U.S. patent application number 17/305187 was filed with the patent office on 2021-12-16 for suturing devices and methods for suturing an anatomic structure.
The applicant listed for this patent is HeartStitch, Inc.. Invention is credited to Benjamin G. Brosch, William Ettlinger Cohn, Daniel W. Haines, Anthony A. Nobles.
Application Number | 20210386420 17/305187 |
Document ID | / |
Family ID | 1000005800458 |
Filed Date | 2021-12-16 |
United States Patent
Application |
20210386420 |
Kind Code |
A1 |
Nobles; Anthony A. ; et
al. |
December 16, 2021 |
SUTURING DEVICES AND METHODS FOR SUTURING AN ANATOMIC STRUCTURE
Abstract
Suturing devices and systems used to close openings into a
biological structure. The suturing device can comprise an elongate
member having a proximal end, a distal end, one or more arms, and
one or more needles. One or more sheaths may be used with the
device to maintain or substantially maintain haemostasis while the
device is used and while a procedure is performed in the biological
structure.
Inventors: |
Nobles; Anthony A.; (St.
Thomas, VI) ; Brosch; Benjamin G.; (Mission Viejo,
CA) ; Cohn; William Ettlinger; (Bellaire, TX)
; Haines; Daniel W.; (Garden Grove, CA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
HeartStitch, Inc. |
Fountain Valley |
CA |
US |
|
|
Family ID: |
1000005800458 |
Appl. No.: |
17/305187 |
Filed: |
July 1, 2021 |
Related U.S. Patent Documents
|
|
|
|
|
|
Application
Number |
Filing Date |
Patent Number |
|
|
16576253 |
Sep 19, 2019 |
11051802 |
|
|
17305187 |
|
|
|
|
15645438 |
Jul 10, 2017 |
10420545 |
|
|
16576253 |
|
|
|
|
14400309 |
Nov 10, 2014 |
9706988 |
|
|
PCT/US2013/040418 |
May 9, 2013 |
|
|
|
15645438 |
|
|
|
|
61646188 |
May 11, 2012 |
|
|
|
61715123 |
Oct 17, 2012 |
|
|
|
61779901 |
Mar 13, 2013 |
|
|
|
Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61B 17/3478 20130101;
A61B 2017/3405 20130101; A61M 25/09 20130101; A61B 2017/00243
20130101; A61B 2017/048 20130101; A61B 2017/0414 20130101; A61B
2017/00623 20130101; A61B 2017/00575 20130101; A61B 2017/00336
20130101; A61B 2017/0061 20130101; A61B 2017/0472 20130101; A61B
17/0491 20130101; A61B 17/3403 20130101; A61B 2217/005 20130101;
A61B 17/3415 20130101; A61B 2017/0406 20130101; A61B 17/06166
20130101; A61B 2017/00663 20130101; A61B 17/06066 20130101; A61B
17/0057 20130101; A61B 17/3423 20130101; A61B 17/0469 20130101;
A61B 2017/00349 20130101; A61B 2017/0237 20130101; A61B 17/0485
20130101; A61B 2017/047 20130101 |
International
Class: |
A61B 17/04 20060101
A61B017/04; A61B 17/00 20060101 A61B017/00; A61B 17/06 20060101
A61B017/06; A61B 17/34 20060101 A61B017/34; A61M 25/09 20060101
A61M025/09 |
Claims
1.-27. (canceled)
28. A method of performing a procedure on the heart of a patient,
the method comprising: delivering an elongate device through a
heart wall such that the a distal section of the device is
positioned within the heart; and removing fluid exiting the heart
along the distal section of the elongate device and through the
heart wall, said removing of fluid comprising causing said fluid to
flow through at least one opening positioned on the elongate device
on an outside of the heart to remove fluid that may accumulate
between the outside of the heart and the pericardial sac.
29. The method of claim 28, wherein fluid flows through the at
least one opening by applying negative pressure to the at least one
opening from outside of the patient.
30. The method of claim 28, wherein the elongate device comprises a
distally facing surface in its distal section, and delivering the
elongate device comprises pushing the distal facing surface against
an outer surface of the heart.
31. The method of claim 30, wherein the elongate device comprises a
plurality of openings proximal to the distally facing surface.
32.-43. (canceled)
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application is a continuation of U.S. patent
application Ser. No. 15/645438, filed Jul. 10, 2017, titled
SUTURING DEVICES AND METHODS FOR SUTURING AN ANATOMIC STRUCTURE,
which is a continuation of U.S. patent application Ser. No.
14/400,309 filed Nov. 10, 2014, titled SUTURING DEVICES AND METHODS
FOR SUTURING AN ANATOMIC STRUCTURE, which is a U.S. National Phase
of International Patent Application No. PCT/US2013/040418, filed
May 9, 2013, titled SUTURING DEVICES AND METHODS FOR SUTURING AN
ANATOMIC STRUCTURE, which claims priority to U.S. Provisional
Application No. 61/779,901, filed Mar. 13, 2013; U.S. Provisional
Application No. 61/715,123, filed Oct. 17, 2012; and U.S.
Provisional Application No. 61/646,188, filed May 11, 2012, the
contents of all of which are hereby incorporated by reference
herein.
TECHNICAL FIELD
[0002] Embodiments of the present invention relate to suturing
devices and methods. Some embodiments relate to suturing devices
and methods for suturing an anatomic structure, such as a
heart.
BACKGROUND
[0003] Health practitioners frequently use sutures to close various
openings such as cuts, punctures, and incisions in various places
in the human body. Generally, sutures are convenient to use and
function properly to hold openings in biological tissue closed
thereby aiding in blood clotting, healing, and prevention of
scarring.
[0004] There are some circumstances under which it is not feasible
to use conventional sutures and suturing methods to close an
opening. Additionally, there are some circumstances under which the
use of conventional sutures and suturing methods require invasive
procedures that subject a patient to risk of infection, delays in
recovery, increases in pain, and other complications.
SUMMARY OF THE DISCLOSURE
[0005] Embodiments of suturing devices used to suture closed
openings into a biological structure while maintaining or
substantially maintaining haemostasis are described herein. The
suturing devices and methods can also be used to place sutures
prior to a surgical procedure and to prepare access for the
procedure while maintaining or substantially maintaining
haemostasis. The placed sutures can then be used to tighten an
opening while any devices or tools are withdrawn, closing the
opening while the final device or tool leaves the opening such that
the opening is never without a device or tool inside it during the
course of the procedure.
[0006] In the embodiments described herein, the disclosed devices
are used to place sutures to close an opening into a heart,
although they are not limited to applications within a heart. The
heart can be accessed through a sternotomy or limited thoracotomy,
or alternatively the device can pass through a trocar or other
element into the thoracic cavity and then be led toward the opening
in the heart, typically by following a guide wire. In some
embodiments, the opening is a puncture made at or near the apex of
the heart. The puncture can also be made at other areas of the
heart. In some embodiments, suturing devices and methods disclosed
herein can be used to minimize the collection of fluid between the
heart and the pericardial sac that surrounds the heart.
[0007] In some embodiments, a suturing system can include a
suturing device having an elongate body with a proximal end and a
distal end, and a plurality of arms near the distal end. Each arm
can be configured to move between a first position in which the arm
is retracted within the elongate body and a second position in
which the arm has a free end extending away from the elongate body.
Each arm can have at least one suture mount at the free end. The
device can also have a plurality of needles, each needle configured
to move between a retracted position in which the needle is within
the elongate body to a deployed position in which the distal point
of the needle extends out of the elongate body and into a
corresponding suture mount.
[0008] The system can also include a first sheath adapted to
surround at least a portion of the elongate body, a second sheath
adapted to surround at least a portion of the first sheath, and a
plurality of suture portions. Each suture portion can have a suture
end releasably retained within a suture mount of a corresponding
arm, and each suture portion can extend from a corresponding suture
end, between the first sheath and the second sheath, to a position
proximal to at least the second sheath.
[0009] Methods of use are also described. In some embodiments, a
suturing system can be delivered through a heart wall, and the
suturing system can include a suturing device with an elongate body
having a proximal end and a distal end, the suturing device also
having a distal section that extends through the heart wall and
into the heart once the suturing system is delivered. The suturing
device can also have a plurality of arms positioned outside of the
heart and a plurality of needles positioned inside the heart once
the suturing system is delivered. The suturing system can also
include a first sheath positioned over the suturing device, a
distal end of the first sheath being proximal to the plurality of
arms once the suturing system is delivered, and a second sheath
positioned over the first sheath.
[0010] The plurality of arms can be extended from the elongate body
of the suturing device, each of the arms carrying a suture portion
having a suture end releasably retained in a respective arm, each
suture portion extending from its respective arm proximally between
the first sheath and the second sheath to a location outside of the
patient. The plurality of arms can be positioned against the
outside surface of the heart, and the plurality of needles can be
advanced from the elongate body through the heart wall, each needle
aligned with a respective arm and engaging a respective suture end
carried by the respective arm. The plurality of needles can be
retracted through the heart wall to draw the respective suture ends
through the heart wall and the arms can be retracted into the
elongate body of the suturing device while maintaining a distal
section of the elongate body within the heart. The first sheath
positioned around the elongate body can be advanced into the
opening in the heart wall and the elongate body can be withdrawn
from the heart wall while leaving the first sheath within the heart
wall, the withdrawing of the elongate body drawing the suture ends
engaged by the needles through a lumen of the first sheath to a
location outside of the patient.
[0011] In some embodiments, a suturing device for suturing an
opening in a heart wall can include an elongate body with a
proximal end and a distal end, a first section at the distal end, a
second section proximal to the first section, and a distally facing
body surface between the first and second sections. The second
section can have a larger outer dimension than the first section
and the distally facing body surface can be configured to press
against an external surface of a heart when the first section is
advanced into the opening in the heart. The device can also include
a plurality of arms near the distal end in the second section, each
arm configured to move between a first position wherein the arm is
retracted within the elongate body, and a second position wherein
the arm has a free end extending away from the elongate body. Each
arm has at least one suture mount at the free end and configured to
releasably retain a suture portion. The device can also include a
plurality of needles, each needle configured to move between a
retracted position in which the needle is within the elongate body
to a deployed position in which a distal point of the needle
extends out of the elongate body and into a suture mount.
[0012] In some embodiments, an elongate device can be delivered
through a heart wall such that a distal section of the device is
positioned within the heart. Fluid exiting the heart along the
distal section of the elongate device and through the heart wall
can be removed. The removal can include the step of causing the
fluid to flow through at least one opening positioned on the
elongate device on an outside of the heart to remove fluid that may
accumulate between the outside of the heart and the pericardial
sac.
[0013] In some embodiments, a suturing device can include an
elongate body with a proximal end and a distal end, the distal end
of the elongate body configured to be delivered through a heart
wall into a heart. The device can also include a plurality of arms
near the distal end, each arm configured to move between a first
position in which the arm is retracted within the elongate body and
a second position in which the arm has a free end extending away
from the elongate body. Each arm can have at least one suture mount
at the free end and configured to releasably retain a suture
portion. Each arm can also have a proximal side configured to
engage the pericardial sac as the arm moves from the first position
to the second position, and each arm in its second position can be
configured to be positioned along an outer surface of the heart.
The device can also include a plurality of needles, each needle
configured to move between a retracted position in which the needle
is within the elongate body to a deployed position in which a
distal point of the needle extends out of the elongate body and
into a suture mount, passing through the heart wall when the arms
are positioned along an outer surface of the heart.
[0014] In some embodiments, a suturing device having an elongate
body can be delivered through a heart wall such that a distal
section of the device is positioned within the heart. The device
can have a plurality of arms and a plurality of needles, and each
arm can be moved from a first position wherein the arm is retracted
within the elongate body to a second position wherein the arm has a
free end extending away from the elongate body. The arms can engage
the pericardial sac and move it away from an outer surface of the
heart as they move to their second positions. Each arm can have at
least one suture mount at the free end releasably retaining a
suture portion, and the plurality of needles can be moved from a
retracted position in which needles are within the elongate body to
a deployed position in which distal points of the needles extend
out of the elongate body, through the heart wall and into a suture
mount of a corresponding arm.
[0015] In some embodiments, an opening in a heart can be closed by
inserting four sutures through tissue of the heart wall such that
each suture has an end that runs through the opening in the heart
and an end that runs outside of the heart. The four sutures can
include a first pair and a second pair of sutures, and the sutures
of the first pair can be positioned opposite each other with
respect to the opening in the heart and the sutures of the second
pair can be positioned opposite each other with respect to the
opening in the heart. A first pledget can be attached to a first
end of a first suture and a second pledget can be attached to a
first end of a second suture, where the first suture and a third
suture make up the first pair, and the second suture and a fourth
suture make up the second pair. The ends of the first pair that run
through the opening of the heart can be secured together, and the
ends of the second pair that run through the opening of the heart
can be secured together. At least one of the ends that run outside
the heart of each pair can then be pulled.
BRIEF DESCRIPTION OF THE DRAWINGS
[0016] The above-mentioned and other features disclosed herein are
described below with reference to the drawings of specific
embodiments. The illustrated embodiments are intended for
illustration, but not limitation. The drawings contain the
following figures:
[0017] FIG. 1A is a perspective view of one embodiment of a
suturing device.
[0018] FIG. 1B is a perspective view of a distal assembly of one
embodiment of a suturing device.
[0019] FIG. 2 is a perspective view of a portion of a suturing
device showing suture arms in a retracted position and with certain
external components not illustrated.
[0020] FIG. 3 is a perspective view of a portion of a suturing
device showing suture arms in an extended position and with certain
external components not illustrated.
[0021] FIG. 4 is a perspective view of a portion of a suture device
showing needles, and with certain external components not
illustrated.
[0022] FIG. 5 is a cross sectional view of a portion of a suturing
device used to lock needles to a drive tube.
[0023] FIG. 6 is a transparent view of a portion of the distal
assembly.
[0024] FIG. 7 is a cross sectional view of a distal assembly taken
along the line 7-7 of FIG. 6.
[0025] FIG. 8 is a cross sectional view of one embodiment of a
distal assembly.
[0026] FIG. 9A is a perspective view of a section of one embodiment
of a distal assembly.
[0027] FIG. 9B is a top view of the second of FIG. 9A.
[0028] FIG. 10 is a cross sectional schematic representation of the
device of FIG. 1 passing through an opening at the apex of a
heart.
[0029] FIG. 11 is a schematic representation as in FIG. 10 showing
arms of the device in contact with the heart.
[0030] FIG. 12 is a schematic representation as in FIG. 11 showing
suture catch mechanisms engaging suture clasps.
[0031] FIG. 13 is a schematic representation as in FIG. 12 showing
the suture catch mechanisms retracted into the device and suture
portions extending through the heart wall.
[0032] FIG. 14 is a schematic representation as in FIG. 13 showing
the device partially withdrawn from the heart.
[0033] FIG. 15 is a schematic representation as in FIG. 14 showing
arms of the device in a retracted position.
[0034] FIG. 16 is a schematic representation as in FIG. 15 showing
a first sheath advancing and the device withdrawing from the
heart.
[0035] FIG. 17 is a schematic representation as in FIG. 16 showing
the device withdrawn and the first sheath advanced into the heart
wall.
[0036] FIG. 18 is a schematic representation as in FIG. 17 showing
suture ends passing through a trocar inserted into a chest
wall.
[0037] FIG. 19 is a schematic representation as in FIG. 18 showing
a suture portion pulled into the heart.
[0038] FIG. 20A is a schematic view of one embodiment of a
threader.
[0039] FIG. 20B is a schematic view of a pledget having been
threaded with the threader of FIG. 20A.
[0040] FIG. 21A is a schematic view of one embodiment of a
threader.
[0041] FIG. 21B is a schematic view of a pledget having been
threaded with the threader of FIG. 21A.
[0042] FIG. 22 is a schematic perspective view of a portion of a
heart with four separate sutures running through heart tissue.
[0043] FIG. 23A is a schematic view of the portion of the heart of
FIG. 22 with two pledgets attached to sutures according to one
embodiment.
[0044] FIG. 23B is a schematic view of the portion of the heart of
FIG. 22 with two pledgets attached to sutures according to one
embodiment.
[0045] FIG. 24A is a schematic view of pledgets arranged according
to the embodiment of FIG. 23A.
[0046] FIG. 24B is a schematic view of pledgets arranged according
to the embodiment of FIG. 23B.
[0047] FIG. 25 is a side view of a distal assembly of one
embodiment of a suturing device.
[0048] FIG. 26 is a cross sectional schematic representation of the
device of FIG. 25 passing through an opening at the apex of a heart
with arms extended.
[0049] FIG. 27 is a cross sectional schematic representation of the
device of FIG. 25 passing through an opening at the apex of a heart
with arms retracted.
[0050] FIG. 28 is a schematic representation as in FIG. 27 showing
the arms extended.
DETAILED DESCRIPTION OF SPECIFIC EMBODIMENTS
[0051] Embodiments of suturing devices used to suture closed
openings into a biological structure while maintaining or
substantially maintaining haemostasis are described herein. The
suturing devices and methods can also be used to place sutures
prior to a surgical procedure and to prepare access for the
procedure while maintaining or substantially maintaining
haemostasis. The placed sutures can then be used to tighten an
opening while any devices or tools are withdrawn, closing the
opening while the final device or tool leaves the opening such that
the opening is never without a device or tool inside it during the
course of the procedure.
[0052] In the embodiments described herein, the disclosed devices
are used to place sutures to close an opening into a heart,
although they are not limited to applications within a heart. In
some embodiments, the opening is a puncture made at or near the
apex of the heart. The puncture can also be made at other areas of
the heart. The heart can be accessed through a sternotomy or
limited thoracotomy, or alternatively the device can pass through a
trocar or other element into the thoracic cavity and then be led
toward the puncture in the heart, typically by following a guide
wire.
[0053] A heart is surrounded by a pericardial sac (or pericardium),
and in order to puncture into the heart the pericardium must also
be punctured or cut and moved out of the way. Accessing the heart
in this manner presents a risk that blood may leak through the
opening and collect between the pericardium and the heart wall.
This blood can put pressure against the heart and in some cases can
cause a cardiac tamponade. In some embodiments described herein,
the device can be used to limit the risk of blood collecting
between the pericardium and the heart wall. This can be achieved by
creating a space outside of the heart where blood can collect
without running between the pericardium and the heart, and by
creating a flow path from the space and into the device. In some
embodiments, a negative pressure can be used to draw blood from the
space and into the device.
[0054] In some embodiments described herein, the device can be used
to limit the risk of blood collecting between the pericardium and
the heart wall by suturing the opening closed with sutures that
pass through the heart wall but not through the pericardium. The
pericardium can thereby remain loose around the heart wall, blood
can more easily drain out, and the pericardium can be sutured
closed after blood has drained out.
[0055] In some embodiments, the suturing devices can be used to
close or reduce a variety of other tissue openings, lumens, hollow
organs or natural or surgically created passageways in the body. In
some embodiments, the suturing devices can be used to suture
prosthetics, synthetic materials, or implantable devices in the
body. For example, the devices can be used to suture a pledget
within the body.
[0056] Further details of suturing devices and methods that may be
used to suture an opening in a heart can be found in U.S. Patent
Publication No. 2011/0190793 A1, published Aug. 4, 2011, which is
hereby incorporated by reference in its entirety. Features and
procedures described in the aforementioned publication can be
incorporated into the embodiments described herein.
[0057] FIGS. 1A and 1B illustrate perspective views of one
embodiment of a suturing device 1. FIG. 1A is an embodiment of the
entire device, and FIG. 1B illustrates a section of a distal
assembly 2 of the device. The device can be used to insert sutures
through the outer wall of a heart in anticipation of a surgical
procedure within the heart, while maintaining haemostasis. The
device has a proximal and a distal end. At the distal end, the
device can have a guide wire lumen 8, which can allow the device to
follow a guide wire to a desired position. At the proximal end, the
suturing device can comprise one or more handles 7 with various
mechanisms that can be used to control the elements of the distal
assembly. Further details regarding handles and associated
components, including actuator rods, are provided in U.S Patent
Application Publication No. 2008/0269786, published on Oct. 30,
2008, which is hereby incorporated by reference herein in its
entirety.
[0058] The device can comprise an elongate body 3 which can include
a plurality of suture arms 20. The suture arms 20 can move from a
retracted position, as illustrated, in which the suture arms are at
least partially within the elongate body 3, to an extended
position, described and illustrated below in which the suture arms
extend outward from the elongate body. The suture arms can also be
positioned at varying angles from each other around the
circumference of the elongate body. The illustrated embodiment has
four suture arms 20 spaced 90 degrees apart. In some embodiments,
there may be more suture arms spaced varying degrees apart. In some
embodiments, there may be just one suture arm, which can be rotated
about an opening in the heart to place multiple sutures around the
opening. For purposes of closing the opening, it can be desirable
to have an even number of suture arms, such as 2, 4, 6, or 8, each
suture arm part of a pair with another suture arm spaced 180
degrees apart around the circumference of the elongate body. In
some embodiments, the device can also have an odd number of suture
arms. If just a single suture arm is used to position multiple
sutures around the opening, the sutures can be positioned in pairs
spaced 180 degrees apart around the opening.
[0059] The suture arms 20 can comprise one or more suture mounts or
clasps 22 at a distal end. The suture clasps 22 can be adapted to
releasably retain a suture portion 30. In some embodiments, the
suture clasps can releasably retain a suture portion 30 while the
suture arms 20 are in the retracted position and in the extended
position. In some embodiments, as illustrated, the suture clasps
may not retain a suture portion until the suture arms move toward
the extended position. In some embodiments, a suture end may be
retained in the suture clasps. In some embodiments, the suture
clasps may retain a portion of suture that is not the suture
end.
[0060] When the device is assembled, it can be pre-loaded with a
first sheath 4 (for example an 18 french sheath) that surrounds at
least a portion of the elongate body and a second sheath 5
surrounding at least a portion of the first sheath 4. In some
embodiments, as illustrated, a distal end of the first sheath 4 can
extend to a position just proximal to the suture arms, thereby
allowing the suture arms to move into the extended position or into
the retracted position. The suture portions 30 can run outside of
the first sheath 4 and through the second sheath 5 to a position
proximal to at least the second sheath 5. The second sheath can
help confine the suture portions such that they do not get tangled
or otherwise interfere with a procedure, described below. In some
embodiments, the second sheath 5 is shorter than first sheath 4. In
some embodiments, the second sheath 5 can be a peel-away sheath
that can be removed from around the first sheath and around the
suturing device.
[0061] The device can also include suture catch mechanisms
(referred to herein as needles), described below, that can retrieve
sections of suture from the suture clasps 22. In some embodiments,
the device can include one or more needle exit channels 26, from
which the needles can exit an interior of the elongate body 3 in
order to reach the suture clasps 22. In some embodiments, there can
be an equal number of needle exit channels 26 as there are suture
arms 20, and the needle exit channels can be configured to align
with a corresponding suture arm.
[0062] FIGS. 2 and 3 illustrate the suture arms 20 in more detail.
FIG. 2 is a perspective view of a portion of the device with
certain external components not illustrated in order to improve
visibility. The device can have a suture arm driver 23, to which
the suture arms 20 can rotatably attach at a first end thereof. The
suture arms can be free at a second end opposite the first end,
allowing the second end to swing outward such that the arms can
move from the retracted position to the extended position, or to
swing inward such that the arms can move from the extended position
to the retracted position.
[0063] As illustrated, the suture arms 20 can rotate about a
proximal end of the suture arm. In some embodiments, the suture
arms can slide or move in other ways from the retracted to the
extended position, or from the extended to the retracted position.
In the illustrated embodiment, as the suture arms 20 rotate from
the extended to the retracted position, the suture clasps 22 will
move toward a distal end of the suturing device. In some
embodiments, the suture arms can be configured such that the suture
clasp moves distally as the arms rotate from the retracted to the
extended position. In some embodiments, the suture arms can rotate
about a distal end of the suture arm.
[0064] In some embodiments, as illustrated in FIG. 2, the suture
arm driver 23 can translate along a central shaft 80. As it
translates it can move the suture arms 20 with it. In some
embodiments, the suture arm driver can translate far enough such
that the suture arms can contact a section 81 of the elongate body
3, as illustrated. In some embodiments, the section 81 of the
elongate body contacted by the suture arms can be angled. The ends
of the suture arms opposite the suture arm driver can also have an
angled surface 21, and as the suture arm driver moves farther
toward the section 81 the suture arms 20 will be pushed outward
toward the extended position. To move the arms from the extended
position to the retracted position, the suture arm driver 23 can
translate along the central shaft 80 in the opposite direction, and
the suture arms 20 can return to the retracted position.
[0065] FIG. 3 is a perspective view of a section of the distal
assembly 2 with certain external components not illustrated in
order to improve visibility. FIG. 3 illustrates one embodiment of
the suture arms 20 in an extended position. In some embodiments,
the suture arms 20 can be generally straight. In some embodiments,
the suture arms 20 can extend from the elongate body at
approximately 90 degrees. In some embodiments, the suture arms can
extend from the elongate body at an angle less than 90 degrees or
greater than 90 degrees. In some embodiments, the suture arms can
have angled or curved segments, and can extend from the elongate
body at a first angle and have other sections at other angles
relative to the elongate body. In some embodiments, the suture
clasps 22 can be on a section of the suture arms that is at an
angle relative to the elongate body that is different from the
first angle.
[0066] With continued reference to FIGS. 2 and 3, in some
embodiments the suture arms 20 can each have a bumper 28. The
bumpers can be positioned such that they provide clearance for the
suture arms to rotate to or from the extended position. Preferably,
the bumpers 28 have a curved surface, but in some embodiments they
can have flat sections. In some embodiments, the suture clasps 22
can have a beveled or tapered section 122 that is configured to
receive a needle. The taper can help guide the needles into the
suture clasps and toward a suture portion within a clasp. This can
be beneficial if a needle has prolapsed slightly or otherwise
deviated from a preferred alignment, such as an alignment with the
center of a suture clasp 22.
[0067] FIG. 4 is a perspective view of a section of the distal
assembly 2 with certain external components not illustrated or made
transparent in order to improve visibility. FIG. 4 illustrates two
needles 24 instead of four for clarity, but as discussed above, in
various embodiments the device can have a different number of
needles. The needles are preferably located distal to the suture
arms 20 and preferably point proximally toward the suture arms. In
some embodiments, the needles can be located proximal to the suture
arms and point distally toward the suture arms. The needles 24 can
attach to a needle drive tube 82, which can be positioned around
the central shaft 80 and which can translate along the central
shaft. In some embodiments, as illustrated, a collar 84 can be used
to lock the needles 24 to the needle drive tube 82.
[0068] FIG. 5 illustrates a cross sectional view of one embodiment
where a collar 84 is used to lock the needles 24 to the needle
drive tube 82. The needles 24 can have a notch 85 adjacent one end,
and the needle drive tube 82 can have a corresponding protrusion
that can slot into the notch. The collar 84 can surround both the
needles and the needle drive tube, locking them into their
respective positions. In some embodiments, as illustrated, the
needle drive tube 82 can be narrower where it receives the collar
than in other locations of the needle drive tube. This can help
seat the collar so that it does not slide further along the needle
drive tube. In some embodiments, the needles can attach to the
needle drive tube without a collar. Also visible in FIG. 5 is the
central shaft 80 with a guide wire lumen 8.
[0069] Returning to FIG. 4, when the needles 24 and needle drive
tube 82 translate along the central shaft 80, they can also
translate relative to an outer body 88. In some embodiments, the
outer body 88 can have channels 86 that can guide the needles
within the outer body. The channels can help direct the needles and
can also provide a measure of support to the needles to prevent
them from prolapsing or buckling. In some embodiments, each needle
can fit entirely within a respective channel. In some embodiments,
each needle can fit partially or at least partially within a
respective channel. Also visible in FIG. 4 is a distal sleeve 83,
present in some embodiments, which can help channel a guide wire
into the central shaft 80.
[0070] The needle drive tube 82 can move the needles toward or away
from the suture arms 20. As the drive tube moves the needles toward
the suture arms 20 the needles will eventually reach the needle
exit channels 26 (visible in FIG. 1B). The needle exit channels can
be angled to direct the needles toward the suture arms 20, and
specifically the suture clasps 22.
[0071] FIG. 6 is a transparent view of a portion of the distal
assembly 2 when the needle drive tube (not visible in this figure)
has moved the needles 24 through the needle exit channels 26 and
out of the distal assembly. Only one needle is illustrated in FIG.
6 so that the shape of the needle exit channels 26 can be more
easily seen, but the illustrated embodiment would have four
needles. FIG. 7 illustrates a sectional view of the distal assembly
2, taken along the line 7-7 visible in FIG. 6. As illustrated in
FIG. 7, in some embodiments the needle exit channels 26 can extend
radially outward along a line that passes through the longitudinal
axis of the distal assembly. When a needle 24 is in a deployed
position passing into a corresponding suture arm 20 and suture
mount 22, at least the portion of the needle external to the distal
assembly can form a plane with the corresponding suture arm 20. In
some embodiments, the longitudinal axis of the distal assembly can
lie on the plane formed by the needle and the corresponding suture
arm. In some embodiments, the plane formed by at least the portion
of the needle 24 external to the distal assembly 2 and the
corresponding suture arm 20 can be parallel to and offset from the
longitudinal axis of the distal assembly. In some embodiments, the
longitudinal axis of the distal assembly can be angled relative to
the plane formed by the needle and the corresponding suture
arm.
[0072] FIG. 8 illustrates a cross-sectional view, similar to the
view of FIG. 7, of one embodiment of a distal assembly 2 with
needle exit channels 26 that do not extend radially outward along a
line that passes through the longitudinal axis of the distal
assembly. Rather, the exit channels 26 can each have a longitudinal
axis that is offset from a longitudinal axis of the distal assembly
2. This arrangement can be used with embodiments in which the
longitudinal axis of the distal assembly is either parallel to and
offset from the plane formed by a needle and corresponding suture
arm, as described above, or is angled relative to the plane.
[0073] FIGS. 9A and 9B illustrate one embodiment in which the
longitudinal axis of the distal assembly is angled relative to the
plane formed by at least the portion of a needle 24 external to the
distal assembly 2 and the corresponding suture arm 20. FIG. 9A is a
perspective view of a section of the distal assembly with various
components removed for visibility. FIG. 9B is a top view of the
section shown in FIG. 9A. As illustrated, the needle exit channels
26 can be arranged as in FIG. 8, and the suture arms 20 can extend
radially outward along a line passing through the longitudinal axis
of the distal assembly. As illustrated in FIG. 9A, the needle exit
channels 26 are spaced or offset from a plane defined by an
extended suture arm and the longitudinal axis of the distal
assembly, so that the needle 24 extends at an angle to this plane
and intersects the plane at suture mount 22. As above, in some
embodiments the suture arms can be symmetrically spaced about the
distal assembly 2. In embodiments with four suture arms, as
illustrated, they can be spaced 90 degrees apart from each other
when extended.
[0074] In some embodiments, the suture arms can each have a
longitudinal axis offset from the longitudinal axis of the distal
assembly. In some embodiments, the offset for the suture arms can
be the same as the offset for the needles, and the plane formed by
a needle and corresponding suture arm can be parallel to and offset
from the longitudinal axis of the distal assembly. In some
embodiments, the needle exit channels can be arranged as in FIG. 7,
the suture arms can each have a longitudinal axis offset from the
longitudinal axis of the distal assembly, and the longitudinal axis
of the distal assembly can be angled relative to the plane formed
by a needle and corresponding suture arm.
[0075] In some embodiments, the needles 24 can attach to a mounting
plate 87 positioned around a central shaft 80 of the distal
assembly. The mounting plate can have one or more cutouts 89. In
some embodiments, each needle can have a notch, as described above,
and the needles can be positioned such that a notch interfaces with
a cutout 89. This can at least partially lock the needles in place,
allowing relative movement between each needle and the mounting
plate only along the length of the cutout in which the needle is
positioned. In some embodiments, a retaining ring or collar 84 can
be positioned around the plate to lock the needles into position
within the cutouts. In some embodiments, cutouts can be sized to
substantially prevent any needle movement.
[0076] FIG. 9A illustrates the needles 24 in a deployed position in
which a distal tip of each needle is within a suture mount 22. The
mounting plate 87 can be configured to move along the length of the
distal assembly, moving the needles with it. For example, the
mounting plate can move away from the suture arms 20, pulling the
needles 24 with it. In some embodiments, moving away from the
suture arms can be in the distal direction. In some embodiments,
moving away from the suture arms can be in the proximal direction.
When the mounting plate moves far enough, the needles can move to a
retracted position in which they are entirely or substantially
within the elongate body.
[0077] In some embodiments, needles 24 can have different
configurations that can help prevent prolapse or buckling. For
example, as illustrated in FIG. 9A, in some embodiments a needle 24
can include a first, proximal section 27 with a first diameter and
a second, distal section 29 with a second diameter. In some
embodiments, the second diameter can be sized for insertion into a
suture clasp to receive a suture end. In some embodiments, the
first diameter can be greater than the second diameter. The greater
first diameter can help improve resistance of the needle to
prolapse, buckling, or any other undesired movements. In some
embodiments, the needle can transition from the first section to
the second section between a needle exit channel 26 and a suture
clasp 22.
Methods of Use
[0078] The suturing device can have a guide wire lumen, not
illustrated, that can allow the suturing device to follow a guide
wire 6 into a position within the heart. In a typical procedure, a
hollow needle (delivered, for example, through a trocar into the
thoracic cavity) can be used to puncture an opening at or near the
apex of the heart and to feed a guide wire through the opening and
into the heart. The suturing device can then follow the guide wire
into the opening and into the heart. The suturing device can have a
tapered end at the distal end of the elongate body 3, as
illustrated in FIG. 2, and the taper can be configured such that
the device is capable of following the guide wire through the
opening formed by the needle, widening the opening as the device is
advanced further into the heart. The device can then be used to
place a plurality of sutures through the tissue of the heart near
the opening, while maintaining or nearly maintaining haemostasis,
as described below. The device can then be removed, leaving the
sutures in place and the first sheath within the opening in the
heart, thereby allowing other devices to be inserted through the
sheath to perform a desired procedure within the heart. The sutures
can then be used to tighten the opening closed after the desired
procedure has been performed and while the sheath and/or device is
being removed.
[0079] FIGS. 10-19 illustrate one method of using the suturing
device 1 to place sutures through tissue near an opening in the
heart and to position a sheath through the opening to allow for
entry of other devices, while maintaining or nearly maintaining
haemostasis. As discussed above, the device 1 can follow a guide
wire 6 through a puncture in or near the apex of a heart, the
tapered end of the device widening the opening in the heart wall
10, as the device enters further into the heart. The suture arms 20
can be moved into an extended position, as illustrated in FIG. 10,
which is a view of the device of FIG. 1 as it enters a heart. FIGS.
10-19 show a cross sectional view of the heart, and only show the
two arms 20 of the device that lie in the illustrated planes.
Although the method illustrated in FIGS. 10-19 can be performed
with a device having only the two illustrated arms, the description
of the method will be with reference to the device of FIG. 1, which
has four arms. Each suture arm 20 holds a separate suture 30, so
there are a total of four separate sutures when the device is
positioned as in FIG. 10.
[0080] With the suture arms in the extended position, the device
can be further advanced into the heart until the suture arms press
against tissue of the heart, as illustrated in FIG. 11. Once in
position at the base of the heart, needles 24 can fire and extend
from a distal end of the elongate body 3, through tissue of the
heart, and into the suture clasps 22, as illustrated in FIG. 12. In
some embodiments, the device can have a needle 24 that corresponds
to each suture arm, a needle that corresponds to multiple suture
arms, or multiple needles that correspond to a single suture arm.
The needles can engage the sutures 30, releasably positioned in the
suture clasp, such that when the needles retract back into the
elongate body they draw a portion of suture with them, as
illustrated in FIG. 13. In some embodiments, the needles can fire
simultaneously, and in some embodiments they can fire
sequentially.
[0081] Once the needles have fired and drawn sutures through tissue
of the heart, the device can be withdrawn slightly from the heart
in order to allow the suture arms to return to a retracted
position, as illustrated in FIG. 14. In embodiments where the
distal ends of the suture arms move proximally as the suture arms
rotate from an extended to a retracted position, it may not be
necessary to withdraw the device prior to retracting the suture
arms. Once the suture arms have been retracted, as illustrated in
FIG. 15, the sutures 30 will run from within the device, through
the tissue of the heart, and to a proximal end of the device while
passing beneath the second sheath 5 but over the first sheath 4, as
illustrated in FIG. 15. The first sheath 4 can then be moved into
the opening in the heart while the elongate body 3 is withdrawn, as
illustrated in FIG. 16. In some embodiments, the sheath can fully
pass into the opening before the elongate body has begun to be
withdrawn. In some embodiments, the elongate body can begin to be
withdrawn before the sheath has entered the opening of the heart.
Regardless of the order in which the motions occur, in order to
maintain haemostasis either the sheath or the elongate body are
preferably at least partially within the opening of the heart
during the procedure. In FIG. 16, the sheath has begun to be
advanced into the opening of the heart while the elongate body has
begun to be withdrawn.
[0082] In FIG. 17, the first sheath 4 has been fully advanced into
the opening of the heart and the elongate body has been withdrawn.
The first sheath 4 can have a hemostatic valve (not illustrated)
that can prevent extraneous bleed back, and in some embodiments the
valve can be at a proximal end of the first sheath 4. The suture
ends that were within the elongate body now pass through the first
sheath 4 and run to a proximal position outside of the patient
where they can be manipulated, as illustrated in FIG. 18. From the
proximal position of those suture ends, the sutures run through the
sheath and into the heart, through tissue of the heart, and back to
the proximal position while remaining outside of the first sheath 4
and inside of the second sheath 5. The second sheath 5 has been
illustrated wider than in previous figures in order to improve
visibility of sutures 30 running between the first and second
sheaths. In some embodiments, the second sheath 5 can be wider or
narrower in order to have a looser or tighter fit around the first
sheath 4, and the first sheath can be wider or narrower in order to
have a looser or tighter fit around the elongate body.
[0083] In FIG. 18, the second sheath 5 has been removed from around
the first sheath 4 (e.g. by peeling it off), and the portions of
the sutures 30 within the first sheath 4 are illustrated. FIG. 18
also illustrates the proximal end of the first sheath 4, which can
be extending through a trocar 50 positioned through the chest wall
16. Each suture 30 has a free end at the proximal position outside
of the patient that passes through the first sheath 4, into the
heart, through tissue of the heart, and back to the proximal
position while remaining outside of the first sheath 4. FIG. 18
only illustrates two separate sutures 30, but the illustrated
embodiment has two more sutures 30 (for a total of four) that pass
through heart tissue in a plane substantially perpendicular to the
illustrated plane. Thus, there are four suture ends that pass
through the first sheath 4 and four suture ends that pass outside
of the first sheath 4. The four separate sutures are shown
schematically in FIG. 22, discussed further below. The guide wire 6
also passes through the first sheath 4, but it is not shown within
the first sheath in FIG. 18 for the sake of clarity.
[0084] Suture ends that pass through the first sheath 4 can be
secured together with a knot or other device. Further details
regarding a device for joining sutures are provided in U.S. Patent
Application Publication No. 2011/0190793, published on Aug. 4,
2011, which is hereby incorporated by reference herein in its
entirety. In some embodiments, suture ends that pass through the
first sheath 4 can be secured together in pairs, each pair having
suture ends that had been releasably attached to arms 20 spaced 180
degrees about the circumference of the elongate body 3 of the
device 1. By then pulling on one or more of the remaining free
suture ends, the joined suture 30 can be pulled through the first
sheath 4 and into the heart, as illustrated in FIG. 19. FIG. 19
only shows one suture, but when the two pairs of suture ends that
pass through the first sheath 4 have been secured together and
pulled into the heart, a second suture would pass through the heart
in the plane substantially perpendicular to the illustrated cross
section.
[0085] In some embodiments, the point where a pair of suture ends
has been joined together can be passed through the tissue of the
heart and outside of the heart by pulling on one of the remaining
free suture ends. In some embodiments, prior to joining the two
suture ends that pass through the first sheath, a pledget can be
slidably attached to a suture end, such as by threading a suture
end through a hole in the pledget. After the two suture ends that
pass through the first sheath have been secured together, the
joined suture can be pulled through the tissue of the heart by one
of the remaining free ends until the pledget contacts an inner
surface of the heart wall, where it may remain. In some
embodiments, prior to or after joining the two suture ends within
the sheath, a pledget can be attached to a free suture end that
passes outside of the first sheath 4. With the two suture ends
within the first sheath joined, the opposite free suture end can be
pulled until the pledget contacts an outer surface of the heart,
where it may remain.
[0086] FIGS. 20A-24B illustrate various methods and embodiments of
closing an opening within a heart, including the use and placement
of pledgets. The methods and embodiments described herein can also
be used to close openings in other biological structures. Thus,
although the ends of sutures are variously referred to herein as
passing through or outside of the first sheath, such descriptions
can also refer respectively to suture ends that pass through or
outside of an opening in a heart or other biological structure.
[0087] In some embodiments, it can be useful to use a threader 60
to attach a pledget to a suture. FIG. 20A illustrates one
embodiment of a threader, which can have a handle 62 and a section
extending from the handle 62 to form a collapsible loop 64 at one
end. In some embodiments, the loop can be made of wire. The loop 64
can be fed through a pledget 70, as illustrated. Also as
illustrated, the loop can be fed through the pledget in two
locations, though in some embodiments it can be fed through only
one or more than two locations. A free end of suture can then be
fed through the loop and the loop can be pulled back through the
pledget, bringing the suture with it. FIG. 20B illustrates a single
suture 30 pulled through a pledget 70 in two locations. This can be
done by arranging the threader and pledget as illustrated in FIG.
20A, or by using a threader to feed a suture through a first end of
the pledget and then using the threader to feed the suture through
the second end of the pledget.
[0088] In some embodiments, a threader 60 can have a first
collapsible loop 64 and a second collapsible loop 66, as
illustrated in FIG. 21A. In some embodiments, each loop can be
passed through separate locations of a pledget 70, as illustrated.
A separate suture can be fed through each loop and then pulled
through the pledget, leading to the arrangement of FIG. 21B. In
some embodiments, the arrangement of FIG. 21B can be achieved by
using a threader with a single loop to separately pull a different
suture through each end of the pledget. In some embodiments, a
threader can have more than two collapsible loops.
[0089] FIG. 22 illustrates a schematic of a perspective view of a
portion of a heart in which a suturing device has inserted four
separate sutures through the tissue of the heart wall 10. In some
embodiments, this can be done with a suturing device that has four
arms. As discussed above, a sheath, such as the first sheath 4, can
be positioned at least partially within the opening in the heart. A
length of suture corresponding to each arm of the device can pass
from outside of the heart, through tissue of the heart, and then
through the sheath. For example, as illustrated, a first suture 32,
a second suture 34, a third suture 36, and a fourth suture 38 pass
through the tissue of the heart. Each suture has a first end 32',
34', 36', 38' that passes through the sheath 4 and a respective
second end 32'', 34'', 36'', 38'' that runs outside of the sheath.
Pledgets can then be attached to various suture ends according to
any method described above.
[0090] FIGS. 23A and 23B illustrate two ways in which pledgets
(internal pledgets) can be attached to the first suture ends, each
way yielding a different result when the pledgets are then pulled
into the heart. FIG. 23A illustrates an embodiment where adjacent
suture ends that run through the sheath 4 are fed through opposite
ends of the same pledget 70. Thus, for example, the first end 32'
of the first suture 32 can be fed through a first end of a pledget
70 while the first end 36' of the third suture 36 can be fed
through a second end of the pledget 70. Similarly, the first end
34' of the second suture 34 can be fed through a first end of a
second pledget 70 while the first end 38' of the fourth suture 38
can be fed through a second end of the second pledget 70.
[0091] FIG. 23B illustrates an embodiment where opposite suture
ends that run through the sheath 4 are fed through opposite ends of
the same pledget 70. Thus, for example, the first end 32' of the
first suture 32 can be fed through a first end of a pledget 70
while the first end 34' of the second suture 34 can be fed through
a second end of the pledget 70. Similarly, the first end 36' of the
third suture 36 can be fed through a first end of a second pledget
70 while the first end 38' of the fourth suture 38 can be fed
through a second end of the second pledget 70. In some embodiments,
other arrangements of attaching suture ends to pledgets can be
employed.
[0092] Once the sutures have been fed through the pledgets,
opposing suture sections that pass through the first sheath can be
secured together and pulled into the heart, as discussed with
respect to FIG. 19. For example, suture ends 36' and 38' can be
secured together to form a single suture, as can suture ends 32'
and 34'. One or more of the suture ends 32'', 34'', 36'', 38'',
which run outside of the sheath 4, can then be pulled until the
pledgets are brought into the interior of the heart. After a
procedure is performed within the heart and the sutures are
tightened to close the opening in the heart, the pledgets 70 will
form different arrangements depending on how they were originally
placed on the sutures.
[0093] FIGS. 24A and 24B illustrate a schematic view from inside of
the heart of two different pledget placements once the opening in
the heart has been tightened. FIGS. 24A and 24B correspond to the
pledget placement of FIGS. 23A and 23B, respectively. As can be
seen, placing the pledgets according to the embodiment of FIG. 23A
yields two adjacent pledgets 70. In some embodiments, the pledgets
can partially overlap. The arrangement of FIG. 23B yields pledgets
that cross each other, as illustrated in FIG. 24B.
[0094] In some embodiments, one or more pledgets (external
pledgets) can be placed on the second suture ends 32'', 34'', 36'',
38'', which run outside of the sheath 4. The same placement
techniques described above can be used. For example, suture ends
that are located across from each other can be fed through opposite
ends of a single pledget. In such embodiments, where four or more
separate suture strands are used the pledgets can cross each other.
Similarly, where adjacent suture ends are fed through opposite ends
of a single pledget, the pledgets can be adjacent to each
other.
[0095] The external pledgets are preferably placed on the sutures
after the internal pledgets are placed on the first suture ends
32', 34', 36', 38'. In some embodiments, however, the external
pledgets can be placed before the internal pledgets are placed. In
some embodiments, the external pledgets can be placed even if no
internal pledgets are placed. Once external pledgets are placed on
the lengths of suture, they can be moved to a position adjacent
heart tissue through a variety of methods. In some embodiments,
external pledgets can be moved adjacent heart tissue by pulling a
respective first suture end 32', 34', 36', 38' before first suture
ends are secured together. In some embodiments, external pledgets
can be moved adjacent heart tissue by sliding a sheath, catheter,
or other cannulated instrument over the one or more suture ends
passing through a pledget and pushing the pledget until it is at a
desired location adjacent the heart. In some embodiments, a knot
placement device, discussed below, can be used to push an external
pledget or pledgets adjacent the heart.
[0096] In some embodiments the device can have more than four
suture arms. In some embodiments, there can be more or fewer than
four separate sutures with more or fewer than four suture end
portions that pass through the first sheath 4 and more or fewer
than four suture end portions that remain outside of the first
sheath 4. It can be desirable to secure together suture end
portions that were previously attached to suture arms that were
approximately 180 degrees apart around the circumference of the
elongate body, or suture end portions that are spaced approximately
180 degrees apart around an opening in a heart, as discussed above.
When more than two pairs of suture end portions that pass through
the first sheath are thus joined and pulled into the heart as
illustrated in FIG. 19, the result will be a first length of suture
as illustrated in FIG. 19 and two or more lengths of suture similar
to the first length but rotated about an axis of the opening in the
heart wall.
[0097] Determining which of the sutures running within the sheath
are approximately 180 degrees apart can be done by pulling on the
sutures to mechanically see which sutures runs through which point.
In some embodiments, different colored sutures can be used to more
easily determine which suture ends are approximately 180 degrees
apart. For example, in an embodiment with four suture arms, the
suture end attached to a first suture arm can be a first color and
the suture end attached to a second suture arm 180 degrees about
the circumference of the elongate body from the first suture arm
can also be of the first color. A third suture end attached to a
third arm can be of a second color, and a fourth suture end
attached to a fourth arm 180 degrees about the circumference of the
elongate body from the third arm can be of the second color, as
well. Then, when the four suture ends run through the first sheath,
the two ends of the first color can be secured together and the two
ends of the second color can be secured together.
[0098] Once the suture ends that pass through the first sheath 4
have been appropriately secured and pulled into the heart, as
illustrated in FIG. 19, a suturing or other surgical device can be
inserted through the first sheath 4 and into the interior of the
heart. In some embodiments, prior to inserting a device into the
heart, it may be desirable to replace the first sheath with a
different sheath. This can be done by standard procedures known in
the art, and can also be done while maintaining a sheath within the
opening of the heart to thereby maintain haemostasis. For example,
an obturator may be slid over the first sheath 4. The sheath 4 can
then be removed, and a larger sheath may be delivered over the
obturator.
[0099] Once the desired procedure has been performed, the sheath
can be withdrawn while tightening the sutures to close the opening
around the sheath as the sheath is withdrawn. In some embodiments,
a tapered sheath can be inserted prior to closing the opening,
which can make it easier to close the opening tightly around the
sheath as the sheath is withdrawn from the heart. In some
embodiments, a knot delivery device, such as the device mentioned
above and described in U.S. Patent Application Publication No.
2011/0190793 and incorporated by reference herein, can be
pre-loaded with the two or more of the end portions of sutures 30
and delivered into the thoracic cavity alongside the sheath, making
it easier to maintain a tightening pressure as the sheath is
withdrawn. The opening in the heart can then be closed by applying
or tying a knot to the suture ends or by other known methods.
Further Device Embodiments
[0100] FIG. 25 illustrates an embodiment of a device 101 that can
be used to limit or prevent blood or other fluid from collecting
between the heart and the pericardial sac that surrounds the heart.
Many aspects of the device can function substantially the same as
aspects of the device described with respect to FIGS. 1-19, even if
not specifically illustrated or described with reference to the
embodiment of FIG. 25. For example, the embodiment illustrated in
FIG. 25 can be used with a sheath or sheaths as discussed above to
place sutures through the wall of the heart and allow for
performance of a procedure within the heart while maintaining or
substantially maintaining haemostasis. Unless discussed otherwise,
components can be considered to have substantially the same
function and operate in substantially the same manner as similarly
labeled components described with respect to FIGS. 1-19.
[0101] The distal end 102 of the device can have a first section
140 and a second section 142, as illustrated in FIG. 25. The device
can also have one or more openings or holes 146 positioned at a
distal end of the second section. The one or more openings or holes
can connect to one or more lumens that run through the proximal end
of the device. In some embodiments, the lumen(s) can connect to a
source of negative pressure, a stopcock, a syringe, or any other
device or receptacle. In some embodiments, each of the one or more
openings connects to a corresponding lumen. In some embodiments,
some of the one or more openings connect to the same lumen.
[0102] The first and second sections are separated by a distally
facing surface 144, which can be formed from a step, notch,
chamfer, bevel, or other geometry between the first and second
sections whereby the second section has a larger outer dimension
than the first section. In some embodiments, the second section 142
has a cross sectional area immediately adjacent the surface 144
that is greater than a cross sectional area of the first section
140 immediately adjacent the surface 144. As illustrated, the
surface 144 is formed from a step between the first and second
sections. The surface 144 can be at varying angles relative to the
first and second sections such that in some embodiments the surface
144 is only partially distally facing, but the surface is
configured such that when the first section 140 of the device
enters an opening in the outer wall of a heart that is smaller than
the second section 142, the surface 144 will press against the
outer surface of the heart to block further entry of the device
rather than expanding the opening to allow the second section 142
to enter the opening.
[0103] This mechanism can be seen in FIG. 26, which illustrates the
device after it has been inserted into the heart. In some
embodiments a sheath (e.g. first sheath 4) can be delivered into
the heart first and then pulled back before the device is inserted
into the heart. The surface 144 has pressed against the outer wall
of the heart, compressing it inward to form a gap or space 114.
Blood that makes it out of the heart and into the space 114 can
drain through the holes 146, either through gravity or some form of
negative pressure applied to the lumen(s) that connect to the holes
146. Consequently, blood is much less likely to end up between the
pericardium 12 and the heart wall 10.
[0104] As illustrated, the arms 120 of the device are extended and
pressing against the pericardium 12 and wall of the heart 10. The
arms extend from the device at less than a 90 degree angle, but in
some embodiments the arms can extend from the device at 90 degrees.
As described above, the arms can releasably retain suture portions
(not shown), and the device can comprise needles that can fire
through the heart wall 10 and the pericardium 12 to capture the
suture portions, and then drawn them back through the tissue and
into the device.
[0105] In some embodiments, it may be desired to have the sutures
pass only through tissue of the heart wall, but not through the
pericardium 12. The pericardium can then be left open as a drain,
it can be separately sutured shut, or a drainage device can be
installed near or within an opening in the pericardium and it can
be sutured later. FIGS. 22 and 23 illustrate one method of using
the device of FIG. 25 to pass sutures through tissue of the heart
but not the pericardium.
[0106] As illustrated in FIG. 27, the device can be inserted while
the arms 120 remain in a retracted position until the distal ends
of the arms reach a point between the pericardium 12 and an
external surface of the heart wall 10. In some embodiments a sheath
(e.g. first sheath 4) can be delivered into the heart first and
then pulled back before the device is inserted into the heart. As
illustrated, when the device has been inserted the surface 144 has
begun to compress the heart wall when the distal ends of the arms
are between the pericardium and the external surface of the heart
wall. In some embodiments, the arms can reach that position before
the surface contacts the heart wall.
[0107] Once the arms are in position they can rotate to the
extended position, catching the pericardium and drawing it outward,
as illustrated in FIG. 28. In some embodiments, the arms can have a
hook, sharp edge, notch, or other structure on an outer surface of
the arms that can engage with the pericardium and make it easier to
draw the pericardium outward. Once the arms have been extended to a
desired position, the device can be advanced farther into the heart
until the arms are against the heart wall 10. From that position,
any of the procedures discussed with reference to FIGS. 10-24B can
be used.
[0108] Although the foregoing description of the preferred
embodiments has shown, described and pointed out the fundamental
novel features of the invention, it will be understood that various
omissions, substitutions, and changes in the form of the detail of
the apparatus as illustrated as well as the uses thereof, may be
made by those skilled in the art, without departing from the spirit
of the invention.
[0109] Reference throughout this specification to "one embodiment"
or "an embodiment" means that a particular feature, structure or
characteristic described in connection with the embodiment is
included in at least one embodiment. Thus, appearances of the
phrases "in one embodiment" or "in an embodiment" in various places
throughout this specification are not necessarily all referring to
the same embodiment. Furthermore, the particular features,
structures or characteristics of any embodiment described above may
be combined in any suitable manner, as would be apparent to one of
ordinary skill in the art from this disclosure, in one or more
embodiments.
[0110] Similarly, it should be appreciated that in the above
description of embodiments, various features of the inventions are
sometimes grouped together in a single embodiment, figure, or
description thereof for the purpose of streamlining the disclosure
and aiding in the understanding of one or more of the various
inventive aspects. This method of disclosure, however, is not to be
interpreted as reflecting an intention that any claim require more
features than are expressly recited in that claim. Rather, as the
following claims reflect, inventive aspects lie in a combination of
fewer than all features of any single foregoing disclosed
embodiment. Thus, the claims following the Detailed Description are
hereby expressly incorporated into this Detailed Description, with
each claim standing on its own as a separate embodiment.
* * * * *