U.S. patent application number 11/836026 was filed with the patent office on 2008-02-14 for methods for determining characteristics of an internal tissue opening.
This patent application is currently assigned to Coherex Medical, Inc.. Invention is credited to Clark C. Davis, Daryl R. Edmiston, DeWayne C. Fox, Richard J. Linder, Scott D. Miles.
Application Number | 20080039743 11/836026 |
Document ID | / |
Family ID | 39051828 |
Filed Date | 2008-02-14 |
United States Patent
Application |
20080039743 |
Kind Code |
A1 |
Fox; DeWayne C. ; et
al. |
February 14, 2008 |
METHODS FOR DETERMINING CHARACTERISTICS OF AN INTERNAL TISSUE
OPENING
Abstract
A medical system for treating an internal tissue opening can
include a closure device and associated delivery device. The
closure device can include a multi-cellular body portion
operatively associated with a first anchor and a second anchor. The
delivery device can include an actuating assembly configured to
partially deploy the closure device by a first movement, and deploy
a second portion of the closure device by a second movement. The
delivery device can also include a release assembly to selectively
release or disconnect the closure device from the delivery device.
A method of measuring a characteristic of a PFO or verifying
placement of the closure device can include positioning the closure
device in the PFO and utilizing two or more indicators to determine
a characteristic of the PFO, such as tunnel width, or estimating
placement of the closure device.
Inventors: |
Fox; DeWayne C.; (South
Jordan, UT) ; Davis; Clark C.; (Holladay, UT)
; Miles; Scott D.; (Sandy, UT) ; Edmiston; Daryl
R.; (Draper, UT) ; Linder; Richard J.; (Sandy,
UT) |
Correspondence
Address: |
WORKMAN NYDEGGER
60 EAST SOUTH TEMPLE
1000 EAGLE GATE TOWER
SALT LAKE CITY
UT
84111
US
|
Assignee: |
Coherex Medical, Inc.
Salt Lake City
UT
|
Family ID: |
39051828 |
Appl. No.: |
11/836026 |
Filed: |
August 8, 2007 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
60821947 |
Aug 9, 2006 |
|
|
|
60821949 |
Aug 9, 2006 |
|
|
|
60829507 |
Oct 13, 2006 |
|
|
|
60866047 |
Nov 15, 2006 |
|
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|
60942625 |
Jun 7, 2007 |
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Current U.S.
Class: |
600/587 |
Current CPC
Class: |
A61B 2017/00867
20130101; A61B 2017/00592 20130101; A61B 2017/00579 20130101; A61B
2017/0061 20130101; A61B 2017/00623 20130101; A61B 2017/00407
20130101; A61B 17/0057 20130101; A61B 17/12168 20130101; A61B
2017/00597 20130101; A61B 17/12172 20130101; A61B 2017/00858
20130101; A61B 2017/00588 20130101; A61B 2017/12054 20130101; A61B
2017/00862 20130101; A61B 2017/00601 20130101; A61B 2017/00619
20130101; A61B 2017/00654 20130101; A61B 2017/00575 20130101; A61B
2017/00884 20130101; A61B 2017/00084 20130101; A61B 17/12122
20130101; A61B 2017/00606 20130101 |
Class at
Publication: |
600/587 |
International
Class: |
A61B 5/107 20060101
A61B005/107 |
Claims
1. A method for measuring characteristics of a tissue structure,
comprising the steps of: positioning at least a portion of a
medical device in the tissue structure, said medical device
comprising a multi-cellular structure, at least one anchor linked
to said multi-cellular structure, and two or more indicators; and
measuring a physical characteristic of the tissue structure
utilizing said two or more indicators of said medical device.
2. A method as recited in claim 1, wherein said measuring a
physical characteristic comprises determining the distance between
two of said two or more indicators.
3. A method as recited in claim 1, wherein said positioning
comprises moving a delivery device linked to said medical
device.
4. A method as recited in claim 1, wherein said physical
characteristic comprises the width of a tunnel of a PFO.
5. A method as recited in claim 1, wherein said medical device
comprises a PFO closure device.
6. A method as recited in claim 1, wherein at least one of said two
or more indicators comprises a dense material associated with said
medical device.
7. A method as recited in claim 1, wherein at least one of said two
or more indicators comprises a radiopaque material.
8. A method for measuring the tunnel width of a Patent Foramen
Ovale, comprising the steps of: locating at least a portion of a
medical device in a tunnel of the Patent Foramen Ovale of a heart,
said medical device comprising a multi-cellular body portion, a
first anchor linked to said multi-cellular body structure and a
second anchor linked to said multi-cellular body structure;
positioning said first anchor against a left atrial wall of the
heart; deploying said second anchor; and measuring the tunnel width
of at least a portion of the tunnel of the Patent Foramen Ovale
utilizing at least one of said first anchor, said second anchor or
said multi-cellular body portion.
9. A method as recited in claim 8, wherein said locating comprises
inserting at least a portion of a delivery device into the
heart.
10. A method as recited in claim 8, wherein said positioning
comprises moving a delivery device in a distal direction.
11. A method as recited in claim 8, wherein said positioning
comprises moving a handle body of a delivery device.
12. A method as recited in claim 8, wherein said deploying said
second anchor comprises rotating an actuating assembly of a
delivery device.
13. A method as recited in claim 8, further comprising deploying
said first anchor in the left atrium of the heart.
14. A method as recited in claim 8, wherein said measuring
comprises measuring a distance between two or more indicators
positioned on said medical device.
15. A method for verifying the placement of a medical device,
comprising the steps of: deploying at least a portion of a first
anchor of a medical device in the left atrium of a heart, said
medical device comprising a multi-cellular structure operatively
associated with said first anchor, a second anchor operatively
associated with said multi-cellular structure, and two or more
indicators; deploying at least a portion of said second anchor in
at least one of a tunnel of a Patent Foramen Ovale or the right
atrium of the heart; and estimating placement of said medical
device with respect to the Patent Foramen Ovale utilizing said two
or more indicators.
16. A medical device as recited in claim 15, wherein said first
anchor is deployed by a first movement of an actuating assembly of
a delivery device.
17. A medical device as recited in claim 15, wherein said second
anchor is deployed by a second movement of the actuating assembly
of a delivery device.
18. A medical device as recited in claim 15, wherein said two or
more indicators are positioned on said first anchor.
19. A medical device as recited in claim 15, wherein said two or
more indicators are positioned on said multi-cellular
structure.
20. A medical device as recited in claim 15, wherein said
estimating comprises determining the relative positions of said two
or more indicators after said second anchor is deployed.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application claims the benefit of U.S. Provisional
Application No. 60/821,947, filed Aug. 9, 2006, U.S. Provisional
Application No. 60/821,949, filed Aug. 9, 2006, U.S. Provisional
Application No. 60/829,507, filed Oct. 13, 2006, U.S. Provisional
Application No. 60/866,047, filed Nov. 15, 2006, and U.S.
Provisional Application No. 60/942,625, filed Jun. 7, 2007, the
contents of each of which are hereby incorporated by reference in
their entirety. This application relates to U.S. patent application
Ser. No. ______, filed Aug. 8, 2007, titled DEVICES FOR REDUCING
THE SIZE OF AN INTERNAL TISSUE OPENING (Attorney Docket No.
16348.27.1), U.S. patent application Ser. No. ______, filed Aug. 8,
2007, titled DEVICES FOR REDUCING THE SIZE OF AN INTERNAL TISSUE
OPENING (Attorney Docket No. 16348.27.2), U.S. patent application
Ser. No. ______, filed Aug. 8, 2007, titled DEVICES FOR REDUCING
THE SIZE OF AN INTERNAL TISSUE OPENING (Attorney Docket No.
16348.27.3), U.S. patent application Ser. No. ______, filed Aug. 8,
2007, titled SYSTEMS AND DEVICES FOR REDUCING THE SIZE OF AN
INTERNAL TISSUE OPENING (Attorney Docket No. 16348.27.4), U.S.
patent application Ser. No. ______, filed Aug. 8, 2007, titled
SYSTEMS AND DEVICES FOR REDUCING THE SIZE OF AN INTERNAL TISSUE
OPENING (Attorney Docket No. 16348.27.5), and U.S. patent
application Ser. No. ______, filed Aug. 8, 2007, titled METHODS,
SYSTEMS AND DEVICES FOR REDUCING THE SIZE OF AN INTERNAL TISSUE
OPENING (Attorney Docket No. 16348.27.7), the contents of each of
which are hereby incorporated by reference in their entirety.
BACKGROUND OF THE INVENTION
[0002] 1. The Field of the Invention
[0003] The present invention relates generally to medical devices
and methods of use for treating an internal tissue structure. More
particularly, the present invention relates to medical devices,
systems, and methods for reducing the size of an internal tissue
opening.
[0004] 2. The Relevant Technology
[0005] Physical malformations or defects that are present at birth
can be detrimental and even lethal when left uncorrected. A PFO is
an example of a cardiac birth defect that can be problematic and
even result in death when combined with other factors such as blood
clots or other congenital heart defects. A PFO occurs when an
opening between the upper two chambers of the heart fail to close
after birth.
[0006] Some of the problems associated with a PFO can occur when a
blood clot travels from the right to the left atria of the heart
through the PFO, and lodges in an artery that feeds blood to the
brain. A blood clot in the left atrium can be passed through the
aorta and travel to the brain or other organs, and cause
embolization, stroke, or a heart attack. A PFO can be treated by
being closed by a surgical procedure. Additionally, other similar
defects (e.g. septal or otherwise) where some tissue needs to be
closed in order to function properly can include the general
categories of atrial-septal defects ("ASDs"), ventricular-septal
defects ("VSD's") and patent ductus arteriosus ("PDA"), and the
like.
[0007] FIGS. 1A-1C depict various views of a heart having a PFO.
The heart 10 is shown in a cross-section view in FIG. 1A. In a
normal heart 10, the right atrium 30 receives systemic venous blood
from the superior vena cava 15 and the inferior vena cava 25, and
then delivers the blood via the tricuspid valve 35 to the right
ventricle 60. However, in the depicted heart 10 a septal defect,
which is shown as a PFO 50, is present between right atrium 30 and
left atrium 40.
[0008] The PFO 50 is depicted as an open flap on the septum between
the heart's right atrium 30 and left atrium 40. In a normal heart
10, the left atrium 40 receives oxygenated blood from the lungs via
pulmonary artery 75, and then delivers the blood to the left
ventricle 80 via the mitral valve 45. In a heart 10 having a PFO 50
some systemic venous blood can also pass from the right atrium 30
through the PFO 50 and mixes with the oxygenated blood in left
atrium 40, and then is routed to the body from left ventricle 80
via aorta 85.
[0009] During fetal development of the heart 10, the
interventricular septum 70 divides the right ventricle 60 and left
ventricle 80. In contrast, the atrium is only partially partitioned
into right and left chambers during normal fetal development, which
results in a foramen ovale fluidly connecting the right and left
atrial chambers. As shown in FIG. 1B, when the septum primum 52
incompletely fuses with the septum secundum 54 of the atrial wall,
the result can be a tunnel 58 depicted as a PFO 50.
[0010] FIG. 1C provides a view of the crescent-shaped, overhanging
configuration of the septum secundum 54 from within the right
atrium 30 in a heart 10 having a PFO 50. The septum secundum 54 is
defined by its inferior aspect 55, corresponding with the solid
line in FIG. 1C, and its superior aspect 53 represented by the
phantom line, which is its attachment location to the septum primum
52. The septum secundum 54 and septum primum 52 blend together at
the ends of the septum secundum 54. The anterior end 56a and
posterior end 56p are referred to herein as "merger points" for the
septum secundum 54 and septum primum 52. The length of the overhang
of the septum secundum 54, which is the distance between superior
aspect 53 and inferior aspect 55, increases towards the center
portion of the septum secundum as shown.
[0011] The tunnel 58 between the right atrium 30 and left atrium 40
is defined by portions of the septum primum 52 and septum secundum
54 between the merger points 56a and 56p which have failed to fuse.
The tunnel 58 is often at the apex of the septum secundum 54 as
shown. When viewed within right atrium 30, the portion of the
septum secundum 54 to the left of tunnel 58, which is referred to
herein as the posterior portion 57p of the septum secundum, is
longer than the portion of the septum secundum 54 to the right of
tunnel 58, which is referred to herein as the anterior portion 57a
of the septum secundum 54. In addition to being typically longer,
the posterior portion 57p also typically has a more gradual taper
than the anterior portion 57a as shown. The anterior pocket 59a is
the area defined by the overhang of the anterior portion 57a of the
septum secundum 54 and the septum primum 52, and it extends from
the anterior merger point 56a toward the tunnel 58. Similarly, the
posterior pocket 59p is the area defined by the overhang of the
posterior portion 57p of septum secundum 54 and the septum primum
52, and it extends from the posterior merger point 56p toward the
tunnel 58.
[0012] Conventional treatments for PFO, and other related
conditions have generally involved invasive surgery, which also
presents a risks to a patient. Although there are some less
invasive treatments for PFO, such treatments have been less
efficient at closing the PFO opening than techniques involving
invasive surgery.
BRIEF SUMMARY OF THE INVENTION
[0013] The invention relates to a medical system, devices and
methods of use for reducing the size of an internal tissue opening,
such as a Patent Foramen Ovale ("PFO"). In one embodiment of the
invention, the medical system can include a closure device and an
associated delivery device. The medical system can be configured to
enable a practitioner to selectively position and deploy the
closure device in an internal tissue opening to approximate, or in
other words bring together the tissue of the opening.
[0014] According to one embodiment of the invention, the closure
device can include a multi-cellular body portion operatively
associated with a first anchor and a second anchor. The
multi-cellular body portion can be configured to enable the closure
device to collapse into a relatively narrow non-deployed
orientation and expand into a deployed or expanded orientation
without plastic deformation or failure of the closure device. The
first and second anchors can be configured to engage at least a
portion of a wall of the internal tissue opening and/or tissue,
such as tunnel tissue, of the opening. In one embodiment of the
invention, the closure device can be a non-tubular, substantially
flat stent.
[0015] In one embodiment of the invention the closure device can
include an ingrowth material to facilitate tissue growth. The
closure device can also include one or more indicators to
facilitate the estimation of the position and/or orientation of the
closure device with respect to the internal tissue opening.
[0016] In accordance with the present invention, the delivery
device can include a delivery assembly, an actuating assembly, and
a release assembly operatively associated with a handle body. In
one embodiment of the invention, the delivery assembly facilitates
selective delivery of the closure device from the delivery device,
and is operatively associated with the actuating assembly and the
release assembly. The actuating assembly interacts with the handle
body to selectively deploy the closure device from the delivery
assembly. In one embodiment of the invention, the actuating
assembly can be configured to deploy at least a portion of the
closure device by a first movement and deploy a second portion of
the closure device by a second movement. The release assembly can
be linked to the handle body to facilitate detachment of the
closure device from the delivery device.
[0017] In one embodiment, the closure device is linked to the
delivery device by one or more tethers and one or more wires, the
tethers being coupled to the handle body and the wires being
coupled to a biasing member of the release assembly. The tethers
can be configured to receive a portion of the closure device
therein to facilitate securement of the closure device to the
delivery device. The wires can be detachably coupled to the closure
device to enable selective detachment of the closure device from
the delivery device by movement of the biasing member.
[0018] These and other objects and features of the present
invention will become more fully apparent from the following
description and appended claims, or may be learned by the practice
of the invention as set forth hereinafter.
BRIEF DESCRIPTION OF THE DRAWINGS
[0019] To further clarify the above and other advantages and
features of the present invention, a more particular description of
the invention will be rendered by reference to specific embodiments
thereof which are illustrated in the appended drawings. It is
appreciated that these drawings depict only typical embodiments of
the invention and are therefore not to be considered limiting of
its scope. The invention will be described and explained with
additional specificity and detail through the use of the
accompanying drawings in which:
[0020] FIGS. 1A-1C illustrate exemplary views of a heart having a
Patent Foramen Ovale;
[0021] FIG. 2 illustrates a perspective view of an embodiment of a
medical system according to the present invention;
[0022] FIG. 3A illustrates an embodiment of a closure device
according to the present invention;
[0023] FIG. 3B illustrates an embodiment of a closure device in a
non-deployed orientation according to the present invention;
[0024] FIG. 3C illustrates a cut-out view of a portion of a closure
device according to the present invention;
[0025] FIG. 4 illustrates an embodiment of a delivery device
according to the present invention;
[0026] FIGS. 5A-5C illustrate cross-sectional views of a delivery
device according to the present invention;
[0027] FIG. 6 illustrates an exploded view of a delivery device
according to the present invention;
[0028] FIG. 7 illustrates an embodiment of a coupling system
according to the present invention;
[0029] FIG. 8A illustrates an embodiment of a closure device being
partially deployed in an internal tissue opening;
[0030] FIG. 8B illustrates an embodiment of a delivery device in an
orientation corresponding to the partially deployed closure device
of FIG. 8A;
[0031] FIG. 9 illustrates an embodiment of a partially deployed
closure device according to the present invention;
[0032] FIG. 10A illustrates an embodiment of a closure device
positioned in an internal tissue opening;
[0033] FIG. 10B illustrates an embodiment of a delivery device in
an orientation corresponding to the deployed and detached closure
device of FIG. 10A;
[0034] FIG. 11A illustrates an embodiment of a closure device
having an ingrowth material according to the present invention;
and
[0035] FIG. 11B illustrates a side view of the closure device of
FIG. 11A.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0036] The present invention extends to medical systems, methods,
and apparatus for reducing the size of an internal tissue opening.
By way of explanation, the devices disclosed herein can be used to
treat a variety of internal tissue openings, such as a left atrial
appendage, paravalvular leaks, PDA's, and VSD's, for example.
Although, for purposes of simplicity, frequent reference is made
herein to reducing the size of or closing an opening in heart
tissue known as Patent Foramen Ovale ("PFO"). Accordingly, it will
be understood that references to PFO openings are not limiting of
the invention.
[0037] In the following description, numerous specific details are
set forth to assist in providing an understanding of the present
invention. In other instances, aspects of delivery and/or closure
devices, or medical devices in general have not been described in
particular detail in order to avoid unnecessarily obscuring the
present invention. In addition, it is understood that the drawings
are diagrammatic and schematic representations of certain
embodiments of the invention, and are not limiting of the present
invention, nor are they necessarily drawn to scale.
Introduction of Medical System 100
[0038] FIG. 2 is a perspective view of a medical system 100
configured to facilitate closure of an internal tissue opening
according to one embodiment of the present invention. In the
illustrated embodiment, the medical system 100 comprises a closure
device 200 adapted to reduce the size of the internal tissue
opening, and a delivery device 300 adapted to facilitate placement
and deployment of the closure device 200 with respect to the
internal tissue opening. The medical system 100 of the present
invention can provide benefits. For example, the medical system 100
can be configured to be used with different sizes, shapes and types
of internal tissue openings. Furthermore, the medical system 100
can provide various safety measures to increase the safety and
effectiveness of positioning the closure device 200. In addition,
the medical system 100 can be configured to provide distributed
lateral force to tissue of the internal tissue opening.
[0039] In the illustrated embodiment, delivery device 300 comprises
a handle body 302, an actuating assembly 320 operatively associated
with handle body 302, a release assembly 340 operatively associated
with the handle body 302 and a delivery assembly 360 operatively
associated with the actuating assembly 320, the release assembly
340 and the handle body 302. Handle body 302 can be configured to
provide a gripping surface for a user. Handle body 302 can be used
to position closure device 200, as well as facilitate deployment of
the closure device 200 from the delivery assembly 360. Actuating
assembly 320 can be moved with respect to handle body 302 to
selectively deploy portions of the closure device 200 from the
delivery assembly 360, as will be discussed more fully herein
below.
[0040] Release assembly 340 can be operatively associated with the
handle body 302 to enable selective detachment of closure device
200 from the delivery assembly 360. Delivery assembly 360 can house
closure device 200 in a non-deployed or constrained orientation,
such as illustrated in FIG. 3B for example, and facilitate
deployment of closure device 200. Delivery assembly 360 can include
one or more tethers 364 linked to the closure device 200 to
facilitate selective detachment of the closure device 200 from the
delivery device 300.
Closure Device 200
[0041] With reference to FIG. 3A, the closure device 200 is
illustrated in a fully deployed, expanded, relaxed or
non-constrained orientation. According to one embodiment of the
invention, the closure device 200 can be configured to reduce the
size of an internal tissue opening so as to close the internal
tissue opening. In one embodiment, the closure device 200 can
reduce the size of an internal tissue opening by approximating, or
in other words bringing together tissue of the internal tissue
opening, such as tunnel tissue in a PFO. The closure device 200 can
approximate tissue by applying lateral force to tissue of the
internal tissue opening, as will be discussed more fully herein
after. Also, the closure device 200 can be configured to enable a
user to estimate the position and/or orientation of the closure
device 200 with respect to an internal tissue opening, during and
after positioning of the closure device 200 in the internal tissue
opening.
[0042] According to one embodiment of the invention, the closure
device 200 can be a non-tubular stent. The closure device 200 can
be configured to assume a substantially flat configuration, or in
other words be configured to be substantially planar, such as
illustrated in FIGS. 3A and 11B for example. Furthermore, the
closure device 200 can be configured to resist movement out of
plane, such as plane 260 of FIG. 11B. However, the closure device
200 may bend out of plane when positioned in a tissue opening.
[0043] The closure device 200 according to one embodiment of the
invention has many advantages. For example, the closure device 200
can be configured to be reliable and compliant. The configuration
of the closure device 200 can enable the closure device 200 to be
movable between a non-deployed orientation and a deployed
orientation without causing failure or plastic deformation of the
closure device 200. The closure device 200 can be used to close
various types, shapes and sizes of internal tissue openings.
Furthermore, the closure device 200 can accommodate for a range of
PFO tunnel lengths, for example. Also, the closure device 200 can
be partially or fully deployed from or received back into the
delivery device 300. Closure device 200 can be configured to
substantially conform to the size and shape of a tissue opening.
For example, the undulations on the distal and proximal anchors can
enable the anchors to substantially, or to a certain degree,
conform to the anatomy of a tissue opening.
[0044] Generally, the closure device 200 can have a substantially
flat aspect having a length and height greater than its depth or
depth thickness. For example, in one embodiment, the closure device
200 has an overall length of 22 mm, a height of 7.5 mm and a depth
thickness of 0.4 mm. According to one embodiment of the present
invention, when the closure device 200 is in the relaxed or
completely expanded orientation, as illustrated in FIG. 3A, the
distance between the opposing ends of the proximal anchor 218 can
be about 22 mm, the distance between the most proximal attachment
member 240 of the body portion 202 and the most distal indicator
220 of the body portion 202 can be about 7.5 mm, and the depth
thickness, designated as DT in FIG. 11B, of the closure device 200
can be about 0.4 mm.
[0045] Furthermore, the majority of segments comprising the closure
device 200 can have a thickness or width that is substantially less
than the depth thickness of the segments. The closure device 200
can resist out of plane movement due to the size and configuration
of the segments. For example, the closure device 200 can be
configured to assume a substantially flat configuration in a first
plane. The configuration of the segments, for example the segments
having a certain depth thickness, can facilitate the closure device
200 resisting movement out of the first plane in a manner similar
to an I beam resisting bending in the direction of the web of the
beam. The first plane can be plane 260 as illustrated in FIG.
11B.
[0046] Also, the closure device 200, according to one embodiment of
the invention, can have a unitary construction. For example, the
closure device 200 can be cut from a single piece of material, such
as cut by a laser, thereby removing the need to assemble or join
different segments together. A unitary construction can provide
advantages, such as ease of manufacturing and reliability. For
example, assembly is not required for a closure device having a
unitary construction. Also, a closure device having a unitary
construction may not include distinct elements or segments which
require joining by joints, thereby reducing a likelihood of
failure. The closure device 200 can be made from a super-elastic
material, such as a super-elastic metal or a super-elastic polymer.
Furthermore, the closure device 200 can be made from NiTiNol,
stainless steel alloys, magnesium alloys, and polymers including
bio-resorbable polymers.
[0047] In some embodiments according to the present invention, the
closure device can be formed by utilizing a pressurized stream of
water, such as a water jet, to remove material from a piece of
material to form the closure device. Furthermore, it is
contemplated that the closure device can be formed by utilizing one
or more of the following: die casting, chemical etching,
photolithography, electrical discharge machining, or other
manufacturing techniques. It is contemplated that the closure
device can be formed through use of a mill or some other type of
device adapted to remove material to form a desired shape.
[0048] It will be appreciated by one of ordinary skill in the art
in view of the disclosure provided herein that the closure device
200 can comprise multiple segments joined together by a known
joining process, such as by an adhesive, by interference fits,
crimping, by fasteners, or a weld, or some combination thereof. For
example, in one embodiment, the closure device can include multiple
segments joined together by various welds to form a closure device
according to the present invention. In other embodiments, the
segments can be joined together by a plurality of means, such as by
the combination of welding, fasteners, and/or adhesives. The
segments can be a wire or multiple joined or rolled wires crimped
together or joined by a joining process to form the closure device
200.
[0049] In the illustrated embodiment, the closure device 200
includes a body portion 202, a first anchor 204 operatively
associated with the body portion 202 and a second anchor 206
operatively associated with the body portion 202. The body portion
202 can be configured to facilitate application of lateral force
against tissue of an internal tissue opening. Also, the body
portion 202 can be configured to enable the closure device 200 be
movable between a non-deployed and deployed orientation. For
example, the closure device 200 can be configured to be
self-expanding from the constrained or non-deployed orientation, as
illustrated in FIG. 3B for example, to the relaxed orientation, as
illustrated in FIG. 3A. In other words, the closure device 200 can
have a preferential orientation, such that movement of the closure
device 200 from a first orientation to a second orientation can
create internal stresses in the closure device 200. These internal
stresses can serve to bias the closure device 200 to the first
orientation. For example, in one embodiment, the closure device 200
can have a preferential orientation of the relaxed or fully
deployed orientation as illustrated in FIG. 3A. In this embodiment,
movement of the closure device 200 to a constrained orientation,
such as illustrated in FIG. 3B for example, can create internal
stresses in the closure device 200, thereby creating in the closure
device 200 a bias to return to the relaxed orientation.
[0050] In the illustrated embodiment, body portion 202 includes one
or more cells 208 defined by a plurality of segments 210. The body
portion 202 can include one or more apertures. In one embodiment,
an aperture is defined by the cell 208, or in other words by the
plurality of segments 210. In one embodiment, segment 210 can be a
strut or a body support segment. Cells 208 can be distinct, or can
be at least partially defined by a common segment. For example,
cell 208A, as the distal most cell, and cell 208C, as the proximal
most cell of body portion 202, are distinct and defined by distinct
segments 210 with respect to each other. However, cell 208B is
partially defined by a segment 210C which also defines a portion of
cell 208A. Similarly, cell 208B is partially defined by a segment
210G which also partially defines cell 208C. Likewise, cell 208D
shares a segment 210D with cell 208A and shares a segment 210H with
cell 208C.
[0051] Segments 210 can be shaped and configured to have a
substantially uniform stress at any given point along a certain
length, when the segment 210 is deflected. For example, segment
210A can include a first portion 230 having a width or thickness
greater than a second portion 232, wherein the width or thickness
decreases from the first portion 230 to the second portion 232, or
in other words is tapered, in a manner which provides for
substantially uniform stress levels along the certain length. In
other embodiments, segments can have a substantially constant width
along their length.
[0052] FIG. 3C is a cut-out view of a portion of the closure device
200, including the first portion 230 and the second portion 232 of
segment 210A. In the illustrated embodiment, the width or thickness
of the segment 210A varies along the portion of the segment 210A
from the location where segment 210A extends from the portion 254
which joins segment 210A to segment 210C to the intermediate
portion 234. As the closure device 200 moves between an expanded or
otherwise related orientation and a constrained or otherwise
collapsed orientation, the segments 210 are deflected, with the
highest levels of stress in the segment 210 being concentrated at
the joining portion 254 and decreasing towards the intermediate
portion 234. The segments 210 can be configured in a manner so as
to have a substantially equal stress level along the length of the
segment 210 between the joining portion 254 and the intermediate
portion 234. The uniform stress level can be accomplished by having
the width of the segment 210 vary from the first portion 230 to the
second portion 232 in a calculated manner. In one embodiment, the
width of the first portion 230 of the segment can be about 0.1 mm
and the taper to a width of about 0.05 mm at the second portion 232
of the segment.
[0053] In other embodiments, the uniform stress level can be
accomplished by utilizing a gradient of material having varying
properties. In other embodiments, the segment 210 can have varying
widths along its length and comprise a gradient of material
sufficient to achieve a substantially uniform stress level between
the first portion 230 and the second portion 232 of the segment. In
the illustrated embodiment, the first portion is adjacent the
joining portion 254 and the second portion is adjacent the
intermediate portion 234. In yet additional embodiments, the joints
of the interconnecting segments can include a biasing member, such
as a spring, thereby enabling the segments to move relative to each
other to collapse or expand the closure device 200. Furthermore,
the biasing member of the joint can cause the segments to have a
preferential orientation with respect to each other.
[0054] With continued reference to FIG. 3A, segments 210 can also
be configured to have a rectangular cross-section. In other
embodiments, segments 210 can have an oval shaped cross section. In
yet another embodiment, sections 210 can have a round or rounded
cross section. Furthermore, in one embodiment, the ratio, or aspect
ratio, of the thickness or width to the depth thickness of the
first and second portions 230, 232 can range between at least about
1:2 to about 1:20. In one embodiment, the aspect ratio of the width
to the depth thickness of the first portion 230 can be at least 1:2
and the ratio of the width to the depth thickness of the second
portion 232 can be at least 1:4. In an alternative embodiment, the
aspect ratio of the first portion 230 can be about 1:4 and the
aspect ratio of the second portion 232 can be about 1:8. In this
manner, the closure device 200 can substantially resist out of
plane movement, while allowing in-plane movement during
reorientation of various portions of the closure device 200.
[0055] Segments 210 can be configured to be compliant. Compliancy
of segments 210 can enable cells 208, and thus the body portion
202, to be oriented in various orientations. For example, body
portion 202 can be oriented, or in other words moved, between a
non-deployed orientation, such as illustrated in FIG. 3B, and a
fully deployed orientation, such as illustrated in FIG. 3A. The
compliancy of segments 210 can facilitate the accommodation by the
closure device 200 of a variety of types, shapes and sizes of
internal tissue openings. For example, the size and configuration
of the first and second anchors 204, 206 and the body portion 202
can enable the closure device 200 to accommodate varying sizes,
shapes and types of internal tissue openings. In one
implementation, the first anchor 204 can engage wall tissue of an
internal tissue opening and the second anchor 206 can engage only
the tunnel tissue of the internal tissue opening to approximate
tissue. In an alternative implementation where the internal tissue
opening has a shorter tunnel length, the second anchor 206 can
engage the tunnel tissue and an opposing wall of the internal
tissue opening to approximate tissue.
[0056] Segments 210 can include an intermediate portion 234
configured to facilitate securement of ingrowth materials to the
closure device 200, or can be used as an indicator 220 to
facilitate estimation of the position of the closure device 200
with respect to an internal tissue opening. Furthermore,
intermediate portion 234 can be configured to facilitate measuring
of a characteristic of an internal tissue opening. In one
embodiment, intermediate portion 234 can include one or more
apertures. The apertures can be configured to receive a securing
element, such as a thread, therethrough to facilitate securing an
ingrowth material to the closure device 200. Intermediate portion
234 can be configured to be stiffer or more rigid than first
portion 230, second portion 232, or both. A stiffer intermediate
portion 234 can increase the reliability of segments 210.
[0057] In another embodiment, the intermediate portion 234 can
include an indicator 220, such as a dense metallic rivet or
concentration of dense material, for use in estimating the
orientation and/or position of the closure device 200.
Understanding of the orientation and/or position of the closure
device 200 can facilitate estimating a physical characteristic of
an internal tissue opening and/or the relative position of the
closure device 200 with respect to the internal tissue opening. For
example, if the distance between the indicators 220 is known, a
practitioner can estimate a physical characteristic, such as the
opening or tunnel width, by determining the new distance between
the indicators 220 when the closure device 200 is positioned in the
tissue opening. Similarly, indicators 220 can be positioned on the
first and second anchors 04, 206. The indicators 220 can be
configured and arranged on the closure device 200 such that when
the first anchor 204 is deployed the indicators 220 are
substantially aligned. In this manner, a practitioner can estimate
whether the first anchor 204 has fully deployed.
[0058] In some cases, it may be difficult to view the closure
device 200 in the event the closure device 200 is at a skewed angle
with respect to the viewing plane, such as a fluoroscope. When the
closure device 200 is skewed in this manner, it can be difficult to
determine accurately the distance of interest. However, when
various distances between indicators is known, a user can use the
known distances to calculate the distances of interest by using
geometry.
[0059] In one embodiment, segments 210 along a similar or common
lateral plane can have substantially equal lengths. Substantially
equal lengths of segments 210 in this manner can enable body
portion 202 to be moved between the non-deployed and deployed
orientation without failure of the segments 210. For example, in
one embodiment, segments 210A and 210B have substantially the same
length, segments 210E, 210C, 210D, and 210K have substantially the
same length, segments 210F, 210G, 210H and 210L have substantially
the same length, and segments 210I and 210J have substantially the
same length. In this configuration, body portion 202 can be
collapsed or oriented into the non-deployed orientation, as
illustrated in FIG. 3B, without causing damage to the body portion
202 of closure device.
[0060] The closure device 200 can be configured to have a
preferential orientation of the fully deployed orientation as
illustrated in FIG. 3A. As the closure device 200 is deployed from
the delivery device 300, the configuration of closure device 200
can cause the closure device 200 to preferentially move toward the
fully deployed orientation. Thus, as the closure device 200 is
deployed in an internal tissue opening, the preferential
orientation of the closure device 200 can cause the closure device
200 to apply lateral force to the tissue of the internal tissue
opening. In other words, the body portion 202, first anchor 204 and
the second anchor 206 are deflected by an applied force in order to
reorient the closure device 200 from the fully deployed orientation
to a non-deployed orientation, for example. In this manner, the
closure device 200, because of the deflection of the body portion
202, first anchor 204 and the second anchor 206, will have tendency
to return to the fully deployed orientation. When the closure
device 200 is positioned in an internal tissue opening, the
deflected body portion 202, first anchor 204 and the second anchor
206 can have a tendency to apply a lateral force to tissue of the
opening as the closure device 200 attempts to return to the fully
deployed orientation.
[0061] Body portion 202 can be operatively associated with the
first anchor 204 and the second anchor 206. First and second
anchors 204, 206 can be configured to move between a deployed and
non-deployed orientation. First and second anchors 204, 206 can be
configured to apply lateral force to tissue of an internal tissue
opening, and to engage and/or contact a portion of wall tissue
and/or tunnel tissue of an internal tissue opening. In one
embodiment, the first anchor 204 can be a left atrial anchor, and
the second anchor 206 can be a right atrial anchor.
[0062] In the illustrated embodiment, the first anchor 204 can
include a first anchor segment 212 and an opposing second anchor
segment 214. Likewise, the second anchor 206 can include a first
anchor member 216 and an opposing second anchor member 218. The
first anchor segment 212 can be configured to move relative to the
second anchor segment 214. Likewise, the first anchor member 216
can be configured to move relative to the second anchor member 218.
In this manner, the closure device 200 can accommodate for a
variety of types, shapes and sizes of internal tissue openings. The
first anchor segment 212 and the second anchor segment 214 can be
configured to be substantially similar in size, shape and
configuration. As such, reference to the configuration and/or
function of one of the first or second anchor segments can apply to
the other anchor segment. In one embodiment of the invention, the
first anchor 204 and/or the second anchor 206 can include one or
more undulations. The undulations can facilitate reorienting or
movement of the anchors with respect to the body portion 202, for
example, from a deployed to a non-deployed configuration.
Furthermore, the undulations can facilitate the anchor
substantially conforming to the anatomy of the tissue opening.
[0063] The first anchor segment 212 can include a distal end 224
and a proximal end 226. The first anchor segment 212 can be defined
by various segments and can include reinforced segments 228 and one
or more engaging members 222. For example, in the illustrated
embodiment, the first anchor segment 212 is at least partially
defined by segment 210K of cell 208D. The engaging members 222 can
be microposts or tines configured to contact and/or engage tissue.
The engaging members 222 can include a sharp tip or can be blunt.
The engaging members 222 can be configured to provide a degree of
surface texture in order to increase engagement of the first anchor
204 with tissue.
[0064] The first anchor segment 212 can be configured to be moved
between a non-deployed orientation, as illustrated in FIG. 3B, and
a fully deployed orientation, as illustrated in FIG. 3A. The first
anchor segment 212 can be configured such that the distance from
the proximal end 226 to the distal end 224 of the segment which
includes the engaging members 222 is substantially equal to the
distance from the proximal end 226 to the distal end 224 of the
segment which includes the reinforced segments 228 and segment
210K. The second anchor segment 214 can be configured similar to
the first anchor segment 212.
[0065] First anchor segment 212 can be configured to define a
closed periphery. For example, first anchor segment 212 can include
the reinforced segment 228 extending from the body portion 202 to
the segment having the engaging members 222 which is connected to
segments 210K, 210L to define a closed periphery with segment 210K.
Furthermore, two reinforced segments 228 can extend from the
joining portion 254 of the body portion 202 and join together near
the distal end 224 of the first anchor 204. As such, there are
multiple anchor portions extending from the body portion 202. In
this manner, anchors of the present invention are reinforced to
provide greater rigidity and strength to facilitate stabilization
and maintenance of the closure device 200 within a tissue
structure.
[0066] First anchor member 216 can include a distal end 236 and a
proximal end 238. The first anchor member 216 can be defined by
various segments and can include one or more engaging members 222.
For example, in the illustrated embodiment, the first anchor member
216 is at least partially defined by segment 210L of cell 208D. The
engaging members 222 can be microposts or tines configured to
contact and/or engage tissue. The engaging members 222 can include
a sharp tip or can be blunt. The engaging members 222 can be
configured to provide a degree of surface texture to increase
engagement of the second anchor 206 with tissue.
[0067] It will be understood by one of ordinary skill in the art in
view of the disclosure provided herein that the engaging members
222 can vary in size and shape, and can be positioned at various
locations on the closure device 200. In alternative embodiments,
one or more engaging members can extend out of plane of the closure
device so as to contact tissue which is perpendicular, for example,
to the substantially flat plane, such as plane 260 of FIG. 11B, of
the closure device 200.
[0068] The first anchor member 216 can be configured to be moved
between a non-deployed orientation, as illustrated in FIG. 3B, and
a fully deployed orientation, as illustrated in FIG. 3A. The first
anchor member 216 can be configured such that the distance from the
proximal end 238 to the distal end 236 of the segment which
includes the engaging members 222 is substantially equal to the
distance from the proximal end 238 to the distal end 236 of the
segment which includes segment 210L. In this manner, first anchor
member 216 can be detachably coupled to the delivery device 300
when in a non-deployed orientation inside the delivery device 300
as illustrated in FIG. 3B. The second anchor member 218 can be
configured similar to the first anchor member 216.
[0069] The first anchor segment 212 can also include a first
portion 256 and a second portion 258 configured to facilitate
engagement of the internal tissue opening. For example, first
anchor segment 212 can be configured to include one or more
undulations causing the first portion 256 to be positioned in close
proximity with second portion 258. In this manner, as tissue is
positioned between the first and second portions 256, 258, the
configuration of the first anchor segment 212 can engage, or to
some degree, pinch the tissue therebetween to facilitate
maintenance of the position of the closure device 200 with respect
to the tissue opening.
[0070] The closure device 200 can also include attachment members
240 for use in detachably linking the closure device 200 to the
delivery device 300, as will be discussed more fully herein after.
The attachment members 240 can include an aperture 242 for use in
facilitating the linking of the closure device 200 to the delivery
device 300.
[0071] FIG. 3B illustrates the closure device 200 in a non-deployed
or constrained orientation. The configuration of the body portion
202, and the first and second anchors 204, 206 enables the closure
device 200 be reoriented from the fully deployed and preferential
orientation, as illustrated in FIG. 3A, to the non-deployed or
collapsed orientation as illustrated. In the collapsed or
non-deployed orientation, the first anchor 204 extends distally and
the second anchor 206 extends proximally, with the attachment
members 240 being the proximal most portions of the second anchor
206 and the body portion 202.
[0072] In the illustrated embodiment, the closure device 200 is
positioned inside of a delivery portion 366 of the delivery device
300. The configuration of the closure device 200 can cause portions
of the closure device to apply force to the wall of the delivery
portion 366 due to the preferential orientation of the closure
device 200. The closure device 200 is configured to be received
into and deployable from the delivery portion 366.
Delivery Device 300
[0073] FIG. 4 illustrates one embodiment of the delivery device
300. In the illustrated embodiment, the delivery assembly 360
includes a catheter 362 having a delivery portion 366, and a
plurality of tethers 364 at least partially housed by the catheter
362. The tethers 364 can be configured to facilitate selective
detachment of the closure device 200 from the delivery device 300.
The delivery portion 366 can be configured to receive the closure
device 200 therein. The catheter 362 can be coupled to the
actuating assembly 320, such that movement of the actuating
assembly 320 can cause movement of the catheter 362.
[0074] In the illustrated embodiment, the actuating assembly 320
includes a first member 322 operatively associated with the handle
body 302, a second member 324 operatively associated with the first
member 322 and the handle body 302, and a knob 338 linked to the
first member 322. The actuating assembly 320 can be utilized by a
user to selectively deploy the closure device 200 from the catheter
362.
[0075] The handle body 302 can include indicia 304 to enable a user
to estimate the degree of deployment of the closure device 200 from
the delivery device 300, as well as predict detachment of the
closure device 200 from the delivery device 300. For example,
indicia 304 can include deployment indicia 306 and release indicia
308. Deployment indicia 306 can be utilized to enable a user to
estimate the degree of deployment of the closure device 200 from
the catheter 362, and the release indicia 308 can be utilized to
predict the detachment of the closure device 200 from the delivery
device 300. The handle body 302 can also include a release pin
groove 310. The release pin groove 310 can be operatively
associated with the release assembly 340 to facilitate the
selective detachment of the closure device 200 from the tethers
364.
[0076] According to one embodiment of the invention, the release
assembly 340 can include a biasing member 342 operatively
associated with the handle body 302 to facilitate detachment of the
closure device 200. A release knob 346 can be provided to
manipulate the position of biasing member 342 in order to release
or detach the closure device 200. In one embodiment, the release
knob 346 is coupled to the biasing member 342, such that movement
of the release knob 346 can cause movement of the biasing member
342. The biasing member 342 can include a release pin 344
configured to be received in, influenced by and movable in the
release pin groove 310. In this manner, release pin groove 310 can
restrict, and thereby influence the movement of the biasing member
342 with respect to the handle body 302.
[0077] The biasing member 342 is configured to interact with the
handle body 302 such that when the release pin 344 is positioned in
a terminating portion of the release pin groove 310, as illustrated
in FIG. 4, the biasing member 342 is biased in the proximal
direction with respect to the handle body 302. In this manner, the
release pin 344 can be moved from the terminating portion of the
release pin groove 310, as illustrated in FIG. 4, to the opposing
terminating portion of the release pin groove 310 adjacent the
release indicia 308B by applying force to the biasing member 342
through the release knob 346 in the distal direction, rotating the
release knob 346 and then moving the release knob 346 in the
proximal direction to release the closure device 200, as
illustrated in FIG. 10B.
[0078] FIG. 5A is a cross-sectional view of the distal end of the
catheter 362. In the illustrated embodiment, the catheter 362
includes a delivery portion 366 for use in positioning the catheter
362. The catheter 362 can be made from a resilient material having
sufficient axial stiffness to allow a practitioner to position the
catheter 362 with respect to an internal tissue opening, and
sufficient rotational stiffness to allow a practitioner to rotate
the catheter 362 by rotating the handle body 302.
[0079] In one embodiment, the catheter 362 comprises a braided
polyimide. In other embodiments, the catheter 362 can be made from
a material having a sufficient axial stiffness, such as a braid
reinforced polymer, axially reinforced polymer, metal reinforced
polymer, carbon reinforced polymer, or some other type of axially
stiff material. The delivery portion 366 can be made from a
thermoplastic elastomer, such as PEBAX.RTM.. In other embodiments,
the delivery portion or tip portion 366 can be made from a material
having sufficient flexible properties, such as a polymeric
material. In other embodiments, the delivery portion 366 can
include a combination of materials, such as metallic materials and
polymeric materials.
[0080] The delivery portion 366 can define a lumen 368 to
facilitate placement of the catheter 362. For example, a guidewire
can be received in the lumen 368 to guide the catheter 362 to a
desired location. In this manner, the closure device 200 can be
located proximate to the internal tissue opening in a quick and
efficient manner. Furthermore, the delivery portion 366 can be
shaped, such as including a bend, in order to facilitate placement
of the delivery portion 366 through a PFO, for example. In one
embodiment of the invention, the catheter 362 can be considered a
rapid exchange catheter wherein the delivery or tip portion 366
enables a guidewire to be linked to the catheter 362 in a quick and
efficient manner for placement of the catheter 362.
[0081] The catheter 362 and delivery portion 366 can be configured
to at least partially house tethers 364 in a lumen which is
distinct and separate from lumen 368. For example, lumen 368 can be
in a spaced apart, non-coaxial arrangement from the lumen which
houses tethers 364, such that a guidewire can be received through
lumen 368 without being introduced into the lumen or space in which
the tethers 364 are housed. In this manner, a user can introduce a
guidewire into the lumen 368 at the distal end of the catheter 362,
rather than the lumen which at least partially houses the tethers
364 which would require the guidewire to be introduced into the
lumen at the proximal end of the catheter 362. In alternative
embodiments, the lumen 368 configured to receive the guidewire
therein can be positioned inside the lumen which houses the tethers
364. In this embodiment, lumen 368 would include an opening and an
exit at the distal end of the catheter 362 in order to facilitate
the quick placement of a guidewire through the lumen 368.
[0082] In one embodiment, catheter 362 can include a rounded
cross-section and the delivery portion 366 can include a
rectangular cross-section. The rectangular cross-section of the
delivery portion 366 can facilitate proper deployment of the
closure device 200 from the delivery device 300, as well as
facilitate the closure device 200 being reintroduced back into the
delivery portion 366. The rectangular cross-section of the delivery
portion 366 can be sized to orient the tethers 364 next to each
other in a linear fashion. In this manner, the likelihood that the
tethers 364 cross each other upon reintroduction of the closure
device 200 into the delivery portion 366 can be reduced.
[0083] In one embodiment of the invention, tethers 364 includes
three tethers 364A-C, each tether 364 being sized and configured to
attach to and/or accommodate therein an attachment member 240 of
the closure device 200. One example of a tether is a line or hollow
tube coupled to the handle body 302. The tether 364 can comprise a
flexible, hollow shaft having sufficient stiffness such that as
actuating assembly 320 moves the catheter 362 proximally with
respect to the handle body 302, the closure device 200 is forced
out of the delivery portion 366. Likewise, the tether 364 can be
configured to pull the closure device 200 back into the delivery
portion 366 as the actuating assembly 320 is moved distally with
respect to the handle body 302.
[0084] In one embodiment, the tether 364 can be a coil of stainless
steel covered by a heatshrunk tubing to give the coil a degree of
tensile strength and rigidity. In an alternative embodiment, the
tether 364 can be a polymeric tube. In yet an additional
embodiment, the tether 364 can be a combination of polymeric
materials and metallic materials. In some embodiments, an
additional heatshrunk tubing covers a proximal segment of the three
tethers 364A-C. The heatshrunk covering can increase the column
strength of the tether 364, which can enable the tethers 364 to
assist with deployment and reintroduction of the closure device 200
from and into the delivery portion 366. The tethers 364 can have a
distal tip configured to correspond to the shape and size of the
attachment members 240 of the closure device, such that the
attachment member 240 can be received into the distal tip of the
tether 364, as illustrated in FIG. 7.
[0085] Tethers 364 can be made from a material having sufficient
flexibility to substantially prevent distortion or otherwise
influence the orientation of the closure device 200 when the
closure device is deployed from the catheter 362, yet have
sufficient axial strength to facilitate deployment of the closure
device 200 when the catheter 362 is moved proximally with respect
to the closure device 200. The tethers 364 can have a lumen
extending therethrough of sufficient size and configuration to
enable a plurality of wires 378 to be housed and movable
therein.
[0086] FIGS. 5B-5C are cross-sectional views illustrating the
delivery assembly 360 in association with the actuating assembly
320. However, for simplicity, FIG. 5B does not include the biasing
member 342 and associated release knob 346, and FIG. 5C illustrates
details about the interaction between the delivery assembly 360 and
the actuating assembly 320 without illustrating the first member
322 and details about the handle body 302 and the second member
324. In the illustrated embodiment, the proximal end of the
catheter 362 is coupled to the distal end of the second member 324.
In this manner, movement of the second member 324 can cause a
corresponding movement in the catheter 362. For example, as the
second member 324 moves proximally with respect to the handle body
302, so also does the catheter 362 move proximally with respect to
the handle body 302.
[0087] According to one embodiment of the invention, the tethers
364 can extend from the delivery portion 366, through the catheter
362 and the second member 324 and are coupled to the handle body
302. The tethers 364 can be coupled to the handle body 302 by, for
example, an intermediate member 376. The tethers 364 can be covered
with a first and second housing 370, 372 to provide a degree of
rigidity to the portions of the tethers 364 located inside of the
handle body 302 and the second member 324. For example, in one
embodiment, the first housing 370 comprises a rigid, hollow, metal
rod configured to house the three tethers 364A-C therein. The first
housing 370 can extend from the intermediate member 376, which
facilitates securement of the tethers 364 to the handle body 302,
and terminate at some point beyond the handle body 302.
[0088] In the illustrated embodiment, the second housing 372 can
extend from the distal end of the first housing 370 and extend into
the catheter 362. The second housing 372 can comprise a resilient
material configured to resist axial stretching while allowing a
degree of bending. In one embodiment, the second housing 372
comprises a coil of metal, such as stainless steel, configured to
resist axial stretching, yet allow a degree of bending. The second
housing 372 can allow a practitioner to bend a portion of the
catheter 362, if needed, in order to manipulate delivery device 300
for placement of the closure device 200. A seal 374 can be provided
between the first housing 372 and the second member 324 in order to
reduce or substantially prevent bodily fluid, which may have
entered the catheter 362, from entering the handle body 302 or
otherwise inappropriately being expelled from the delivery device
300.
[0089] In the illustrated embodiment, the second member 324 can
comprise an elongate shaft defining an axial lumen 348 and a lumen
350 in fluid communication therewith. Lumen 350 can be configured
to couple to a medical device for removal of fluid from the
delivery device 300. The axial lumen 348 can be sized to
accommodate and allow movement of the tethers 362, the first
housing 370 and the second housing 372 therein. The second member
324 can include a guide 326. The guide 326 can be configured to
cooperate with a first pin 352 and a second pin 354 to influence
movement of the second member 324 with respect to the handle body
302, as will be discussed more fully herein below.
[0090] In the illustrated embodiment, the first member 322
comprises a hollow elongate tube sized and configured to enable the
second member 324 to be received into and moveable within the first
member 322. The first member 322 can be operatively associated with
the handle body 302 and the second member 324 to facilitate
deployment of the closure device 200. For example, the first member
322 is linked to the handle body 302 by a third pin 356. The third
pin 356 is received in a guide 358 of the first member 322. The
guide 358 is configured to interact with the third pin 356 in order
to influence the movement of the first member 322 with respect to
the handle body 302.
[0091] The first pin 352 can link the first member 322 to the
second member 324. When the first pin 352 links the first member
322 to the second member 324, the second pin 354 links the handle
body 302 to the second member 324, and the third pin 356 links the
handle body 302 to the second member 322, movement of the first
member 322 can selectively deploy the closure device 200 from the
delivery portion 366.
[0092] With reference to FIGS. 5A-C and 6, the association between
the first member 322, the second member 324, the handle body 302
and the biasing member 342 will be discussed. FIG. 6 is an exploded
view of the actuating assembly 320 and the release assembly 340. In
the illustrated embodiment, the second member 324 is received into
the first member 322, and the first member 322 is received into the
knob 338 and the handle body 302, as illustrated in FIGS. 4 and
5B-5C.
[0093] According to one embodiment of the invention, the second
member 324 can include a guide 326 having a first portion 326a and
a second portion 326b, which guide 326 can be defined by a slot
formed on the outer surface of the second member 324. In the
illustrated embodiment, the first portion 326a is straight and
extends along at least a portion of the length of the first member
324 and joins with the second portion 326b of the guide 326. The
second portion 326b can include a helical groove or slot that
begins with and is contiguous with the first portion 326a and
extends distally therefrom.
[0094] The guide 326 of the second member 324 is configured to
interact with the handle body 302 and the first member 322 to
selectively retract the catheter 362 in order to deploy the closure
device 200. For example, the first portion 326a of the guide 326 is
configured to interact with the second pin 354, which is secured
into the handle body 302 by means of threads and extend into the
first portion 326a of the guide 326. In this manner, the second
member 324 can move laterally with respect to the handle body 302.
Thus, rotation of the handle body 302 can translate to rotation of
the second member 324, and thus, the catheter 362 and the delivery
portion 366.
[0095] The second portion 326b of the guide 326 is configured to
interact with the first pin 352, which is secured to the first
member 322 by means of threads and extends into the second portion
326b of the guide 326. In this manner, as the first member 322 is
rotated, the first pin 352 will interact with the second portion
326b to move the second member 324 in the proximal direction. As
the second member 324 is moved in the proximal direction with
respect to the handle body 302, the catheter 362 moves proximally
with respect to the handle body 302 thereby exposing or deploying
the closure device 200 from the delivery portion 366.
[0096] In the illustrated embodiment, the first member 322 can
include a guide 358 defined by a slot or groove formed in the outer
surface of the first member 322. In the illustrated embodiment, the
guide 358 can include a first portion 358a connected to a second
portion 358b. The first portion 358a of guide 358 can be straight
and extend along at least a portion of the length of the first
member 322, and then join and be contiguous with the second portion
358b. The second portion 358b of the guide 358 can be a helical
groove that wraps around at least a portion of the outer surface of
the first member 322 and extends along at least a portion of the
length of the first member 322.
[0097] As described previously, the third pin 356, which is secured
to the handle body 302 by means of threads, can extend into the
guide 358 in order to influence movement of the first member 322
with respect to the handle body 302. For example, as the third pin
356 is positioned in the most proximal portion of the first portion
358a, the closure device 200 is completely received into and
enclosed by the delivery portion 366. As the first member 322 is
moved in the proximal direction as illustrated by the arrow in FIG.
4, the third pin 356 moves in the first portion 358a of the guide
358 to deploy the first anchor 204 of the closure device 200 from
the delivery portion 366.
[0098] The length of the first portion 358a can correspond with the
distance that the first member 322, and thus the catheter 362, must
move in order to deploy the first anchor 204 of the closure device
200 from the delivery portion 366. For example, a practitioner can
move the knob 338, which is coupled to the first member 322, in the
proximal direction. Movement of the knob 338 in the proximal
direction can cause the third pin 356 to move linearly in the first
portion 358a of the guide 358. In this manner, the second member
324 can move correspondingly with the first member 322 because of
the first pin 352, which links the first member 322 to the second
member 324. As the third pin 356 is positioned in the location of
the guide 358 where the first portion 358a meets with the second
portion 358b, the first member 322 can be rotated in order to
selectively deploy the remaining portions of the closure device 200
from the delivery portion 366 of the delivery device 300.
[0099] As the first member 322 is rotated, the third pin 356 is
positioned in the second portion 358b to influence movement of the
first member 322 with respect to the handle body 302, and the first
pin 352, which is coupled to the first member 322, interacts with
the second portion 326b of the guide 326 to move the second member
324 in the proximal direction with respect to the handle body 302.
Movement of the second member 324 in the proximal direction in this
manner can cause further deployment of the closure device 200 from
the delivery portion 366. As will be appreciated, the knob 338 can
be coupled to the first member 322 to facilitate and enable
movement of the first member 322 with respect to the handle body
302.
[0100] The dual movement required to deploy the closure device 200
can provide some efficiency and safety advantages. For example, a
practitioner can move the knob 338 in a first direction (i.e.,
proximally in a linear fashion) to deploy the first anchor 204 from
the delivery portion 366. Thereafter, the practitioner can move the
handle body 302 to position the first anchor 204 against the wall
tissue of an internal tissue opening, such as against the left
atrial wall of a heart, for example. Once the first anchor 204 is
positioned against the wall, the practitioner can move the knob 338
in a second direction (i.e., rotate the knob) to further deploy the
closure device 200 from the delivery portion 366. The dual movement
enables a user to predict the deployment of the closure device 200
to reduce the risk of premature deployment of the closure
device.
[0101] It will be understood by one of ordinary skill in the art in
view of the disclosure provided herein that other means of
controlling movement of one member with respect to the other, such
as the first member with respect to the second member, can be
utilized without departing from the scope and spirit of the
invention. For example, a structure configured to substantially
restrict or control movement of the first element with respect to
the second element and/or handle body can be utilized. In one
embodiment, the structure can include a cam and a follower. In an
alternative embodiment, the structure can include a slider.
[0102] The release assembly 340 can be configured to be received in
the proximal end of the handle body 302. The release assembly 340
can be configured to provide additional safety features for the
practitioner and patient by reducing the risk of premature
detachment of the closure device 200 before it is positioned
appropriately in an internal tissue opening. For example, a
practitioner using the medical system 100 of the present invention
can manipulate the actuating assembly 320 to deploy the closure
device 200 for positioning in an internal tissue opening. In order
to deploy a first portion of the closure device 200, a user can
move the knob 338, and thus the first member 322, in the proximal
direction with a first movement, which is a linear movement, then
deploy the remaining portions of the closure device 200 by a
rotational movement. Once the closure device 200 is deployed, the
practitioner can be required to move their hands in order to
utilize the release assembly 340 to release the closure device 200
from the delivery device 300.
[0103] In the illustrated embodiment the release assembly 340 can
include a release knob 346 coupled to a biasing member 342, which
is received into the proximal end of the handle body 302. The
biasing member 342 can be configured to include a plurality of
slots 318 configured and arranged to act similar to a spring. The
slots 318 can be configured and arranged in the biasing member 342
to enable at least a portion of the biasing member 342 to be
compressed. Compression of the biasing member 342 can cause the
release pin 344 to move toward the distal end of the biasing member
342.
[0104] The biasing member 342 can be configured such that when
biasing member 342 is positioned in the handle body 302, the
biasing member 342 naturally tends to maintain its position with
the release pin 344 in the release pin groove 310 as illustrated in
FIG. 4. As force is applied to the release knob 346 in the distal
direction (i.e., compress the biasing member 342), the release pin
344 can be moved out of a terminating portion of the release pin
groove 310 and rotated and moved into a proximal terminating
portion of the release pin groove 310 to release the closure device
200 from the delivery device 300.
[0105] The closure device 200 is released from the delivery device
300 by moving a plurality of wires 378 which are housed by a tether
364 and coupled to the biasing member 342. Illustrated in FIG. 7 is
a cross-sectional view of attachment member 240 of the closure
device 200 received into a tether 364 and coupled by first and
second wires 378a, 378b. In the illustrated embodiment, a second
wire 378b can extend through and out of the tether 364 and form a
loop. The loop can extend through an aperture 242 of the attachment
member 240 of the closure device 200. With the loop of second wire
378b positioned through the aperture 242 of the attachment member
240, a first wire 378a, which extends through and out of the tether
364, can extend through the loop of the second wire 378b to form a
locking feature. When the first wire 378a extends sufficiently
through the loop of the second wire 378b, the closure device 200
can remain coupled to the delivery device 300 until the first wire
378a is pulled through the loop of the second wire 378b, and the
second wire 378b is pulled out of the aperture 242 of the
attachment member 240.
[0106] The first wire 378a and the second wire 378b can be attached
at their proximal ends to the biasing member 342. In this manner,
movement of the biasing member 342 in the proximal direction can
cause movement of the wires 378 also in the proximal direction. In
one embodiment, the wires 378 can be coupled to the biasing member
342 such that movement of the biasing member 342 will cause the
first wire 378a to move a distance sufficient to be removed from
the loop of second wire 378b before the second wire 378b is moved
by the biasing member 342. The wire 378 can comprise a metallic
wire, such as a NiTiNol wire. The wire 378 can also include a
stainless steel wire or some other type of metal or stiff polymer.
The wires 378 can be made from a material having a sufficient
tensile strength to secure the closure device 200 to the tethers
364 without causing the wires 378 to fail or substantially deform.
In one embodiment of the invention, the wire 378B can include a
stainless steal wire and wire 378A can include a NiTiNol wire.
[0107] Other types and configurations of biasing members can be
utilized without departing from the scope and spirit of the
invention. For example, in one embodiment, the release assembly can
include a rotating member coupled to the securing elements. In this
embodiment, rotation of the rotating member can cause the securing
elements to wind around the rotating member thereby causing the
distal ends of the securing elements to move proximally with
respect to the handle body.
[0108] The method of use of the medical system 100 will now be
described with reference to a particular internal tissue opening,
namely a PFO. FIG. 8a illustrates the positioning of the catheter
362 through the tunnel 58 of a PFO with the first anchor 204 of the
closure device 200 deployed. The medical system 100 is utilized to
close an internal tissue opening by positioning the catheter 362
through an internal tissue opening and moving the first member 322
by a first movement (i.e., linearly) in the proximal direction to
deploy the first anchor 204 of the closure device 200. After the
first anchor 204 of the closure device 200 is deployed, the
delivery device 300 can be moved in the proximal direction in order
to seat the first anchor 204 against the wall of the tissue opening
or otherwise engage the wall of the internal tissue opening, as
illustrated in FIG. 9. This can be done by moving the handle body
302 in the proximal direction.
[0109] After the first anchor 204 has been positioned against the
wall of the internal tissue opening, the knob 338, and thus the
first member 322, can moved by a second movement, or in other
words, rotated to deploy additional portions of the closure device
200 as illustrated in FIG. 9. After the closure device 200 has been
fully deployed and conforms to the anatomy of the internal tissue
opening, the release assembly 340 can be actuated to selectively
detach the delivery device 300 from the closure device 200 as
illustrated in FIGS. 10a and 10b.
[0110] The release assembly 340 can be actuated by moving the
biasing member 342 distally with respect to the handle body 302,
then rotating the biasing member with respect to the handle body
302, and then moved proximally with respect to the handle body 302.
In this manner, closure device 200 substantially conforms to the
anatomy of the internal tissue opening. As noted previously, the
configuration of the closure device 200 is such that when
positioned in the internal tissue opening as illustrated, the
members of the closure device 200 apply lateral force to the tissue
of the internal tissue opening, such as the tunnel 58 of the PFO,
to approximate tissue of the PFO for closure.
[0111] FIG. 11A illustrates one embodiment of a closure device 200
that can include a member 250, such as an ingrowth material. The
member 250 can be configured to induce tissue growth. The member
250 can be fixed to the closure device 200 by means of a securing
element, such as a thread 252. For example, the thread 252 can
extend through the member 250 and through the apertures in the
intermediate portions 234 in order to secure the member 250 to the
closure device 200. In other embodiments, the member 250 can be
secured to the closure device 220 by a known securing means, such
as by an adhesive, a heat weld, or some other known or hereafter
developed means for securement.
[0112] The member 250 and the thread 252 can include a
bio-resorbable material, such as polylactide or polyglycolide or
collagen. The member 250 can be sized and configured to enable the
closure device 200 to be deployed from and received into the
delivery portion 366 of the delivery device 300. Furthermore, the
member 250 can be configured to interact with tissue of the
internal tissue opening to stimulate growth of tissue for closure
of the internal tissue opening. For example, the member 250 can
interact with the tunnel tissue 58 of a PFO in order to stimulate
growth of tissue in the PFO tunnel 58.
[0113] The member 250 can be any suitable material which can or
tends to promote tissue growth. Examples of such material can
include a polymeric material, or a woven material, such as a woven
metallic or biological material. In one embodiment, the member 250
can be a piece of foam. In alternative embodiments, the member 250
can be a piece of yarn, fabric or string, or some combination
thereof. Other tissue growth promoting members can include a
coating disposed on the closure device 200. In other embodiments,
the member 250 can be a piece of foam, braided material such as a
piece of yarn or string, or fabric which has a coating disposed
thereon.
[0114] The member 250 can include materials such as a piece of
polyurethane or some other biocompatible polymer, including
bio-resorbable polymers. The member 250 can also include Dacron or
polymeric threaded material which have been woven or knitted, or
formed into compressed, non-woven fabrics. The member 250 can also
include a metallic material, such as a NiTiNol, stainless steal or
some other biocompatible alloy or bio-resorbable metal, such as
magnesium alloy, or some combination thereof. In one embodiment,
the member 250 comprises a metallic wire.
[0115] FIG. 11B illustrates a side view of the closure device 200,
and illustrates one example of the closure device having a
substantially flat configuration. In the illustrated embodiment,
the closure device 200 can include a depth or depth thickness
designated as DT, and a plane 260 extending perpendicular into and
out of the plane of the page. In this embodiment, the member 250
can extend beyond at least a first edge 262 of the closure device
200. Furthermore, the member 250 can extend beyond both the first
edge 262 and a second edge 264 of the closure device 200. In this
manner, member 250 can contact tissue adjacent the closure device
200 to promote tissue growth in the tissue opening.
[0116] The member 250 can be sized and configured to extend beyond
at least the first edge 262 of the closure device 200 a sufficient
distance to contact tissue of the tissue opening. In one
embodiment, the member 250 can extend beyond at least the first
edge 262 a sufficient distance to contact tissue adjacent the first
edge 262, thereby causing the end of the member 250 which is in
contact with the tissue to deflect or bend. In this manner, more
surface area of the member 250 can be in contact with tissue to
thereby facilitate an increase in tissue growth. In other
embodiments, the member 250 can extend beyond both the first edge
262 and the second edge 264 a sufficient distance to cause both
ends of the member 250 to bend, which can result in more surface
area contacting the tissue. In one embodiment, the member 250 can
extend between at least 0.5 mm and 5 mm beyond the first edge 262.
In another embodiment, the member 250 can extend between at least
0.5 mm and 5 mm beyond the first edge 262, and can extend between
at least 0.5 mm and 5 mm beyond the second edge 264. Furthermore,
the member 250 can have a thickness of between at least 0.25 mm and
2 mm.
[0117] In addition, in some embodiments the member 250 can be
configured to decrease the size of a remaining void in the tissue
opening after the closure device 200 has been positioned in the
tissue opening. Member 250 extending beyond the first edge 262 of
the closure device 200 is an example of the member 250 extending
substantially out of plane of the substantially flat
configuration.
[0118] The present invention can also include the following
methods, systems and devices.
[0119] A medical device comprising: a body portion comprising two
or more cells, said body portion being movable between a deployed
and non-deployed orientation; and at least one anchor linked to
said body portion, said at least one anchor being adapted to reduce
proximal movement of the medical device when the medical device is
positioned in an internal tissue opening.
[0120] A medical device comprising: a multi-cellular structure
adapted to selectively expand and contract between a deployed and
non-deployed orientation; a first anchor operatively associated
with said multi-cellular structure, said first anchor being adapted
to selectively engage at least a portion of a wall of an internal
tissue opening; and a second anchor operatively associated with
said multi-cellular structure, said second anchor being adapted to
engage at least a portion of at least another portion of the wall
of the tissue opening.
[0121] A method for closing a Patent Foramen Ovale, comprising the
steps of: positioning at least a portion of a medical device into a
left atrium of a heart, said medical device comprising a first
anchor, a multi-cellular structure linked to said first anchor, and
a second anchor linked to said multi-cellular structure, said first
anchor, said multi-cellular structure and said second anchor being
adapted to selectively move between a non-deployed and deployed
orientation; locating at least a portion of said first anchor
against at least a portion of a left atrial wall of the heart; and
locating at least a portion of said second anchor against at least
a portion of at least one of a tunnel of the Patent Foramen Ovale
or a right atrial wall of the heart.
[0122] A medical device for approximating tissue of an internal
tissue opening together, the medical device comprising: a body
portion comprising two or more cells, said body portion being
adapted to apply lateral force to tissue of an internal tissue
opening; and at least one anchor operatively associated with said
body portion.
[0123] A medical device for approximating tissue of an internal
tissue opening together, the medical device comprising: a
multi-cellular structure adapted to selectively expand and contract
between a deployed and non-deployed orientation, said
multi-cellular structure configured to preferentially expand; and
at least one anchor operatively associated with said multi-cellular
structure, said at least one anchor being adapted to move between a
deployed and non-deployed orientation, at least a portion of said
at least one anchor being adapted to apply lateral force to at
least a portion of tissue of an internal tissue opening when said
first anchor is deployed.
[0124] A method for reducing the size of an internal tissue
opening, comprising the steps of: positioning at least a portion of
a medical device through an internal tissue opening, said medical
device comprising a multi-cellular structure and at least a first
anchor associated with said multi-cellular structure, said at least
one anchor and said multi-cellular structure being adapted to
selectively move between a non-deployed and deployed orientation;
and applying lateral force to tissue of the internal tissue opening
by at least partially deploying said at least one anchor.
[0125] A medical device comprising: two or more cells forming a
body portion, said body portion being adapted to move between a
collapsed and expanded orientation to apply lateral force to tissue
of an internal tissue opening; and at least one anchor linked to
said body portion, said at least one anchor being adapted to extend
distally when said at least one anchor is collapsed and extend
laterally when said at least one anchor is moved from a collapsed
to an expanded orientation.
[0126] A method for deploying a closure device, the method
comprising the steps of deploying a left anchor of a closure device
from a delivery device, said delivery device comprising an
actuating assembly operatively associated with a handle body, said
left anchor being adapted to deploy by linearly moving at least a
portion of said actuating assembly with respect to said handle
body; and deploying a second anchor of said closure device from
said delivery device by rotating at least a portion of said
actuating assembly with respect to said handle body.
[0127] A delivery device for an internal tissue opening closure
device, the delivery device comprising: a handle body including
first and second guide members; a first member operatively
associated with said handle body, at least a portion of said first
member defining a guide, said first guide member cooperating with
said guide to influence movement of said first member with respect
to said handle body, said first member including a guide structure;
and a second member operatively associated with said first member,
at least a portion of said second member defining a second guide,
said guide structure cooperating with said second guide to
influence the movement of said second member with respect to said
first member, and said second guide member cooperating with said
second guide to influence the movement of said second member with
respect to said handle body.
[0128] A delivery device for an internal tissue opening closure
device, the delivery device comprising: a handle body; a first pin
coupled to said handle body; a second pin coupled to said handle
body; a first cam adapted to be at least partially received into
and movable with respect to at least a portion of said handle body,
said first cam including a slot formed on an external surface of
said first cam, said slot including a first portion and a second
portion, said first portion of said slot extending along at least a
portion of the length of said first cam, said second portion of
said slot extending at least partially around said first cam, said
first pin received in said slot; a third pin coupled to said first
cam; and a second cam adapted to be at least partially received
into and movable with respect to at least a portion of said first
cam, said second cam including a first and second slot formed on an
external surface of said second cam, said first slot of said second
cam extending at least partially around said second cam and said
second slot of said second cam extending along at least a portion
of the length of said second cam, said third pin received in said
first slot of said second cam and said second pin received in said
second slot of said second cam.
[0129] A medical device for closing an internal tissue opening, the
medical device comprising: a multi-cellular structure configured to
assume a substantially flat configuration; at least one anchor
operatively associated with said multi-cellular structure, said at
least one anchor comprising a plurality of segments at least
partially defining a closed periphery.
[0130] A medical device for closing an internal tissue opening, the
medical device comprising: a multi-cellular structure adapted to be
moveable between a first orientation and a second orientation; at
least one anchor operably associated with said multi-cellular
structure; and a tissue growth member associated with said
multi-cellular structure, said tissue growth member being adapted
to enhance tissue growth in the internal tissue opening.
[0131] The present invention may be embodied in other specific
forms without departing from its spirit or essential
characteristics. The described embodiments are to be considered in
all respects only as illustrative and not restrictive. The scope of
the invention is, therefore, indicated by the appended claims
rather than by the foregoing description. All changes which come
within the meaning and range of equivalency of the claims are to be
embraced within their scope.
* * * * *