Note: Descriptions are shown in the official language in which they were submitted.
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APPARATUS AND METHOD FOR SEPTAL PUNCH
CROSS REFERENCE TO RELATED APPLICATIONS
[0001]
This application claims priority to and benefit of U.S. Provisional Patent
Application No. 62/994,751, entitled -Apparatus and Method for Septal Punch,"
filed March
25, 2020, the entire disclose of which is incorporated herein by reference in
its entirety.
BACKGROUND
[0002]
Embodiments are described herein that relate to devices and methods for
use in
accessing the left side of the heart.
[0003]
Many diseases and disorders, such as, for example, heart failure, atrial
fibrillation, mitral valve disease, and others, specifically impact or are
addressable in the left
side of the heart. Accordingly, many interventional percutaneous cardiac
procedures require
access to the left side of the heart, including, for example,
electrophysiological procedures, left
atrial appendage occlusion procedures, mitral valve repair and replacement
procedures, atrial
shunt procedures, and many more. In additional to therapeutic interventional
procedures,
indications for access to the left side of the heart also include diagnostic
procedures, including,
for example, hemodynamic measurements (e.g., left atrial pressure, trans-
mitral pressure
gradient, etc.). Minimally-invasive access to the left side of the heart is
challenging and not
without significant risk.
[0004]
Some catheter-based procedures access the left side of the heart by
puncturing
the atrial septum (-AS") of the heart, which separates the left atrium (-LA")
of the heart from
the right atrium ("RA") of the heart. Such procedures use a catheter
containing a sheathed
needle, which is advanced from the femoral vein in the groin of the patient to
the superior vena
cava (-SVC") through the RA of the heart. The sheathed needle is often a long,
stiff-wire
needle that has a bend of approximately twenty degrees near its tip. With the
catheter assembly
disposed within the SVC, the catheter assembly is then slowly withdrawn
inferiorly from the
SVC and into the RA until its tip rests within the fossa ovalis ("fossaT, "FO-
, or "F-). The FO
is a thumbprint-sized depression in the wall of the RA, and is the thinnest
portion of the
interatrial septum (i.e., the wall between the RA and LA). Once the operator
visualizes contact
between the tip of the catheter assembly and the F, the needle is advanced
such that it punctures
the F. With the needle extending from the LA into the RA, a guidewire is
advanced through
the catheter and into the RA. The needle is then removed from the LA, and a
device (e.g., an
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AF ablation device, a catheter, percutaneous mitral valve repair delivery
system or catheter, as
examples) can be inserted into the LA.
[0005]
Alternative procedures include the use of a blunt needle, electrified by
radiofrequency, to puncture or perforate the atrial septum.
[0006]
The above procedure has significant limitations. It is difficult to learn,
time
intensive, and prone to premature, misaligned, and inadvertent puncturing of
the FO. Further,
precisely and accurately locating the F with the tip of the device is
difficult, and if the catheter
assembly is withdrawn from the SVC too far, time-intensive procedural steps
must be repeated
because such a device cannot be moved cephalad. Moreover, the shape of the
needle may need
to be customized or adjusted based on a patient's particular anatomy, thereby
further
complicating the process.
[0007]
Furthermore, such catheters are typically very flexible and not very
stable within
the SVC, and thus easily inadvertently maneuvered out of an ideal position,
particularly during
normal dynamic cardiac activity. Even more, the needle is not fixed to the
catheter, thereby
resulting in accidental needle exposure, and possibly inadvertent cardiac
puncture, which can
be lethal. Further complicating this procedure is potentially distorted or
abnormal anatomy
due to, for example, aortic or mitral valve disease, leading to changes in the
location of the FO
and obfuscation of typical anatomical landmarks. Yet even more, for patients
undergoing a
repeat procedure, the FO may be thickened or scarred, necessitating
application of greater
puncturing force and increased risk of unintended damage to nearby anatomy.
[00081
It can be crucial for many left-heart procedures that the septal puncture
is
performed in a specific location within the FO. For delivering a replacement
mitral valve, for
example, it may be important to puncture an inferior portion of the FO, while
for a native valve
leaflet clip implant procedure, it may be important to puncture a post / mid
portion of the FO.
Existing systems do not provide for sufficient accurate and precise targeting
of an intended
puncture site, such as a particular region within the FO. Failure to puncture
the septum in a
proper location can result in prolonged, unsuccessful, or canceled procedures.
[0009]
Thus, a need exists for improved devices and methods for faster, more
stable,
safer, more accurate, and more precise access to the LA.
SUMMARY
[0010]
Devices and methods are described herein for use in minimally-invasively
accessing various portions of a patient's anatomy, such as, for example,
accessing a left atrium
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of a heart through a transseptal puncture. In some embodiments, a method
includes inserting
a shaft having (1) a side catheter guide attached thereto via a guide coupler,
and (2) a guide
stabilizer / actuator ("GSA") in a delivery configuration and slidably
attached thereto, into an
inferior vena cava of a heart of a patient and a superior vena cava of the
heart such that the
GSA is disposed in a right atrium of the heart. The method further includes
applying a distal
force to the side catheter guide such that a distal end of the side catheter
guide deflects laterally
about the guide coupler towards a septum of the heart. The method further
includes, with the
GSA in its delivery configuration in the right atrium of the heart, actuating
the guide stabilizer
/ actuator to transition the GSA from its delivery configuration to a deployed
configuration.
After initiating the applying the distal force and with the guide stabilizer /
actuator in its
deployed configuration, disposing the GSA in contact with the side catheter
guide to laterally
stabilize the side catheter guide relative to the shaft. The method further
includes with the
distal end of the side catheter guide laterally deflected about the guide
coupler towards the
septum and laterally stabilized by the GSA, extending a side catheter that is
disposed within
the side catheter guide distally from the side catheter guide towards and into
contact with the
septum. The method further includes, with the distal end of the side catheter
in contact with
the septum, extending a septum penetrator that is slidably disposed within the
side catheter
distally from the side catheter such that the septum penetrator pierces the
septum.
BRIEF DESCRIPTION OF THE DRAWINGS
[NM
FIG. 1A is a schematic illustration of a septum puncture device, disposed
in a
delivery configuration, according to an embodiment.
[0012]
FIG. 1B is a schematic illustration of the septum puncture device of FIG.
1A,
disposed in a deployed configuration.
[0013]
FIG. 2A is a schematic illustration of the septum puncture device of FIG.
1A,
disposed in the delivery configuration within a right atrium ("RA-) of a heart
of a patient, and
coupled to a first guide wire extending from an inferior vena cava (-1VC") of
the heart across
the RA and into a superior vena cava ("SVC-) of the heart.
[0014]
FIG. 2B is a schematic illustration of the septum puncture device of FIG.
1A,
disposed in the deployed configuration and such that it has accessed and
delivered to the LA a
second guide wire.
[0015]
FIG. 3 is a flowchart illustrating a method of using a septum puncture
device to
access a left atrium of a heart of a patient, according to an embodiment.
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[0016]
FIGS. 4A and 4B illustrate in perspective and partially exploded view a
septum
puncture device 300 in a delivery configuration and a deployed configuration,
respectively.
The septum puncture device 300 is shown partially exploded to illustrate the
lumens defined
by the body 310.
[0017]
FIGS. 5A and 5B illustrate in cross-sectional view a portion of the septum
puncture device 300 of FIGS. 4A and 4B, in perspective view and front view,
respectively.
[0018]
FIGS. 6A-6H illustrate in side view a deployment sequence of and at a
distal end
portion of the septum puncture device 300, according to an embodiment.
[0019]
FIGS. 7A and 7B illustrate a portion of the septum puncture device 300 in
its
delivery configuration and its deployed configuration, respectively.
[0020]
FIG. 8 illustrates the guide coupler 340 of the septum puncture device 300
coupled to and between the main shaft 320 and the side catheter guide 330 in
an assembled
arrangement (at right), and in detailed, partially assembled, arrangement (at
left).
[0021]
FIG. 9 is a flowchart illustrating a method of using a septum puncture
device to
access a left atrium of a heart of a patient, according to an embodiment
[0022]
FIGS. 10-12 illustrate in perspective bottom view, perspective side view,
and
side view, respectively, a portion of a septum puncture device 500 in a
deployed configuration,
according to another embodiment.
[0023]
FIGS. 13A-13F illustrate a partial delivery and deployment sequence using
the
septum puncture device 500 of FIGS. 10-12, according to an embodiment.
[00241
FIGS. 14A-14K illustrate an illustrate an example deployment sequence of a
septum puncture device 600, according to an embodiment.
[0025]
FIGS. 15-17 illustrate a septum puncture device 700 in perspective view,
front
view, and side view, respectively, according to an embodiment.
[0026]
FIGS. 18A-18C illustrate a first a guide stabilizer / actuator (-GSA")
850A and
a second GSA 850B, of a septum puncture device 800, in a deflated, delivery
configuration, a
partially inflated, partially deployed configuration, and an inflated,
deployed configuration,
respectively, according to an embodiment.
[0027]
FIGS. 19-21 illustrate a septum puncture device 900 in perspective view,
front
view, and detailed, partial perspective view, respectively, that includes two
side catheters,
according to an embodiment.
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[0028]
FIGS. 22 and 23 illustrate a septum puncture device 1000, in front view
and
perspective view, respectively, having a single GSA and two side catheters,
according to an
embodiment.
[0029]
FIGS. 24 and 25 illustrate a septum puncture device 1100, in perspective
front
view and perspective side view, respectively, having a single GSA and a single
side catheter,
according to an embodiment.
[0030]
FIGS. 26A and 26B illustrate an example delivery and deployment sequence
of
the septum puncture device 1100 in the context of a heart of a patient,
according to an
embodiment.
[0031]
FIG. 27 illustrates a septum puncture device 1200 having a GSA with a
concave
shape and a GSA with a convex shape, according to an embodiment.
[0032]
FIG. 28 illustrates a septum puncture device 1300 having a GSA with a
particular
curvature, according to an embodiment.
[0033]
FIG. 29 illustrates in top view a septum puncture device 1400 having a tri-
lobed
GSA, according to an embodiment
[0034]
FIG. 30 illustrates in top view a septum puncture device 1500 having a GSA
with
multiple lobes, according to an embodiment.
[0035]
FIG. 31 illustrates in side view a septum puncture device 1600 having GSAs
configured to limit blood flow occlusion, according to an embodiment.
[0036]
FIG. 32 illustrates in side view a septum puncture device 1700 having GSAs
rotatably offset and interlocked with each other, according to an embodiment.
[0037]
FIG. 33 illustrates in side view and top view a septum puncture device
1800
having an asymmetric GSA, according to an embodiment.
[0038]
FIG. 34 illustrates in side view a septum puncture device 1900 defining
two
pathways between GSAs, according to an embodiment.
[0039]
FIGS. 35A-35D illustrate a deployment sequence of a septum puncture device
2000, according to an embodiment.
[0040]
FIG. 36 illustrates a portion of a septum puncture device 2100 having an
intracardiac echo (-ICE") sensor, according to an embodiment.
[0041]
FIG. 37 illustrates a portion of a septum puncture device 2200 having a
camera,
according to an embodiment.
[0042]
FIGS. 38 and 39 illustrate in cross-sectional side view and front view,
respectively, a portion of a septum puncture device 2300, according to an
embodiment.
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[0043] FIGS. 40A and 40B illustrate the stylus 2310, according
to an embodiment.
[00441 FIG. 41 illustrates handle 2318, according to an
embodiment.
[0045] FIGS. 42A-42D illustrate an example deployment sequence
of the septum
puncture device 2300, according to an embodiment.
[0046] FIGS. 43A and 43B illustrate in side view and cross-
sectional side view,
respectively, a portion of the septum puncture device 2300.
[0047] FIG. 44 illustrates in perspective view a portion of the
septum puncture device
2300 including an end effector.
[0048] FIGS. 45A-45D illustrate the end effector of FIG. 44.
[0049] FIGS. 46A and 46B illustrate in cross-sectional side
view and front view,
respectively, a portion of the septum device 2300, including a stiffening
element.
[0050] FIGS. 47A-48D illustrate a segmented septum puncture
device 2400, according
to an embodiment.
[0051] FIGS. 49-52 illustrate a septum puncture device 2500,
according to an
embodiment.
[0052] FIGS. 53A-53C illustrate various implementations of the
septum puncture
device 2500.
[0053] FIGS. 54A-54C illustrate various implementations of the
septum puncture
device 2500.
[0054] FIG. 55 illustrates a sheath of the septum puncture
device 2500.
[0055] FIG. 56 illustrates various implementations of the
septum puncture device 2500.
[0056] FIGS. 57 and 58 illustrate a handle assembly 2680,
according to an embodiment.
[0057] FIGS. 59A-59D illustrate an example deployment sequence
of a septum puncture
device, according to an embodiment.
[0058] FIGS. 60A-60D illustrate a portion of a septum puncture
device 2700, according
to an embodiment.
[0059] FIGS. 61A-62B illustrate various implementations of the
septum puncture
device 2700.
[0060] FIGS. 63A-63C illustrate a portion of a septum puncture
device 2800, according
to an embodiment.
[0061] FIG. 64 illustrates a portion of a septum puncture
device 2900 having a balloon
covered in mesh, according to an embodiment.
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[0062]
FIG. 65A is a schematic illustration of a septum puncture device, disposed
in a
delivery configuration, according to an embodiment.
[0063]
FIG. 65B is a schematic illustration of the septum puncture device of FIG.
65A,
disposed in a deployed configuration.
[0064]
FIG. 66A illustrates a portion of a septum puncture device, disposed in a
delivery
configuration, according to an embodiment.
[0065]
FIG. 66B illustrates a portion of the septum puncture device of FIG. 66A,
disposed in a deployed configuration.
[0066]
FIG. 67 illustrates a portion of a septum puncture device having an
atraumatic
tip, disposed in a delivery configuration, according to an embodiment.
[0067]
FIG. 68A illustrates a portion of a septum puncture device having an
atraumatic
tip, disposed in a delivery configuration, according to an embodiment.
[0068]
FIG. 68B illustrates a portion of the septum puncture device of FIG. 68A,
disposed in a deployed configuration.
[0069]
FIG. 69A illustrates a portion of a septum puncture device having an
atraumatic
tip, disposed in a delivery configuration, according to an embodiment.
[00701
FIG. 69B illustrates a portion of the septum puncture device of FIG. 69A,
disposed in a deployed configuration.
[0071]
FIG. 70A illustrates a portion of a septum puncture device in side view,
disposed
in a deployed configuration, according to an embodiment.
[00721
FIG. 70B illustrates the septum puncture device of FIG. 70A in perspective
view.
[0073]
FIGS. 71A-71D illustrate a portion of a septum penetrator having a
variable inner
diameter, according to an embodiment.
[0074]
FIGS. 72A and 72B illustrate a portion of a septum puncture device having
an
atraumatic tip, disposed in a delivery configuration, in side view and
perspective view,
respectively, according to an embodiment.
DETAILED DESCRIPTION
[0075]
Devices and methods are described herein for use in accessing the left
side of the
heart (e.g., LA) from the right side of the heart (e.g., RA) without requiring
open-heart surgery.
The methods described herein are minimally invasive and utilize a septum
puncture device to
access the left side of the heart in a safe (e.g., atraumatic), efficient,
timely, accurately and
precisely located and repeatable manner. This is accomplished, in part, by
providing a steerable
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(e.g., translatable and rotatable) stable platform between the IVC and SVC
from which a
puncture member can be extended laterally and into a target puncture location
(e.g., the FO) of
the atrial septum.
[00761
In some embodiments, a method includes inserting a shaft having (1) a side
catheter guide attached thereto via a guide coupler, and (2) a guide
stabilizer / actuator ("GSA-)
in a delivery configuration and slidably attached thereto, into an inferior
vena cava of a heart
of a patient and a superior vena cava of the heart such that the guide
stabilizer / actuator is
disposed in a right atrium of the heart. The method further includes applying
a distal force to
the side catheter guide such that a distal end of the side catheter guide
deflects laterally about
the guide coupler towards a septum of the heart. The method further includes,
with the guide
stabilizer / actuator in its delivery configuration in the right atrium of the
heart, actuating the
guide stabilizer / actuator to transition the guide stabilizer / actuator from
its delivery
configuration to a deployed configuration. After initiating the applying the
distal force and
with the guide stabilizer / actuator in its deployed configuration, disposing
the side catheter
guide in contact with the side catheter guide to laterally stabilize the side
catheter guide relative
to the shaft. The method further includes with the distal end of the side
catheter guide laterally
deflected about the guide coupler towards the septum and laterally stabilized
by the guide
stabilizer / actuator, extending a side catheter that is disposed within the
side catheter guide
distally from the side catheter guide towards and into contact with the
septum. The method
further includes, with the distal end of the side catheter in contact with the
septum, extending
a septum penetrator that is slidably disposed within the side catheter
distally from the side
catheter such that the septum penetrator pierces the septum.
[0077]
In some embodiments, a method includes a shaft having a side catheter
guide
attached thereto via a guide coupler into an inferior vena cava of a heart of
a patient and a
superior vena cava of the heart such that the guide coupler is disposed in a
right atrium of the
heart. The method further includes applying a distal force to a proximal
portion of the side
catheter guide such that a distal end of the side catheter guide deflects
laterally about the guide
coupler towards a septum of the heart. The method further includes, with the
distal end of the
side catheter guide laterally deflected about the guide coupler towards the
septum, extending a
side catheter that is disposed within the side catheter guide distally from
the side catheter guide
towards and into contact with the septum. The method further includes, with
the side catheter
in contact with the septum, extending a septum penetrator that is slidably
disposed within the
side catheter distally from the side catheter such that the septum penetrator
pierces the septum.
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[0078]
In some embodiments, a method includes inserting a shaft having a guide
stabilizer / actuator in a delivery configuration and slidably attached
thereto, into an inferior
vena cava of a heart of a patient and a superior vena cava of the heart such
that the guide
stabilizer / actuator is disposed in a right atrium of the heart, a side
catheter guide being coupled
to the guide stabilizer / actuator. The method further includes, with the
guide stabilizer /
actuator in its delivery configuration in the right atrium of the heart,
actuating the guide
stabilizer / actuator to transition the guide stabilizer / actuator from its
delivery configuration
to a deployed configuration such that a distal end of the side catheter guide
is laterally deflected
about the shaft towards the septum of the heart and laterally stabilized in
part by the guide
stabilizer / actuator being in its deployed configuration. With the guide
stabilizer / actuator in
its deployed configuration, the side catheter guide extends proximally from
its distal end that
is disposed beyond a first side of the shaft, across the shaft, and to a
second side of the shaft
opposite the first side of the shaft, and then turns and extends proximally
towards a proximal
end of the shaft. The method further includes, with the distal end of the side
catheter guide
laterally deflected about the shaft towards the septum and laterally
stabilized in part by the
guide stabilizer / actuator, extending a side catheter that is disposed within
the side catheter
guide distally from the distal end of the side catheter guide towards and into
contact with the
septum. The method further includes, with the side catheter in contact with
the septum,
extending a septum penetrator that is slidably disposed within the side
catheter distally from
the side catheter such that the septum penetrator pierces the septum.
[00791
In some embodiments, an apparatus includes a body that defines a first
lumen
and a second lumen. The apparatus further includes a shaft that has a first
section fixedly
coupled to the body and extends distally from the first lumen of the body, and
a second section
disposed partially within and telescopable with respect to the first section
of the shaft. The
apparatus further includes a guide wire coupler that is coupled to the body
and extends distally
from within a lumen defined by the shaft. The guide wire coupler defines a
guide wire lumen
configured to slidably receive a first guide wire. The apparatus further
includes a side catheter
guide that is coupled to the body and extends distally from within the second
lumen of the
body. The side catheter guide is coupled to the first section of the shaft via
a guide coupler.
The side catheter guide is configured to be transitioned between a delivery
configuration and a
deployed configuration in which a distal end of the side catheter guide is
laterally deflected
about the guide coupler when transitioned from its delivery configuration to
its deployed
configuration. The apparatus further includes a guide stabilizer / actuator
that is coupled to the
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second section of the shaft and configured to transition between a delivery
configuration and a
deployed configuration to cause the distal end of the side catheter guide to
further laterally
deflect about the guide coupler and laterally stabilize. The side catheter
guide defines a lumen
that is configured to slidably receive a side catheter. The side catheter
defines a lumen
configured to slidably receive a puncture member. The puncture member is
configured to
puncture tissue of a patient.
[0080]
In some embodiments, an apparatus includes a body that defines a first
lumen
and a second lumen. The apparatus further includes a shaft that has a first
section fixedly
coupled to the body and extends distally from the first lumen of the body, and
a second section
disposed partially within and telescopable with respect to the first section
of the shaft. The
apparatus further includes a guide wire coupler that is coupled to the body
and extends distally
from within a lumen defined by the shaft. The guide wire coupler defines a
guide wire lumen
configured to slidably receive a first guide wire. The apparatus further
includes a side catheter
guide that is coupled to the body and extends distally from within the second
lumen of the
body. The side catheter guide is coupled to the first section of the shaft via
a guide coupler.
The side catheter guide is configured to be transitioned between a delivery
configuration and a
deployed configuration in which a distal end of the side catheter guide is
laterally deflected
about the guide coupler when transitioned from its delivery configuration to
its deployed
configuration. The side catheter guide defines a lumen that is configured to
slidably receive a
side catheter. The side catheter defines a lumen configured to slidably
receive a puncture
member. The puncture member is configured to puncture tissue of a patient.
[0081]
In some embodiments, an apparatus includes a shaft having a proximal end
and
a distal end, and a lumen extending therethrough. The shaft defines (1) a
first aperture, and (2)
a second aperture and a third aperture both disposed distal to the first
aperture. The apparatus
further includes a first guide stabilizer / actuator (-GSA") and a second GSA
both (1)
circumferentially disposed about the shaft, and (2) configured to transition
between a delivery
configuration and a deployed configuration. The apparatus further includes a
side catheter
guide coupled to the shaft and extending distally into the lumen at the
proximal end of the shaft,
exiting the shaft through the first aperture, and extending distally between
the first GSA and
the second GSA and into the second aperture, and then exiting the shaft
through the third
aperture. The first GSA and the second GSA are configured such that transition
from the
delivery configuration to the deployed configuration causes a distal end of
the side catheter
guide to (1) laterally deflect about, and (2) stabilized relative to, a
central axis of the shaft. The
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side catheter guide defines a lumen configured to slidably receive a side
catheter. The side
catheter defines a lumen configured to slidably receive a puncture member that
is configured
to puncture tissue of a patient.
[00821
As used herein, the terms "proximal" and "distal" refer to the direction
closer to
and away from, respectively, an operator (e.g., a surgeon, physician, nurse,
technician, etc.)
who would insert the septum puncture device into the patient, with the tip-end
(i.e., distal end)
of the device inserted inside a patient's body first. Thus, for example, the
end of a main shaft
described herein first inserted inside the patient's body would be the distal
end, while the
opposite end of the main shaft (e.g., the end of the main shaft being
manipulated by the
operator) would be the proximal end of the main shaft.
[0083]
As used herein, the terms "advance," "advanced," and "advancing" each
refer to
distal movement. Advancing a device within a patient's vasculature, for
example, refers to
moving at least a portion of the device distally within the patient's
vasculature. Similarly, as
used herein, the terms -withdraw," -withdrawn,", and withdrawing" each refer
to proximal
movement Withdrawing a device within a patient's vasculature, for example,
refers to moving
at least a portion of the device proximally within the patient's vasculature.
In some instances,
advancing and withdrawing can refer to relative movement of the device itself
Advancing a
side catheter, for example, can refer to moving a side catheter distally
relative to a side catheter
guide to which the side catheter is movably coupled. Similarly, withdrawing
the side catheter,
for example, can refer to moving the side catheter proximally relative to the
side catheter guide
to which the side catheter is movably coupled.
[0084]
The septum puncture device 100 can be used to access a left side of the
heart
(e.g., left atrium) from the right side of the heart (e.g., right atrium) and
to deliver a guidevvire
to the left side of the heart. As shown in FIG. 1A, the septum puncture device
100 includes a
body 110 coupled to a main shaft 120, a side catheter guide 130, a side
catheter 160, and a
septum penetrator 170. The main shaft 120 is coupled to the side catheter
guide 130 via a guide
coupler 140, the side catheter guide 130 is coupled to the side catheter 160,
and the side catheter
160 is coupled to the septum penetrator 170, as shown in FIG. 1A. The side
catheter guide 130
is configured to define a pathway through or across which the side catheter
160 can travel (e.g.,
be advanced and/or withdrawn). Said another way, and as described in further
detail herein,
the side catheter guide 130 can be manipulated (e.g., actuated from a delivery
state to a
deployed state) to guide the side catheter 160 in a desired direction (the
actuated or deployed
state of the side catheter guide 130 is shown in FIG. 1B), e.g., towards the
left atrium.
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[0085]
As described in further detail herein, the guide coupler 140 can couple
the side
catheter guide 130 to the main shaft 120 to minimize or prevent relative
translational movement
between the main shaft 120 and the side catheter guide 130, but to allow
relative rotational
movement between the main shaft 120 and the side catheter guide 130, as
illustrated
schematically in FIG. 1B. In this manner, the guide coupler 140 can facilitate
transition of
the side catheter guide 130 from a delivery configuration (e.g., parallel to
or substantially
parallel to the main shaft 120), e.g., for insertion through the patient's
vasculature and into the
RA, to a deployed configuration such that a distal end of the side catheter
guide 130 is deflected
laterally (e.g., perpendicular or substantially perpendicular) relative to the
main shaft 120, e.g.,
towards the patient's left atrium (e.g., the FO of the atrial septum). In some
embodiments, the
guide coupler 140 can be a hinge to facilitate lateral deflection of the side
catheter guide 130
relative to the main shaft 120, as described in further detail herein. In such
embodiments, for
example, a distal force can be applied to a proximal end portion of the side
catheter guide 130,
thereby causing the hinge to rotate and cause a distal end portion of the side
catheter guide (i.e.,
a portion of the side catheter guide 130 that extends distal to the guide
coupler 140) to laterally
deflect. In some implementations, the amount of lateral deflection or the
defined between the
side catheter guide 130 and the main shaft 120 after such lateral deflection
is adjustable by the
operator intra-procedure, i.e., in real-time, such that, for example, the
operator has procedural
flexibility when locating the target puncture location.
[0086]
In some implementations, one or more of the main shaft 120, the side
catheter
guide 130, or the side catheter 160 can have a circular cross-sectional shape,
while in other
implementations, one or more of the main shaft 120, the side catheter guide
130, or the side
catheter 160 can have a non-circular cross-sectional shape. In some instances,
for example, the
main shaft 120 and the side catheter guide 130 can have circular cross-
sectional shapes, and
can be operably coupled together, as discussed in further detail herein, such
that the main shaft
120 and the side catheter guide 130 are at least partially disposed side-by-
side (e.g., during
delivery). In other instances, for example, the main shaft 120 may have a non-
circular cross-
section (e.g., a half-moon shape, c-shape a convex or concave shape, or any
other suitable
noncircular cross-sectional shape) such that when coupled to the side catheter
guide 130, a
portion of the side catheter guide 130 can be nestled within a space defined
at least in part by
the non-circular curvature of the main shaft 120. In this manner, the
collective cross-sectional
area, footprint, diameter, etc. of the main shaft 120 and side catheter guide
130 can be reduced.
In some instances, a similar relationship can be had by the main shaft 120 and
the side catheter
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160 (e.g., in embodiments in which a septum puncture device does not have a
side catheter
guide).
[0087]
In some embodiments, the septum puncture device 100 includes a side
catheter
guide stabilizer / actuator ("GSA") 150 (also referred to herein as "guide
stabilizer / actuator"),
and a GSA actuator 154 operably coupled to the GSA 150 and configured to
actuate the GSA
150. In some implementations, the GSA 150 can be configured to stabilize
(e.g., laterally,
axially (proximally or distally), e.g., with respect to the main shaft 120)
the side catheter guide
130 to facilitate the side catheter's 160 engagement with the FO and the
septum penetrator's
170 penetration of the FO. In this manner, the guide coupler 140 can laterally
deflect the side
catheter guide 130, and the GSA 150 can stabilize the side catheter guide 130
(and in turn the
side catheter 160, optional end effector 162, and septum penetrator 170) to
optimize subsequent
penetration of the septum and access to the left atrium. In some
implementations, in addition
to or instead of stabilizing the side catheter guide 130, the GSA 150 can be
configured to
laterally deflect (e.g., laterally deflect in addition to the lateral
deflection caused or facilitated
by the guide coupler 140, as described above) the side catheter guide 130 (and
in turn the side
catheter 160 and septum penetrator 170, given their coupling to the side
catheter guide 130).
In this manner, in some implementations, the guide coupler 140 and the GSA 150
can
collectively laterally deflect and stabilize the side catheter guide 130 (and
in turn the side
catheter 160, optional end effector 162, and septum penetrator 170) to
optimize subsequent
penetration of the septum and access to the left atrium.
[0088]
The GSA 150 can be manipulatable in any manner suitable to provide the
above-
described functionality. In some embodiments, for example, the GSA 150 can be
a balloon,
and as such, it can be configured to be inflatable and deflatable. In such
embodiments, the
GSA 150 can be fluidically coupled to a lumen extending from the GSA 150 to
the GA actuator
154 such that the GA actuator 154 can selectively deliver fluid to the GA
actuator 154 to inflate
the GSA 150 (i.e., deploy the GSA 150), and selectively withdraw fluid from
the GSA 150 to
deflate the GSA 150 for removal of the GSA 150 from the heart (e.g., after
left atrium access
has been achieved).
[0089]
In embodiments in which the GSA 150 is a balloon, the balloon can have any
shape and size suitable to perform the desired functions described herein. In
some
embodiments, for example, the balloon can be cone-shaped, while in other
embodiments, it can
be at least partially concave, convex, circular, oval, or the like. Further,
in some embodiments,
the balloon can have one or more lobes, e.g., it can be bi-lobed or tri-lobed,
to, for example,
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allow blood flow along the balloon and past the device. Further, the balloon
can have additional
features configured to improve stabilization of the side catheter guide 130
(e.g., improve
coupling between the balloon and the side catheter guide 130). In some
embodiments, for
example, a balloon can have dimples, protrusions, ridges, adhesives, etc.
[0090]
The balloon can be formed of any material or combination of materials
suitable
to perform its functionality described herein. In some embodiments, for
example, the balloon
can be formed of one or more of Polyethylene, Polyethylene terephthalate
("PET), a polymer,
a thermoplastic polymer, an elastomer, nylon, polyurethane, any non-compliant
material, etc.
The balloon can be configured to be inflated to any suitable pressure, e.g.,
from about 2 ATM
to about 20 ATM, as an example. In some instances, higher inflation pressures
can result in
greater or improved rigidity of the balloon, thereby providing better
stabilization of the side
catheter guide, side catheter, septum penetrator, etc.
[0091]
The GSA 150 can be formed of any material suitable to perform its
functions
described herein. In some embodiments the GSA 150 can include or be formed of
shape
memory material (e.g., Nitinol) and configured to be transitioned between a
delivery /
withdrawal configuration in which the GSA 150 is constrained, compressed, or
otherwise
placed in a relatively small arrangement, and a deployed configuration in
which the GSA 150
is unconstrained, expanded, or otherwise placed in a larger arrangement
sufficient to laterally
deflect or stabilize the side catheter guide 130 as described in further
detailed herein.
[0092]
Similar to the guide coupler 140, in some embodiments, the GSA 150 can
include
or be formed of radiopaque material to assist the operator in locating that
portion of the septum
puncture device 100 before, during, or after deployment. In this manner, the
operator can in
real time selectively position the septum penetrator 170 in a position
suitable to penetrate the
FO upon actuation of the septum penetrator 170. In embodiments in which the
GSA 150 is a
balloon, for example, in some instances the GSA 150 can be inflated with a
contrast agent (or
a combination of a contrast agent and another fluid, such as saline) to
provide visualization
(e.g., under any suitable imaging modality) for the operator when the GSA 150
is disposed
within the patient.
[0093]
As described in further detail herein, with the side catheter guide 130
laterally
deflected and stabilized at a suitable angle relative to the FO or the main
shaft 120, and with
(1) one or more landmark portions of the septum puncture device 100 and (2) a
desired puncture
location (e.g., the FO) on the septum visible to the operator from outside the
patient, the
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operator can manipulate the main shaft 120 translationally or rotationally in
any suitable
manner to align the side catheter guide 130 with the FO.
[0094]
Further as shown in FIG. 1A, the septum puncture device 100 includes a
guide
wire coupler 122 configured to couple the main shaft 120 to a guide wire (not
shown in FIG.
1A) to facilitate delivery of the septum puncture device 100 into a patient
(e.g., through the
vasculature of the patient) and to the patient's heart, and a guide wire
coupler 172 configured
to couple a guide wire (not shown in FIG. 1A) to the septum penetrator 170, to
facilitate
delivery of that guide wire to the left side of the heart (e.g., the left
atrium).
[0095]
Further as shown in FIG. 1A, the septum puncture device 100 optionally
includes
a shaft actuator 124 operably coupled to the main shaft 120 and configured to
actuate the main
shaft 120 to advance or withdraw the main shaft 120 relative to the body 110.
The septum
puncture device 100 further includes (1) a side catheter actuator 164 operably
coupled to and
configured to actuate the side catheter 160 to advance or withdraw the side
catheter 160,
thereby transitioning the side catheter 160 between a delivery configuration
and a deployed
configuration (the side catheter 160 shown in an actuated or deployed
configuration in FIG.
1B), and a (2) a septum penetrator actuator (or "penetrator actuator") 174 to
actuate the septum
penetrator 170 to advance or withdraw the septum penetrator 170, thereby
transitioning the
septum penetrator 170 between a delivery configuration and a deployed
configuration (the
septum penetrator 170 shown in an actuated or deployed configuration in FIG.
1B), as
described in further detail herein.
[0096]
Further as shown in FIG. 1A, the septum puncture device 100 optionally
includes
a GSA ("GA-) 150 coupled to the main shaft 120. The optional GSA 150 is
operably coupled
to a GA actuator 154 that is configured to actuate the GSA 150, as described
in further detail
herein.
[0097]
Further as shown in FIG. 1A, the septum puncture device 100 optionally
includes
an end effector 162 coupled to and extending distally from the side catheter
160. The end
effector 162 is configured to facilitate subsequent puncture through a target
puncture location,
such as, for example, the FO of the septum of the heart. The end effector 162
can be configured,
for example, to contact or tent the FO, as described in further detail herein.
Such contact or
tenting of the FO can, for example, reduce or minimize the force required to
penetrate the FO
and/or provide for improved force distribution to the FO. The end effector 162
can be
configured to prevent inadvertent puncturing of and/or damage to the FO with
the end effector
162.
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[0098]
In some embodiments, the end effector 162 is formed of or includes a
radiopaque
material such that the end effector 162 can be visualized when within the
heart from outside
the patient under any suitable imaging modality (e.g., fluoroscopy,
echocardiography, etc.), to
facilitate an operator in deploying the end effector 162, e.g., locating the
end effector 162
within the heart or relative to the FO in preparation for deploying the septum
penetrator 170.
[0099]
In some embodiments, the end effector 162 can include multiple
configurations,
e.g., a delivery or withdrawal configuration, in which the end effector 162 is
configured to be
routed through the patient's vasculature, and a deployed configuration in
which the end effector
162 is configured to facilitate subsequent penetration of the FO, as described
in further detail
herein. In such embodiments, for example, the end effector 162 can be
delivered to the heart
in a compressed, deflated, or otherwise relatively small configuration, and
then transitioned
into a deployed configuration in which it is expanded, inflated, or otherwise
increased in size
to then contact or tent the FO. Further, in some embodiments, after deployment
of the end
effector 162, the end effector 162 can be transitioned to a withdrawal
configuration (which can
be the same as or similar to its delivery configuration) in which the end
effector 162 is in a
compressed, deflated, or otherwise small configuration to assist in removal of
the end effector
162 from the patient.
[00100]
The end effector 162 can be formed of any suitable material(s) to
facilitate its
functionality described herein. In some embodiments, for example, the end
effector 162 can
be formed of shape memory material(s) (e.g., Nitinol) or a polymer, or a
combination thereof
(e.g., Nitinol coated with a polymer), such that it can be transitioned
between a constrained or
compressed arrangement (e.g., delivery or withdrawal configuration) and an
unconstrained or
expanded arrangement (deployed configuration). In some embodiments, for
example, the end
effector 152 can be or include a balloon such that it can be delivered to the
heart in a deflated
arrangement and then inflated (e.g., via an inflation lumen fluidically
coupled to and extending
proximally from the end effector 162, not shown) to a deployed configuration.
Various further
embodiments of an end effector are described in further detail below.
[00101]
Each of the main shaft 120, the guide wire coupler 122, the side catheter
guide
130, the guide coupler 140, the optional GSA 150, the side catheter 160, the
septum penetrator
170, and the guide wire coupler 172 are translatable (e.g., distally
advanceable and/or
extendable, and proximally withdrawable and/or retractable) relative to the
body 110. The side
catheter 160 is translatable relative to the side catheter guide 130, and the
septum penetrator
170 is translatable relative to the side catheter 160, as described in further
detail herein.
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[00102]
The septum penetrator 170 can be sized, shaped, and formed of any material
suitable to effectively penetrate and traverse a target tissue such as the FO.
In some
embodiments, for example, the septum penetrator 170 can be a needle. In some
embodiments,
the septum penetrator 170 can be a non-coring needle (e.g., a needle with a
sharp tip that has a
cutting edge, such as, for example, a Quincke-type needle). In some
embodiments, the septum
penetrator 170 can have variable material properties. In such embodiments, for
example, a
distal portion of the septum penetrator 170 can have a stiffness greater than
a stiffness of a
portion proximal to that distal portion. In this manner, the stiffer distal
portion can be
configured for penetration through the septum, while the portion proximal can
be configured
for delivery through the patient's vasculature. In some embodiments, the
septum penetrator
170 can be solid-tipped and can be electrified with radiofrequency ("RF")
energy to puncture
the FO.
[001031
The septum penetrator 170 can have any suitable length, for example, any
length
suitable to reach the LA. In some embodiments, for example, the septum
penetrator 170 can
have an effective length (i.e., the length extendable from the distal end of
the side catheter 160
(or from the distal end of the end effector 162) of about 5mm to about 25mm.
In some
instances, an effective length of the septum penetrator 170 can be about 8mm
or about lOmm,
or any length therebetween. In some embodiments, the septum penetrator 170 can
contain or
be configured to receive a stylet to limit or minimize tissue coring. In some
embodiments, the
septum penetrator 170 can include a pressure transducer (not shown) configured
to monitor
pressure through a lumen of the septum penetrator 170. In some embodiments, a
port or leuer
lock can be incorporated into the septum puncture device 100 to flush the
septum penetrator
170.
[00104]
Turning to FIGS. 2A and 2B to describe the septum puncture device 100 (1)
in
context with the anatomy of a patient and (2) in a sample procedure to access
the LA of the
patient, FIG. 2A is a schematic illustration of the septum puncture device 100
disposed in a
delivery configuration within the RA of the heart and coupled to a first guide
wire GW1
extending from the IVC across the RA and into a SVC and FIG. 2B is a schematic
illustration
of the septum puncture device 100 disposed in a deployed configuration and
such that it has
accessed and delivered to the LA a second guide wire that can be used to
provide subsequent
access to the LA.
[00105]
In use, prior to introducing into the patient the septum puncture device
100, a
guide wire GW1 can be inserted through an entry site of the patient (e.g.,
femoral vein puncture
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site) (not shown) and advanced through the patient's vasculature across the
IVC and RA, and
into the SVC using known, suitable techniques for guidewire delivery. With the
guide wire
GW1 disposed in such a manner, the septum puncture device 100 can be movably
coupled to
the guide wire GW1 via the guide wire coupler 122 and advanced from the entry
site of the
patient towards the heart. In some embodiments, the guide wire coupler 122 can
be a lumen
defined by the main shaft 120 through which the guide wire GW1 can be disposed
and such
that the main shaft 120 can be slidably disposed about the guide wire GW1. The
guide wire
GW1 can be any suitable size. In some embodiments, for example, the guide wire
GW1 can
have a diameter of about 0.014 inches to about 0.035 inches in diameter. In
some embodiments,
the guide wire GW1 can be about 0.025 inches diameter. With the guide wire
coupler 122
movably coupled to the delivered guide wire GW1, the septum puncture device
100 can be
advanced along the guide wire GW1 into the heart, as shown in FIG. 2A. More
specifically,
with the main shaft 120 coupled to (1) the body 110 and (2) the side catheter
guide 130 via the
guide coupler 140, the body 110, the main shaft 120, the guide coupler 140,
the side catheter
guide 130, the side catheter 160, the septum penetrator 170, and the guide
wire coupler 172 all
can be advanced into the heart of the patient as shown in FIG. 2A, such that
body 110 extends
through the IVC and into the RA, and the main shaft 120 extends into the SVC.
With the main
shaft 120 spanning the IVC, RA, and SVC, the main shaft 120 can provide a
foundation or
backstop against which the side catheter guide 130, side catheter 160, and
septum penetrator
170 can be deployed and advanced towards the septum, as described in further
detail herein.
[00106]
In some instances, a distal end of the (1) main shaft 120, (2) side
catheter guide
130, (3) side catheter 160, and septum penetrator 170 (and accompanying
couplers, e.g., the
guide wire coupler 122 and the guide wire coupler 172), can be disposed within
the body 110
(e.g., within one or more lumens (not shown) defined by the body 110). In this
manner, during
delivery, the patient's anatomy can be protected or shielded by the body 110
to avoid
inadvertent trauma to or contact with the patient's anatomy from such
components. With a
distal end of the body 110 disposed in or near the RA, the body 110 can be
withdrawn (and/or
one or more of the components movably coupled thereto can be advanced),
thereby exposing
the side catheter guide 130 and guide coupler 140 within the RA.
[001071
With the side catheter guide 130 exposed within the RA and translationally
fixedly coupled to the main shaft 120 via the guide coupler 140, the side
catheter guide 130
can be actuated to laterally deflect the distal end of the side catheter guide
130 (and as a result,
also the side catheter 160, the septum penetrator 170, and the guide wire GW2
if disposed in
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the side catheter guide 130 during its lateral deflection), as shown in FIG.
2B. The side catheter
guide 130 can be laterally deflected at any angle suitable to direct the side
catheter 160 and
septum penetrator 170, which are movably attached to the side catheter guide
130, towards the
target penetration site, e.g., the FO, as shown in FIG. 2B. In some instances,
an optimal angle
of entry to the FO is 90 degrees or substantially 90 degrees relative to a
surface line tangent to
the FO, which can be about a similar angle relative to a central axis of the
main shaft 120. Such
a perpendicular (or substantially perpendicular) angle of entry can minimize
the force required
to penetrate the FO because the entire or substantially entire force vector is
directed at the plane
of the FO (rather than a tangential approach). Additionally, such a
perpendicular (or
substantially perpendicular) angle of entry, given the nature of a patient's
anatomy, directs the
septum penetrator 170 to a relatively large open space within the LA, thereby
minimizing risk
of inadvertent puncture within the LA (e.g., inadvertent puncture of a wall of
the LA).
[00108]
In other instances, the angle of entry relative to the FO or relative to
the central
axis of the main shaft 120 can be anywhere within a range of about 50 degrees
to about 90
degrees. In some instances, the preferred angle of entry can be selected based
on a particular
therapy planned for the left side of the heart. The angle of entry, for
example, defines the
trajectory for the subsequent therapeutic device to enter the left side of the
heart, and so in
some instances an optimal angle and location of entry through the FO is based
on a particular
therapeutic device or procedure.
[00109]
Note that the guide wire GW2 can be delivered in any suitable manner. In
some
instances, for example, the guide wire GW2 is disposed within the side
catheter guide 130
during delivery of the side catheter guide 130, while in other instances the
guide wire GW2 is
inserted at a later time during the procedure, e.g., after the septum
penetrator 170 has penetrated
the FO and reached the LA.
[00110]
With the side catheter guide 130 transitioned to its deployed
configuration, in
which the side catheter guide 130 is laterally deflected towards the FO, the
side catheter
actuator 164 can be actuated to advance the side catheter 160 along a path
defined at least in
part by the side catheter guide 130 and towards the FO. In some instances the
side catheter
160 is advanced until it's distal end tents or otherwise contacts the FO. For
embodiments that
include the end effector 162, the side catheter 160 can be advanced until the
end effector 162
extending from the distal end of the side catheter 160 tents or otherwise
contacts the FO.
[00111]
In embodiments in which the end effector 162 is expandable and
compressible,
the end effector 162 can be delivered to the Right Atrium RA in a compressed
or relatively
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small configuration, and then transitioned to a deployed configuration in
which the end effector
162 is expanded to a relatively larger configuration, and then advanced to
engage with the FO.
After sufficient penetration of the Atrial Septum AS with the septum
penetrator 170, as
described in further detail herein, the end effector 162 can be transitioned
to its retracted or
compressed configuration suitable to be withdrawn from the patient. In
embodiments in which
the side catheter 160 is slidably disposed within a lumen defined by the side
catheter guide 130,
the end effector 162 can similarly be slidably disposed within the lumen
defined by the side
catheter guide 130 such that the side catheter guide 130 contains the end
effector 162 in its
constrained or compressed configuration during delivery, and then as the side
catheter actuator
164 is actuated to advance the side catheter 160 distally from the distal end
of the side catheter
guide 130, the end effector 162 can transition to its expanded or
unconstrained configuration
as or after it exits the lumen of the side catheter guide 130.
[001121
With the side catheter 160 (or end effector 162) in sufficient contact
with the FO,
the penetrator actuator 174 can be actuated to advance the septum penetrator
170 relative to
and along a path defined at least in part by the side catheter 160. The septum
penetrator 170
can be advanced through the FO and across the Atrial Septum AS and into the
Left Atrium LA.
In some embodiments, the side catheter 160 defines a lumen through which the
septum
penetrator 170 is slidably disposed such that actuating the penetrator
actuator 174 advances the
septum penetrator 170 through the lumen of the side catheter 160. The septum
penetrator 170
can be advanced in this manner to penetrate the FO and to extend into the left
atrium LA.
During such penetration, the main shaft 120 can provide lateral or axial
stability to the septum
penetrator 170.
[00113]
As the distal end of the septum penetrator 170 is advanced across the
Atrial
Septum AS and into the Left Atrium LA, the guide wire GW2 can follow via the
guide wire
coupler 172 and the septum penetrator 170 in instances in which the guide wire
GW2 is coupled
to the side catheter guide 130 during delivery of the side catheter guide 130.
In other instances,
the guide wire GW2 can be inserted at a later time during the procedure, e.g.,
after the septum
penetrator 170 has penetrated the FO and reached the LA In some embodiments,
the guide
wire coupler 172 is a lumen defined by the septum penetrator 170 and through
which the guide
wire GW2 can be slidable disposed. In such embodiments, the guide wire GW2 can
be
disposed within the lumen of the septum penetrator 170 during delivery and
deployment of the
septum penetrator 170 into the Left Atrium LA.
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[00114]
With the septum penetrator 170 and the guide wire GW2 disposed within the
Left Atrium LA, the guide wire GW2 can be further advanced into the Left
Atrium LA by
manipulation of the guide wire GW2 at its proximal end, and/or the septum
penetrator 170 can
be withdrawn from the Left Atrium LA, across the puncture or entry site of the
FO, leaving the
guide wire GW2 within the Left Atrium LA.
[00115]
With the guide wire GW2 delivered to the Left Atrium LA, and extending
proximally from the Left Atrium LA across the puncture or entry site of the
FO, into the Right
Atrium RA, the IVC, and through the vasculature of the patient to the entry
point of the patient
(for subsequent access to the Left Atrium AS), the septum puncture device 100
can be
withdrawn from the heart proximally over guide wire GW2 and from the patient.
[00116]
The guide wire GW2 can be any guide wire suitable to provide desirable
subsequent access to the Left Atrium LA. In some embodiments, for example, the
guide wire
GW2 can be a pigtail, atraumatic guide wire or other suitable guide wire
conventionally used
in transseptal procedures. For example, the guide wire GW2 can have a
flexible, spiral tip,
pigtail, and can be configured to anchor the septum puncture device 100 to the
LA, thereby
limiting or preventing the guide wire GW2 from being inadvertently withdrawn
or removed
from the LA in response to or while the septum puncture device 100 is being
withdrawn along
the guide wire GW2 and from the patient. Another example guide GW2 can be a
ProTrackTm
Pigtail Wire from Baylis Medical Company, Inc.
[00117]
The septum puncture device 100 can be configured to be withdrawn from the
patient in any suitable sequence (e.g., after the guide wire GW2 has been
delivered to the Left
Atrium LA). With the guide wire GW2 disposed within the Left Atrium LA, for
example, the
portions of the septum penetrator 170 and guide wire coupler 172 disposed
within the Left
Atrium LA can be withdrawn relative to the guide wire GW2 and through the
puncture site in
the FO and into the Right Atrium RA. In embodiments in which the side catheter
160 defines
a lumen through which the septum penetrator is slidably disposed, the septum
penetrator 170
can be withdrawn relative to and into the lumen defined by the side catheter
160. In this
manner, the septum penetrator 170, and particular it's distal that is designed
to penetrate tissue,
can be sheathed or shielded by the side catheter 160 to facilitate safe
withdrawal from the
patient and avoid inadvertent contact with the patient's heart or vasculature
during removal of
the septum puncture device 100 from the patient.
[00118]
Similarly, the side catheter 160 can be withdrawn relative to the side
catheter
guide 130. For example, in embodiments in which the side catheter guide 130
defines a lumen
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through which the side catheter 160 is slidably disposed, the side catheter
160 can be withdrawn
into the lumen of the side catheter guide 130. In embodiments in which the
septum puncture
device 100 includes an end effector 162, the side catheter guide 160 can be
withdrawn relative
to and into the lumen of the side catheter guide 130 such that the end
effector 162 is also
withdrawn into the lumen of the side catheter guide 130. In embodiments in
which the end
effector 162 has a deployed configuration with a diameter larger than an
internal diameter of
the side catheter guide 130, the end effector 162 can be configured to be
transitioned from its
deployed configuration to its withdrawal (or delivery) configuration. For
example, if the end
effector 162 is a balloon, it can be deflated and then withdrawn into the
lumen of the side
catheter guide 130. As another example, if the end effector 162 includes or is
formed of shape
memory material, the end effector 162 can be compressed, constrained, or
otherwise
transitioned to a smaller arrangement such that it can be withdrawn into the
side catheter guide
130. In some instances, withdrawal of the end effector 162 into the side
catheter guide 130 can
cause the end effector 162 to transition to its constrained or compressed
configuration.
[00119]
Further, the side catheter guide 130 can be configured to transition from
its
deployed configuration in which its distal portion is laterally deflected
relative to the main shaft
120 to its withdrawal (or delivery) configuration in which the side catheter
guide 130 is at least
substantially linear and parallel to the main shaft 120. In some embodiments,
for example, a
proximal force can be applied to a proximal end portion of the side catheter
guide 130 to
withdraw the side catheter guide 130 relative to the main shaft.
With the septum puncture device 100 disposed as shown in FIG. 2A, for
example, after delivering the guide wire GW2, the septum puncture device 100
can be
withdrawn from the heart and from the patient. For example, the body 110, and
all of the
components coupled thereto, can be withdrawn from the heart, through the
patient's
vasculature, and out through the initial entry site into the patient (e.g., a
the femoral puncture
site).
[00121]
Although embodiments described herein refer to introducing a guide wire
and
septum puncture device into the patient's vasculature, and across the IVC and
RA, and into the
SVC, access to the RA for purposes of deploying a septum penetrator, can be
accomplish in a
variety of ways. In some embodiments, for example, the guide wire and septum
puncture
device can be inserted into a patient's jugular vein (e.g., right internal
jugular vein), and then
advanced into and across the SVC and RA, and into the IVC, such that a distal
end of the
septum puncture device is disposed in the IVC (or beyond).
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[00122]
Although embodiments described herein refer to a single FO puncture to
deliver
a single guide wire to the LA, it should be understood that the septum
puncture devices
described herein can be used to perform multiple punctures and to deliver
multiple guide wires.
In some instances, for example, a double puncture and delivery of two guide
wires may be
desirable, e.g., in connection with an atrial fibrillation ablation procedure.
In such instances,
the septum puncture devices described herein can be deployed twice to puncture
the septum
twice, with each puncture providing access to deliver a guide wire, as
described herein. In
some procedures that require multiple punctures and guide wires delivered to
the LA, for
example, it can be crucial that the punctures are in a particular location and
located a particular
distance from each other, and as described through this disclosure, the septum
puncture devices
described herein provide just that.
[00123]
Further, instead of using a septum puncture device described herein to
administer
multiple punctures in series (e.g., with a single penetrator, single side
catheter, single side
catheter guide, etc.), in some embodiments, any of the septum puncture devices
described
herein can he modified to incorporate additional components. For example, in
some instances,
a septum puncture device can include a body and a main shaft (similar to
septum puncture
device 100), but also include two side catheter guides, two side catheters,
two end effectors,
two septum penetrators, and two guide couplers (for the guide wires being
delivered), and
optionally one or two guide couplers and one or two guide stabilizer /
actuators. In this manner,
two side catheter guides can be deployed (i.e., laterally deflected and
stabilized)
simultaneously, and then two side catheters (optionally with end effectors)
can be advanced,
optionally simultaneously, to contact the septum, and then two septum
penetrators can be
advanced, optionally simultaneously, to penetrate the septum. With two
punctures in the
septum, two guide wires can then be delivered, optionally simultaneously. In
such instances,
the preferred distance between the two punctures can be selectively defined by
the distance
between the side catheters from which the septum penetrators are advanced.
[00124]
FIG. 3 illustrates a method 200 of using the septal puncture device 100 to
access
a left atrium of a heart of a patient, according to an embodiment. At 201, the
guide wire GW1
is inserted through the IVC, across the RA, and into SVC of the heart (e.g.,
via a femoral vein
puncture and through the patient's vasculature disposed between the femoral
vein puncture site
and the IVC). At 202, the septal puncture device 100 is delivered over the
guide wire GW1
until a distal end of a main shaft 110 is disposed within the SVC. At 204, the
GSA 150 is
actuated to laterally deflect and direct the side catheter guide 130 towards
the FO. Optionally,
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at 206, the main shaft 110 and the side catheter guide 130 are selectively
positioned (e.g.,
translated or rotated) relative to the FO. Optionally, at 208, the end
effector 162 is deployed.
At 210, the end effector 162 (or distal end of side catheter) is advanced
against and into contact
with the FO (e.g., to tent the FO). Optionally, at 212, the end effector 162
(or distal end of side
catheter 130) is visualized from outside the patient, and if necessary, the
main shaft 110 or the
side catheter guide 130 are adjusted to selectively reposition the end
effector 162 (or distal end
of side catheter 130) relative to the FO.
[00125]
At 214, the septum penetrator 170 is advanced through the FO and into the
LA.
Optionally, at 216, visualization techniques are used to confirm crossing of
the septum
penetrator 170 into the LA. At 220, the guide wire GW2 is advanced relative to
the septum
penetrator 170 and into the LA or the septum penetrator 170 is withdrawn
relative to the septum
penetrator 170, thereby leaving a portion of the guide wire GW2 in the LA. At
222, the septum
penetrator 170 is withdrawn, the end effector 162 is optionally withdrawn, the
main shaft 120
is withdrawn, the guide actuator 150 is deactuated, and the device 100 is
withdrawn over the
guide wire GW1 and removed from the patient.
[00126]
Although not shown, in some embodiments, any of the main shafts described
herein can define a channel through which an intra-cardiac echo can be
disposed or slidably
coupled to assist in navigation through the patient.
[00127]
FIGS. 4A and 4B illustrate in perspective view a septum puncture device
300 in
a delivery configuration and a deployed configuration, respectively; FIGS. 5A
and 5B illustrate
a cross-sectional view of a portion of the septum puncture device 300, in
perspective view and
front view, respectively; and FIGS. 6A-6H illustrate a deployment sequence at
a distal end
portion of the septum puncture device 300, according to another embodiment.
[00128]
Similar to or the same as described with respect to the septum puncture
device
100, the septum puncture device 300 can be used to access a left side of the
heart (e.g., left
atrium) from the right side of the heart (e.g., right atrium) and to deliver a
guidewire to the left
side of the heart. The septum puncture device 300 can be constructed the same
as or similar
to, and can function the same as or similar to, the septum puncture device
100. Thus, portions
of the septum puncture device 300 are not described in further detail herein.
[001291
In this embodiment, the septum puncture device 300 includes a body 310
defining a first lumen 311 and a second lumen 312, through which various
portions of the
septum puncture device 300 are disposed or slidably disposed, as described in
further detail
herein. Coupled to the body 310 are a main shaft 320 and a side catheter guide
330, and the
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main shaft 320 is coupled to the side catheter guide 330 via a guide coupler
340. As shown in
FIGS. 5A and 5B, a proximal end portion of the side catheter guide 330 is
disposed within the
second lumen 312 of the body 310. The side catheter guide 330 defines a lumen
through which
a side catheter 360 is slidable disposed, the side catheter 360 defines a
lumen through which a
septum penetrator 370 is slidably disposed, and the septum penetrator 370
defines a lumen
through which a guide wire GW2 can be slidably disposed (as shown in FIGS. 5A,
5B, and
6H). Extendable from a distal end portion of the side catheter 360 is an end
effector 362.
[00130J
The main shaft 320 is telescopable, i.e., capable of being expanded /
extended /
advanced and contracted / withdrawn in sections. The main shaft 320 includes a
proximal
section 320A, and an inflation section 320B disposed partially within and
telescopable distally
with respect to the proximal section 320A. Although not shown, in some
embodiments, the
septum puncture device 300 can include a lock operably coupled to the
inflation section 320B
of the main shaft 320 and configured to translationally fix the inflation
section 320B with the
proximal section 320A to at least temporarily limit or prevent relative
movement therebetween.
In this manner, an operator can selectively enable and disable the
telescopable feature of the
main shaft 320, as described in further detail herein.
[00131]
The proximal section 320A of the main shaft 320 is coupled to and disposed
within the first lumen 311 of the body 310, and extends distally from a distal
end of the body
310. In some implementations of this embodiment, the proximal section 320A of
the main
shaft 320 is fixedly coupled to the body 310 (e.g., welded within the first
lumen 311 of the
body). Disposed circumferentially about and fluidically coupled to the
inflation section 320B
of the main shaft 320 (the inflation section 320B being fluidically and
slidably coupled to the
proximal section 320A) is a guide stabilizer / actuator ("GSA") 350. In this
embodiment, the
GSA 350 is a balloon configured to be inflated for deployment and deflated for
delivery or
withdrawal. To inflate, the GSA 350 is configured to receive one or more
fluids (e.g., one or
more of saline, air, or a contrast agent for visualization) via the inflation
section 320B. In use,
for example, one or more fluids can be conveyed from a lumen defined by the
proximal section
320A to a lumen defined by the inflation section 320B and into a volume
defined by the GSA
350. The same fluid(s) can be withdrawn from the GSA 350 (e.g., via the same
pathway used
to deliver the fluid(s)) to deflate the GSA 350 such that the GSA 350 can be
withdrawn from
the patient. The balloon can be any size suitable to perform that desired
functionality disclosed
herein, for example, in some embodiments, the balloon can be about 10 mm to
about 60 mm
in diameter when inflated. In some embodiments, for example, the balloon can
be 20 mm or
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about 20 mm in diameter when inflated. In some implementations of this
embodiment, the
septum puncture device 300 can include a GA actuator (not shown, but e.g.,
disposed at or
operably coupled to the handle 380) configured to inflate or deflate the GSA
350.
[001321
As shown, the inflation section 320B includes an inflation portion 326,
circumferentially about which the GSA 350 is disposed, and a distal portion
327 extending
distally from the GSA 350. In use, for example, with the GSA 350 deployed
within the right
atrium of the heart of the patient, the distal portion 327 extends into the
SVC of the patient to
provide stability between the IVC and SVC for subsequent puncture of the FO.
Although not
shown, in some embodiments, the distal portion 327 can have a diameter greater
than a
diameter of the inflation portion 326. In this manner, the cross-sectional
area or footprint
collectively assumed within the atrium of the heart by the GSA 350 and the
inflation portion
326 about which the GSA 350 is coupled can be minimized while the diameter of
the distal
portion 327 can be relatively larger to provide additional stability (e.g., by
having relatively
greater stiffness) to ensure a stable platform bridged between the IVC and
SVC. In other
embodiments, for a similar purpose, other design considerations (e.g.,
thickness, material, etc.)
can be employed to increase the stiffness or stability of the distal portion
327, relative to the
inflation portion 326.
[00133]
Disposed within the first lumens defined by the main shaft 320 is a guide
wire
coupler 322. The guide wire coupler 322 extends distally from the body 310 and
is configured
in use to extend from the body 310 to the SVC of the patient. The guide wire
coupler 322
defines a lumen through which the guide wire GW1 can be routed and slidably
disposed. In
some implementations of this embodiment, the guide wire coupler 322 is fixedly
coupled (e.g.,
welded) to an inner surface of the main shaft 320. As shown best in FIG. 5B,
an inflation
volume IV (e.g., a crescent-shaped void or volume) is defined between an
external surface a
portion of the guide wire coupler 322 and an inner surface of the main shaft
320. This volume
is fluidically coupled to the GSA 350 disposed about the main shaft 320 such
that it provides
a conduit through which fluid can be delivered from outside the patient to the
interior of the
GSA 350 when the GSA 350 is disposed within the heart of the patient.
[00134]
In this embodiment, the guide coupler 340 is formed from a single thread
of
suture (although in other embodiments a guide coupler 340 could be formed from
any suitable
number of sutures, e.g., two or more). Any suture suitable to translationally
fixedly couple the
main shaft 320 with the side catheter guide 330, but allow relative
rotationally movement
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between the main shaft 320 and the side catheter guide 330, can be used. In
some embodiments,
for example, a polymer such as Dacron, can be used.
[00135]
To couple the guide coupler 340 with the main shaft 320 and side catheter
guide
330, the suture can be circumferentially wrapped around each of the side
catheter guide 330
and main shaft 320 separately and can be circumferentially wrapped around the
side catheter
guide 330 and main shaft 320 collectively. For additional securement, in some
embodiments,
an adhesive can be applied between the guide coupler 340 and the main shaft
320, between the
guide coupler 340 and the side catheter guide 330, or between the side
catheter guide 330 and
the main shaft 320, or any combination thereof
[00136]
As with many minimally-invasive surgical procedures in the cardiac space,
it can
be important to minimize the size, and in particular the cross-sectional
footprint, of the
device(s) inserted into the patient. Forming the guide coupler 340 with suture
addresses this
goal by allowing for flush or substantially flush contact (e.g., direct or
substantially direct
contact) between the main shaft 320 and the side catheter guide 330. In some
embodiments,
for example, the suture can be wrapped around each of the main shaft 320 and
the side catheter
guide 330 such that the distance between an external surface of the main shaft
320 and an
external surface of the side catheter guide 330 is equal to or substantially
equal to an external
diameter of the thread of suture. In such embodiments, using, for example, a
suture having a
United States Pharmacopeia ("USP") of 4-0 having an external diameter of 0.15
mm can allow
for a distance between the main shaft 320 and the side catheter guide 330 of
0.15 mm. In some
implementations, other suture sizes could be used, such as, for example, USP 2-
0, USP 3-0,
USP 5-0, USP 6-0, or USP 7-0.
[00137]
Although in this embodiment the guide coupler 340 is formed of suture, in
other
embodiments, a guide coupler can be formed, additionally or alternatively, of
other materials,
such as, for example, a textile, polymer, fine wire, metal, or braided
material. As another
example, in some embodiments a guide coupler can be a sleeve (e.g., a textile
sleeve), and in
some implementations, the sleeve could serve in conjunction with a suture
(e.g., formed into a
cow hitch), and the free ends of the suture can be stabilized with an adhesive
coating.
[00138]
Further, in this embodiment, and as shown FIG. 4B, the side catheter guide
330,
from top view, is disposed to the right of the main shaft 320. Offsetting the
side catheter guide
330 relative to the central axis of the main shaft 320 in this manner in many
instances aligns
the distal end of the side catheter guide 330 with the FO, given the common
anatomical location
of the FO relative to the IVC, SVC, and RA. The FO is often offset from a
central axis defined
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from the IVC to the SVC, so aligning the side catheter guide 330 to be offset
from the central
axis of the main shaft 320, may in some instances, place the side catheter
guide 330 in a more
suitable position for subsequent puncture. In this manner, the arrangement of
the side catheter
guide 330 and the main shaft 332 can optimize the time and number of steps
required of the
operator to locate the FO with the side catheter 360 (or end effector 362),
for subsequent
puncturing of the FO with the septum penetrator 370.
[00139]
Similar to as described elsewhere herein, in this embodiment, the septum
puncture penetrator 370 has variable stiffness. More specifically, a distal
end portion of the
septum penetrator 370 is configured to be stiffer / more rigid than a proximal
end portion of
the septum penetrator 370, with the distal end portion being optimized to
penetrate the FO and
the proximal end portion being optimized to advance (with flexibility) through
the curved side
catheter guide 330. Accommodating a rigid septum penetrator 370 suitable to
puncture the
septum and be able to make a suitable turn from the central axis of the main
shaft 320 within
the RA and towards the FO, can be challenging given the anatomical spatial
constraints within
the heart
[00140]
To address such constraints, as shown in FIG. 4B, the side catheter guide
330,
when deployed, assumes a curved shape as it extends distally from the body
310. More
specifically, in front view, the side catheter guide 330 extends proximally
from its distal end
and from below the central axis of the main shaft 320, across the central axis
of the main shaft
320 and above the central axis of the main shaft 320, and then curves left and
towards and into
the second lumen 312 of the body 310. In this manner, a linear section at the
distal end portion
of the side catheter guide 360, when deployed, can have a length sufficient to
slidably contain
or house the septum penetrator 370. That length, for example, can be greater
than a thickness
of the FO. In some embodiments, that length can be about 5mm to about 15mm, or
greater. In
this embodiment, that length is greater than a diameter of the GSA 350 when
deployed.
Further, this curved configuration allows for a more gradual lateral
deflection / turn towards
the FO than would otherwise be attainable, e.g., rather than the lateral
deflection towards the
FO being initiated from a linear axis parallel to the central axis of the main
shaft 320.
[00141]
In use, for example, when advancing the main shaft 320 from entry into the
patient, through the patient's vasculature, and into the IVC, RA, and SVC, it
is desirable to
avoid any traumatic contact with the patient's anatomy. To limit or prevent
undesirable trauma
to the patient from the septum puncture device 300, in this embodiment the
septum puncture
device 300 includes a flexible, atraumatic distal component 328 coupled to and
extending from
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the main shaft 320. Although this embodiment illustrates the atraumatic distal
component 328
as a separate component that is coupled to the main shaft 320, in other
embodiments a distal
end portion (e.g., a distal tip) of the main shaft 320 can be configured to be
atraumatic (e.g.,
flexible, soft, or any other design features configured to avoid undesirable
trauma to the
patient). The atraumatic distal component 328, in some implementations, can be
tapered such
that its proximal end portion has a cross-sectional area greater than its
distal end portion. In
some instances, the portion of the atraumatic distal component 328 having the
greatest cross-
sectional area, diameter, or width, can have the same, about the same, or
larger cross-sectional
area, diameter, or width of the GSA 350 (when the GSA 350 is in its delivery
configuration).
In this manner, the atraumatic distal component 328 can facilitate a smooth
delivery through
the patient.
[00142]
Further, as shown, the septum puncture device 300 includes a handle 380
coupled
to the body 310 and configured to be manipulatable by the operator to deliver
and deploy the
septum puncture device 300 as described in more detail herein. The handle 380
can include
or be coupled to one or more shaft actuators (when included, not shown), the
GA actuator 354,
a side catheter actuator (not shown), and a penetrator actuator (not shown).
Further, the handle
can be manipulatable to actuate one or more of the actuators.
[00143]
Turning now to an exemplary deployment sequence, FIGS. 6A-6H illustrate in
side view an exemplary deployment sequence of and at a distal end portion of
the septum
puncture device 300, according to an embodiment.
[001441
FIG. 6A illustrates a portion of the septum puncture device 300 prior to
deployment. It is in this configuration that the septum puncture device 300
can be inserted into
the patient (e.g., via a femoral vein puncture), through the patient's
vasculature, and into the
heart of the patient such that the main shaft 320 extending distally from the
body 310 spans the
IVC, RA, and SVC to provide a stable platform against which the septum
puncture device 300
can be deployed to puncture the FO. As shown, during delivery the septum
puncture device
300 is in its delivery configuration in which the main shaft 320 and the side
catheter guide 330
are parallel or substantially parallel to each other. In this manner, for
example, the cross-
sectional footprint of the septum puncture device 300 can be minimized or
optimized for
minimally-invasive delivery through the patient.
[00145]
As shown in FIG. 6A, during delivery the distal end of the side catheter
guide
330 is in physical contact with a proximal side of the GSA 350. In some
instances, for example,
the proximal side of the GSA 350 and the distal end of the side catheter guide
330 can be in
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such close contact that a portion of the distal end of the side catheter guide
330 can be nestled
partially within, or covered partially by the proximal side of the GSA 350. In
this manner, the
GSA 350 can shield the distal end of the side catheter guide 330 from
inadvertent contact with
the patient's anatomy. In such instances, a subsequent step can include
telescoping the main
shaft 320, including advancing the inflation section 320B of the main shaft
320 to separate the
distal end of the side catheter guide 330 from the GSA 350 or unshield the
distal end of the
side catheter guide 330. In other instances, the septum puncture device 300
can be delivered
with separation between the side catheter guide 330 and the GSA 350 such that
the unshielding
step is unnecessary.
[00146]
With the main shaft 320 extended from the IVC to the SVC, and the GSA 350
and guide coupler 340 disposed within the RA, the side catheter guide 330 can
be deployed, as
shown in FIG. 6B. More specifically, a distal force is applied to a proximal
end portion of the
side catheter guide 330 such that the force is transferred to the guide
coupler, causing the guide
coupler 340 to rotate or deflect, resulting in rotation or deflection of a
portion of the side
catheter guide 330 extending distally from the guide coupler 340 about the
guide coupler 340.
In this embodiment, as shown in FIG. 6B, the deflection occurs such that the
distal end portion
of the side catheter guide 330 laterally deflects about 90 degrees and about
perpendicular to
the central axis of the main shaft 320. In alternative embodiments, the
lateral deflection may
be less than about 90 degrees, such as, for example, about 15 degrees, about
30 degrees, about
45 degrees, about 60 degrees, about 75 degrees, or any degrees therebetween.
In some
instances, the lateral deflection may be about 75 degrees to about 85 degrees,
e.g., about 80
degrees. In even further embodiments, the lateral deflection may be greater
than about 90
degrees, such as, for example, about 105 degrees, about 120 degrees, about 135
degrees, or any
degrees therebetween. Although in this embodiment actuation of the side
catheter guide 330
is sufficient to laterally deflect a portion of the side catheter guide 330
such that that portion is
about perpendicular to the central axis of the main shaft 320, in other
embodiments, for
example, in which the lateral deflection is less than about 90 degrees,
additional lateral
deflection / rotation can be applied by the GSA 350, as discussed in further
detail herein.
[00147]
Next, the GSA 350 is actuated, i.e., in this embodiment, inflated, as
shown in
FIG. 6C. More specifically, fluid is administered to the GSA 350 to inflate
the GSA 350. With
the GSA 350 inflated, the inflation section 320B about which the GSA 350 is
disposed is
telescoped proximally, including withdrawn relative to the proximal section
320A such that
the proximal side of the GSA 350 is brought into physical contact with the
side catheter guide
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350, as shown in FIG. 6D. The inflation section 320B can be withdrawn relative
to the
proximal section 320A any distance and with any safely-administrable amount of
force suitable
to sufficiently contact or stabilize the side catheter guide 330. In some
instances, such
withdrawal can apply a force to the side catheter guide 350 to further
laterally deflect the side
catheter guide 350 (although as shown and described in this embodiment, the
side catheter
guide 350 is laterally deflected about 90 degrees prior to being physically
contacted by the
GSA 350), resulting in the distal end portion of the side catheter guide 350
being, for example,
perpendicular or about perpendicular to the central axis of the main shaft 320
or a surface line
tangent to the FO or main shaft 320. Further, such withdrawal force causes the
GSA 350 to
contact or abut the distal end portion of the side catheter guide 350 to
stabilize (e.g., laterally,
axially (proximally or distally)) relative to the main shaft 320. Although not
shown, in some
instances, the withdrawal force can be sufficient to cause the GSA 350 to
become indented
with an impression of the side catheter guide 330 or envelop a portion of the
side catheter guide
330. In this manner, the side catheter guide 330 can be sufficiently
stabilized and temporarily
sufficiently coupled to the GSA 350. In some embodiments, the GSA 350 can be
configured
to possess variable amounts of compliance. In some embodiments, for example, a
proximal
portion of the GSA 350 that is configured to contact the side catheter guide
330 can have a first
level of compliance while another portion of the GSA 350 can have a second
level of
compliance that is different from the first level of compliance. Further, in
some embodiments,
the proximal side of the GSA 350 can include features configured to further
stabilize the side
catheter guide 330 relative to the GSA 350. These features can include, for
example, dimples,
protrusions, adhesives, or the like.
[00148]
With the GSA 350 actuated and in sufficient contact with the side catheter
guide
330 and providing sufficient stabilization of the side catheter guide 330
relative to the main
shaft 320, the end effector 362 is deployed, as shown in FIG. 6E. To deploy
the end effector
362, the side catheter 360 from which the end effector 362 distally extends is
advanced relative
to the side catheter guide 330 such that the end effector 362 is allowed to
expand to its expanded
/ deployed configuration as it is released from its constrained configuration
within the lumen
of the side catheter guide 330.
1001491
With the end effector 362 deployed, the end effector 362 can be advanced
towards and into contact with the FO to tent the FO. As described elsewhere
herein, both the
end effector and the tenting of the FO (or other portion of the septum) are
visible to the operator
from outside the patient via various imaging technologies, such as, for
example, ultrasound or
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related suitable imaging technologies. To advance the end effector 362 towards
and into contact
with the FO, the side catheter 360 can be advanced (e.g., by actuating the
side catheter actuator,
not shown) relative to the side catheter guide 330) or by manipulating (i.e.,
translating or
rotating) the main shaft 320.
[00150]
In instances in which the operator is not satisfied with the location on
the septum
contacted or tented by the end effector 362, e.g., if the end effector 362 is
misaligned with the
FO, the end effector 362 can be withdrawn from contact with the FO or septum
(e.g., by
withdrawing the side catheter 360 relative to the side catheter guide 330 or
by manipulating
the main shaft 320), and then the operator can make another approach at
landing the end
effector 362 on the FO in a manner sufficient for subsequent puncturing of the
FO. This process
can be repeated until the operator is satisfied.
[00151]
With the FO properly tented by the end effector 362, the septum penetrator
370
can be advanced relative to the side catheter 360 and the end effector 362,
and shown in FIG.
6G, and through the FO and into the LA. With the FO sufficiently penetrated by
the septum
penetrator 370, and a distal end of the septum penetrator 370 disposed within
the LA, the guide
wire GW2 is advanced relative to and through the lumen defined by the septum
penetrator 370
such that at least a distal end portion of the guide wire GW2 exits the distal
end of the septum
penetrator 370 (as shown in FIG. 6H) and advances into the LA, which can be
confirmed by
the operator under imaging technologies. Once confirmed that the GW2 is
sufficiently
disposed within the LA, the septum penetrator 370 can be withdrawn relative to
and into the
lumen of the side catheter 360, the GSA 350 can be deflated (e.g., into its
delivery
configuration), and the side catheter guide 330 can be withdrawn into its
linear, pre-deployed,
delivery configuration, suitable for removal from the patient. Further, in
some instances, the
end effector 362 can be withdrawn relative to and into the lumen defined by
the side catheter
360.
[001521
With the septum penetrator 370 withdrawn from the LA, the operator can
manipulate the septum puncture device 300 (e.g., the handle 380, the body 310,
or the main
shaft 320) to withdraw the entire septum puncture device 300 along the guide
wire GW2 until
the septum puncture device 300 exits the patient.
[001531
FIGS. 7A and 7B further illustrate actuation of or transition of the side
catheter
guide 340 and the guide coupler 340 between their respective delivery (FIG.
7A) and deployed
configurations (FIG. 7B). As shown in FIG. 7A, with the septum puncture device
300 disposed
in its delivery configuration, the main shaft 320 and the side catheter guide
330 extend distally
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and relatively parallel or about parallel from the body 310, and are coupled
to each other via
the guide coupler 340. More specifically, the guide coupler 340 is coupled to
and between the
side catheter guide 330 and the proximal section 320A of the main shaft 320.
With the guide
coupler 340 coupled to the proximal section 320A of the main shaft 320, the
inflation section
320B of the main shaft 320 can be advanced relative to the proximal section
320A, in some
instances, for example, without disturbance to or by the guide coupler 340.
[00154]
As described in further detail herein, the side catheter guide 340 can be
configured to transition its delivery configuration (FIG. 7A) to its deployed
configuration
(FIG. 7B) in response to a distal force applied to a portion of the side
catheter guide 340 that is
disposed proximal to the guide coupler 340 (e.g., a distal force applied at
the handle 380). With
a portion of the side catheter guide 340 translationally fixed but
rotationally movably coupled
to the proximal section 320A of the main shaft 320 via the guide coupler 340,
the side catheter
guide 330 is configured to deform as shown in FIG. 7B, and such that the
portion of the side
catheter guide 330 that is disposed distal to the guide coupler 340 rotates
clockwise about the
guide coupler 340.
[00155]
Further, the distal force applied to the side catheter guide 340 causes
the portion
of the guide coupler 340 disposed about the side catheter guide 340 to rotate
about the portion
of the guide coupler 340 that is disposed about the main shaft 320, as shown
in FIG. 7B. Said
another way, the distal force applied to the side catheter guide 340 is
transferred at least in part
to the guide coupler 340 such that the hinging feature of the guide coupler
340 is activated to
allow the side catheter guide 330 to transition from its delivery
configuration to its deployed
configuration.
[00156]
In this embodiment the guide coupler 340 is formed of suture, and is
threaded or
routed about and between both the main shaft 320 and the side catheter guide
330 to limit or
prevent relative translational movement but allow rotational relative movement
between the
main shaft 320 and the side catheter guide 330, as described in further detail
herein. The suture
can be threaded or routed about and between the main shaft 320 and the side
catheter guide
330 in any manner suitable to provide it's intended functionality. In some
implementations, a
fastener can be added to the suture to improve its fixation to the main shaft
320 and the side
catheter guide 330. The fastener, can be, for example, an adhesive, which in
some instances,
is used to bond the wraps / loops of suture and the loose ends of the suture.
[00157]
FIG. 8 illustrates an example arrangement of the suture (the guide coupler
340).
As shown (at left of FIG. 8), the suture is initiated with a cow hitch 340CH
about the side
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catheter guide 330, and then a first working end of the suture is routed in a
first direction D1
about the main shaft 320, spiraling or looping about the main shaft 320, and a
second working
end of the suture is routed in a second direction D2 (opposite the first
direction D1) about the
main shaft 320, spiraling or looping about the main shaft 320 in a manner
similar to the first
working end. Each end of the suture can be secured by being tucked under,
between, or
threaded through one or more of the loops, or the suture can be secured by an
additional
fastener, such as, for example, an adhesive coating.
[00158[
FIG. 9 illustrates a method 400 of using the septum puncture device 300 to
access
a left atrium of a heart of a patient, according to an embodiment. At 401, the
guide wire GW1
is inserted through the IVC, across the RA, and into SVC of the heart (e.g.,
via a femoral vein
puncture and through the patient's vasculature disposed between the femoral
vein puncture site
and the IVC). At 402, the septum puncture device 300 is delivered over the
guide wire GW1
until the distal end of a main shaft 320 is disposed within the SVC. In some
instances, the
guide wire GW1 can be advanced or wedged into the uppermost aspect of the SVC
(e.g., the
bifurcation of the SVC into the right and left brachiocephalic (innominate)
veins, to provide
additional stability for the main shaft 520 and associated components (e.g.,
side catheter guide
530). At 404, the side catheter guide 330 is actuated to direct a distal end
of the side catheter
guide 330 towards a FO of a septum of the heart. At 406, the balloon 550 that
is disposed about
the main shaft 320 is inflated, and the inflation section 320B of the main
shaft 320 is withdrawn
relative to the proximal section 320B of the main shaft 320 such that the
balloon 350 abuts the
side catheter guide 330.
[00159]
At 408, optionally, the main shaft 320 and the side catheter guide 330 are
fine
positioned (e.g., translated, rotated, etc.) relative to the FO. At 410, the
side catheter 360 is
advanced and the end effector 362 is deployed from a distal end portion of the
side catheter
guide 330 such that the side catheter 360 contacts and tents the FO. At 412,
optionally, an
operator visualizes the tenting of the FO. At 414, the septum penetrator 370
is advanced
relative to the side catheter 360 through the FO and into the LA. At 416,
optionally, an operator
visualizes the septum penetrator 370 to confirm that the septum penetrator 370
crossed into the
LA. At 418, the second guide wire GW2 is advanced relative to the septum
penetrator 370 into
the LA. At 420, the septum penetrator 370 is withdrawn relative and into a
lumen defined by
the side catheter 360, the inflation section 320B of the main shaft 320 is
advanced relative to
the proximal section 320A, the side catheter guide 330 is withdrawn relative
to the main shaft
320, and the balloon 350 is deflated. Optionally, at 420, the end effector362
is withdrawn
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relative to the side catheter guide 330. In some instances, withdrawing the
end effector 362
relative to the side catheter guide 330 includes withdrawing the end effector
362 into the lumen
defined by the side catheter guide 330 to place the end effector 362 back into
its delivery
configuration.
[00160]
Although the septum puncture device 300 is shown and described as having
the
GSA 350, in alternative embodiments, for example, a septum puncture device
could be similar
to the septum puncture device 300, but not include a GSA. In such embodiments,
the septum
puncture device could, for example, rely on the guide coupler for both lateral
deflection and
stabilization of the side catheter guide, side catheter, and septum
penetrator. FIGS. 7A and 7B
can be referred to as an illustrative example of such an alternative
embodiment, given that these
figures show only a portion of the septum puncture device 300, not including
the GSA 350.
[00161]
FIGS. 10-12 illustrate in perspective bottom view, perspective side view,
and
side view, respectively a portion of a septum puncture device 500 in a
deployed configuration,
according to another embodiment. Similar to or the same as described with
respect to other
septum puncture devices described herein (e.g., septum puncture device 100,
septum puncture
device 300, etc.), the septum puncture device 500 can be used to access a left
side of the heart
(e.g., left atrium) from the right side of the heart (e.g., right atrium) and
to deliver a guidewire
to the left side of the heart. The septum puncture device 500 can be
constructed the same as or
similar to, and can function the same as or similar to, any of the septum
puncture devices
described herein. Thus, portions of the septum puncture device 500 are not
described in further
detail herein.
[00162]
In this embodiment, as shown, the septum puncture device 500 includes a
main
shaft 520 that defines a lumen therethough (e.g., through which a guide wire
can be routed).
The main shaft 520 includes a proximal section 520A at its proximal end, a
distal section 520C
at its distal end, and an inflation section 520B disposed therebetween. The
proximal section
520A defines a first aperture AP1, and the inflation section 520B defines a
second aperture
Al2 and a third aperture AP3 disposed opposite the second aperture AP2, both
in fluid
communication with the lumen of the main shaft 520. As shown best in FIG. 12,
in this
embodiment, a proximal end of the inflation section 520B is inserted into the
proximal section
520A, and a distal end of the inflation section 520B is inserted into the
distal section 520C. In
alternative embodiments, however, other main shaft designs suitable to provide
stability for
lateral puncture can be used. In some embodiments, for example, two or three
of the proximal
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section, inflation section, distal section can be monolithically formed,
rather than formed
separated and then coupled together.
[00163]
The septum puncture device 500 further includes a side catheter guide 530
that
extends distally into the lumen of the main shaft 520 at a proximal end of the
proximal section
520A of the main shaft 520, out the first aperture AP1 (see e.g., FIG. 11),
towards and into the
second aperture AP2, and out the third aperture AP3, as shown.
[00164]
The inflation section 520B of the main shaft 520 defines (1) a first
inflation
portion 526A about which a first stabilizer / actuator guide (-GSA") 550A is
disposed, and (2)
a second inflation portion 526B about which a second stabilizer / actuator
guide ("GSA") 550B
is disposed. In this embodiment, the first GSA 550A and the second GSA 550B
are balloons
disposed circumferentially about the main shaft 520. A distal portion of the
side catheter guide
530 can be translationally coupled (relative to the main shaft 520) directly
to the main shaft
520 between the first GSA 550A and the second GSA 550B (e.g., using any
suitable fastener),
or the distal portion of the side catheter guide 530 can be translationally
fixed relative to the
main shaft 520 by way of contact, abutment, interference fit, etc., from the
distal side surface
of the first GSA 550A and the proximal side surface of the second GSA 550B. In
some
implementations, the distal portion of the side catheter guide 530 can be
fastened to one or both
of the first GSA 550A or second GSA 550B.
[00165]
The first GSA 550A and the second GSA 550B are configured to be inflated
for
deployment and deflated for delivery or withdrawal. To inflate, the first GSA
550A is
configured to receive one or more fluids (e.g., one or more of saline, air, or
a contrast agent for
visualization) from and through an opening 0 (FIG. 12) defined by the first
inflation portion
526A; and similarly, the second GSA 550B is configured to receive one or more
fluids from
and through an opening 0 (FIG. 12) defined by the second inflation portion
526B. In use, for
example, one or more fluids can be conveyed through the lumen of the main
shaft 320 and into
a volume defined by the first GSA 550A (via the opening 0 in the first
inflation portion 526A)
and into a volume defined by the second GSA 550B (via the opening 0 in the
second inflation
portion 526B). The same fluid(s) can be withdrawn from the first GSA 550A and
the second
GSA 550B (e.g., via the same pathway used to deliver the fluid(s)) to deflate
the first GSA
550A and the second GSA 550B such that the cross-sectional area or footprint
of the first GSA
550A and the second GSA 550B is reduced to facilitate removal from the
patient. The balloons
can be any size suitable to perform that desired functionality disclosed
herein, for example, in
some embodiments, the balloons can be 20mm or about 20mm in diameter when
inflated. In
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some implementations of this embodiment, the septum puncture device 500 can
include a GSA
actuator (not shown, but e.g., disposed at or operably coupled to a handle of
the septum
puncture device, which is also not shown) configured to inflate or deflate the
first GSA 550A
and the second GSA 550B.
[00166]
As shown, and similar to other embodiments described herein, routing the
side
catheter guide 530 distally around the first GSA 550A and then through a
pathway defined by
and between the first GSA 550A and the second GSA 550B, the side catheter
guide 530
assumes a curve such that a length of the side catheter guide 530 extends from
beyond a first
side of the main shaft 520 to beyond a second side of the main shaft 520
(e.g., at least a distance
equal to a diameter of the first GSA 550A or the second GSA 550B, when
inflated), thereby
providing a suitable straight or substantially straight length (e.g., about
3cm to about 4cm in
some instances) to house a septum penetrator (or a rigid portion of the septum
penetrator), as
described in further detail herein with respect to other embodiments.
[00167]
As recited above, some components of the septum puncture device 500 are
similar to or the same as (in form or function) components from other septum
puncture devices
described herein, and some of those components are not described or
illustrated again with
respect to the septum puncture device 500. For example, in some embodiments,
the septum
puncture device 500 includes a body, a handle, a side catheter (with or
without an end effector
extending therefrom), a septum penetrator, guide wire coupler(s), or actuators
(e.g., shaft
actuator, GSA actuator, side catheter actuator, penetrator actuator), none of
which are
illustrated in FIGS. 10-12. The following example method of using the septum
puncture device
500 refers to some of those components.
[00168]
In use, for example and similar to as described herein with respect to
other
embodiments, the septum puncture device 500 can be inserted into the patient
(e.g., via a
femoral vein puncture), through the patient's vasculature, and into the heart
of the patient such
that the main shaft 520 spans the IVC, RA, and SVC to provide a stable
platform against which
the septum puncture device 300 can be deployed to puncture the FO. In some
instances, the
septum puncture device 500 can be inserted over a guide wire (not shown) that
is routed through
the lumen of the main shaft 520 (or in some instances, through a guide wire
coupler, not
shown). During such delivery, the septum puncture device 500 is in its
delivery configuration
in which the first GSA 550A and the second GSA 550B deflated (not shown). In
this manner,
for example, the cross-sectional area or footprint of the septum puncture
device 500 can be
minimized or optimized for minimally-invasive delivery through the patient.
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[00169]
With the main shaft 520 extended from the IVC to the SVC, and the first
GSA
550A, the second GSA 550B, and the distal end portion of the side catheter
guide 530 disposed
within the RA, the first GSA 550A and the second GSA 550B can be inflated to
deploy the
side catheter guide 530, as shown in FIGS. 10-12. Inflating the first GSA 550A
and the second
GSA 550B in this manner causes the distal end portion of the side catheter 530
(1) to laterally
deflect to a preferred angle and towards the FO, and (2) to stabilize the
distal end portion of
the side catheter 530, to facilitate subsequent tenting or puncturing of the
FO. In this
embodiment, as shown in FIG. 11, the deflection occurs such that the distal
end portion of the
side catheter guide 530 laterally deflects to perpendicular or about
perpendicular to a central
axis of the main shaft 520 or to a surface line tangent to the FO or the main
shaft 520. In
alternative embodiments, as described with respect to other embodiments, the
lateral deflection
may selectively be less than about or greater than about 90 degrees. Although
not shown, in
some instances, the first GSA 550A or the second GSA 550B can be inflated such
that the first
GSA 550A or the second GSA 550B become indented with an impression of the
distal end
portion of the side catheter guide 530 or envelop a portion of the same. In
this manner, the side
catheter guide 530 can be sufficiently stabilized and temporarily sufficiently
coupled to the
first GSA 550A or the second GSA 550B. In some embodiments, the GSA 550A or
the GSA
550B can be configured to possess variable amounts of compliance. In some
embodiments,
for example, a distal portion of the first GSA 550A and a proximal portion of
the second GSA
550B can have a first level of compliance while another portion of the first
GSA 550A and
another portion of the second GSA 550B can have a second level of compliance
that is different
from the first level of compliance. Further, in some embodiments, the distal
side of the first
GSA 550A and the proximal side of the second GSA 550B can include features
configured to
further stabilize the side catheter guide 530 relative to the GSA 550. These
features can
include, for example, dimples, protrusions, adhesives, or the like.
[00170]
With the first GSA 550A and the second GSA 550B actuated and in sufficient
contact with the side catheter guide 530 and providing sufficient
stabilization of the side
catheter guide 530 relative to the main shaft 520, an end effector (not shown)
can be deployed
from the side catheter guide 530, similar to or the same as described in other
embodiments. To
deploy the end effector, for example, a side catheter (not shown) from which
the end effector
distally extends can be advanced relative to the side catheter guide 530
(e.g., through a lumen
defined by and extending through the side catheter guide 530) such that the
end effector is
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allowed to expand to its expanded / deployed configuration as it is released
from its constrained
or delivery configuration within the lumen of the side catheter guide 530.
[00171]
With the end effector deployed, the end effector can be advanced towards
and
into contact with the FO to tent the FO. As described elsewhere herein, both
the end effector
and the tenting of the FO (or other portion of the septum) are visible to the
operator from
outside the patient via various imaging technologies, such as, for example,
ultrasound or related
suitable imaging technologies. To advance the end effector towards and into
contact with the
FO, the side catheter can be advanced (e.g., by actuating a side catheter
actuator, not shown)
relative to the side catheter guide 530) or by manipulating (i.e., translating
or rotating) the main
shaft 520.
[00172]
In instances in which the operator is not satisfied with the location on
the septum
contacted or tented by the end effector, e.g., if the end effector is
misaligned with the FO, the
end effector can be withdrawn from contact with the FO or septum (e.g., by
withdrawing the
side catheter relative to the side catheter guide 530 or by manipulating the
main shaft 520), and
then the operator can make another approach at landing the end effector on the
FO in a manner
sufficient for subsequent puncturing of the FO. This process can be repeated
until the operator
is satisfied.
[00173]
With the FO properly tented by the end effector, the septum penetrator
(not
shown) can be advanced relative to the side catheter (e.g., through a lumen
defined by and
extending through the side catheter) and the end effector, and through the FO
and into the LA.
With the FO sufficiently penetrated by the septum penetrator, and a distal end
of the septum
penetrator disposed within the LA, a second guide wire can advanced relative
to and through a
lumen defined by and extending through the septum penetrator such that at
least a distal end
portion of the guide wire exits the distal end of the septum penetrator and
advances into the
LA, which can be confirmed by the operator under imaging technologies.
[00174]
Once confirmed that the second guide wire is sufficiently disposed within
the
LA, the septum penetrator can be withdrawn relative to and into the lumen of
the side catheter,
the first GSA 550A and the second GSA 550B can be deflated, in preparation for
removal of
the septum puncture device 500 from the patient. Further, in some instances,
the end effector
can be withdrawn relative to and into the lumen defined by the side catheter.
[00175]
With the septum penetrator withdrawn from the LA, the operator can
manipulate
the septum puncture device 500 (e.g., the handle, the body, or the main shaft
520) to withdraw
the entire septum puncture device 500 along the second guide wire until the
septum puncture
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device 500 exits the patient, leaving the second guide wire within the patient
for subsequent
access to the left atrium (e.g., without further penetration of the FO).
[00176]
In some implementations, during delivery, the side catheter guide 530 (or
any
components disposed therein) can be protected from deploying or advancing
prematurely or
from inadvertently undesirably contacting the patient's anatomy. In some
instances, for
example, the side catheter guide 530 (or side catheter and end effector
extending or protruding
from the distal end of the side catheter guide 530) can be at least partially
encased within the
first GSA 550A and the second GSA 550B, in their delivery, or deflated
configurations. As an
example illustration, FIGS. 13A-13F show a partial delivery and deployment
sequence. FIG.
13A shows the septum puncture device 500 in a delivery configuration in which
the first GSA
550A and the second GSA 550B are deflated and disposed circumferentially about
the side
catheter guide 530. FIG. 13B shows the first GSA 550A and the second GSA 550B
in
deployed, inflated configurations, in which the side catheter guide 530 is
laterally deflected
relative to the main shaft 520 such that a distal end of the side catheter
guide 530 is directed
towards the FO, and extends proximally in a linear fashion between the first
GSA 550A and
the second GSA 550B, towards and beyond the main shaft 520. Arrow L and arrow
R represent
a linear axis and an angular axis, respectively, along which the main shaft
520 can be adjusted
by the operator to align the distal end of the side catheter guide (or end
effector of the side
catheter) with the FO.
[00177]
FIG. 13C shows the side catheter 560 with end effector 562 advanced from
the
side catheter guide 530 and in contact with and tenting the FO. The side
catheter 560 can be
advanced any suitable distance to probe the FO. In some instances, for
example, the side
catheter 560 can advance about 1 cm to about 4 cm from the side catheter guide
530. In other
instances, as another example, the side catheter 560 can advance about 2 cm to
about 3 cm
from the side catheter guide 530.
[00178]
FIG. 13D shows the septum penetrator 570 advanced from the side catheter
560,
through the FO and into the LA, and a guide wire GW2 (with a pigtail
configuration) advanced
from the septum penetrator 570 through the FO and into the LA. The septum
penetrator 570
can be advanced any suitable distance from the side catheter 560 to penetrate
the FO and enter
the LA. In some instances, for example, the septum penetrator 570 can be
advanced about 0.5
cm to about 1 cm from the side catheter 560.
[00179]
With the guide wire GW2 disposed within the LA, the septum penetrator 570
can
be withdrawn from the LA, as described in more detail herein, and as shown in
FIG. 13E.
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Further, as shown in FIG. 13F, the first GSA 550A and the second GSA 550B can
be deflated,
and the septum puncture device 500 can be withdrawn relative to and along the
guide wire
GW2, leaving the guide wire GW2 extending from within the LA, through the
puncture in the
FO, into the LA, and through the patient's vasculature and out of the patient,
for subsequent
minimally-invasive access to the LA.
[00180]
Although the septum puncture device 500 is shown and described as having
the
second aperture AP2 and third aperture AP3 in the main shaft 520 through which
the side
catheter guide 530 can be disposed, in other embodiments, a similar septum
puncture device
could include a side catheter guide that extends or is routed along an
exterior surface of the
main shaft, rather than through the main shaft. In such embodiments, for
example, the septum
puncture device can include a guide coupler that is similar to or the same as,
in form or function,
to any of the guide couplers described herein with respect to other
embodiments. The guide
coupler, for example, can be disposed between a first GSA and a second GSA,
and used to
couple (e.g., translationally fixedly couple, and rotatably couple) the side
catheter guide to the
main shaft, such that the side catheter guide can laterally deflect about the
guide coupler in
response to the inflation / deployment of the first GSA and the second GSA.
The guide coupler,
in some implementations, can be a hinge, such as a hinge formed of suture,
similar to or the
same as described herein in other embodiments.
[00181]
Although the septum puncture device 500 is shown and described as having a
side catheter guide 530 through which the side catheter 560 (and end effector
562), septum
penetrator 570, and guide wire GW2 can be slidably disposed, in alternative
embodiments, a
septum puncture device can, for example, not include a side catheter guide.
FIGS. 14A-14K
illustrate such an alternative embodiment. More specifically, FIGS. 14A-14K
illustrate an
example deployment sequence of and at a distal end portion of a septum
puncture device 600,
according to an embodiment.
[001821
Similar to or the same as described with respect to other septum puncture
devices
described herein, the septum puncture device 600 can be used to access a left
side of the heart
(e.g., left atrium) from the right side of the heart (e.g., right atrium) and
to deliver a guidewire
to the left side of the heart. The septum puncture device 600 can be
constructed the same as or
similar to, and can function the same as or similar to, any of the septum
puncture devices
described herein. Thus, portions of the septum puncture device 600 are not
described in further
detail herein.
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[00183]
In this embodiment, as shown in FIG. 14A, prior to deployment, the septum
puncture device 600 has a protective sleeve 629 coupled to and
circumferentially disposed
about a portion of the main shaft 620, the first GSA 650A, the second GSA
650B, and a portion
of the side catheter 660. The protective sleeve 629, for example, can shield
the aforementioned
components of the septum puncture device 600 prior to use of the septum
puncture device 600.
In such instances, the protective sleeve 629 could be removed prior to
insertion of the septum
puncture device 600 into the patient. Further, in some instances, the
protective sleeve 629 can
shield the aforementioned components of the septum puncture device 600 during
delivery of
the septum puncture device 600 into and through the patient. As an example,
the septum
puncture device 600 could be inserted into the patient's vasculature, through
the IVC and into
the RA, similar to as described herein with respect to other embodiments. In
such instances,
the protective sleeve 629 can be configured to prevent inadvertent contact or
trauma to the
patient's surrounding tissue. Additionally, or alternatively, the protective
sleeve 629 can be
configured to constrain the first GSA 650A, the second GSA 650B, or the side
catheter 660 to
define a cross-sectional profile or footprint suitable to be delivered through
the patient. In this
manner, the protective sleeve 629, and components disposed therein, could be
delivered to the
RA of the heart, and then the protective sleeve 629 can be withdrawn along the
main shaft 620
(or in some instances advanced along the main shaft 620) to expose the first
GSA 650A, the
second GSA 650B, and a portion of the side catheter 660.
[00184]
With the protective sleeve 629 withdrawn or advanced, the side catheter
630 can
assume it's curved orientation, as described herein in other embodiments and
as shown in FIG.
14B. Further, as shown in FIG. 14B, in some instances the end effector 662 can
be disposed
between the first GSA 650A and the second GSA 650B such that the end effector
662 is at least
partially shielded. Said another way, the end effector 662 is spaced a
distance from the central
axis of the main shaft 620 that is less than a radius of the first GSA 650A
and the second GSA
650B. Further, the side catheter 660 is slidably disposed relative to the main
shaft 620 and the
first GSA 650A and the second GSA 650B. As such, the side catheter 660 (and
end effector
662) can be advanced relative to the main shaft 620 to provide sufficient
space within which
the first GSA 650A and the second GSA 650B can expand or inflate, as shown in
FIG. 14C.
[00185]
With the end effector 662 advanced in this manner, the first GSA 650A and
the
second GSA 650B are inflated, as shown in FIG. 14D. Also, as shown, inflation
of the first
GSA 650A and the second GSA 650B causes the distal end portion of the side
catheter 660 to
laterally deflect and to stabilize with respect to the main shaft 620. The
lateral deflection was
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measured during an experiment, and the measurement is shown in FIGS. 14E and
14F as an
illustrative example. As shown in FIG. 14E, prior to inflation of the first
GSA 650A and the
second GSA 650B, an angle between (1) a central axis of the portion of the
side catheter 660
extending distally from (a) the central axis of the main shaft 620 and (b) the
first GSA 650A
and the second GSA 650B, and (2) the central axis of the main shaft 620, is
between about 65
to about 70 degrees. Upon inflation of the first GSA 650A and the second GSA
650B, that
angle changes to about 90 degrees, as shown in FIG. 14F.
[00186J
With the side catheter 660 laterally deflected in this manner, the side
catheter
660 optionally can be advanced further relative to the main shaft 620 such
that the effective
length (e.g., the length of the side catheter extending distally from the
closest external surfaces
of the first and second GSA 650A, 650B) is increased to a desirable amount for
tenting of the
FO, as shown in FIG. 14G. Next, the septum penetrator 670 can be advanced
relative to the
end effector 662, as shown in FIGS. 14H, to, for example, penetrate the FO.
Further, and as
described herein in other embodiments, a guide wire GW2 can be advanced
through a lumen
defined by the septum penetrator 670 and relative to the end effector 662, as
shown in FIG.
141.
[00187]
With the guide wire GW2 sufficiently advanced, the septum penetrator 670
can
be withdrawn into the lumen defined by the side catheter 670 (e.g., to prevent
any inadvertent
contact (and risk of damage) between a sharp edge of the septum penetrator 670
and the guide
wire GW2, and the sharp edge of the septum penetrator 670 and the patient's
surrounding
anatomy, as shown in FIG. 14J. Further, as shown in FIG. 14J, the first GSA
650A and the
second GSA 650B can be deflated, and the side catheter (and end effector 662)
can be
withdrawn about the guide wire GW2, relative to the main shaft 620, and
towards its delivery
position, as shown in FIG. 14K.
[00188]
Although (1) the septum puncture device 500 is shown and described as
having
a side catheter guide 530 routed through a lumen defined by the main shaft 520
(or a central
axis of the main shaft 520), or more specifically, into the second aperture
AP2 and out of the
third AP3 of the main shaft 520, and (2) the septum puncture device 600 is
shown and described
as having a side catheter 660 routed through a lumen or central axis of the
main shaft 620, in
other embodiments, a side catheter guide or side catheter can be routed along
an external
surface of the main shaft, i.e., offset from the central axis of the main
shaft. The side catheter
guide or side catheter, from top view, for example, can be disposed to one
side of the main
shaft. Offsetting the side catheter guide or side catheter relative to the
central axis of the main
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shaft in this manner in many instances better aligns the distal end of the
side catheter guide or
side catheter with the FO, given the common anatomical location of the FO
relative to the IVC,
SVC, and RA (e.g., measured laterally from a central longitudinal axis from
the IVC to the
SVC). The FO is often offset from a central axis defined from the IVC to the
SVC by about
4mm to about 6mm, so aligning the side catheter guide a comparable distance
offset from the
central axis of the main shaft, may in some instances, place the side catheter
guide or side
catheter in a more suitable position for subsequent puncture. In this manner,
the arrangement
of the side catheter guide or side catheter with the main shaft can optimize
the time and number
of steps required of the operator to locate the FO with the side catheter (or
end effector), for
subsequent puncturing of the FO with the septum penetrator.
[00189]
One such example is illustrated in FIGS. 15-17, which show a septum
puncture
device 700 in a perspective view, front view, and side view, respectively,
according to an
embodiment. Similar to or the same as described with respect to other septum
puncture devices
described herein, the septum puncture device 700 can be used to access a left
side of the heart
(e.g., left atrium) from the right side of the heart (e.g., right atrium) and
to deliver a guidewire
to the left side of the heart. The septum puncture device 700 can be
constructed the same as or
similar to, and can function the same as or similar to, any of the septum
puncture device
described herein. Thus, portions of the septum puncture device 700 are not
described in further
detail herein.
[00190]
In this embodiment, the septum puncture device 700 includes a main shaft
720,
a first GSA 750A, a second GSA 750B, and a side catheter 760 routed around or
about the first
GSA 750A and then between the first GSA 750A and the second GSA 750B, and
along an
external surface of the main shaft 720 (and offset from the central axis of
the main shaft 720),
as shown. In this manner, in some instances, the side catheter 760 can be
better aligned with
the FO of the patient. Although not shown in FIGS. 15-17, in some
implementations, the side
catheter 760 can be slidably attached via a guide coupler (not shown) to the
main shaft 720.
The guide coupler, for example, can be configured to slidably and rotatably
attach the side
catheter 760 to the main shaft 720 to prevent the side catheter 760 from
separating from the
main shaft 720 or from between the first GSA 750A and the second GSA 750B. In
other
implementations, for example, the guide coupler can be attached to, part of,
or extend from the
first GSA 750A or the second GSA 750B. An illustrated example of a guide
coupler 840 of a
septum puncture device 800 is shown in FIGS. 18A-18C, according to an
embodiment.
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[00191]
Similar to or the same as described with respect to other septum puncture
devices
described herein, the septum puncture device 800 can be used to access a left
side of the heart
(e.g., left atrium) from the right side of the heart (e.g., right atrium) and
to deliver a guidevvire
to the left side of the heart. The septum puncture device 800 can be
constructed the same as or
similar to, and can function the same as or similar to, any of the septum
puncture device
described herein. Thus, portions of the septum puncture device 700 are not
described in further
detail herein.
[00192.[
FIGS. 18A-18C illustrate the first GSA 850A and the second GSA 850B in a
deflated, delivery configuration (in which the side catheter 860 is at least
partially axially
aligned with the main shaft 820), a partially inflated, partially deployed
configuration (in which
the side catheter 860 has been laterally deflected a first number of degrees),
and an inflated,
deployed configuration (in which the side catheter 860 has been laterally
deflected a second
number of degrees that is greater than the first number of degrees,
stabilized, and directed
towards the representative model of a FO), respectively.
[00193]
As shown, the guide coupler 840 in this embodiment extends from the main
shaft
820 and circumferentially surrounds or engages the side catheter 860. More
specifically, the
guide coupler 840 defines an eyelet through which the side catheter 860 is
threaded. In this
manner, the side catheter 860 has freedom to translate (advance or be
withdrawn) through the
eyelet. In some implementations, the eyelet can be sized to have at least a
partial interference
fit, thereby providing some friction between the guide coupler 840 and the
side catheter 860
such that the side catheter 860 isn't inadvertently translated. Further, the
guide coupler 840 is
configured to rotate about the main shaft 820 in response to inflation of the
first GSA 850A
and the second GSA 850B, to allow the side catheter 860 to laterally deflect
towards its target
location (e.g., the FO), as shown in FIG. 18C. After delivery of a guide wire
GW2 (not shown),
as discussed herein with respect to other embodiments, the first GSA 850A and
the second
GSA 850B can be deflated and the guide coupler 840 can be rotated in a
direction opposite to
the direction it rotated during deployment.
[00194]
Although various embodiments of septum puncture devices described herein
disclose having a single side catheter guide or single side catheter (with
single end effector), in
some embodiments, a septum puncture device can include two side catheter
guides or two side
catheters (with or without the side catheter guide(s)). Such an embodiment is
illustrated in
FIGS. 19-21. FIGS. 19 -21 illustrate a septum puncture device 900 in
perspective view, front
view, and detailed, partial perspective view, respectively, that includes a
two side catheters.
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[00195]
Similar to or the same as described with respect to other septum puncture
devices
described herein, the septum puncture device 900 can be used to access a left
side of the heart
(e.g., left atrium) from the right side of the heart (e.g., right atrium) and
to deliver a guidevvire
to the left side of the heart. The septum puncture device 900 can be
constructed the same as or
similar to, and can function the same as or similar to, any of the septum
puncture device
described herein. Thus, portions of the septum puncture device 900 are not
described in further
detail herein.
[00196[
In this embodiment, the septum puncture device 900 includes a first side
catheter
960A and second side catheter 960B, each being configured to be delivered and
deployed
within a patient, as described herein with respect to other embodiments. The
septum puncture
device 900 further includes a first end effector 962A extending from the first
side catheter 960A
and a second end effector 962B extending from the second side catheter 960B.
As shown, the
main shaft 920 defines a lumen through which the first side catheter 960A and
the second side
catheter 960B can be slidably disposed, and an aperture AP through which the
first side catheter
960A and the second side catheter 960B can be advanced or withdrawn. The
septum puncture
device 900 further includes a first GSA 950A disposed circumferentially about
the main shaft
920 and proximal to the aperture AP, and a second GSA 950B disposed
circumferentially about
the main shaft 920 and distal to the aperture AP. In this manner, the first
side catheter 960A
and the second side catheter 960B can extend distally from the AP and through
a pathway
defined between the first GSA 950A and the second GSA 950B.
[001971
In use, similar to as described herein with respect to other embodiments,
the first
GSA 950A and the second GSA 950B can be inflated to laterally deflect and
stabilize (e.g.,
laterally, axially (proximally, distally)) the first side catheter 960A and
the second side catheter
960B, such that a first and second septum penetrator (not shown) can be
advanced or withdrawn
there through, and a first and second guide wire (not shown), can be advanced
and withdrawn
via the first and second septum penetrator. In accessing the LA, for example,
with the first
GSA 950A and the second GSA 950B disposed within the RA in inflated, deployed
configurations, and the first side catheter 960A and the second side catheter
960B directed
towards the septum, the first side catheter 960A and the second side catheter
960B can be
advanced to tent the FO, and then the first and second septum penetrators can
be advanced
(optionally simultaneously) to pierce the FO, or other target location(s) of
the septum. The
puncture sites can be separated by a predefined distance, set by a distance
between the side
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catheter lumens. With two punctures in the septum, two guide wires can then be
advanced
(optionally simultaneously) into the LA, one through each puncture.
[00198]
Although the septum puncture device 900 is shown and described as having
two
GSAs, in other embodiments, a septum puncture device can be similar to or the
same as the
septum puncture device 900, but include only a single GSA. An example
embodiment is shown
in FIGS. 22 and 23, in which a septum puncture device is shown in front view
and perspective
view, respectively. Similar to or the same as described with respect to other
septum puncture
devices described herein, the septum puncture device 1000 can be used to
access a left side of
the heart (e.g., left atrium) from the right side of the heart (e.g., right
atrium) and to deliver two
guidewires to the left side of the heart. The septum puncture device 1000 can
be constructed
the same as or similar to, and can function the same as or similar to, any of
the septum puncture
device described herein. Thus, portions of the septum puncture device 1000 are
not described
in further detail herein.
[00199]
In this embodiment, the septum puncture device 1000 includes a first side
catheter 1060A and second side catheter 1060B, each being configured to be
delivered and
deployed within a patient, as described herein with respect to other
embodiments. The septum
puncture device 1000 further includes a first end effector 1062A extending
from the first side
catheter 1060A and a second end effector 1062B extending from the second side
catheter
1060B. As shown, the main shaft 1020 defines a lumen through which the first
side catheter
1060A and the second side catheter 1060B can be slidably disposed, and an
aperture AP
through which the first side catheter 1060A and the second side catheter 1060B
can be
advanced or withdrawn. The septum puncture device 1000 further includes a GSA
1050
disposed circumferentially about the main shaft 1000 and distal to the
aperture AP. In this
manner, the first side catheter 1060A and the second side catheter 1060B can
extend distally
from the AP and along a proximal end surface of the GSA 1050, as shown.
[00200]
Although not shown, with the GSA 1050 in its deflated, delivery
configuration,
the first side catheter 1060A and the second side catheter 1060B can be
orientated in a more
delivery-friendly position, e.g., about parallel to the central axis of the
main shaft 1020, along
an external surface of the deflated GSA 1050. As described in further detail
herein with respect
to other embodiments, the GSA 1050 can be configured to be inflated or
deployed to laterally
deflect the first side catheter 1060A and the second side catheter 1060B
relative to the main
shaft 1020, as shown in FIGS. 22 and 23. As described in further detail herein
with respect to
other embodiments, the GSA 1050 can also be configured to stabilize the first
side catheter
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1060A and the second side catheter 1060B relative to the main shaft 1020. In
some
implementations, for example, the GSA 1050 can include dimples, protrusions,
ridges,
adhesives, etc., configured to improve stabilization of the first side
catheter 1060A and the
second side catheter 1060B.
[00201]
With the first side catheter 1060A and the second side catheter 1060B
laterally
deflected and stabilized in this manner, the first side catheter 1060A and the
second side
catheter 1060B can be advanced relative to the main shaft 1020 and towards a
target tissue
(e.g., the septum, or FO), and a first septum penetrator, a second septum
penetrator, a first guide
wire, and a second guide wire (none of which are shown in FIGS. 19 and 20) can
be deployed,
e.g., to penetrate the septum and delivery the first guide wire and the second
guide wire.
[00202]
Although the septum puncture device 1000 is shown and described as having
two side catheters, in other embodiments, a septum puncture device can be
similar to or the
same as the septum puncture device 1000, but include only a single GSA. An
example
embodiment is shown in FIGS. 24 and 25, in which a septum puncture device is
shown in
perspective front view and perspective side view, respectively. Similar to or
the same as
described with respect to other septum puncture devices described herein, the
septum puncture
device 1100 can be used to access a left side of the heart (e.g., left atrium)
from the right side
of the heart (e.g., right atrium) and to deliver two guidewires to the left
side of the heart. The
septum puncture device 1100 can be constructed the same as or similar to, and
can function the
same as or similar to, any of the septum puncture device described herein.
Thus, portions of
the septum puncture device 1100 are not described in further detail herein.
[00203]
In this embodiment, the septum puncture device 1100 includes a side
catheter
configured to be delivered and deployed within a patient, as described herein
with respect to
other embodiments. The septum puncture device 1100 further includes an end
effector 1162
extending from the side catheter 1160. As shown, the main shaft 1120 defines a
lumen through
which the side catheter 1160 and the second side catheter 1160 can be slidably
disposed, and
an aperture AP through which the side catheter 1160 and the second side
catheter 1160 can be
advanced or withdrawn. The septum puncture device 1100 further includes a GSA
1150
disposed circumferentially about the main shaft 1100 and distal to the
aperture AP. In this
manner, the side catheter 1160 can extend distally from the AP and along a
proximal end
surface of the GSA 1150, as shown.
[00204]
Although not shown, with the GSA 1150 in its deflated, delivery
configuration,
the side catheter 1160 can be orientated in a more delivery-friendly position,
e.g., about parallel
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to the central axis of the main shaft 1120, along an external surface of the
deflated GSA 1150.
As described in further detail herein with respect to other embodiments, the
GSA 1150 can be
configured to be inflated or deployed to laterally deflect the side catheter
1160 relative to the
main shaft 1120, as shown in FIGS. 24 and 25. As described in further detail
herein with
respect to other embodiments, the GSA 1150 can also be configured to stabilize
the side
catheter 1160 relative to the main shaft 1120. In some implementations, for
example, the GSA
1150 can include dimples, protrusions, ridges, adhesives, etc., configured to
improve
stabilization of the first side catheter 1160.
[00205]
With the side catheter 1160 laterally deflected and stabilized in this
manner, the
side catheter can be advanced relative to the main shaft 1120 and towards a
target tissue (e.g.,
the septum, or FO), and a first septum penetrator, a second septum penetrator,
a first guide
wire, and a second guide wire (none of which are shown in FIGS. 24 and 25) can
be deployed,
e.g., to penetrate the septum and delivery the first guide wire and the second
guide wire.
[00206]
An example delivery and deployment of the septum puncture device 1100 in
the
context of a heart of a patient is shown in FIGS. 26A and 26R As shown in FIG.
26A, the
septum puncture device 1100 can be disposed within the RA of the heart, such
that the main
shaft 1120 spans the IVC, RA, and SVC, and the GSA 1150 and the side catheter
1160 are
disposed within the RA. As described in further detail herein with respect to
other
embodiments, the GSA 1150 can be inflated into its deployed configuration to
laterally deflect
and stabilize the side catheter 1160 relative to the main shaft 1120 and
towards the FO, as
shown in FIG. 26B. Further as shown in FIG. 26B, the side catheter 1160 can be
advanced
such that the end effector 1162 contacts or tents the FO, after which the
septum penetrator 1170
can be advanced relative to and distally from the end effector 1162, and the
guide wire GW2
can be advanced into the LA.
[00207]
Although various embodiments of septum puncture devices are described
herein
as having one or more GSAs, some of which can be a balloon, having a
particular shape, size,
etc., any of the embodiments described herein can be modified to have one or
more GSAs
having any shape, size, inflation volume, material(s), surface feature(s),
etc. suitable to be
inflatably and deflatably coupled to a main shaft, and to laterally deflect
and stabilize one or
more side catheter guides or one or more side catheters (and any components
disposed therein,
such as, for example, end effectors, septum penetrators, and guide wires).
Various
embodiments of GSAs, as illustrative examples, are described below with
respect to FIGS. 27-
34, and referred to as being part of septum puncture devices 1200-1900, all of
which can be
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the same has or similar to, and function the same as or similar to, other
septum puncture devices
described herein. Thus, portions of the septum puncture devices 1200-1900 are
not described
in further detail herein.
[002081
In some embodiments, for example, a GSA can have a concave or a convex
shape. One such embodiment is illustrated in FIG. 27, which shows a portion of
a septum
puncture device 1200 including a first GSA 1250A having a concave shape at its
distal end,
and a second GSA 1250B, disposed distal to the first GSA 1250A, and having a
convex shape
at its proximal end. As shown, such a combination of shapes can define a
pathway through
which the side catheter 1260 can be slidably disposed (or through which a side
catheter guide
can be disposed, in alternative embodiments).
[00209]
In another embodiment, a GSA can be configured to define an optimal
pathway
along which a side catheter guide or side catheter can extend from a proximal
end of the GSA
to a distal end of the GSA. One such embodiment is illustrated in FIG. 28,
which shows a
portion of a septum puncture device 1300 including a first GSA 1350A having a
particular
curve C along which the side catheter 1360 (or side catheter guide in other
implementations)
can extend and engage with the first GSA. As shown, in this embodiment, the
curve C is
different from the corresponding section of the second GSA 1350B.
[00210]
In some embodiments, a septum puncture device can include one or more GSAs
with multiple lobes (bi-lobed, tri-lobed, etc.). Multiple lobes, for example,
can reduce or limit
the footprint of the GSAs, thereby reducing the risk of undesirable occlusion
within the patient.
In instances in which the GSAs are disposed within a patient's RA, for
example, it may be
advantageous to minimize the cross-sectional area or footprint of the GSAs to
allow blood to
flow in line with normal functioning of the heart. A tri-lobed GSA, for
example, is shown in
FIG. 29, in top view. As shown, the main shaft 1420 (of a septum puncture
device 1400)
extends axially between a first lobe GSA 1450A, a second lobe GSA 1450B, and a
third lobe
GSA 1450C, with the first lobe GSA 1450A defining a pathway through which a
side catheter
or side catheter guide can be routed.
[00211]
In some embodiments, a septum puncture device can include GSAs with
multiple
lobes in which at least two of the multiple lobes are dissimilar in size or
shape, as illustrated in
FIG. 30, in top view. As shown in FIG. 30, the septum puncture device 1500
includes a first
lobe GSA 1550A, a second lobe GSA 1550B, and a third lobe GSA 1550C, in which
the first
lobe GSA 1550A has a size different from a size of the second lobe GSA 1550B.
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[00212]
In some embodiments, to further reduce the risk of blood flow occlusion,
one or
more GSAs can have a particular aspect ratio. For example, a portion of a
septum puncture
device 1600 is in FIG. 31, in side view, in which a first GSA 1650A and a
second GSA 1650A
have a collective height of Ll. Minimizing Li, in some instances, can help
limit any risk of
blood flow occlusion. In this implementation, for example, Li is less than a
collective width
or collective diameter of the first GSA 1650A and the second GSA 1650B, as
illustrated by L2.
[00213]
In some embodiments, a septum puncture device can include interlocked
GSAs.
For example, as shown in FIG. 32, in side view, a first tri-lobed GSA 1750A
and a second tri-
lobed GSA 1750B of a septum puncture device 1700 are rotatably offset about
the main shaft
1750 and relative to each other, and then brought into engagement and
interlocked. In some
implementations, for example, the first tri-lobed GSA 1750A can be rotated
about 60 degrees
about the main shaft 1750 and relative to the second tri-lobed GSA 1750B, and
then
interlocked. In other implementations, other degrees of rotations can be used.
[00214]
In some embodiments, a septum puncture device can include an asymmetric
GSA. For example, as shown in FIG 33, in side view and top view, a septum
puncture device
1800 includes an asymmetric GSA 1850 circumferentially disposed about a main
shaft 1820.
[002151
In some embodiments, a septum puncture device can include two side
catheters
(or side catheter guides) extending and disposed between GSAs in different or
opposite
directions such that the main shaft can be rotated to selectively align one,
but not the other, side
catheter (or side catheter guide) with a target location to be penetrated. For
example, as shown
in FIG. 34, in side view, a septum puncture device 1900 includes a first GSA
1950A and a
second GSA 1950B, collectively defining two pathways therebetween in an
opposite
directions. In this manner, as shown, a first side catheter 1960A can be
disposed in or routed
through the first pathway defined between the first GSA 1950A and the second
GSA 1950B,
and a second side catheter 1960B can be disposed in or routed through the
second pathway
defined between the first GSA 1950A and the second GSA 1950B. In use, for
example, an
operator can rotate the main shaft 1920 about its central axis to selectively
align only one (at a
time) of the first GSA 1950A or the second GSA 1950B with a target location
(e.g., the septum,
or FO).
[00216]
In some embodiments, a septum puncture device can include a guide coupler
that
is configured to couple a side catheter guide or side catheter (without the
side catheter guide in
some embodiments) to a main shaft such that the guide coupler is slidable with
the side catheter
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and relative to the main shaft. An exemplary embodiment is shown in FIGS. 35A-
35D, in
which a septum puncture device 2000 in shown in various stages of a deployment
sequence.
[00217]
Similar to or the same as described with respect to other septum puncture
devices
described herein, the septum puncture device 2000 can be used to access a left
side of the heart
(e.g., left atrium) from the right side of the heart (e.g., right atrium) and
to deliver a guidewire
to the left side of the heart. The septum puncture device 2000 can be
constructed the same as
or similar to, and can function the same as or similar to, any of the septum
puncture device
described herein. Thus, portions of the septum puncture device 2000 are not
described in
further detail herein.
[00218]
In this embodiment, the septum puncture device 2000 includes a body (not
shown) slidably disposed about a side catheter guide 2030 and a telescopable
main shaft 2020.
The side catheter guide 2030 is coupled to the main shaft 2020 via a guide
coupler 2040, as
shown in FIG. 35A. The guide coupler 2040 is slidable relative to the main
shaft 2020.
Disposed distal to the body (not shown) is a pusher 2096 slidably and
circumferentially
disposed about the main shaft 2020. The main shaft 2020 includes a GSA 2050
disposed distal
to the guide coupler 2040. The pusher 2096 is configured to be advanced
relative to the main
shaft 2020 and into contact with the guide coupler 2040 to push / advance the
guide coupler
2040, and attached side catheter guide 2030, towards and into contact with the
GSA 2050, such
that a distal end portion of the side catheter guide 2030 laterally deflects
about the guide coupler
2040 and the GSA 2050, similar to as described herein in other embodiments,
and as shown
across FIGS. 35A-35D.
[00219]
In some procedures involving a septum puncture device it may be desirable
to
sense various parameters, such as pressure, flow, temperature, oxygen, etc.,
at or near the
septum puncture device, e.g., within a heart of a patient. In a procedure to
access the LA of
the heart, for example, it may be desirable to determine a pressure within the
heart, such as
within the RA or the LA. Accordingly, in any of the embodiments described
herein, a sensor
can be coupled to the septum puncture device. In some implementations, for
example, a septum
puncture device can include an intracardiac echo ("ICE") sensor configured to
enhance
visualization capabilities for the operator during the procedure. An
illustrative example is
shown in FIG. 36. FIG. 36 illustrates a portion of a septum puncture device
2100 having an
ICE sensor disposed within a catheter C. The catheter can be representative of
a main shaft, a
side catheter guide, a side catheter, or a septum penetrator. In this manner,
the ICE sensor can
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provide visualization from various orientations and positions within the
patient, depending on,
for example, a location within the septum puncture device within which the ICE
is disposed.
[00220]
In some embodiments, in addition to or instead of the ICE sensor or other
suitable
sensors, a septum puncture device can include a camera. An illustrative
example is shown in
FIG. 37. FIG. 37 illustrates a portion of a septum puncture device 2200 having
a camera 2295
disposed within a GSA 2250. The camera 2295 can in some implementations be
configured to
communicate wirelessly, while in other implementations the camera 2295 can
have a physical
connection (e.g., wires, fiber optics, etc.) extending proximally from the
camera 2295 through
the main shaft 2220 of the septum puncture device 2200 and out of the patient.
The camera
2295 can be disposed in various positions within the GSA 2250, such as, for
example, in contact
with and coupled to an internal wall of the GSA 2250, or attached to a
catheter disposed within
the GSA 2250 (as described herein with respect to various embodiments). With
the camera
2295 disposed within the GSA 2250, the camera 2295 can provide direct
visualization of the
procedure, e.g., of the septum or FO before, during, or after puncture.
[00221]
In some procedures involving a septum puncture device it may be desirable
to
flush an area adjacent to a septum penetrator, side catheter, or end effector,
e.g., prior to, during,
or after puncturing. To this end, any of the septum puncture devices described
herein could
include a flusher (not shown) having an outlet near the septum penetrator,
side catheter, or end
effector, and being configured to flush (e.g., with saline) an area at or
adjacent to its location
before, during, or after puncturing. The septum puncture device can also
include a pressure
transducer configured to measure pressure, e.g., within the RA or LA, before
or after
puncturing, e.g., to verify a successful puncture.
[00222]
Referring now to FIGS. 38 and 39, an exemplary septum puncture device
(also
referred to herein as "device") 2300 is depicted. In contrast to many of the
embodiments
described above, rather than having a body that contains a main shaft and a
side catheter side-
by-side, this embodiment, the includes a cannula 2306 with a central lumen,
and a stylus) 2310
disposed in the lumen of cannula 2306. Cannula 2306 extends from a distal end
2302 to a
proximal end 2304. Cannula 2306 has an elongate hollow tubular shape having a
lumen running
throughout. Cannula 2306 includes an opening at its distal end 2302 and at
least one elongate
window 2308 adjacent to its distal end 2302, wherein both the opening and the
at least one
window 2308 are fluidly connected to the lumen of cannula 2306. Cannula 2306
can have any
suitable dimensions. For example, cannula 2306 can have an outer diameter of
between about
14 and 22 French (about 5 mm to 7 mm). In some implementations, cannula 2306
can have one
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or more surface coatings. Suitable surface coatings can reduce friction or
irritation, and can
include anticoagulants such as heparin, ethylenediamine tetraacetic acid
(EDTA), oxalate, or
the like.
[00223]
Device 2300 further includes an elongate, flexible, tubular stylus 2310
sized to
fit within the lumen of cannula 2306. Stylus 2310 corresponds functionally to
the combination
of the side catheter guide and side catheter in the embodiments described
above. In some
implementations, stylus 2310 has an articulated construction, such as in FIGS.
40A and 40B.
The articulation can extend for the entire length of stylus 2310, or only for
a section of stylus
2310. In some implementations, stylus 2310 is articulated for a length of
between about 2 cm
to 4 cm from distal end 2302. Stylus 2310 includes a first lumen sized to fit
a hollow needle
2312, which corresponds to the septum penetrator in the embodiments described
above. Hollow
needle 2312 also has a guidewire lumen (corresponding to the guide wire
coupler in the
embodiments described above) sized to fit any suitable guidewire 2314, such
as, for example,
a 0.035" guidewire. In some implementations, stylus 2310 includes one or more
additional
lumen, each additional lumen sized to fit a cable 2316.
[00224]
Device 2300 further includes handle 2318 at its proximal end 2304 (see
e.g., FIG.
41). Handle 2318 includes an extension knob 2320 and at least one angulation
screw 2322.
Extension knob 2320 is connected to the proximal end of stylus 2310 and is
actuatable to extend
and retract stylus 2310 within cannula 2306. Each of the at least one
angulation screw is
connected to the proximal end of a cable 2316 and is actuatable to extend and
retract a
connected cable 2316 within stylus 2310. In some implementations, handle 2318
further
includes one or more actuatable knobs or screws connectable to needle 2312 and
guidewire
2314, such that extension and retraction of needle 2312 and guidewire 2314
within stylus 2310
may be achieved with precision.
i.Referring now to FIGS. 42A-42D, a device 2300 is shown in several stages of
stylus 2320
deployment. In FIG. 42A, stylus 2320 lies flush within cannula 2316 and does
not protrude
out of window 2318. In this configuration (a delivery configuration), cannula
2316 may be
manipulated to a desired location without being impeded by stylus 2320. For
example device
2300 can be delivered to the desired location over a first, deliver guidewire
(not shown,
disposed in the guidewire lumen of hollow needle 2322. After delivery to the
desired location,
the delivery guidewire can be withdrawn from device 2300, and a second
guidewire can be
disposed through device 2300 and the guidewire lumen of hollow needle 2322.
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[00225]
In FIG. 42B through FIG. 24D, a cable 2326 is retracted within stylus
2320, such
as by way of a connected angulation screw 2332 on handle 2328. Retracting a
cable 3226
causes stylus 20 to angulate out of window 2318 in the direction of the
retracted cable 2326,
towards a deployed configuration. For example, a stylus 2320 having two or
more cables 2326
can have its distal tip angulated in the direction of any of the cables 2326
by retracting one or
more cable 2326. The degree of angulation can be varied between about 0
degrees and 90
degrees relative to the axis of the cannula 2316 by adjusting the amount of
retraction of a cable
2326 at a connected angulation screw 2332. In various implementations, stylus
2320 can be
repositioned within cannula 2316 by adjusting extension knob 2330, such as in
Figure 42D.
The combination of angulation control and positional control of stylus 2320
relative to cannula
2316 enables device 2300 to accurately aim needle 2322 towards the FO. In
certain
implementations, device 2300 can be aimed at a specific location of the FO.
The FO can be
divided into quadrants, wherein a puncture in each quadrant is advantageous
for a specific
procedure. For example, device 2300 can be aimed to puncture slightly
superior, posterior,
and 3.5 cm ¨ 4.5 cm above the mitral valve for typical Mitraclip devices, and
is further
configured to puncture posterior and slightly inferior within the FO for
typical left atrial
appendage occlusion devices.
[00226]
In various implementations, device 2300 can further comprise one or more
modifications to enhance its performance. For example, in some embodiments
device 2300
can include one or more additional instruments positioned within a lumen of
stylus 2320, such
as an endoscope assembly, an ultrasound transducer, a temperature sensor, an
oxygen probe, a
flow sensor, a cauterizer, and the like. In another example, device 2310 can
comprise one or
more radiopaque or echo-bright markers positioned on cannula 2316, stylus
2320, or both. The
markers enable the position of device 2310 to be monitored via fluoroscopy or
echocardiography, and can be placed at or near structures of interest,
including but not limited
to the distal tips of cannula 2316 and stylus 2320 and the at least one window
2318.
[00227]
In some embodiments, device 2300 can include an atraumatic support 2334 as
shown in FIGS. 43A and 43B. Atraumatic support 2334 has an elongate tubular
shape and can
fit within the first lumen of stylus 2320 around needle 2322. Atraumatic
support 2334 further
comprises a blunt tip at its distal end. In some implementations the blunt tip
includes an
inflatable balloon. In still another implementation, the blunt tip is a
flattened end-effector. In
still yet another implementation, the blunt tip is a ring-like end-effector.
The blunt tip of
atraumatic support 2334 provides the distal end of stylus 2320 with a greater
surface area to
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minimize injury and increase stability by providing uniform pressure when
placed against a
tissue surface, such as the FO. In FIG. 44, device 2310 is depicted having
atraumatic support
2336 with a bell-tip configured to be collapsible and withdrawable into a
sheath 2338 attached
to the distal end of stylus 2320. Similar to atraumatic support 2334,
atraumatic support 2336
is generally configured to increase the surface area of stylus 2320 that is in
contact with the FO
tissue (prior to puncturing the FO) to decrease the pressure on the tissue and
to reduce or
prevent the likelihood of premature puncture or damage. A collapsible design
enables device
2310 to support a wide bell-tip, such as width of between about 8 mm and 15
mm, within the
confines of cannula 2316. Referring now to FIGS. 45A-45D, the geometry of
atraumatic
support 2336 is shown in detail. Atraumatic support 2336 comprises a bell-tip
at its distal end
having a plurality of undulating folds. Withdrawing atraumatic support 2336
into sheath 2338
causes the bell-tip to bunch together in a controlled manner to fit within
sheath 2338 while
maintaining a space for the passage of needle 2322. Needle 2322 is thereby
capable of being
extended and retracted past the bell-tip of atraumatic support 2336 regardless
of whether the
bell-tip is in a collapsed or an open configuration
[00228]
In some implementations, device 2300 can include a stiffening element
configured to modify the rigidity of a section of device 2323. Increasing the
stiffness of a
section of device 2300, such as a section of cannula 2316 comprising at least
one window 2318,
provides device 2300 with a stable backbone against which an extended stylus
2320 and needle
2322 can push against to penetrate a tissue.
[00229]
Referring now to FIGS. 46A and 46B, device 2300 is depicted with a
stiffening
element comprising spine 2340 and cable 2342. Spine 2340 is positioned within
a second
lumen of cannula 2316 and extends to at least the location of the at least one
window 2318.
Spine 2340 is constructed such that it is flexible when loose and stiff when
compacted. For
example, in some implementations, spine 2340 is an elongate tubular member
constructed from
a compressible polymer. In other implementations, spine 2340 is made from a
long chain of
interlocking segments or from a series of hollow tubules loosely positioned
next to one another,
constructed, for example, from either a plastic or a metal. Cable 2342 runs
through the entire
length of spine 2340 and comprises a tip at its distal end that is wider than
spine 2340.
Retracting cable 2342 presses its tip against the distal end of spine 2340,
thereby compacting
the entire length of spine 2340 and stiffening spine 2340 and the length of
cannula 2316 that
spine 2340 resides in. Extending cable 2342 relieves the pressure that its tip
exerts on the distal
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end of spine 2340, which relaxes spine 2340 and the length of cannula 2316
that spine 2340
resides in.
[00230]
Referring now to FIGS. 47A-47D, an exemplary segmented septum puncture
device 2400 is depicted. Device 2400 comprises a plurality of interlocking
segments 2456
between a distal end 2452 and a proximal end 2454. Interlocking segments 2456
can have any
suitable construction to form an elongate, flexible member. For example, in
some
implementations, tach interlocking segment 2456 comprises a first end having a
small hollow
spherical shape and a second end having a large hollow spherical shape, such
that the first end
of one interlocking segment 2456 fits flush within the second end of another
interlocking
segment 2456 to form a ball joint. A plurality of interlocking segments 2456
connected in this
manner thereby forms an elongate, articulating series of ball joints. In other
implementations,
interlocking segments 2456 can form a gooseneck member, a snake chain member,
and the
like. Device 2400 further comprises at least a first cable 2458a, a second
cable 2458b, and a
third cable 2458c running throughout its entire length, each cable 2458a,
2458b, and 2458c
being arranged equidistantly from each other in a radial pattern. Each cable
2458a, 2458b, and
2458c is attached to the distal-most interlocking segment 2456, such that
retracting any one or
two of cable 2458a, 2458b, or 2458c causes distal end 2452 of device 50 to
curl in the direction
of the retracted cables. Retracting all of the cables 2458a, 2458b, and 2458c
with the same
amount of force causes device 2450 to stiffen and retain its instant shape.
[00231]
Referring now to FIGS. 48A-48D, two exemplary configurations of device
2450
are shown. In FIGS. 48A-48D, device 2450 fits within the lumen of a cannula
2462 and
comprises a needle 2460 running throughout its hollow interior. In FIGS. 48C
and 48D, device
2450 fits within a first lumen of cannula 2462 and needle 2460 fits within a
second lumen of
cannula 2462. In this configuration, the hollow interior of device 2450 can be
used to house
an additional instrument, such as an endos cope assembly, an ultrasound
transducer, any number
of sensor probes (including temperature probes, oxygen sensors, flow sensors),
or the like.
[00232]
Referring now to FIGS. 49-52, an exemplary septum puncture device 2500 is
depicted. Similar to other septum puncture devices described herein, device
2500 comprises a
cannula 2506 (corresponding to the main body of embodiments described above)
extending
from a proximal end 2502 to a distal end 2504. Cannula 2506 has an elongate
hollow tubular
shape having a lumen running between an opening at its proximal end 2502 and
its distal end
2504. In some embodiments, cannula 2506 can be described as having two
segments, a
proximal cannula 206a and a distal cannula 2506b. Near distal end 2504 and
positioned
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between proximal cannula 2506a and distal cannula 2506b, device 2500 comprises
a balloon
2508 (corresponding to the GSA in embodiments described above) that is
inflatable from a
relaxed state to an expanded state. Balloon 2508 is elastic and can be
waterproof Balloon 2508
may be inflatable to a pressure of between about 2 and 20 atmospheres using
any suitable fluid,
including liquids (such as saline) and gases (such as air). Higher inflation
pressures generally
increase the rigidity of balloon 2508 for increased stabilization (i.e.,
vertical and lateral). In
some embodiments, balloon 2508 can be supported by one or external arms or
enveloped in a
mesh for additional stabilization, such as during inflation or tissue
puncture. Balloon 2508 can
be inflated to any desired diameter. In some embodiments, the inflated
diameter of balloon
2508 is contextual to the anatomical space within which it is positioned. For
example, balloon
2508 can be inflated to have a diameter that presses or does not press against
the walls of a
right atrium or the inferior vena cava, for example, to provide further
stability for extending
stylus 2512 to puncture a FO (in some cases generally reducing the image
guidance
requirements).
[00233]
An exemplary internal arrangement of device 2500 is shown in FIG_ 50 in a
cross-sectional view of device 2500 taken proximal to balloon 2508. The lumen
of cannula
2506 is sized to fit an elongate tubular sheath 2510 (corresponding to the
side catheter guide
of embodiments described above), which has a lumen sized to fit an elongate
tubular stylus
2512 (con-esponding to the side catheter of embodiments described above),
which in turn has
a lumen sized to fit hollow needle 2514 (corresponding to the septum
penetrator of
embodiments described above), which in turn has a lumen sized to fit a
guidewire 2516 (e.g.,
the guidewire to be delivered through the septum, corresponding to guidewire
GW2 in
embodiments described above). Cannula 2506 further comprises a second
guidewire lumen
2517 sized to fit a second guidewire GW1 (e.g. the guidewire over which device
2500 is to be
delivered to the desired location, corresponding to guidewire GW1 in
embodiments described
above). Guidewire 2516 can be any suitable guidewire, such as a 0.035"
guidewire, a 0.025"
guidewire, a curlycue wire (e.g., a Baylis left atrial wire), and the like.
Inflation tube 209 is
provided within the lumen of cannula 2506, wherein inflation tube 2509 has an
internal lumen
fluidly connected to balloon 2508 for inflation and deflation. In some
embodiments, cannula
2506 can include one or more stiffening rods 2518 having a selected length to
provide device
2500 with greater stiffness in desired sections.
[00234]
A distal tip of sheath 2510 is secured to an exterior surface of balloon
2508 by
balloon grommet 2507. In this configuration, balloon 2508 can be inflated and
deflated without
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leaking out of balloon grommet 2507 or sheath 2510, and sheath 5210 can
provide access to
the exterior of balloon 2508. Grommet 2507 can include a smooth interior
surface (or other
surface treatment) to reduce friction between stylus 2512 and grommet 2507,
such as when
inflating or deflating balloon 2508 or when advancing or retracting stylus
2512 through sheath
2510. Grommet 2507 may be constructed from any suitable material, including a
plastic, a
metal, a composite, a ceramic, and the like. Grommet 2507 can be further
configured to have
a particular shape or edging, such that the interior surface has a bevel or
chamfer. In one
embodiment, grommet 2507 is positioned at a widest radial point or
circumference on balloon
208, although grommet 2507 is not limited by placement in other locations.
[00235]
In some implementations, stylus 2512 has an atraumatic end effector 2511
positioned at a distal tip (e.g., similar to or the same as depicted in FIG.
59B), wherein end
effector 2511 has a disc-shape configured to tent a tissue (such as the FO)
and apply pressure
without inadvertent puncturing. End effector 2511 can have a bell-tip
configured to be
collapsible and withdrawable into sheath 2510. A collapsible design enables
device 2500 to
support a wide bell-tip, such as width of between about 8 mm and 15 mm, within
sheath 2510.
End effector 2511 can comprise a bell-tip having a plurality of undulating
folds. Withdrawing
end effector 2511 into sheath 2510 causes the bell-tip to bunch together in a
controlled manner
to fit within sheath 2510 while maintaining a space for the passage of needle
2514. Needle
2514 is thereby capable of being extended and retracted past the tip of end
effector 2511
regardless of whether the tip is in a collapsed or an open configuration. In
some embodiments,
the lumen of stylus 1510 can accept a radiofrequency probe having a rounded
metal tip, wherein
the metal tip can be electrified with a current (e.g., radio ablation) to
puncture tissue in lieu of
a needle.
[00236]
Device 2500 is configured to increase lateral stability of needle 214
while
puncturing a tissue, such as the FO. Balloon 2508 has an expanded state (FIG.
49) and a relaxed
state with a thin profile (FIG. 52). The relaxed state defines a delivery
configuration for device
2500 and permits device 2500 to be guided into the right atrium of a patient's
heart such that
distal end 2504 of device 2500 can be positioned within a subject's superior
vena cava. In some
embodiments, balloon 2508 in a relaxed state can be folded over end effector
2511, stylus 2512,
and sheath 2510, wherein the folded configuration (or delivery configuration)
is maintained
during insertion and advancement of device 2500 to a right atrium (similar to
an intraortic
balloon pump). Thus, device 2500 does not generally require a "sheath"
catheter to be
positioned over (i.e., cover) the assembly of a folded balloon 2508, end
effector 2511, stylus
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2512, and sheath 2510 during insertion or withdrawal. In some implementations,
device 2500
can be provided with a casing or sleeve that slides over balloon 2508 in a
relaxed state. In the
expanded state, balloon 2508 is configured to be sufficiently rigid to enhance
stability (e.g.,
lateral stability). In some embodiments, balloon 2508 is configured to
selectively press against
the wall of a right atrium adjacent to the FO to further enhance stability
(e.g., lateral stability).
Device 2500 thereby provides stability in the area immediately behind stylus
2512 by
expanding to provide a larger clearance for FO access.
[00237[
In some embodiments, balloon 2508 is configured to increase the stability
and
precision (i.e., steerability of stylus 2512) of puncturing tissue. For
example, grommet 2507
can be placed at a point on balloon 2508, as described above, such that stylus
2512 protrudes
through balloon 2508 by way of sheath 2510 at an angle with respect to a long
axis of cannula
206 when balloon 2508 is in an expanded state. Thus, balloon 2508 functions
similar to the
GSA in embodiments described above. In some embodiments, the angle is between
about 60
and 180 degrees. In some embodiments, the angle is between about 60 and 140
degrees. In
some embodiments, the angle is between about 60 and 100 degrees. In some
embodiments, the
angle is between about 80 and 120 degrees. In some embodiments, the angle is
approximately
90 degrees. In some embodiments, the angle is approximately 80 degrees (e.g.,
see FIG. 59A).
In some embodiments, the angle is approximately 110 degrees. In some
embodiments, stylus
2512 can protrude approximately 3-4 cm from balloon 2508, such that the
protruding portion
of stylus 2512 is generally straight.
[00238]
Balloon 2508 can be further configured to affect the angle of stylus 2512
when
inflated. For example, balloon 2508 may have a generally spherical-like shape,
while in other
implementations balloon 2508 has an elliptical-like shape. Still further,
balloon 2508 may be
generally symmetric or asymmetric (see FIG. 53A). For example, an asymmetric
balloon 2508
may have an inflated radius that is larger at grommet 2507 than at a portion
of balloon 2508
opposite grommet 2507. In another example, an asymmetric balloon 2508 may have
an inflated
radius that is different at grommet 2507 than at portions of balloon 2508
circumferentially
adjacent to grommet 2507. From a cross-sectional view, cannula 2506 would
thereby be non-
centric with an inflated balloon 2508. Thus, grommet 2507 can be positioned at
a point on
balloon 2508 (having an inflated radius) that provides a preferred angle of
stylus 2512 when
balloon 2508 is in an expanded state to increase stability and steerability of
stylus 2512.
[00239]
In some implementations, balloon 2508 can be shaped to allow blood flow
around balloon 2508. For example, balloon 2508 may have a plurality of lobes,
such as
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longitudinally-oriented (or axially-oriented) lobes (see FIG. 53B). In an
expanded state, lobes
on balloon 2508 provide lateral stability by positioning stylus 2512 at a
preferred angle, while
a varied inflated radius of balloon 2508 permits blood to flow around portions
of balloon 2508
(e.g., if balloon 2508 were to become wedged in either the superior or
inferior vena cava).
Furthermore, lobes on balloon 2508 may have lateral aspects to further
increase lateral stability
of stylus 2512. For example, the plurality of lobes may form spiral-like or
helical shapes or
patterns.
[00240[
In some implementations, balloon 2508 may be positioned adjacent to
cannula
2506. As shown in FIG. 53C, sheath 2510 can be cradled within a groove in
cannula 2506 with
balloon 208 folded around sheath 210. Inflating balloon 2508 pushes sheath
2510 away from
cannula 2506, thereby positioning stylus 2512 within at a desired angle. In
some
implementations, the angle can be adjusted by varying the amount of inflation
in balloon 2508.
[00241]
In some implementations, balloon 2508 may be shaped to have a concave or
convex surface. For example, FIGS. 54A-54C depict a device 2500 having a
balloon 2508 with
a concave proximal surface. Sheath 2510 can be attached to the concave
proximal surface and
curve accordingly, thereby being configured to direct stylus 2512 outward in a
lateral direction.
In some implementations, sheath 2510 can be external or partially external to
balloon 2508.
For example, FIG. 55 depicts a cross-sectional view of a sheath 2510 that is
partially embedded
within an exterior surface of balloon 2508. It should be understood that
sheath 2510 can have
any desired cross-sectional shape, including but not limited to the oval-like
and arcuate cross-
sections depicted in FIG. 55.
[00242]
In various implementations, device 2500 can further comprise one or more
modifications to enhance its performance. For example, device 2500 can be
modified to include
additional sheaths 2510, styluses 2512, needles 2514, and guidewires 2516,
similar to the
embodiments illustrated in FIGS. 19-23 and described above. As shown in FIG.
56, the
additional sheaths 2510, styluses 2512, needles 2514, and guidewires 2516 can
be secured to
balloon 2508 to provide separate puncture sites. In this way, stylus 2512 can
be used to allow
separate punctures to perform different procedures or perform different steps
of a procedure,
such a first needle 2514 for a first procedure or step and a second needle
2514 for a second
procedure or step, etc. Each needle 2514 can be positioned relative to each
other on the FO
(e.g., by positioning stylus 2512 within the right atrium, rotating stylus
2512, and adjusting the
angle of stylus 2512) to preferably position each of the needles 2514 on the
FO for each
respective procedure or step of the procedure that they are being used. Thus,
device 2500 can
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be configured to have multiple extendable elements in close proximity to allow
simultaneous
punctures.
[00243]
In another example, device 2500 can comprise one or more corrugations or
radiopaque, echo-bright, or sonically opaque markers. The markers enable the
position of
device 2500 to be monitored via fluoroscopy or echocardiography, and can be
placed at or near
structures of interest, including but not limited to at least a portion of
cannula 2506, stylus
2512, end effector 2511, balloon 2508, or the like.
[00244J
The various components of the embodiments described herein can be
constructed
using any suitable method. The method of making may vary depending on the
materials used.
For example, components substantially comprising a metal may be milled from a
larger block
of metal or may be cast from molten metal. Likewise, components substantially
comprising a
plastic or polymer may be milled from a larger block, cast, or injection
molded. In some
embodiments, the devices may be made using 3-dimensional ("3D-) printing or
other additive
manufacturing techniques. Further, it should be understood that any
descriptions applicable to
one embodiment of the present invention are equally applicable to all
embodiments described
elsewhere herein.
[00245]
The septum puncture devices described herein can be used in conjunction
with
any suitable handle adapted to the components of the devices. Referring now to
FIG. 57, an
exemplary handle assembly 2680 is depicted. Handle assembly 2600 comprises
main shaft
handle 2602 engaged to a side catheter handle 304 by a side catheter
deflection knob 2606.
Knob 2606 can be tightened to secure handle 2604 to handle 2602 and loosened
to permit
handle 2604 to be actuated relative to handle 2602. Handle assembly 2680
further comprises a
plurality of lumens connected to openings, the lumens and openings sized to
receive guidewires
and needles. Handle 2602 comprises a lumen and opening connected to a balloon
inflation
syringe 2608. A valve or stopcock 2610 is provided at the engagement between
handle 2602
and syringe 2608. Handle assembly 2680 further comprises a needle tube handle
2612 and a
needle safety tab 2614.
[00246]
While handle assembly 2680 is connectable to any septum puncture device
described herein, it is now described in relation to device 2500 by example.
Handle 2602 is
connectable to a proximal end of a cannula of a septum puncture device, such
as cannula 2506,
to manipulate, rotate, advance, and withdraw the cannula. Handle 2604 is
connectable to a
proximal end of a stylus of a septum puncture device, such as stylus 2512, to
manipulate, rotate,
advance, and withdraw the stylus. A venous guidewire 2516 inserted into the
distal opening of
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device 2500 is configured to exit handle assembly 2680 through a side opening
on handle 2602.
Syringe 2608 is fluidly connected to inflation lumen 2509 to inflate and
deflate balloon 2508,
wherein stopcock 2610 can be actuated to maintain or release the inflated
state of balloon 2508.
Needle 2514 is connected at a proximal end to handle 2612, wherein needle
safety tab 2614
can be clipped onto the proximal end of needle 2514 between handle 2604 and
handle 2612 to
prevent inadvertent extension of needle 2514. An atrial guidewire 2516
residing within needle
2514 can extend proximally from handle 2612. In various embodiments, handle
assembly 2680
further comprises one or more actuatable knobs or screws connectable to the
cannula, styluses,
needles, and guidewires, such that extension and retraction of the components
may be achieved
with precision. In some embodiments, handle assembly 2600 can include
components
configured to further steer the components, such as pull cables.
[00247]
Referring now to FIG. 58 and FIGS. 59A-59D, the operation of device 2500
using handle assembly 2680 is described. In FIG. 59A, balloon 2508 is inflated
to an expanded
state using syringe 2608 and is maintained in an expanded state by closing
stopcock 2610. The
inflation of balloon 2508 angles sheath 2510 away from cannula 2506, such as
by an angle of
80 degrees relative to a long axis of cannula 2506. In FIG. 59B, knob 2606 is
loosened to
advance handle 604 towards handle 2602 and extend stylus 2512 out of sheath
2510, exposing
end effector 2511. Stylus 2512 can be extended by any desired length, such as
about 3-4 cm,
and held in place by tightening knob 2606. In FIG. 59C, device 2500 is
positioned adjacent to
an atrial septum such that end effector 2511 presses against and tents the FO.
In FIG. 59D,
needle safety tab 2614 is removed to allow handle 2612 to be advanced toward
handle 304 and
extend needle 2514 out of stylus 2512 to pierce the FO. Needle 2514 can be
extended by any
desired length, such as about 4-10 mm. Atrial guidewire 2516 can then be
advanced in a distal
direction to pass through needle 2514, the FO, and into the left atrium.
[00248]
Another embodiment of a device 2700 is shown in FIGS. 60A to 60D. Device
2700 has a plurality of slits 2775 positioned near its distal end uniformly
distributed around the
body, defining therebetween a plurality of arms 2776. Compressing device 2700
on either side
of the plurality of slits 2775 expands the arms 2776 outwards, exposing stylet
catheter section
2778, which may have a rigid construction, formed by either a hard plastic or
a metal, and
permits at least the distal end 2771 of cannula 2774 to advance proximally
over catheter section
2778 to achieve expansion of arms 2776. In certain embodiments, the distal end
2771 of
cannula 2774 is manipulated using one or more pull cables running through the
length of device
2700. For example, the one or more pull cables can be equally retracted to
expand each arm
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2776 uniformly and to form equally sized openings between each arm 2776. In
another
example, the one or more pull cables can be selectively retracted, such that
pull cables subjected
to more tension cause greater expansion in the arms 2776 closest to those pull
cables, varying
the geometry of the opening between each arm 2776. Expanded arms 2776 provide
clearance
for the extension of stylet 80 out of catheter section 78, and also for the
extension of hollow
needle 82 out of stylet 80 and any desired guidewires out of hollow needle
2782.
[00249]
A device 2700 has a relaxed state with a thin profile (or delivery
configuration,
shown in FIG. 60A) and an expanded state (or deployed configuration, shown in
FIG. 60B).
The relaxed state permits device 2700 to be guided into the right atrium of a
patient's heart
such that the distal end of device 2700 rests in the patient's super vena
cava. In the expanded
state, the plurality of arms 2776 are configured to selectively press against
the wall of the right
atrium adjacent to the FO to enhance stability (e.g., lateral stability).
Device 2700 thereby
provides at least two stable platforms for septum puncture using stylet 2780:
the plurality of
arms 2776 pressing directly against the heart tissue, and the catheter section
2778 suspended
between the plurality of arms 2776. Selective retraction of pull cables in
device 2700 to non-
uniformly expand device 2700 can be desirable in certain situations. For
example, device 2770
can be expanded such that the arms 2776 adjacent to stylet 2780 are greatly
expanded to provide
a larger clearance for FO access, while the arms 2776 behind stylet 2780 can
be expanded to a
lesser degree to increase stability in the area immediately behind stylet
2780.
[00250]
Referring now to FIGS. 61A-61H, further implementations of various
configurations of device 2700 are depicted. While exemplary devices 2700 are
depicted with
three and six arms 2776, it should be understood that device 2700 can have any
suitable number
of arms 2776, such as between about three and ten arms. In certain
embodiments, the plurality
of arms 2776 can each be linked by one or more bands 2786, as shown in FIGS.
61E and 61F.
By linking each arm 2776 to its adjacent arm 2776, band 2786 increases the
stability of device
2700 by mitigating lateral motion of each arm 2776 and prevents injury from
excessive
expansion of arms 2776. In certain embodiments, the plurality of arms 2776 can
be encased in
covering 2788, as shown in FIGS. 61G and 61H. Covering 2788 is elastic and can
be
waterproof to smoothly guide device 2700 in a relaxed state and to provide a
greater surface
area in an expanded state that spreads out pressure and decrease trauma.
Covering 2788 also
provides the same benefits of band 86, in that covering 88 mitigates lateral
motion and
excessive expansion of arms 76 to improve stability. In FIG. 61H, stylet 2780
and needle 2782
are depicted as capable of piercing through covering 2788 to access and
puncture the FO.
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[00251]
Referring now to FIGS. 62A and 62B, an exemplary implementation of device
2700 is depicted having loop guide 2789. Loop guide 2789 provides additional
stability by
linking an extended stylus 2780 to an expanded arm 2776. In some embodiments,
loop guide
2789 is attached to the distal end of stylus 2780, such that after expanding
the plurality of arms
2776, stylus 2780 can be extended along an expanded arm 2776 as loop guide
2789 slides over
the expanded arm 2776. In other embodiments, loop guide 2789 is welded to both
the distal
end of stylus 2780 and to an expanded arm 2776, such that the expanding action
of arm 2776
simultaneously extends stylus 2780 and curves stylus 2780 towards a FO.
[00252]
Referring now to FIGS. 63A-63C, an exemplary hinged septum puncture device
90 is depicted. Device 2800 has a distal end 2891, a proximal end 2892, and a
cannula 2894
running throughout. Device 2800 has a hinged arm 2895 near its distal end
2891, the hinged
arm 2895 resting within cannula 2894 adjacent to window 2896. Hinged arm 2895
is attached
to the distal end of stylus 2898, such that rotating hinged arm 2895 out of
window 2896 extends
stylus 2898 out of cannula 2894 to face towards a FO. While exemplary
embodiments of
device 2800 are shown with one and two points of articulation in FIGS. 63B and
63C,
respectively, it should be understood that hinged arm 2895 can have any
suitable number of
points of articulation, such as between about one and ten. Hinged arm 2895 can
be rotated
using any suitable means, including but not limited to one or more pull
cables, one or more
servomotors, one or more hydraulic pistons, or the like.
[00253]
Moreover, in general, devices such a catheters introduced into the
vasculature of
a patient carry a risk of inadvertent trauma to the patient's vascular wall
and/or associate
tissues, organs, etc. A sharp edge of a device, for example, could lacerate a
vascular wall. In
the context of this disclosure, a main shaft (e.g., main shaft 120), and/or a
side catheter guide
(e.g., side catheter guide 130) of a septum puncture device could exert a
traumatic force against
a wall of a curved or tortuous vessel. This could be of particular concern,
for example, when
a relatively stiff main shaft is used (e.g., for purposes of providing
stability between the IVC
and SVC). Further, having a side catheter guide adjacent the main shaft may
present additional
similar risks. To address such risks, any suitable portions of the septum
puncture devices
described herein can have atraumatic designs. FIGS. 65A and 65B illustrate
such a septum
puncture device 2900, according to an embodiment. Similar to or the same as
described with
respect to the septum puncture devices described herein, the septum puncture
device 2900 can
be used to access a left side of the heart (e.g., left atrium) from the right
side of the heart (e.g.,
right atrium) and to deliver a guidewire to the left side of the heart. The
septum puncture device
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2900 can be constructed the same as or similar to, and can function the same
as or similar to,
any of the septum puncture devices described herein (e.g., septum puncture
device 100). Thus,
portions of the septum puncture device 2900 are not described in further
detail herein.
[00254]
As shown in FIG. 65A, the septum puncture device 2900 includes a body 2910
coupled to a main shaft 2920, a side catheter guide 2930, a side catheter 2960
(with an optional
end effector 2962 extending therefrom), a septum penetrator 2970, and an
atraumatic tip 2945.
The main shaft 2920 is coupled to the side catheter guide 2930 via a guide
coupler 2940, the
side catheter guide 2930 is coupled to the side catheter 2960, and the side
catheter 2960 is
coupled to the septum penetrator 2970, as shown in FIG. 65A. The side catheter
guide 2930 is
configured to define a pathway through or across which the side catheter 2960
can travel (e.g.,
be advanced and/or withdrawn). Said another way, and as described in further
detail herein,
the side catheter guide 2930 can be manipulated (e.g., actuated from a
delivery state to a
deployed state) to guide the side catheter 2960 in a desired direction (the
actuated or deployed
state of the side catheter guide 2930 is shown in FIG. 65B), e.g., towards the
left atrium.
[00255]
The atraumatic tip 2945 is configured to protect the patient from
inadvertent
trauma caused by a portion of the side catheter guide 2930, such as, for
example, a distal end
portion of the side catheter guide 2930, which during insertion is guided into
the patient's
vasculature by the main shaft 2920. The atraumatic tip 2945 can be formed of
any suitable
material and can have any suitable shape. In some implementations, the
atraumatic tip 2945
can be mounted on and/or coupled to the main shaft 2920. In some
implementations, for
example, the atraumatic tip 2945 be a nosecone (e.g., a blunt nosecone)
mounted on and/or
coupled to the main shaft 2920, with a tapered leading edge and a radiused
trailing edge (e.g.,
such that the atraumatic tip 2945 is void of sharp edges). In some
implementations, the
atraumatic tip 2945 can be asymmetrically mounted on or coupled to the main
shaft 2945 such
that the atraumatic tip 2945 protects a distal end portion of the side
catheter guide 2930 while
limiting an overall diameter, cross-sectional area, and/or profile of the main
shaft 2920 and
side catheter guide 2930.
[00256]
In some implementations, the atraumatic tip 2945 can be formed separately
and
then coupled to the main shaft 2920 and/or the side catheter guide 2930, while
in other
implementations, the atraumatic tip 2945 and the main shaft 2920 can be
monolithically
formed.
[00257]
As described in further detail herein in other embodiments, the guide
coupler
2940 can couple the side catheter guide 2930 to the main shaft 2920 to
minimize or prevent
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relative translational movement between the main shaft 2920 and the side
catheter guide 2930,
but to allow relative rotational movement between the main shaft 2920 and the
side catheter
guide 2930, as illustrated schematically in FIG. 65B. In this manner, the
guide coupler 2940
can facilitate transition of the side catheter guide 2930 from a delivery
configuration (e.g.,
parallel to or substantially parallel to the main shaft 2920), e.g., for
insertion through the
patient's vasculature and into the RA, to a deployed configuration such that a
distal end of the
side catheter guide 2930 is deflected angularly and/or laterally relative to
the main shaft 2920,
e.g., towards the patient's left atrium (e.g., the FO of the atrial septum).
[00258]
The atraumatic tip 2945 can be configured to facilitate such transition of
the side
catheter guide 2930 into its deployed configuration. In some implementations,
for example,
the atraumatic tip 2945 can define one or more apertures and/or slots through
which the distal
end portion of the side catheter guide 2930 can angularly and/or laterally
deflect, and/or
through which a portion of the side catheter guide 2930 that is proximal to
the distal end portion
of the side catheter guide 2930 can extend and/or deflect (e.g., the proximal
portion being one
a first side of a central axis of the shaft while the distal portion is on a
second side of the central
axis opposite the first side of the central axis. In this manner, the side
catheter guide 2930 is
shielded prior to deployment, and free to deflect and assume an increased
profile during
deployment.
[00259]
In some implementations, the entire atraumatic tip 2945 can be disposed
distal
to the guide coupler 2940, while in some implementations, the atraumatic tip
2945 can extend
across and beyond the guide coupler 2940.
[00260]
The atraumatic tip 2945 can be of any suitable size. For example, in some
implementations, the atraumatic tip 2945 can have an outer diameter of about
14F. As another
example, in some implementations, the atraumatic tip 2945 can have a length in
a range of
about lmm to about 150mm. In some implementations, the atraumatic tip 2945 can
have a
length of about 10-30 times its diameter; such a length could be, for example,
75mm, 100mm,
150mm, or any value therebetween.
[00261]
In some implementations, the atraumatic tip 2945 can include a radiopaque
material and/or marker (e.g., a band and/or a groove) such that the atraumatic
tip 2945 can be
visualized when within the heart from outside the patient under any suitable
imaging modality
(e.g., fluoroscopy, echocardiography, etc.), to facilitate an operator in
deploying the side
catheter guide 2930 and/or the side catheter 2960.
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[00262]
Further as shown in FIG. 65A, the septum puncture device 2900 includes a
guide
wire coupler 2922 configured to couple the main shaft 2920 to a guide wire
(not shown in FIG.
65A) to facilitate delivery of the septum puncture device 2900 into a patient
(e.g., through the
vasculature of the patient) and to the patient's heart, and a guide wire
coupler 2972 configured
to couple a guide wire (not shown in FIG. 65A) to the septum penetrator 2970,
to facilitate
delivery of that guide wire to the left side of the heart (e.g., the left
atrium).
[00263]
Further as shown in FIG. 65A, the septum puncture device 2900 optionally
includes a shaft actuator 2924 operably coupled to the main shaft 2920 and
configured to
actuate the main shaft 2920 to advance or withdraw the main shaft 2920
relative to the body
2910. The septum puncture device 2900 further includes (1) a side catheter
actuator 2964
operably coupled to and configured to actuate the side catheter 2960 to
advance or withdraw
the side catheter 2960, thereby transitioning the side catheter 2960 between a
delivery
configuration and a deployed configuration (the side catheter 2960 shown in an
actuated or
deployed configuration in FIG. 65B), and (2) a septum penetrator actuator (or -
penetrator
actuator") 2974 to actuate the septum penetrator 2970 to advance or withdraw
the septum
penetrator 2970, thereby transitioning the septum penetrator between a
delivery configuration
and a deployed configuration (the septum penetrator 2970 shown in an actuated
or deployed
configuration in FIG. 65B), as described in further detail herein.
[00264]
Further as shown in FIG. 65A, the septum puncture device 2900 optionally
includes an end effector 2962 coupled to and extending distally from the side
catheter 2960.
The end effector 2962 is configured to facilitate subsequent puncture through
a target puncture
location, such as, for example, the FO of the septum of the heart. The end
effector 2962 can
be configured, for example, to contact or tent the FO, as described in further
detail herein. Such
contact or tenting of the FO can, for example, reduce or minimize the force
required to penetrate
the FO and/or provide for improved force distribution to the FO. The end
effector 2962 can be
configured to prevent inadvertent puncturing of and/or damage to the FO with
the end effector
2962.
[00265]
Each of the main shaft 2920, the guide wire coupler 2922, the side
catheter guide
2930, the guide coupler 140, the side catheter 2960, the septum penetrator
2970, and the guide
wire coupler 2972 are translatable (e.g., distally advanceable and/or
extendable, and proximally
withdrawable and/or retractable) relative to the body 2910. The side catheter
2960 is
translatable relative to the side catheter guide 2930, and the septum
penetrator 2970 is
translatable relative to the side catheter 2960, as described in further
detail herein.
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[00266]
FIGS. 66A and 66B illustrate a portion of a septum puncture device 3000 in
a
delivery configuration and a deployed configuration, respectively, according
to an
embodiment.
[00267]
Similar to other septum puncture devices described herein, the septum
puncture
device 3000 can be used to access a left side of the heart (e.g., left atrium)
from the right side
of the heart (e.g., right atrium) and to deliver a guidewire to the left side
of the heart. The
septum puncture device 3000 can be constructed the same as or similar to, and
can function the
same as or similar to, any of the septum puncture devices described herein.
Thus, portions of
the septum puncture device 3000 are not described in further detail herein.
[00268]
In this embodiment, the septum puncture device 3000 includes a main shaft
3020
and a side catheter guide 3030 coupled to the main shaft 3020 via a guide
coupler 3040, similar
to as described in connection with other embodiments. The septum puncture
device 3000
further includes an atraumatic tip 3045 coupled to and disposed about the main
shaft 3020, and
abutting a distal end portion of the side catheter guide 3030 when the side
catheter guide 3030
is in a delivery configuration. As shown in FIG 66A, the distal end of the
side catheter guide
3030 is shielded or at least partially covered by the atraumatic tip 3045. In
this manner, during
insertion of the septum puncture device 3000 into the patient, with the side
catheter guide 3030
in its delivery configuration, the atraumatic tip 3045 protects the patient's
vasculature and
associated anatomy from inadvertent trauma from the side catheter guide 3030.
When
deployed, as illustrated in FIG. 66B, the distal end of the side catheter
guide 3030 is angularly
deflected relative to the main shaft 3020, as described in other embodiments
herein, such that
a side catheter (not shown) can then be extended distally therethrough.
Although in this
embodiment the atraumatic tip 3045 abuts the distal end portion of the side
catheter guide 3030
when the side catheter guide 3030 is in the delivery configuration, in other
embodiments the
atraumatic tip can be axially offset from the distal end portion of the side
catheter guide such
that the atraumatic tip is not in contact with the side catheter guide.
[00269]
Further, in this embodiment, the atraumatic tip 3045 has an asymmetric
shape
such that during delivery, as shown in FIG. 66A, the atraumatic tip 3045
shields the entire
distal end of the side catheter guide 3030, while limiting the overall
footprint of the atraumatic
tip 3045. More specifically, in this embodiment, the atraumatic tip 3045
reduces in cross-
sectional area from its proximal end to its distal end.
[00270]
Further, the atraumatic tip 3045 includes a radiopaque (e.g.,
fluoroscopic) marker
band 3046 disposed circumferentially about an exterior surface of the
atraumatic tip 3045. The
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atraumatic tip 3045 defines a grove on which the radiopaque marker band 3046
is disposed
such that the band 3046 does not increase the overall profile, cross-sectional
area, and/or
diameter of the remaining portion of the atraumatic tip 3045.
[002711
In some embodiments, an atraumatic tip can define or include a slot or
recess
through which a side catheter guide can deflect. FIG. 67 illustrates a portion
of a septum
puncture device 3100 in a delivey configuration, according to such an
embodiment.
[00272]
Similar to other septum puncture devices described herein, the septum
puncture
device 3100 can be used to access a left side of the heart (e.g., left atrium)
from the right side
of the heart (e.g., right atrium) and to deliver a guidewire to the left side
of the heart. The
septum puncture device 3100 can be constructed the same as or similar to, and
can function the
same as or similar to, any of the septum puncture devices described herein.
Thus, portions of
the septum puncture device 3100 are not described in further detail herein.
[00273]
In this embodiment, the septum puncture device 3100 includes a main shaft
3120
and a side catheter guide 3130 coupled to the main shaft 3120 via a guide
coupler 3140 and
extending distally from a body 3110, similar to as described in connection
with other
embodiments. The septum puncture device 3100 further includes an atraumatic
tip 3145
coupled to and disposed about the main shaft 3120, and abutting a distal end
portion of the side
catheter guide 3130 when the side catheter guide 3130 is in a delivery
configuration. Although
in this embodiment the atraumatic tip 3145 abuts the distal end portion of the
side catheter
guide 3130 when the side catheter guide 3130 is in the delivery configuration,
in other
embodiments the atraumatic tip can be axially offset from the distal end
portion of the side
catheter guide such that the atraumatic tip is not in contact with the side
catheter guide.
[00274]
The atraumatic tip 3145 can be constructed the same as or similar to, and
can
function the same as or similar to, the atraumatic tip 3045, except the
atraumatic tip 3145, as
shown, includes a slot at its proximal end through which a distal end of the
side catheter guide
3130 is disposed during delivery, and through and/or beyond which the distal
end of the side
catheter guide 3130 can extend when deployed.
[00275]
In some embodiments, an atraumatic tip can extend distally from a location
proximal to the guide coupler, across the guide coupler, and distal to the
distal end of the side
catheter guide, and can define or include one or more slots or recesses
through which the side
catheter guide can be deployed and/or deflected. FIGS. 68A and 68B illustrate
a portion of a
septum puncture device 3200 in a delivery configuration and a deployed
configuration,
respectively, according to such an embodiment.
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[00276]
Similar to other septum puncture devices described herein, the septum
puncture
device 3200 can be used to access a left side of the heart (e.g., left atrium)
from the right side
of the heart (e.g., right atrium) and to deliver a guidewire to the left side
of the heart. The
septum puncture device 3200 can be constructed the same as or similar to, and
can function the
same as or similar to, any of the septum puncture devices described herein.
Thus, portions of
the septum puncture device 3200 are not described in further detail herein.
[00277]
In this embodiment, the septum puncture device 3200 includes a main shaft
3220
and a side catheter guide 3230 coupled to the main shaft 3220 via a guide
coupler 3240. The
septum puncture device 3200 further includes an atraumatic tip 3245 coupled to
and disposed
about the main shaft 3220, and the side catheter guide 3230 when the side
catheter guide 3230
is in its delivery configuration (FIG. 68A). As shown best in FIG. 68B, the
atraumatic tip 3245
defines a first slot 3246A and a second slot 3256B (collectively referred to
herein as -the slots
3246-). During delivery, the side catheter guide 3230 remains within the
profile defined by
the atraumatic tip 3245, such that the side catheter guide 3230 does not
extend through and/or
beyond the slots 3246, as shown in FIG. 68A. When deployed, as shown in FIG.
68B, the side
catheter guide 3230 angularly deflects such that a distal end portion of the
side catheter guide
3230 points in first direction (e.g., towards a septum), and a portion of the
side catheter guide
3230 proximal the distal end portion and opposite a central axis of the main
shaft 3220 when
compared to the distal end portion, angularly and laterally deflects in a
second direction
different from the first direction. In this manner, the atraumatic tip 3245
covers and/or envelops
the side catheter guide 3230 to shield the side catheter guide 3230 from
inadvertent contact
with and/or trauma to surrounding anatomy. Also, as shown, a distal end of the
atraumatic tip
3245 is tapered (e.g., similar to a bullet nose or nose cone) so as to be
atraumatic.
[00278]
In various embodiments described herein, during deployment, a distal end
portion of the side catheter guide laterally deflects relative to a central
axis of the main shaft,
such that the distal end of the side catheter guide is disposed laterally
beyond an exterior surface
of the main shaft (e.g., towards a septum). In some instances, it is desirable
to minimize and/or
avoid such lateral deflection, such that during deployment, the distal end of
the side catheter
guide angularly deflects such that the distal end of the side catheter guide
does not extend
beyond an exterior surface of the main shaft when viewed in side view, and/or
does not extend
beyond an exterior surface of the atraumatic tip when viewed in side view
(e.g., in applicable
embodiments in which the septum puncture device includes an atraumatic tip).
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[00279]
FIGS. 69A and 69B illustrate a portion of a septum puncture device 3300 in
a
delivery configuration and a deployed configuration, respectively, according
to such an
embodiment. Similar to other septum puncture devices described herein, the
septum puncture
device 3300 can be used to access a left side of the heart (e.g., left atrium)
from the right side
of the heart (e.g., right atrium) and to deliver a guidewire to the left side
of the heart. The
septum puncture device 3300 can be constructed the same as or similar to, and
can function the
same as or similar to, any of the septum puncture devices described herein.
Thus, portions of
the septum puncture device 3300 are not described in further detail herein.
[00280]
In this embodiment, the septum puncture device 3300 includes a main shaft
3320
and a side catheter guide 3330 coupled to the main shaft 3320 via a guide
coupler 3340. The
septum puncture device 3300 further includes an atraumatic tip 3345 coupled to
and disposed
about the main shaft 3320, and the side catheter guide 3330 when the side
catheter guide 3330
is in its delivery configuration (FIG. 69A). As shown best in FIG. 69B, the
atraumatic tip 3345
defines a first slot 3346A and a second slot 3356B (collectively referred to
herein as -the slots
3346").
[00281]
In this embodiment, the guide coupler 3340 is disposed close to a distal
end of
the side catheter guide 3330 such that when the side catheter guide 3330 is
deployed, its distal
end deflects angularly, without any substantial lateral deflection, such that
the distal end of the
side catheter guide 3330 when deployed does not increase the collective cross-
sectional area
of the main shaft 3320 and the atraumatic tip 3345. Said another way, the
distal end of the side
catheter guide 3330, when deployed, extends a distance from the central axis
of the main shaft
that is less than or equal to the shortest distance of an exterior surface of
the atraumatic tip to
the central axis. Said another way, the distal end of the side catheter guide
3330, when
deployed, does not extend laterally beyond the exterior surface of the
atraumatic tip when
viewed in side view.
[00282]
Similarly, in any of the embodiments described herein, including, for
example,
embodiments described without an atraumatic tip, the guide coupler can be
similarly disposed
adjacent to the distal end of the side catheter guide such that the distal end
of the side catheter
guide, when deployed, angularly deflects without substantial lateral
deflection. In this manner,
for example, in some implementations, when deployed, the distal end of the
side catheter guide
may be disposed between the central axis of the main shaft and a line tangent
the exterior
surface of the main shaft when viewed in side view, such that deployment of
the side catheter
guide does not cause the distal end of the side catheter guide to increase the
collective cross-
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sectional area of the side catheter guide and the main shaft. In some
implementations, for
example, the distal end of the side catheter guide, when deployed, is a
distance from the central
axis that is equal to or less than a radius of the main shaft (the radius
being the radius of the
main shaft at or adjacent to the guide coupler). In some implementations, for
example, the
distal end of the side catheter guide, when deployed, extends a lateral
distance from the closest
exterior surface of the main shaft of about less than the radius of the main
shaft.
[00283]
Although various atraumatic tips described herein are shown as a material
that is
formed separately and then coupled to the main shaft, in some embodiments, the
functionality
of an atraumatic tip (e.g., the atraumatic tip 3245) can be incorporated into
and provided by the
main shaft. FIGS. 70A and 70B illustrate a portion of a septum puncture
device, in side and
perspective view, respectively, in a deployment configuration, according to
such an
embodiment.
[00284]
Similar to other septum puncture devices described herein, the septum
puncture
device 3400 can be used to access a left side of the heart (e.g., left atrium)
from the right side
of the heart (e.g., right atrium) and to deliver a guidewire to the left side
of the heart The
septum puncture device 3400 can be constructed the same as or similar to, and
can function the
same as or similar to, any of the septum puncture devices described herein.
Thus, portions of
the septum puncture device 3400 are not described in further detail herein.
[00285]
In this embodiment, the septum puncture device 3400 includes a main shaft
3400
and a side catheter guide 3430 coupled to the main shaft 3420 via a guide
coupler (not shown).
A portion of the side catheter guide 3430 disposed proximal to the guide
coupler is slidably
disposed within a lumen defined by the main shaft 3420, and a portion of the
side catheter
guide 3430 disposed distal to the guide coupler is disposed within and
deflectable relative to
the lumen of the main shaft 3420. Slidably disposed within the side catheter
guide 3430 is a
side catheter 3460, and slidably disposed within the side catheter 3460 is a
septum penetrator
3460. Although not shown in this embodiment, as can be the case in any of the
embodiments
described herein, in some implementations, the septum puncture device (e.g.,
including the
septum puncture device 3400) can include an end effector (e.g., similar to or
the same as in
form and/or function as any of the end effectors described herein). As shown
best in FIG. 70B,
the main shaft 3420 defines a first slot 3446A and a second slot 3446B (both
of which are in
communication with the lumen of the main shaft 3420). During deployment, the
side catheter
guide 3430 can deflect and extend through and beyond the first slot 3446A and
the second slot
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3446B, similar to as described above with respect to the septum puncture
device 3200 and the
septum puncture device 3330.
[00286]
Various embodiments described herein include a side catheter guide
disposed
adjacent and coupled to the main shaft via the guide coupler, however, it
should be understand
that any of these embodiments could be modified such that side catheter guide
is disposed
within a lumen defined by the main shaft (e.g., either through the guide wire
coupler defined
by or associated with the main shaft, or through a separate lumen defined by
the main shaft).
In such modified embodiments, the main shaft can define slots and/or apertures
through which
the side catheter guide can extend or traverse during deployment of the side
catheter guide.
[00287]
Various configurations and methods of using septum puncture devices for
puncturing one or more holes through an atrial septum have been described
herein. In some
instances it may be desirable to verify that a puncture in fact was performed
in the desired
location, e.g., to verify communication with the left atrium, and verify an
established
communication lumen between the left atrium and outside the patient's body via
the septum
penetrator. For example, it may be desirable to identify an errant puncture
(e.g, in an aorta or
interatrial tissue) while the puncture is relatively small (e.g., before
dilating the hole).
[002881
Once communication is established between the target region (e.g., the
left
atrium) and outside the patient via the lumen defined by the septum penetrator
that has been
extended into the left atrium, a variety of verification techniques can be
used. For example,
one or more of the following verification techniques can be used: measuring a
pressure within
the septum penetrator lumen, withdrawing a blood sample through the septum
penetrator
lumen, injecting through the septum penetrator lumen a contrast agent
configured to be visible
by an imaging modality such as fluoroscopy and/or echocardiography, and/or the
like.
[00289]
In some implementations in which verification is desired, there are
multiple
competing design goals. A first goal is clearly to provide a communication
lumen from outside
the patient to the target region (e.g., the left atrium). This goal can be
accomplished, as
described in various embodiments here, by providing a septum penetrator with a
lumen defined
therein. A second goal is to limit the cross-sectional area and/or overall
profile of the septum
penetrator and thereby the hole that it creates. This goal can be accomplished
by closely
matching the outer diameter of the guidewire to be inserted into the left
atrium with the inner
diameter of the septum penetrator such that no, or close to no, annular gap
exists between the
internal surface of the septum penetrator and the exterior surface of the
guidewire. A third goal
is to preload the guidewire so as to minimize the time period required for the
guidewire to be
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inserted into left atrium following the puncture. Said another way, with the
guidewire
preloaded or disposed within the septum penetrator lumen before the septum
penetrator lumen
punctures the FO, the remaining distance needed for the guidewire to travel to
reach the left
atrium is less than if the guidewire were first introduced into the septum
penetrator lumen after
the septum penetrator punctures the FO.
[00290]
With those goals in mind, in some embodiments, it is desirable to design a
septum penetrator having a lumen of varying diameter such that an annular gap
between the
external surface of the guidewire and the internal surface of the septum
penetrator can be
provided while still preloading the guidewire and keeping the septum
penetrator diameter to a
minimum.
[00291]
FIGS. 71A-71D are schematic illustrations of a portion of a septum
penetrator of
a septum puncture member 3500, according to such an embodiment. Similar to
other septum
puncture devices described herein, the septum puncture device 3500 can be used
to access a
left side of the heart (e.g., left atrium) from the right side of the heart
(e.g., right atrium) and to
deliver a guidewire to the left side of the heart The septum puncture device
3500 can he
constructed the same as or similar to, and can function the same as or similar
to, any of the
septum puncture devices described herein. Thus, portions of the septum
puncture device 3500
are not described in further detail herein.
[00292]
As shown in FIGS. 71A and 71B in cross-sectional side view and in side
view in
line form, respectively, the septum puncture member 3500 includes a septum
penetrator 3560
that defines a lumen therethrough. In this embodiment, the septum penetrator
3560 is divided
into three segments, including a first segment Li, a second segment L2, and a
third segment
L3. At the distal end of the septum penetrator 3560 is the sharp end portion
of the septum
penetrator 3560 that is configured to puncture the target tissue (e.g., the FO
of the septum).
This sharp end portion defines the first segment Li with little to no annular
gap between its
inner diameter and the external diameter of the guidewire, while the sharp end
portion has a
wall thickness strong enough to maintain enough rigidity to suitably puncture
the septum. The
second segment L2 is disposed immediately proximal to the first segment Li and
has an inner
diameter greater than the external diameter of the guidewire GW2 thereby
providing an annular
gap between its inner wall and an external surface of the guidewire GW2.
Further, the second
segment L2 is sufficiently flexible to assume a curved orientation as defined
by the side catheter
(not shown) within which it is slidably disposed when deflected with the side
catheter guide
(not shown). Further, the second segment L2 is configured to have a length
sufficient to extend
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the entire curved distance. The third segment L3 is disposed immediately
proximal to the
second segment L2, and also has an inner diameter greater than the external
diameter of the
guidewire GW2, but does not necessarily have the same characteristics (e.g.,
flexibility,
material, etc.) as the second segment L2. The third segment L3 has a length
sufficient to extend
proximally from the second segment L2, when the second segment L2 is disposed
within the
heart of the patient, to outside the patient (e.g., and coupled to a handle).
[00293]
FIG. 71C illustrates in cross-sectional side view the septum penetrator
3560
having the guidewire GW2 preloaded in the third segment L3, with the distal
end of the
guidewire GW2 terminating within the third segment L3, and FIG. 71D
illustrates in cross-
sectional side view the septum penetrator 3560 with the guidewire GW2
extending distally
relative to the preloaded position and distal to the septum penetrator 3560.
As described in
various embodiments, in use, with the guidewire GW2 delivered distally from
the septum
penetrator 3560 and into the left atrium, the septum penetrator 3560 can then
be withdrawn
proximally relative to the guidewire GW2, leaving the guidewire GW2 disposed
within the left
atrium. In the context of this embodiment, referring to FIG. 71C in which the
distal end of the
guidewire GW2 is disposed proximal to the first segment Li, the proximal end
of the septum
penetrator 3560 is in fluid communication with the distal end portion of the
septum penetrator
(e.g., the first segment Li and the second segment L2) via its lumen, such
that the verification
techniques described herein can be employed using the lumen. For example, in
some instances,
a contrast agent can be introduced into the lumen of the septum penetrator
3560 at its proximal
end (e.g., from outside the patient) and conveyed around the guidewire GW2
(i.e., within the
annular gap defined between the inner surface of the septum penetrator 3560
and the exterior
surface of the guidewire GW2), through and out of the distal end of the septum
penetrator 3560,
and into the left atrium, whereby the contrast agent can be viewed via
fluoroscopy, and/or
similar imaging modalities. After verification, the annular gap is no longer
needed, and so the
guidewire GW2 can then be extended distally relative to the septum penetrator
3560 and
delivered to the left atrium.
[00294]
Although the guidewire GW2 is shown preloaded into the third segment L3,
but
proximal to the second segment L2, in other implementations, the guidewire GW2
can be
preloaded into the second segment L2, but proximal to the first segment L2,
such that fluid
communication is similarly provided from the first segment Li, proximally
through the second
segment L2 and the third segment L3, and further proximally through the septum
penetrator
3560 and out the patient, e.g., and to a handle assembly (not shown).
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[00295]
Although the septum penetrator 3560 is shown and described as having three
segments, in some embodiments, the septum penetrator 3560 can have any
suitable number of
segments (e.g., one segment, two segments, or more than three segments). For
example, in
some embodiments, the most-distal segment of the septum penetrator can have a
first lumen
having a first diameter, and a second segment proximal to the most-distal
segment can have a
second lumen having a second diameter greater than the first diameter. In this
manner, similar
to as described with respect to the septum penetrator 3560 and the guidewire
GW2, a guidevvire
can be disposed within the second lumen and upstream the first lumen, thereby
providing
fluidic communication between the first lumen and the second lumen, and hence
to outside the
patient (e.g. via a handle assembly to which a proximal end portion of the
septum penetrator is
coupled).
[00296]
In some embodiments, instead of or in addition to a septum penetrator
having
variable lumen diameters, the septum penetrator can include multiple distinct
or partially
distinct lumens. In such embodiments, for example, the septum penetrator can
have two distinct
lumens extending across the entire septum penetrator; one designated for the
guidewire and the
other designated for fluidic communication for purposes of verification, as
described in further
detail herein. As another example, the septum penetrator can have a single
lumen extending
proximally from its most-distal end, and then bifurcate into two lumens, one
of which can be
designated for the guidewire and the other of which can be designated for
fluidic
communication for purposes of verification. In this manner, in use, the
guidewire can be
preloaded within one of the bifurcated lumens when the septum penetrator
punctures the
septum, a verification technique can be employed via the other bifurcated
lumen, and then the
guidewire can be advanced distally into the single lumen and delivered
distally from the septum
penetrator and into the left atrium (or other target region).
[00297]
FIGS. 72A and 72B illustrate a portion of a septum puncture device 3600 in
a
delivery configuration in side view and perspective view, respectively,
according to an
embodiment.
[00298]
Similar to other septum puncture devices described herein, the septum
puncture
device 3600 can be used to access a left side of the heart (e.g., left atrium)
from the right side
of the heart (e.g., right atrium) and to deliver a guidewire to the left side
of the heart. The
septum puncture device 3600 can be constructed the same as or similar to, and
can function the
same as or similar to, any of the septum puncture devices described herein.
Thus, portions of
the septum puncture device 3600 are not described in further detail herein.
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[00299]
In this embodiment, the septum puncture device 3600 includes a main shaft
3620
and a side catheter guide 3630 coupled to the main shaft 3620 via a guide
coupler 3640, similar
to as described in connection with other embodiments. The septum puncture
device 3600
further includes an atraumatic tip 3645 coupled to and disposed about the main
shaft 3620, and
slightly axially offset from a distal end portion of the side catheter guide
3030 when the side
catheter guide 3030 is in the delivery configuration. As shown in FIG. 72A,
the distal end of
the side catheter guide 3630 is shielded or at least partially covered by the
atraumatic tip 3645.
In this manner, during insertion of the septum puncture device 3600 into the
patient, with the
side catheter guide 3630 in its delivery configuration, the atraumatic tip
3645 protects the
patient's vasculature and associated anatomy from inadvertent trauma from the
side catheter
guide 3630. When deployed (not shown), the distal end of the side catheter
guide 3630 is
angularly deflected relative to the main shaft 3620, as described in some
embodiments herein,
such that a side catheter (not shown) can then be extended distally
therethrough. As shown, in
this embodiment, the collective cross-sectional area of the main shaft 3620
and the side catheter
guide 3630 is less than the cross-sectional area of the atraumatic tip 3645 at
its proximal end
(i.e., it's maximum cross-sectional area), such that the atraumatic tip 3645
shields the distal
end portion of the side catheter guide 3630. Said another way, when viewed in
front view, the
side catheter guide 3645 is not visible, as its profile is smaller than the
profile of the atraumatic
tip 3645.
[00300]
Further, in this embodiment, the atraumatic tip 3645 has an asymmetric
shape
such that during delivery, as shown in FIG. 72A, the atraumatic tip 3645
shields the entire
distal end of the side catheter guide 3630, while limiting the overall
footprint of the atraumatic
tip 3645. More specifically, in this embodiment, the atraumatic tip 3645
reduces in cross-
sectional area from its proximal end to its distal end.
[00301]
Further, the atraumatic tip 3645 includes a radiopaque (e.g.,
fluoroscopic) marker
band 3646 disposed circumferentially about an exterior surface of the
atraumatic tip 3645. The
atraumatic tip 3645 defines a grove on which the radiopaque marker band 3646
is disposed
such that the band 3646 does not increase the overall profile, cross-sectional
area, and/or
diameter of the remaining portion of the atraumatic tip 3645.
[00302]
In some embodiments, a needle can be aimed at a specific region of the FO
for
puncture. The FO can be divided into quadrants, for example, in which a
puncture in each
quadrant is advantageous for a specific procedure. The needle can thereby be
aimed to puncture
slightly superior, posterior, and 3.5 cm ¨ 4.5 cm above the mitral valve for a
MitraClip device,
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or to puncture posterior and slightly inferior within the FO for typical left
atrial appendage
occlusion devices. After successful puncture and insertion of a guidewire, the
septum puncture
device can be completely removed to make way for any suitable instrument or
device to be
guided into the left atrium of the heart to perform a desired procedure, such
as atrial fibrillation
ablation, left atrial appendage closure, and valve replacements.
[00303]
Various embodiments described herein include a side catheter guide
configured
to transition from a delivery configuration to a deployed configuration in
response to a distal
force applied to a portion of the side catheter guide that is disposed
proximal to the guide
coupler (e.g., a distal force applied at the handle).
In some implementations of such
embodiments described herein, instead of or in addition to such distal force,
a proximal force
can be applied to the main shaft (e.g., proximal the guide coupler) to cause
similar deployment
of the side catheter guide. Said another way, deployment of the side catheter
guide can be
accomplished merely by relative movement between the main shaft and the side
catheter guide,
which can include a proximal force applied to the main shaft and/or a distal
force applied to
the side catheter guide.
[00304]
In various embodiments described herein, a side catheter guide is
deflected such
that a distal end portion of the side catheter guide angularly and/or
laterally deflects about 90
degrees relative to a central axis of a main shaft to which the side catheter
guide is coupled. In
any of the embodiments described herein, in some implementations, such
deflection can be
greater than or less than 90 degrees. In such implementations, the deflection
may be less than
less than about 90 degrees, such as, for example, about 15 degrees, about 30
degrees, about 45
degrees, about 60 degrees, about 75 degrees, or any degrees therebetween. In
some
implementations, the deflection may be about 75 degrees to about 85 degrees,
e.g., about 80
degrees. In even further implementations, the deflection may be greater than
about 90 degrees,
such as, for example, about 95 degrees, about 105 degrees, about 110 degrees,
about 115
degrees, about 120 degrees, about 135 degrees, or any degrees therebetween. In
yet further
implementations, the deflection may be from about 50 degrees to about 90
degrees.
[00305]
Various embodiments described herein include a GSA or balloon configured
to
transition between a delivery configuration and a deployed configuration. In
some
implementations of any of the embodiments described herein, one or more GSAs
or balloons
can be covered partially or completely with a mesh made from any suitable
material (e.g.,
nylon, polymer, etc.). The mesh, coupled to a balloon, for example, can
facilitate a preferred,
predefined shape of the balloon when inflated, or can facilitate the step or
steps of inflating the
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balloon by, e.g., providing additional stability. An example illustrate of a
mesh covering a
balloon is illustrated in FIG. 64 which shows a GSA 2950 covered with a mesh
GSA 2955,
both of which are disposed circumferentially about a main shaft 2920. In some
embodiments,
the mesh can be used for securing (slidably or fixedly) the balloon(s) to a
side catheter guide
or a side catheter.
[00306]
Although various embodiments described herein focus on using a puncture
device to puncture a septum of a heart, the functionality provided by various
puncture devices
described herein can be desirable in other procedures and in other parts of a
patient. For
example, many procedures exist in which it would be desirable to be able to
provide a stable,
precise, safe, and repeatable lateral puncture. In some instances, for
example, any of the
puncture devices described herein could be used to facilitate a tricuspid
annuloplasty. The
puncture device, for example, could be arrange such that a central axis of its
main shaft is
parallel to a plane of the tricuspid valve, and so the puncture device could
provide lateral or
perpendicular access to the annulus of the tricuspid, e.g., to deliver
sutures, screws, or other
anchoring devices for purposes of a tricuspid annul opl asty.
[00307]
As another example, the puncture devices described herein could provide a
access and a direct vector to a coronary sinus of a heart, to, e.g., insert or
deliver a wire, a
catheter, a mitral valve repair device, pacemaker leads, etc. into the
coronary sinus.
[00308]
As another example, the puncture devices described herein could be used
for
delivering therapeutic repair or replacement devices to a mitral valve within
a heart. If, for
example, a side catheter guide or a side catheter disclosed herein were
extended further, and
beyond about 90 degrees, the side catheter could be directed into the LA and
towards the mitral
valve. In some instances, the natural trajectory of the side catheter in some
of the embodiments
described herein would be angled or directed towards the mitral valve if
extended or advanced
a suitable distance. For example, as the side catheter assumes its laterally
deflected shape or
orientation, it may be curved or possess an arc, such that further advancement
relative to the
main shaft results in the side catheter advancing along such a curvature or
arc such that the
distal end of the side catheter turns or is further laterally deflected
towards the mitral valve.
Said another way, in some instances, advancement of the side catheter from its
delivery
configuration to an advanced / deployed configuration can include the distal
end of the side
catheter being laterally deflected up to about 180 degrees.
[00309]
As another example, the puncture devices described herein could
incorporate an
intracardiac echo catheter to enable accelerate transseptal puncture.
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[00310]
As another example, the puncture devices described herein could be used in
connection with cardiac arrest. In such instances, for example, one or more
puncture devices
could be used in combination with a broad, curved catheter, to enable a guide
wire to be
directed or delivered from the femoral vein, across the FO, through the mitral
valve and out the
left ventricular outflow tract ("LVOT-) / aortic valve. In some embodiments a
balloon/flow-
directed catheter would be advanced across the FO, into the LA, across the
mitral valve and
then across the LVOT / aortic valve; the balloon, for example, would serve to -
flow direct- the
catheter out the LVOT and across the aortic valve into the aorta. Once in
position, the wire
could be used as a track for a small catheter that could provide
extracorporeal membrane
oxygenation ("ECMO") and oxygen to the brain. A distal end of the catheter in
the aorta would
be the outflow, and more proximal ports (e.g., in the RA or the IVC) would be
the inflow to
the pump.
[00311]
As another example, the puncture devices described herein could be used in
an
aorta to facilitate delivery of branch vessel stents, to deliver coils to
branch vessels, or to deliver
a screen for cerebral embolic protection to the head vessel.
[00312]
Detailed embodiments of the present disclosure have been disclosed herein
or
purposes of describing and illustrating claimed structures and methods that
can be embodied
in various forms, and are not intended to be exhaustive in any way, or limited
to the disclosed
embodiments. Many modifications and variations will be apparent without
departing from the
scope of the disclosed embodiments. The terminology used herein was chosen to
best explain
the principles of the one or more embodiments, practical applications, or
technical
improvements over current technologies, or to enable understanding of the
embodiments
disclosed herein. As described, details of well-known features and techniques
can be omitted
to avoid unnecessarily obscuring the embodiments of the present disclosure.
[00313]
References in the specification to "one embodiment," "an embodiment," "an
example embodiment," or the like, indicate that the embodiment described can
include one or
more particular features, structures, or characteristics, but it shall be
understood that such
particular features, structures, or characteristics may or may not be common
to each and every
disclosed embodiment disclosed herein. Moreover, such phrases do not
necessarily refer to
any one particular embodiment per se. As such, when one or more particular
features,
structures, or characteristics is described in connection with an embodiment,
it is submitted
that it is within the knowledge of those skilled in the art to affect such one
or more features,
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structures, or characteristics in connection with other embodiments, where
applicable, whether
or not explicitly described.
[00314]
Parameters, dimensions, materials, and configurations described herein are
meant to be examples and that the actual parameters, dimensions, materials,
and/or
configurations will depend upon the specific application or applications for
which the inventive
teachings is/are used. It is, therefore, to be understood that the foregoing
embodiments are
presented by way of example only and that, within the scope of the appended
claims and
equivalents thereto; and that embodiments can be practiced otherwise than as
specifically
described and claimed. Embodiments of the present disclosure are directed to
each individual
feature, system, article, material, kit, and/or method described herein. In
addition, any
combination of two or more such features, systems, articles, materials, kits,
and/or methods, if
such features, systems, articles, materials, kits, and/or methods are not
mutually inconsistent,
is included within the scope of the present disclosure.
[00315]
As you herein, the phrase -and/or" should be understood to mean -either or
both" of the elements so conjoined, i.e., elements that are conjunctively
present in some cases
and disjunctively present in other cases. Multiple elements listed with
"and/or" should be
construed in the same fashion, i.e., "one or more" of the elements so
conjoined. Other elements
may optionally be present other than the elements specifically identified by
the "and/or- phrase,
whether related or unrelated to those elements specifically identified. Thus,
as a non-limiting
example, a reference to "A and/or B", when used in conjunction with open-ended
language
such as "comprising" or "including" can refer, in one embodiment, to A only
(optionally
including elements other than B); in another embodiment, to B only (optionally
including
elements other than A); in yet another embodiment, to both A and B (optionally
including other
elements); etc.
[00316]
As used herein, the term, -or" should be understood to have the same
meaning
as "and/or" as defined above. For example, when separating items in a list,
"or" or "and/or"
shall be interpreted as being inclusive, i.e., the inclusion of at least one,
but also including more
than one, of a number or list of elements, and, optionally, additional
unlisted items. Only terms
clearly indicated to the contrary, such as -only one of' or -exactly one of,"
or, when used in
the claims, "consisting of,- will refer to the inclusion of exactly one
element of a number or
list of elements. In general, the term -or" as used herein shall only be
interpreted as indicating
exclusive alternatives (i.e. "one or the other but not both") when preceded by
terms of
exclusivity, such as "either," "one of," "only one of," or "exactly one of"
"Consisting
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essentially of," when used in the claims, shall have its ordinary meaning as
used in the field of
patent law.
[00317]
As used herein, the terms "about" and/or "approximately" when used in
conjunction with values and/or ranges generally refer to those values and/or
ranges near to a
recited value and/or range. In some instances, the terms "about- and
"approximately- may
mean within 10% of the recited value. For example, in some instances,
"approximately a
diameter of an instrument- may mean within 10% of the diameter of the
instrument. The
terms -about" and -approximately" may be used interchangeably. Similarly, the
term
"substantially- when used in conjunction with physical and/or geometric
feature(s),
structure(s), characteristic(s), relationship(s), etc. is intended to convey
that the feature(s),
structure(s), characteristic(s), relationship(s), etc. so defined is/are
nominally the feature(s),
structure(s), characteristic(s), relationship(s), etc. As one example, a first
quantity that is
described as being -substantially equal- to a second quantity is intended to
convey that,
although equality may be desirable, some variance can occur. Such variance can
result from
manufacturing tolerances, limitations, approximations, and/or other practical
con s i derati on s
Thus, the term -substantially."
[00318]
While various embodiments have been described above it should be
understood
that they have been presented by way of example only, and not limitation.
Where schematics
and/or embodiments described above indicate certain components arranged in
certain
orientations or positions, the arrangement of components may be modified.
While the
embodiments have been particularly shown and described, it will be understood
that various
changes in form and details may be made. Although various embodiments have
been described
as having particular features and/or combinations of components, other
embodiments are
possible having a combination of any features and/or components from any of
embodiments
described herein.
[003191
The specific configurations of the various components can also be varied.
For
example, the size and specific shape of the various components can be
different from the
embodiments shown, while still providing the functions as described herein.
More specifically,
the size and shape of the various components can be specifically selected for
a desired or
intended usage. Thus, it should be understood that the size, shape, and/or
arrangement of the
embodiments and/or components thereof can be adapted for a given use unless
the context
explicitly states otherwise.
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[00320]
Where methods and/or events described above indicate certain events and/or
procedures occurring in certain order, the ordering of certain events and/or
procedures may be
modified. Additionally, certain events and/or procedures may be performed
concurrently in a
parallel process when possible, as well as performed sequentially as described
above.
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