Note: Descriptions are shown in the official language in which they were submitted.
1
Steerable Electrosurgical Puncture Device
TECHNICAL FIELD
The disclosure relates to a steerable puncturing device configured to create a
puncture in a
tissue.
BACKGROUND OF THE ART
[0001] Certain medical procedures require the use of a medical device
that can create
punctures or channels through tissues of the heart. Specifically, puncturing
the septum of
a heart creates a direct route to the left atrium where numerous cardiology
procedures take
place. One such device that gains access to the left atrium is a transseptal
puncturing device
which, in some devices, delivers radiofrequency energy from a generator into
the tissue to
create the perforation. The user positions the puncturing device at a target
location on the
fossa ovalis located on the septum of the heart and turns the generator on to
begin delivering
energy to the target location. The delivery of radiofrequency energy to a
tissue results in
vaporization of the intracellular fluid of the cells which are in contact with
the energy
delivery device. Ultimately, this results in a void, hole, or channel at the
target tissue site.
[0002] As the field of electrophysiology and interventional cardiology
has developed,
site-specific transseptal punctures have proven to be beneficial for
completing various
interventions on the left side of the heart, such as pulmonary vein isolation,
left atrial
appendage closure, and mitral valve repair.
[0003] Pulmonary vein isolation is used to treat atrial fibrillation which
is an abnormal
heart rhythm due to incorrect electrical impulses being fired. Atrial
fibrillation results in
the atria from contracting or effectively squeezing blood to the ventricles.
The incorrect
electrical impulses tend to originate in the pulmonary veins; therefore, the
goal of
pulmonary vein isolation is to scar the tissue where the irregular signals are
coming from.
Since the pulmonary veins are posterior structures in the left atrium, the
specific location
of the transseptal puncture on the fossa ovalis allow surgeons to create an
optimal pathway
for the catheters used during this procedure. Specifically, a puncture
positioned more
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anteriorly on the fossa ovalis provides the most favourable approach. This
site-specific
puncture allows for a more efficient procedure.
[0004] Patient's with atrial fibrillation have an increased risk of
forming blood clots;
in many cases, these clots are formed in the left atrial appendage which is a
small, pouch-
like sac in the left atrium, although it is unclear what function, if any, the
left atrial
appendage is performs. Blood will clot within the pouch and get released into
the
cardiovascular system. In order to prevent the buildup of blood, the left
atrial appendage is
closed using a variety of methods, some of which involve accessing the left
atrium via a
transseptal puncture. Since the left atrial appendage is located posteriorly,
the positioning
of the transseptal puncture may be used to aid in the delivery of the device
into the atrium,
allowing for a more efficient and effective procedure. More specifically, the
puncture is
ideally positioned more posteriorly on the fossa ovalis.
[0005] A site specific transseptal puncture is also beneficial for
mitral valve repairs in
order to treat mitral valve regurgitation. Mitral valve regurgitation occurs
when the mitral
valve leaflets do not close completely, resulting in blood flowing backwards
or leaking into
the atrium causing increased blood volume and pressure in the left atrium,
which in severe
cases, may lead to fluid build-up in the lungs. A mitral valve repair involves
placing a clip
within the mitral valve that clips together a portion of the leaflet. Proper
positioning of the
clip is important during this procedure. A site-specific transseptal puncture
facilitates in
positioning of the mitral clip, such that it enables the clip to reach the
middle of the mitral
valve; a puncture positioned posterior and slightly superior on the fossa
ovalis is optimal.
[0006] In light of the advantages of site-specific puncturing during a
transseptal
puncture, there exists a need to provide a novel puncturing device to provide
users with the
ability to precisely control the distal tip (i.e., puncturing portion) of the
device.
SUMMARY OF THE INVENTION
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[0007] In one broad aspect of the invention, a puncturing device configured to
create a
puncture in a tissue comprises an elongate member having a proximal portion
and a
maneuverable distal portion. The proximal portion of the puncture device has a
handle with
an actuation mechanism. The maneuverable distal portion is connected to a
distal tip which
is configured to puncture tissue. The maneuverable distal portion is coupled
to the actuation
mechanism such that actuation of the actuation mechanism manipulates the
distal portion
of the puncturing device which manipulates the distal tip of the puncturing
device.
[0008] As a feature of this aspect, the maneuverable distal portion may
comprise a ball and
socket joint. In some embodiments, the puncturing device may comprise at least
one pull
wire which is connected to the ball of the ball and socket joint and extends
the length of
the puncturing device such that the at least one pull wire is coupled to the
actuation
mechanism. In an alternative embodiment, the puncturing device may comprise a
hydraulic
system. The ball of the ball and socket joint may have at least one projection
while the
socket may have at least one hydraulic element such that the hydraulic element
interacts
with the projection. The hydraulic element may be a piston or an inflatable
balloon which
is connected to a lumen where fluid may be injected into, causing the
hydraulic element to
interact with the projection.
[0009] In another feature, the maneuverable distal portion comprises a
plurality of cut-outs
and at least one pull wire, connected to the distal portion, distal the
plurality of cut-outs,
and extending the length of the puncturing device such that the at least one
pull wire is
coupled to the actuation mechanism. In some embodiments, the plurality of cut-
outs may
comprise at least one of c-cuts, spiral shaped cuts, interrupted spiral cuts,
interlocking cuts,
and dove-tail cuts.
[0010] In another feature, the maneuverable distal portion comprises an inner
tube with an
inner tube cut-out portion and an outer tube with an outer tube cut-out
portion. The inner
tube cut-out portion and the outer tube cut-out portion align, reducing the
stiffness of the
distal portion, causing the distal portion to bias towards a direction. In
some embodiments,
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the inner tube is coupled to the actuation mechanism, such that the inner tube
is rotatable
relative to the outer tube. In an alternative embodiment, the outer tube is
coupled to the
actuation mechanism, such that the outer tube is rotatable relative to the
inner tube. In
another embodiment, the inner tube and the outer tube may, both, be coupled to
the
actuation mechanism such that the inner tube and outer tube are rotatable.
[0011] In a further broad aspect, embodiments of the present invention
comprise an
assembly configured to create a puncture in tissue, comprising a dilator
having a proximal
portion and a distal portion with a lumen extending therebetween. The lumen in
the
proximal portion may have a larger diameter than the lumen in the distal
portion, forming
a shoulder. The puncturing device includes a proximal portion and a distal
portion, ending
in a distal tip. Forward pressure on the proximal portion of the puncturing
device results in
the puncturing device interacting with the shoulder of the dilator, creating a
pivot point,
deflecting the distal tip of the puncturing device. In some embodiments, the
dilator may
comprise a securing mechanism at the proximal portion, whereby the securing
mechanism
secures the puncturing device in a desired position. In some embodiments, the
securing
mechanism may be a thumb screw, a hemostasis valve, or may be a Tuohy-Borst
adapter.
[0012] An exemplary method of accessing the left atrium of a patient
using the present
invention may include the following steps:
(i) gaining access to a vasculature;
(ii) advancing the steerable puncturing device to a target location of a
septum
of the heart;
(iii) manipulating the maneuverable distal portion of the
puncturing device
such that a distal tip, configured to puncture the septum, is at a desired
position on the target location; and
(iv) puncturing at the desired position on the target location, creating a
site-
specific puncture.
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BRIEF DESCRIPTION OF THE DRAWING
[0013] In order that the invention may be readily understood,
embodiments of the
invention are illustrated by way of examples in the accompanying figures, in
which:
[0014] Fig. 1 is an illustration of an exemplary system for a transseptal
puncture.
[0015] Fig. 2a is an illustration of a cross-sectional view of a
puncturing device with a
maneuverable distal portion comprising of a ball and socket joint.
[0016] Fig. 2b is an illustration of a cross-sectional view of a
puncturing device
comprising a ball and socket joint with pull wires welded to the ball.
[0017] Fig. 2c is an illustration of a perspective view of the puncturing
device
comprising a ball and socket joint with pull wires welded directly to the
ball.
[0018] Fig. 2d is an illustration of a top view of the puncturing
device comprising a
ball and socket joint with pull wires.
[0019] Fig. 3 is an illustration of cross-sectional view of a
puncturing device with a
ball and socket joint, movable using a hydraulic mechanism.
[0020] Fig. 4 is an illustration of a cross-sectional view of a
puncturing device with a
maneuverable distal portion where the distal portion comprises a plurality of
cut-outs.
[0021] Fig. 5a is an illustration of a cross-sectional view of a
puncturing device with a
maneuverable distal portion where the distal portion comprises concentric
tubes in a
balanced configuration.
[0022] Fig. 5b is an illustration of a cross-sectional view taken along
the line 5b in Fig.
5a, illustrating a balanced configuration.
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[0023] Fig. 5c is an illustration of a cross-sectional view of a
puncturing device with a
maneuverable distal portion where the distal portion comprises concentric
tubes in a biased
configuration.
[0024] Fig. 5d is an illustration of a cross-sectional view taken along
the line 5c in Fig.
5c, illustrating a biased configuration.
[0025] Fig. 6a is an illustration of a cross-sectional view of a
dilator and a puncturing
device where the dilator comprises a shoulder.
[0026] Fig. 6b is an illustration of a cross-sectional view of a
dilator and a puncturing
device where the puncturing device pivots as it interacts with the shoulder of
the dilator.
DETAILED DESCRIPTION OF THE ILLUSTRATIVE EMBODIMENTS
[0027] Transseptal puncture is a routine procedure used to gain access
to the left side
of the heart. A transseptal puncture creates a pathway from the right atrium
to the left
atrium via the fossa ovalis, located on the septum. As the field of
electrophysiology and
interventional cardiology has evolved, the importance of site-specific
transseptal punctures
has emerged. Site-specific transseptal punctures have optimized various
interventions such
as pulmonary vein isolations, left atrial appendage closures, and mitral valve
repairs. Thus,
there exists a need for a steerable puncturing device which provides users
with the ability
to precisely control the puncturing portion such that site-specific
transseptal punctures may
be performed.
[0028] The inventors of the present invention have discovered systems
and methods
that attempt to overcome the limitations associated with prior art systems.
Specifically, the
invention relates to a steerable puncturing device and method for creating a
perforation in
the atrial septum while using the curvature of the distal portion of the
device to
automatically stop the delivery of energy to the atrial septum upon completion
of the
puncture.
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[0029] With specific reference now to the drawings in detail, it is
stressed that the
particulars shown are by way of example and for purposes of illustrative
discussion of
certain embodiments of the present invention only. Before explaining at least
one
embodiment of the invention in detail, it is to be understood that the
invention is not limited
in its application to the details of construction and the arrangement of the
components set
forth in the following description or illustrated in the drawings. The
invention is capable
of other embodiments or of being practiced or carried out in various ways.
Also, it is to be
understood that the phraseology and terminology employed herein is for the
purpose of
description and should not be regarded as limiting.
[0030] Figure 1 illustrates an embodiment of an exemplary system 100 that
may be
used during a transseptal puncture. The system 100 comprises a puncturing
device 110, a
dilator 120, a sheath 130, and an energy generator 140. The puncturing device
110, is
configured to deliver energy to the tissue via an energy delivery device 112
positioned at
the distal tip 114. The proximal portion of the puncturing device 110 ends in
a handle 116
which connects to the generator 140 via a connector cable 150. The puncturing
device 110
comprises a distal portion 118 which may be manipulated to allow users to
control the
position of the energy delivery device 112 on the fossa ovalis. The
manipulation of the
distal portion 118 may come from the puncturing device 110 itself, or it may
be
manipulated as it interacts with ancillary devices such as the dilator 120 or
sheath 130.
[0031] An exemplary method of accessing the left atrium of a patient using
the present
invention may include the following steps:
(i) Gaining access to the vasculature, for example through the femoral vein
or
subclavian vein.
(ii) Advancing the puncturing device 110 and assembly (i.e., dilator 120
and sheath
130) to the target location of the fossa ovalis on the atrial septum.
Date Recue/Date Received 2021-04-13
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(iii) Depending on the intervention being performed on the left side of the
heart, the
user may now manipulate the distal portion 118 of the puncturing device 110 to
create a site-specific transseptal puncture on the fossa ovalis. For example,
a
mitral valve repair may involve a puncture which is posterior and slightly
superior.
(iv) Once the user is satisfied with the puncture site, energy is delivered
from the
generator to the puncture device; the energy travels along the length of the
puncture device 110 and is delivered to the tissue from the energy deliver
device. This creates a pathway from the right atrium to the left atrium of the
heart.
[0032] In one embodiment, the distal portion 118 may be controlled by
the puncturing
device 110 itself. For example, as seen in Figure 2a, the distal portion 118
of the
puncturing device 110 may be constructed as a ball-and-socket joint 210. The
ball-and-
socket joint 210 may be manipulated through various means which will be
discussed
below. The puncturing device 110 comprises an elongate member which is coated
in an
insulative material 222 from the proximal portion (not show) to the distal
portion 118,
leaving an exposed distal tip in the form of an energy delivery device 112.
The puncturing
device 110 may further include a lumen 216 extending the length of the
puncturing device
110; in some embodiments, the ball 212 may include a lumen 217 which leads to
outlet
ports 218 to allow for the injection or aspiration of fluids during the
procedure.
[0033] Figure 2b illustrates a cross-sectional view of the puncture
device 110
including a ball-and-socket joint 210 which can be manipulated by pull wires
224. The pull
wires 224 may be directly connected to the ball 212, extending along the
length of the
puncturing device 110 such that they may be controlled by the handle 116. For
example,
the handle 116 may comprise a system which converts a rotation to linear
movement (not
shown). Some mechanisms which may be employed can be found in current
steerable
medical devices, such as steerable sheaths. In some embodiments, this may be
in the form
Date Recue/Date Received 2021-04-13
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of an actuator with one or more pull wires 224, and a means for deflecting the
pull wires
224 by translating the actuation of the actuator into movement of the pull
wires 224. The
distal end of the pull wires 224 are coupled to the distal portion 118 of the
puncturing
device 110, such as coupled the ball 212. The pull wires 224 may be coupled to
the ball
212 through welding. The proximal end (not shown) of the pull wires 242 are
coupled to
the means for deflecting the pull wires 242. In one embodiment, the actuator
located on the
handle 116 may comprise a rotational knob, whose rotational movement is
converted into
linear movement via a sliding assembly; in other words, the rotational knob is
coupled to
the linear sliding assembly which moves within the housing of the handle 116.
Rotating
the knob will move the slide assembly such that the linear movement of the
slide assembly
is converted into deflection of the distal portion 118 via the pull wires 242.
Further details
of this mechanism are disclosed in application number PCT/IB2017/058137
publication
number W02018/116162, and are incorporated herein.
[0034] The ball 212, at the distal portion 219 of the puncture device
110, may be
contained between extended arms 215, as shown in Figure 2c. The arms 215 act
as the
socket 214 of the ball-and-socket joint. Figure 2d illustrates a top view of
the distal portion
219 of the puncture device 110. In this embodiment, the pull wires (not shown)
which
attach to the ball 212 can be inserted through the holes 225, where they may
then extend
the length of the puncture device 110 and connect to the control system to
allow for
actuation. In some embodiments, the holes 225 may be positioned in an
alternating fashion
between the extended arms 215 of the socket 214.
[0035] In alternative embodiments, the distal portion 118 may be
manipulated using
hydraulics. With reference now to Figure 3, the ball 212 may comprise at least
two
extension arms 310 positioned on opposite sides of the ball 212. The socket
214 comprises
at least two inflatable features 312, positioned such that the inflatable
features 312 may
push against the extension arms 310, rotating the ball 212, which in turn
rotates the distal
portion 118. The inflatable features 312 are each connected to a lumen 314
that extends the
length of the puncturing device 110. At the proximal end of the puncturing
device, the
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handle 116 comprises a port (not shown) which connects to each lumen 314. A
fluid, such
as saline may be injected into the lumen 314 via the port at the handle 116,
this will cause
the inflatable feature 312 to expand distally, pushing the extension arm 310
upwards which
will cause the ball 212 to rotate. Similarly, if the fluid is withdrawn from
the lumen 314,
the inflatable feature 312 will deflate, causing the extension arm 310 to move
downwards,
as there is no longer a force pushing against it. The inflatable feature 312
may be a semi-
compliant balloon or a piston such that when pressure is applied, the balloon
or piston will
expand to push against the extension arms 310, similarly when pressure is
removed, the
balloon or piston may deflate or retract.
[0036] The puncturing device 110 may be constructed of an electrically
conductive
material to provide the energy delivery device 112 with energy, creating a
puncture at the
target location. The puncturing device 110 may be composed of stainless
steels, copper,
titanium, and nickel-titanium alloys (for example, Nitinol ), amongst others.
Energy is
delivered from the generator to the handle 116 of the puncturing device; the
energy then
travels along the conductive body to the energy delivery device at the distal
tip and to the
tissue. The ball 212 and socket 214 may be constructed of an electrically
conductive
material as well, with an electrically conductive lubricant provided between
the ball 212
and socket 214 to ensure smooth movement of the distal portion 118. The shaft
of the
puncturing device 110 may be coated in an electrically insulating material to
ensure energy
is delivered to the energy delivery device 112 at the distal tip 114. The
layer of insulation
222 may be one of many biocompatible dielectric materials, including, but not
limited to,
polytetrafluoroethylene (PTFE, Teflon ), parylene, polyimides, polyethylene,
terephthalate (PET), polyether block amide (PEBAX ), and polyetheretherketone
(PEEKTm), or any combinations thereof. The portion of the ball 212 not in
contact with the
socket may be coated in electrically insulating material, up to the distal
portion 118 of the
puncturing device, with an exposed distal tip 114, forming the energy delivery
device 112.
[0037] Figure 4 illustrates an alternative embodiment of a puncturing
device with a
maneuverable distal portion 118. The distal portion 118 comprises a plurality
of cuts 410
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through its sidewall which may be made by various means, including laser
cutting, into the
electrically conductive elongate member. These cuts in the distal portion will
create a
portion of increased flexibility. Different configuration of cuts are
possible, including c-
cuts, spiral shaped cuts, interrupted spiral cuts, interlocking cuts, and dove-
tail cuts. In
some embodiments, the puncturing device 110 may be composed of stainless
steels,
copper, titanium, and nickel-titanium alloys (for example, Nitinol ), amongst
others. The
puncturing device 110 may comprise a layer of insulation 222 which may be one
of many
biocompatible dielectric materials, including, but not limited to,
polytetrafluoroethylene
(PTEEõ Teflon ), parylene, polyimides, polyethylene, terephthalate (PET),
polyether
block amide (PEBAX ), and polyetheretherketone (PEEKTm), or any combinations
thereof In an alternative embodiment, the distal portion 118 may comprise of
different
kinds of tubing such as PEEK braids, woven plastics, or flexible plastics in
order to provide
flexibility instead of providing laser cuts in the distal portion 118. In
these embodiments,
the distal portion 118 may further comprise pull wires 224 which may be welded
directly
to the puncturing device 110, distal to the plurality of cuts 410. In an
alternative
embodiment, an o-ring may be connected to pull wires (not shown). The pull
wires 224
may be operably coupled to an actuator in the handle to provide the user with
the ability to
control and manipulate the distal portion 118 of the puncturing device 110.
The handle may
comprise a system which converts a rotation to linear movement (not shown).
Some
mechanisms which may be employed can be found in current steerable medical
devices,
such as steerable sheaths. In some embodiments, this may be in the form of an
actuator
with one or more pull wires 224, and a means for deflecting the pull wires 224
by
translating the actuation of the actuator into movement of the pull wires 224.
The distal
end of the pull wires 224 are coupled to the distal portion 118 of the
puncturing device 110,
such as coupled to an o-ring or directly welded to the puncturing device 110.
The proximal
end of the pull wires 224 are coupled to the means for deflecting the pull
wires 224. In one
embodiment, the actuator located on the handle may comprise a rotational knob,
whose
rotational movement is converted into linear movement via a sliding assembly;
in other
words, the rotational knob is coupled to the linear sliding assembly which
moves within
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the housing of the handle. Rotating the knob will move the slide assembly such
that the
linear movement of the slide assembly is converted into deflection of the
distal portion 118
via the pull wires 224. In an alternative embodiment, this actuation method
may be coupled
with shape memory properties of the material to provide even more curvature to
the needle.
For example, shape memory properties may be activated by using body
temperature or bi-
metallic stripes to control the macro-curvature of the needle, using pull-
wires to provide
the micro-movement of the distal tip.
[0038] With reference to Figure 5a ¨ 5d, an alternative embodiment of the
present
invention may comprise a puncturing device 110 comprising concentric tubes in
order to
.. control the curvature of the distal portion 118. The puncture device 110
comprises an inner
tube 514 and an outer tube 512 which surrounds the inner tube 514. In some
embodiments
the inner 514 and outer tubes 512 are comprised of a conductive,
biocompatible, material
which is covered in a layer of insulation 222. For example, the inner 514 and
outer tube
512 may be composed of stainless steels, copper, titanium, and nickel-titanium
alloys (for
example, Nitinol ), amongst others. The layer of insulation 222 may be one of
many
biocompatible dielectric materials, including, but not limited to,
polytetrafluoroethylene
(PTFE, Teflon ), parylene, polyimides, polyethylene, terephthalate (PET),
polyether
block amide (PEBAX ), and polyetheretherketone (PEEKTm), or any combinations
thereof. The inner 514 and outer tube 512 each comprise a cut-out portion 510
located in
the distal portion 518 of the puncture device 110. In some embodiments, the
inner tube 514
ends in a puncturing tip which may comprise an energy delivery device 112. The
inner tube
514 may comprise an inner lumen 516 which extends from the proximal portion of
the
device to the distal portion 118, ending in outlets 218 at the distal tip. In
some
embodiments, the inner tube 514 is rotatable within the outer tube 512. The
inner tube 514
may be coupled to an actuation mechanism at the proximal end of the puncturing
device
110. For example, this actuation mechanism may comprise a rotatable knob
which, upon
rotation, rotates the inner tube 514. In alternative embodiments, the outer
tube 512 may be
rotatable relative to the inner tube 514. In this embodiment, the outer tube
512 may be
coupled to the actuation mechanism. In even further embodiments, both the
inner tube 514
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and outer tube 512 may be rotatable, independent of one another. Figure 5a
illustrates the
puncture device 110 in a balanced configuration, that is when the cut-out
section 510 has
the inner 514 and outer tube 512 are opposing one another, this can be seen in
Figure 5b
which illustrates the cross-sectional view of the cut-out portion. This
configuration
provides the distal portion 118 of the puncturing device 110 to have increased
stiffness and
allows the distal portion 118 be substantially straight. Figure 5c illustrates
the puncture
device 110 in a biased configuration, when the cut-out section 510 of both the
inner 514
and outer tube 512 are aligned; a cross-sectional view of the cut-out portion
510 can be
seen in Figure 5d. In this configuration, the stiffness of the distal portion
118 is decreased,
which results in the distal portion 118 being curved such that the side of the
puncturing
device 110 which has the aligned cut-out 510 is in compression.
[0039] In some embodiments, ancillary devices may be used to manipulate and
control the
direction of the puncturing device. In one embodiment, the dilator 120 may
comprise a
shoulder 610 along the lumen within the distal portion 612 of the dilator. The
shoulder 610
is created by decreasing the lumen 630 from a larger diameter to a smaller
diameter, as
illustrated in Figure 6a ¨ 6b. The dilator 120 may be comprised of a harder
material, such
as high-density polyethylene (HDPE) or a softer material, for example
polyurethane or
polyether block amide. The puncturing device 110 may be constructed from an
electrically
conductive material to provide the pathway for energy to be delivered from the
generator
to the distal tip (e.g., energy delivery device 112) of the puncturing device
110. The
puncturing device 110, as seen in Figure 6a, is an elongate member comprised
of materials
such as stainless steels, copper, titanium, and nickel-titanium alloys (for
example,
Nitinol ), amongst others. This provides the puncturing device 110 with
flexibility such
that it can bend easily but still return to the original shape. The puncturing
device 110 may
further comprise a layer of insulation 222 which terminates at an energy
delivery device
112 at the distal tip. In one embodiment, the puncturing device 110 may
further include a
lumen 216 which runs from the proximal end to the distal end, terminating at
outlet ports
218. At the proximal end, the lumen 216 may connect to a side port to enable
injection,
withdrawal, or aspiration of fluids. The distal portion of the puncturing
device 110
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comprises a taper 620 as the diameter moves from a larger diameter to a
smaller diameter.
With reference now to Figure 6b, the taper 620 of the puncturing device 110
interacts with
the shoulder 610 of the dilator 120 to create a fulcrum or a pivot point;
during this
interaction, the puncturing device 110 pivots and deflects, allowing the user
to manipulate
the puncturing tip 112. The more forward force applied to the puncturing
device 110, the
more the distal tip 112 will pivot. In some embodiments, at the proximal
portion of the
dilator 120, a mechanism may be provided to secure the puncturing device 110
in place
once the correct pivot or deflection position has been achieved. This may
comprise some
type of mechanism to cinch the proximal end of the puncturing device 110, for
example a
thumb screw mechanism, hemostasis valve, or Tuohy-Borst adapter.
[0040] The embodiments of the invention described above are intended to be
exemplary
only. The scope of the invention is therefore intended to be limited solely by
the scope of
the appended claims.
[0041] It is appreciated that certain features of the invention, which are,
for clarity,
described in the context of separate embodiments, may also be provided in
combination in
a single embodiment. Conversely, various features of the invention, which are,
for brevity,
described in the context of a single embodiment, may also be provided
separately or in any
suitable subcombination.
[0042] Although the invention has been described in conjunction with
specific
embodiments thereof, it is evident that many alternatives, modifications and
variations will
be apparent to those skilled in the art. Accordingly, it is intended to
embrace all such
alternatives, modifications and variations that fall within the broad scope of
the appended
claims. All publications, patents and patent applications mentioned in this
specification are
herein incorporated in their entirety by reference into the specification, to
the same extent
as if each individual publication, patent or patent application was
specifically and
individually indicated to be incorporated herein by reference. In addition,
citation or
Date Recue/Date Received 2021-04-13
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identification of any reference in this application shall not be construed as
an admission
that such reference is available as prior art to the present invention.
Date Recue/Date Received 2021-04-13
