of the LAA 104, the occluder cable
124 may be detached from the occluder device 120 and removed from
the LAA 104. Furthermore, the anchor cable 122 may be detached from
the anchor 112 and removed from the LAA 104. The delivery wire 100
and/or a buddy wire 102 may also be withdrawn from the LAA 106,
leaving the occluder device 120 anchored securely in the LAA 104 by
the anchoring system 90 of the present invention.
[0140] In yet another aspect of the present invention, a method of
implanting and retrieving an occluder device within a LAA is
illustrated in FIG. 19. The method of the present invention
comprises providing an anchoring system 90. The anchoring system 90
may comprise a pericardial catheter 94, wherein the pericardial
catheter 94 may be a single or double-lumen pericardial catheter.
The anchoring system 90 may further comprise an outer sheath 96 and
an inner sheath 98. A balloon-occlusion catheter may also be
utilized by the present invention. However, it is intended that
other catheters standard in the industry may also be utilized. The
pericardial catheter 94 may be configured to fit a delivery wire
100 and/or a buddy wire 102, also standardly used in the industry.
A diameter of the delivery wire 100 may range between approximately
0.025-0.052 inches and a diameter of the buddy wire 102 may range
between approximately 0.008-0.025 inches.
[0141] Further shown in FIG. 19, the method of the present
invention further comprises inserting the outer sheath 96 into LAA
104 via the left atrium proper of the heart by crossing the atrial
septum using a transeptal procedure to the LAA wall 106. If a
balloon-occlusion catheter has been utilized, the balloon occlusion
may be expanded to occlude the LAA 104 from the left atrium proper.
Expanding the balloon occlusion may improve stabilization of the
outer sheath 96 within the LAA 104 and allow for better imaging of
the LAA 104 by an interventional cardiologist. The pericardial
catheter 94 may be advanced through the outer sheath 96 to the LAA
wall 106. The buddy wire 102 is next advanced through the
pericardial catheter 94 and the adjacent LAA wall 106, wherein the
buddy wire 102 penetrates the inner endocardium layer, middle
myocardium layer, and outer epicardium layer of the LAA wall 106 to
extend into the pericardial space 108. The pericardial catheter 94
is next advanced over the buddy wire 104 and through the LAA wall
106, penetrating the inner endocardium layer, middle myocardium
layer, and outer epicardium layer of the LAA wall 106 to extend
into the pericardial space 108. Thus, the pericardial catheter 94
creates a small hole 110 through the LAA wall 106 of the heart. If
utilized, the expanded balloon occlusion of the balloon-occlusion
catheter decreases the likelihood of fluid accumulating within the
pericardial space 108 via the small hole 110. While the pericardial
catheter 94 remains inside the pericardial space 108 via the small
hole 110, the delivery wire 100 may then be advanced through the
pericardial catheter 94, wherein the delivery wire 100 enters the
pericardial space 108. The pericardial catheter 94 may then be
removed from the outer sheath 96, leaving the delivery wire 100 and
the buddy wire 102 inside the pericardial space 108 via the small
hole 110 in the LAA wall 106.
[0142] Illustrated in FIG. 20, the method of the present invention
further comprises providing an occluder device 120 and an occluder
cable 124. It is contemplated that the method of the present
invention may be used with a diverse range of LAA occluder devices
120 such as coil implants, foam plugs, expandable frames,
combinations thereof, and other occluder devices currently used in
the industry and/or to be developed in the future. Specific
examples of occluder devices 120 that may be used by the present
invention include, but are not limited to, WATCHMAN.RTM.,
ATRICLIP.RTM., PLAATO LAA Occlusion System.RTM., AMPLATZER.TM., and
AMULET.TM.. In the present invention, the occluder device 120 may
have a distal end with a hole approximately 1-5 mm in diameter.
[0143] As shown in FIG. 20, the occluder cable 124 may be a hollow
coaxial cable standardly used in the industry. The occluder cable
124 may be attached to the occluder device 120, wherein the
occluder cable 124 may be used for deploying and retrieving the
occluder device 120 within the LAA 104. The occluder device 120 and
the occluder cable 124 may encompass the inner sheath 98, wherein
the inner sheath 98 may traverse through an inner lumen of the
occluder device 120 and an inner lumen of the occluder cable 124.
The occluder device 120 may reside between the inner sheath 98 and
the outer sheath 96.
[0144] As further shown in FIG. 20, the method of the present
invention comprises advancing the inner sheath 98 through the outer
sheath 96 to the LAA wall 106 adjacent the small hole 110.
Particularly, the delivery wire 100 may traverse through the inner
sheath 98, the occluder device 120, and the occluder cable 124. The
buddy wire 102 may reside outside the inner sheath 98 and yet
inside the outer sheath 96.
[0145] Also shown in FIG. 20, the method of the present invention
further comprises providing an anchor 112 and an anchor cable 122.
The anchor cable 122 may be attached to the anchor 112, wherein the
anchor cable 122 may be used for deploying the anchor 112 within
the LAA wall 106. The anchor cable 122 may be a hollow coaxial
cable standardly used in the industry. The anchor cable 122 and
anchor 112 may encompass the delivery wire 100, wherein the
delivery wire 100 may traverse through an inner lumen of the anchor
112 and an inner lumen of the anchor cable 122. The delivery wire
100 may be used to navigate the anchoring system 90 through the LAA
104. Alternatively, the anchor 112 and anchor cable 122 may be
advanced through the inner sheath 98 into the pericardial space 108
without using the delivery wire 100. The buddy wire 102 may remain
inside the pericardial space 108 and is a safety feature in case of
emergencies. The buddy wire 102 allows an interventional
cardiologist to advance another catheter through the LAA wall 106
and place a plug within the small hole 110 if a malfunction is
observed with the anchor 112 or the occluder device 120.
[0146] Illustrated in FIGS. 21A and 21B, the anchor 112 may have an
elongate contracted first position (FIG. 21A) (e.g.,
straight--coil) when the delivery wire 100 is traversing the inner
lumen of the anchor 112, and a deployed second position (FIG. 21B)
(e.g., double-coil) when the delivery wire 100 has been removed
from the inner lumen of the anchor 112. The delivery wire 100 when
inside the inner lumen of the anchor 112 straightens the anchor 112
from its natural coiled state (deployed second position) into the
elongated straight-coil (contracted first position). In the
contracted first position (FIG. 21A), the anchor 112 has a diameter
of approximately 0.5-2 mm and a length of approximately 2-40 mm. In
the deployed second position (FIG. 21B), the anchor 112 may
comprise a first coil 114, a second coil 116, wherein the first
coil 114 and second coil 116 are connected together by a shaft 118.
In the deployed second position (FIG. 21B), the first coil 114 and
second coil 116 expand outwards a distance of approximately 5-15 mm
in diameter, the shaft 118 remains approximately 0.5-2 mm in
diameter, wherein the total length of the anchor 112 is
approximately 1-10 mm. The anchor 112 may self-expand from the
contracted first position (FIG. 21A) to the deployed second
position (FIG. 21B).
[0147] Illustrated in FIG. 21B, the first coil 114 and second coil
116 of the anchor 112 may be shaped like circular disks, although
it is contemplated that other anchor shapes may also be utilized in
the method of the present invention. For instance, the anchor coils
114, 116 may comprise a square, rectangle, flat, sphere, circle,
oval, pentagon, octagon, or any other shape. The anchor 112 may be
circular in diameter, however, it is contemplated that other
cross-sectional shapes may also be utilized, including but not
limited to, square, rectangular, triangular, pentagonal, and
octagonal depending on the manufacturing technique. The anchor 112
may be comprised of stainless steel, platinum, Nitinol, Elgiloy or
other materials standardly used in the industry. The anchor 112 may
also comprise antibiotics, drugs that prevent the LAA pericardium
wall from bleeding, ePTFE, any variety of materials which
facilitate cellular in-growth, hydrogel, anticoagulants, fibrin
hairs and/or other pharmaceuticals. The anchor 112 may further
include barbs, points, bristles, spurs, screws, hooks, pins,
sutures, adhesives, pledgets, or other means of attachment.
[0148] Illustrated in FIG. 22, the method of the present invention
comprises advancing the anchor 112 in the contracted first position
(FIG. 21A) through the inner sheath 98 using the anchor cable 122
and the delivery wire 100, wherein the anchor 112 is further
advanced through the small hole 110 to penetrate the inner
endocardium layer, middle myocardium layer, and outer epicardium
layer of the LAA wall 106 to extend into the pericardial space 68.
The delivery wire 100 may then be retracted, allowing the second
coil 116 of the anchor 112 to self-expand from the contracted first
position to the deployed second position within the pericardial
space 108. While the second coil 116 of the anchor 112 is in the
deployed second position, the shaft 118 and the first coil 114 of
the anchor 112 remain temporarily in the contracted first
position.
[0149] Illustrated in FIG. 23, the method of the present invention
comprises retracting the inner sheath 98 adjacent the LAA wall 106,
along with the delivery wire 100, to allow the first coil 114 of
the anchor 112 to self-expand from the contracted first position to
a partially deployed second position within the occluder device
120. The occluder device 120 remains inside the outer sheath 96
adjacent the LAA wall 106. The shaft 118 resides inside the inner
endocardium layer, middle myocardium layer, and outer epicardium
layer of the LAA wall 106. The second coil 116 of the anchor 112
remains in the deployed second position within the pericardial
space 108, wherein the first coil 114 of the anchor 112 is in the
partially deployed second position within the occluder device 120.
Alternatively, the anchor 112 and occluder device 120 may be
integral, wherein the occluder device 120 may be a coil occluder
device. Thus, the integral anchor 112 and occluder device 120 may
be advanced together through the inner sheath 98, wherein the
anchor 112 is implanted in the LAA wall 106 using the system 90 of
the present invention described above.
[0150] Illustrated in FIG. 24, the method of the present invention
comprises retracting the outer sheath 96 to allow the occluder
device 120 to expand inside the LAA 104. Moreover, retracting the
outer sheath 96 allows the first coil 114 of the anchor 112 to
fully expand into the deployed second position within the occluder
device 120. Thus, the shaft 118 of the anchor 112 may extend
through the hole in the distal end of the occluder device 120,
wherein the distal end of the occluder device 120 pinches down on
the shaft 118. Furthermore, the first coil 114 of the anchor 112 in
the deployed second position may pin the occluder device 120
against the LAA wall 106, wherein the anchor 112 effectively moors
the occluder device 120 inside the LAA 104. At this time the
expanded anchor 112 in the deployed second position covers a large
surface area and therefore retains the occluder device 120 in an
implanted position within the LAA 104. Moreover, by anchoring the
occluder device 120 via the anchor 112 through all three layers of
the LAA wall 106--instead of merely latching onto the thin
endocardium layer--the method of the present invention lowers the
risk of embolization. The second coil 116 located within the
pericardial space 108 may unwind in a clockwise fashion, while the
first coil 114 located in the LAA 104 may unwind in an
reverse-clockwise fashion. Thus, there would be counter-forces
acting on the coils, wherein the second coil 116 exerts proximal
traction and the first coil 114 exerts distal traction against
opposite sides of the LAA wall 106. Such counter-forces discourage
the anchor 112 from unraveling while in the deployed second
position within the LAA wall 106.
[0151] The anchor cable 122 remains attached to the anchor 112 and
the occluder cable 124 remains attached to the occluder device 120
in case problems arise after deployment of the occluder device 120.
If no problems arise and a determination is made that the occluder
device 120 is in an optimal location of the LAA 104, the occluder
cable 124 may be detached from the occluder device 120 and removed
from the LAA 104. Furthermore, the anchor cable 122 may be detached
from the anchor 112 and removed from the LAA 104. The buddy wire
102 and delivery wire 100 may also be withdrawn from the LAA 106,
leaving the occluder device 120 anchored securely in the LAA 104 by
the method of the present invention.
[0152] FIG. 25 illustrates the method of the present invention if
problems arise after deployment of the occluder device 120. For
instance, the method comprises making a determination that the
occluder device 120 is not placed in an optimal location of the LAA
104 after deployment to achieve maximum occlusion. In this
situation--prior to release of the occluder cable 124 from the
occluder device 120 and the anchor cable 122 from the anchor
112--the outer sheath 96 may be advanced over the occluder device
120, wherein the occluder device 120 is retracted inside the outer
sheath 96 using the occluder cable 124. The delivery wire 100 may
be further advanced through the anchor cable 112 and first coil 114
of the anchor 112, wherein the first coil 114 retracts from the
deployed second position to the contracted first position and may
be retrieved inside the inner sheath 98. The outer sheath 96
containing the occluder device 120 may then be removed from the LAA
104, or the occluder device 120 may be re-deployed in a more
optimal location of the LAA 104. If the occluder device 120 is
removed from the LAA 104, the delivery wire 100 may be retrieved
thereafter, allowing the first coil 114 of the anchor 112 to
re-expand from the contracted first position to the deployed second
position within the LAA 104. Thus, the deployed anchor 112 remains
inside the LAA 104 and allows for occlusion of the small hole 110
that was created by the pericardial catheter 94 through the inner
endocardium layer, middle myocardium layer, and outer epicardium
layer of the LAA wall 106.
[0153] Illustrated in FIG. 26, if a determination is made that
optimal placement of the anchor 112 was not achieved, the anchor
112 may be released from the anchor cable 122 and deployed alone
within the LAA wall 106. This allows for a new anchor 112 to be
placed within the LAA wall 106 using the method cited above for
achieving optimal placement of the occluder device 120 within the
LAA 104. On the other hand, if the anchor 112 is initially placed
in an optimal location within the LAA wall 106 but there are
problems with the occluder device 120, a second occluder device may
be advanced using the inner sheath 98 and deployed within the LAA
104 using the method cited above. Thus, the method of the present
invention allows an interventional cardiologist to quickly and
cost-effectively implant the occluder device 120 into the LAA 104
using anchor 112, safely retrieve or re-deploy the occluder device
120 if initial placement was improper or if complications arise,
with an option to re-implant a new occluder device and new anchor
in an optimal location of the LAA 104. After optimal placement of
the occluder device 120 within the LAA 104 is achieved, the
delivery wire 100 and the buddy wire 102 may be removed from the
LAA 104.
* * * * *