Note : Les descriptions sont présentées dans la langue officielle dans laquelle elles ont été soumises.
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DYNAMICALLY RIGIDIZING COMPOSITE MEDICAL STRUCTURES
CROSS REFERENCE TO RELATED APPLICATIONS
[0OW] This application claims priority to U.S. Patent
Provisional Application No. 62/835,101, filed
on April 17, 2019, titled "DYNAMICALLY RIGIDIZING COMPOSITE MEDICAL
STRUCTURES,"
and U.S. Patent Provisional Application No. 62/854,199, filed on May 29, 2019,
titled
'DYNAMICALLY RIGIDIZING COMPOSITE MEDICAL STRUCTURES,", the entirety of which
is
incorporated by reference herein. This application may also be related to
International Application No.
PCT/U52019/042650, filed on July 19, 2019, titled "DYNAMICALLY RIGIDIZING
COMPOSITE
MEDICAL STRUCTURES," which priority to U.S. Provisional Application No.
62/835,101, filed April
17, 2019, titled "DYNAMICALLY RIGIDIZING COMPOSITE MEDICAL STRUCTURES," U.S.
Provisional Application No. 62/854,199, filed May 29, 2019, tided "DYNAMICALLY
RIGIDIZING
COMPOSITE MEDICAL STRUCTURES," U.S. Provisional Application No. 62/780,820,
filed
December 17,2018, titled "DYNAMICALLY RIGIDIZING COMPOSITE MEDICAL
STRUCTURES,"
and U.S. Provisional Patent Application No. 62/700,760, filed July 19, 2018,
titled "BRAIDED
DYNAMICALLY RIGIDIZING OVERTUBE," the entireties of which are incorporated by
reference
herein.
[0002] This application may also be related to
International Patent Application Na
PCT/U52018/042946, filed July 19, 2018, titled "DYNAMICALLY RIGIDIZING
OVERTUBE," which
claims priority to U.S. Provisional Patent Application No. 62/672444, filed
May 16, 2018, titled
"DYNAMICALLY RIGIDIZING OVERTUBE," and U.S. Provisional Patent Application No.
62/535,134, filed July 20, 2017, titled "DYNAMICALLY RIGIDIZING OVERTUBE," the
entireties of
which are incorporated by reference herein.
[0003] This application may also be related to U.S.
Patent Application No. 15/757,230, filed March
2,2018, titled "DEVICE FOR ENDOSCOPIC ADVANCEMENT THROUGH THE SMALL
INTESTINE," now U.S. Patent Application Publication No. U52018/0271354, which
national phase
application under 35 USC 371 of International Patent Application No.
PCT/US2016/050290, filed
September 2, 2016, titled "DEVICE FOR ENDOSCOPIC ADVANCEMENT THROUGH THE SMALL
INTESTINE," now International Publication No.. WO 2017/041052, which claims
priority to U.S.
Provisional Patent Application No. 62,339,593, filed May 20, 2016, titled
"DEVICE FOR ENDOSCOPIS
ADVANCEMENT THROUGH THE SMALL INTESTINE," and U.S. Provisional Patent
Application
No. 62/213,908, filed September 3, 2015, and titled "DEVICE FOR ENDOSCOPIC
ADVANCEMENT
THROUGH THE SMALL INTESTINE," the entireties of which are incorporated by
reference herein.
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INCORPORATION BY REFERENCE
[0004] All publications and patent applications mentioned
in this specification are herein
incorporated by reference to the same extent as if each individual publication
or patent application was
specifically and individually indicated to be incorporated by reference.
BACKGROUND
[0005] During medical procedures, the interventional
medical device can curve or loop through the
anatomy, making advancement of the medical device difficult.
[0006] Gastrointestinal looping, caused when the
endoscope can no longer advance due to excessive
curving or looping of the gastrointestinal tract, is a particularly well-known
clinical challenge for
endoscopy. Indeed, one study found that looping occurred in 91 of 100 patients
undergoing colonoscopy
[Shah et al, "Magnetic Imaging of Colonoscopy: An Audit of Looping, Accuracy
and Ancillary
maneuvers." Gastrointest Endosc 2000; 52: 1-8]. Gastrointestinal looping
prolongs the procedure and
can cause pain to the patient because it can stretch the vessel wall and the
mesentery. Furthermore,
gastrointestinal looping leads to an increased incidence of perforations. In
severe cases of gastrointestinal
looping, complete colonoscopies are impossible since looping stretches the
length of the colon and the
colonoscope is not long enough to reach the end. Gastrointestinal looping is
an impediment to precise tip
control, denying the user the coveted one-to-one motion relationship between
the handle and the
endoscope tip. Such problems commonly occur across a wide range of endoscopic
procedures, including
colonoscopy, esophagogastroduodenoscopy (EGD), enteroscopy, endoscopic
retrograde
cholangiopancreatography (ERCP), interventional endoscopy procedures
(including ESD (Endoscopic
Submucosal Dissection) and EMR (Endoscopic Mucosal Resection)), robotic
flexible endoscopy, trans-
oral robotic surgery (TORS), altered anatomy cases (including Roux-en-Y), and
during NOTES (Natural
Orifice Transluminal Endoscopic Surgery) procedures. Accordingly, there is a
need for device that helps
prevent gastrointestinal looping to provide more successful access to the
gastrointestinal tract.
[0007] Similar difficulties in advancing medical
instruments can arise, for example, during
interventional procedures in the lungs, kidneys, brain, cardiac space, and
other anatomical locations.
Accordingly, them is a need for a device that can provide safe, efficient, and
precise access to otherwise
difficult to reach anatomical locations.
SUMMARY OF THE DISCLOSURE
[0008] In general, in one embodiment, a rigidizing device
includes an elongate flexible tube, a braid
layer positioned over the elongate flexible tube, an outer layer over the
flexible tube and the braid layer,
and an inlet between the elongate flexible tube and the outer layer and
configured to attach to a source of
vacuum or pressure. The braid layer has a plurality of strands braided
together at a braid angle of 5-40
degrees relative to a longitudinal axis of the elongate flexible tube when the
elongate flexible tube is
straight. The tigidizing device is configured to have a rigid configuration
when vacuum or pressure is
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applied through the inlet and a flexible configuration when vacuum or pressure
is not applied through the
inlet. The braid angle is configured to change as the rigidizing device bends
when the rigidizing device is
in the flexible configuration.
[0009] This and other embodiments can include one or more
of the following features. The braid
angle can be between 10 and 35 degrees. The braid angle can be between 15 and
25 degrees. The
rigidizing device in the rigid configuration can be at least two times stiffer
than the rigidizing device in
the flexible configuration. The rigidizing device in the rigid configuration
can be at least 5 times stiffer
than the rigidizing device in the flexible configuration. The rigidizing can
further include a slip layer
adjacent to the braid layer and having a lower coefficient of friction than
the braid layer. The elongate
flexible tube can include a reinforcement element extending therein. The
reinforcement element can
include a coil or plurality of hoop elements. The plurality of strands can be
braided together at 4-60 picks
per inch. The strands can include polyethylene terephalate or stainless steel.
The braid layer can provide
a coverage of 30-70% relative to the elongate flexible tube. The plurality of
strands can include 96
strands or more. The inlet can be configured to attach to a source of
pressure, and the rigidizing device
can further include a bladder layer therein. The bladder layer can be
configured to be pushed against the
braid layer when pressure is supplied through the inlet. The outer layer can
further include a plurality of
reinforcement elements therein. The inlet can be configured to attach to a
source of vacuum, and the
outer layer can be a thin flexible sheath. The rigidizing device can further
include a radial gap between
the braid layer and the outer layer. The gap can have a thickness of 0.00002"
¨0.04". The rigidizing
device can further include a steerable distal end. The rigidizing device can
further include a sealed
channel between the elongate flexible tube and the outer layer. The sealed
channel can include a
working channel, a cable guide, or an inflation lumen.
[0010] In general, in one embodiment, a method of
advancing a rigidizing device through a body
lumen includes: (1) inserting a rigidizing device into the body lumen while
the rigidizing device is in a
flexible configuration, where the rigidizing device includes an elongate
flexible tube, a braid layer having
a plurality of strands braided together at a braid angle of 5-40 degrees when
the rigidizing device is
straight, and an outer layer, and where the braid angle changes as the
flexible tube bends in the flexible
configuration; and (2) when the rigidizing device has reached a desired
location in the body lumen,
activating vacuum or pressure between the flexible tube and the outer layer to
transition the rigidizing
device into a rigid configuration that is stiffer than the flexible
configuration.
[0011] This and other embodiments can include one or more
of the following features. The method
can further include releasing vacuum or pressure after activating the vacuum
or pressure to transition the
rigidizing device back to the flexible configuration. The braid angle can be
between 10 and 35 degrees.
The braid angle can be between 15 and 25 degrees. The method can further
include passing a scope
through the rigidizing device while the rigidizing device is in the rigid
configuration. The method can
further include steering a steerable distal end of the rigidizing device
through the body lumen. The body
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lumen can be in the gastrointestinal tract. The body lumen can be in the
heart. The body lumen can be in
the kidneys. The body lumen can be in the lungs_ The body lumen can be in the
brain.
[0012] In general, in one embodiment, a rigidizing device
includes an elongate flexible tube, a braid
layer positioned over the elongate flexible tube, an outer layer over the
flexible tube and the braid layer,
and an inlet between the elongate flexible tube and the outer layer and
configured to attach to a source of
vacuum or pressure. The rigidizing device is configured to have a rigid
configuration when vacuum or
pressure is applied through the inlet and a flexible configuration when vacuum
or pressure is not applied
through the inlet. A ratio of stiffness of the rigidizing device in the rigid
configuration to stiffness of the
rigidizing device in the flexible configuration is greater than 5.
[0013] This and other embodiments can include one or more of the
following features. The ratio can
be greater than 6. The ratio can be greater than 10. The braid layer can have
a plurality of strands
braided together at a braid angle of 5-40 degrees relative to a longitudinal
axis of the elongate flexible
tube when the elongate flexible tube is straight. The braid angle can be
between 10 and 35 degrees_ The
rigidizing device can further include a slip layer adjacent to the braid layer
and having a lower coefficient
of friction than the braid layer. The elongate flexible tube can include a
reinforcement element extending
therein. The reinforcement element can include a coil or plurality of hoop
elements. The braid layer can
include a plurality of strands braided together at 4-60 picks per inch. The
braid layer can include a
plurality of strands braided together, and the strands can include
polyethylene terephalate or stainless
steel. The braid layer can provide a coverage of 30-70% relative to the
elongate flexible tube. The braid
layer can include 96 strands or more strands braided together. The inlet can
be configured to attach to a
source of pressure. The rigidizing device can further include a bladder layer
therein, and the bladder layer
can be configured to be pushed against the braid layer when pressure is
supplied through the inlet. The
outer layer can further include a plurality of reinforcement elements therein.
The inlet can be configured
to attach to a source of vacuum. The outer layer can be a thin flexible
sheath. The rigidizing device can
further include a radial gap between the braid layer and the outer layer. The
gap can have a thickness of
0.00002" ¨ 0.04". The rigidizing device can further include a steerable distal
end. The rigidizing device
can further include a sealed channel between the elongate flexible tube and
the outer layer. The sealed
channel can include a working channel, a cable guide, or an inflation lumen.
[0014] In general, in one embodiment, a method of
advancing a rigidizing device through a body
lumen includes: (1) inserting a rigidizing device into the body lumen while
the rigidizing device is in a
flexible configuration, where the rigidizing device includes an elongate
flexible tube, a braid layer, and an
outer layer; and (2) when the rigidizing device has reached a desired location
in the body lumen,
activating vacuum or pressure between the flexible tube and the outer layer to
transition the rigidizing
device into a rigid configuration that is stiffer than the flexible
configuration. A ratio of stiffness in the
rigid configuration to stiffness in the flexible configuration is greater than
5.
[0015] This and other embodiments can include one or more
of the following features. The method
can further include releasing vacuum or pressure after activating the vacuum
or pressure to transition the
rigidizing device back to the flexible configuration. The ratio can he greater
than 6. The ratio can be
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greater than 10. The method can further include passing a scope through the
rigidizing device while the
rigidizing device is in the rigid configuration. The method can further
include steering a steerable distal
end of the rigidizing device through the body lumen. The body lumen can be in
the gastrointestinal tract.
The body lumen can be in the heart. The body lumen can be in the kidneys. The
body lumen can be in
the lungs. The body lumen can be in the brain.
[0016] In general, in one embodiment, a rigidizing device
includes an elongate flexible tube, a braid
layer positioned radially outwards the elongate flexible tube, a slip layer
adjacent to the braid layer, an
outer layer, and a vacuum or pressure inlet between the elongate flexible tube
and the outer layer. The
outer layer is over the flexible tube, the braid layer, and the slip layer.
The inlet is configured to attach to
a source of vacuum or pressure. The rigidizing device is configured to have a
rigid configuration when
vacuum or pressure is applied through the inlet and a flexible configuration
when vacuum or pressure is
not applied through the inlet. The slip layer is configured to reduce friction
between the braid layer and
the elongate flexible tube or the outer layer when the rigidizing device is in
the flexible configuration.
[0017] This and other embodiments can include one or more
of the following features. The slip
layer can have a lower coefficient of friction than the braid layer. The slip
layer can include a powder.
The rigidizing device in the rigid configuration can be at least two times
stiffer than the rigidizing device
in the flexible configuration. The rigidizing device in the rigid
configuration can be at least 5 times stiffer
than the rigidizing device in the flexible configuration. The braid layer can
have a plurality of strands
braided together at a braid angle of 5-40 degrees relative to a longitudinal
axis of the elongate flexible
tube when the elongate flexible tube is straight. The braid angle can be
between 10 and 35 degrees. The
elongate flexible tube can include a reinforcement element extending therein.
The reinforcement element
can include a coil or plurality of hoop elements. The braid layer can include
a plurality of strands braided
together at 4-60 picks per inch. The braid layer can include a plurality of
strands braided together, and
the strands can include polyethylene terephalate or stainless steel. The braid
layer can provide a coverage
of 30-70% relative to the elongate flexible tube. The braid layer can include
96 strands or more strands
braided together. The inlet can be configured to attach to a source of
pressure. The rigidizing device can
further include a bladder layer therein. The bladder layer can be configured
to be pushed against the braid
layer when pressure is supplied through the inlet. The outer layer can further
include a plurality of
reinforcement elements therein. The inlet can be configured to attach to a
source of vacuum. The outer
layer can be a thin flexible sheath. The rigidizing device can further include
a radial gap between the
braid layer and the outer layer. The gap can have a thickness of 0.00002" ¨
0.04". The rigidizing device
can further include a steerable distal end. The rigidizing device can further
include a sealed channel
between the elongate flexible tube and the outer layer_ The sealed channel can
include a working
channel, a cable guide, or an inflation lumen.
[0018] In general, in one embodiment, a method of advancing a rigidizing
device through a body
lumen includes: (1) inserting a rigidizing device into the body lumen while
the rigidizing device is in a
flexible configuration, where the rigidizing device includes an elongate
flexible tube, a braid layer, a slip
layer adjacent to the braid layer, and an outer layer, and where the slip
layer reduces friction between the
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braid layer and the elongate flexible tube or the outer layer while the
rigidizing device is in the flexible
configuration; and (2) when the rigidizing device has reached a desired
location in the body lumen,
activating vacuum or pressure between the flexible tube and the sheath to
transition the rigidizing device
into a rigid configuration that is stiffer than the flexible configuration.
[0019] This and other embodiments can include one or more of the
following features. The method
can further include releasing vacuum or pressure after activating the vacuum
or pressure to transition the
rigidizing device back to the flexible configuration. The slip layer can have
a lower coefficient of friction
than the braid layer. The slip layer can include a powder. The method can
further include passing a
scope through the rigidizing device while the rigidizing device is in the
rigid configuration. The method
can further include steering a steerable distal end of the rigidizing device
through the body lumen. The
body lumen can be in the gastrointestinal tract. The body lumen can be in the
heart. The body lumen can
be in the kidneys. The body lumen can be in the lungs. The body lumen can be
in the brain.
[0020] In general, in one embodiment, a rigidizing device
includes an inner elongate flexible tube
including a reinforcement element and a matrix, a braid layer positioned
radially outwards the elongate
flexible tube, an outer layer over the braid layer, and a vacuum or pressure
inlet between the elongate
flexible tube and the outer layer and configured to attach to a source of
vacuum or pressure. The
reinforcement element has a width to thickness aspect ratio of over 5:1. The
rigidizing device is
configured to have a rigid configuration when vacuum or pressure is applied
through the vacuum inlet
and a flexible configuration when vacuum or pressure is not applied through
the vacuum inlet.
[0021] This and other embodiments can include one or more of the
following features. The
reinforcement element can be a coil. The reinforcement element can include a
plurality of closed rings.
The closed rings can include a plurality of pockets and notches. The
reinforcement element can include
an undulating wire. The reinforcement element can be a fiber or a metal wire.
The aspect ratio can be
over 10:1. The aspect ratio can be over 11:1. There can be a plurality of
reinforcement elements in the
elongate flexible tube. A spacing between each of the reinforcement elements
can be 0.0006" inches or
less. The elongate flexible tube can further include a matrix within which the
reinforcement element is
embedded. The matrix can include TPU or TPE.
[0022] In general, in one embodiment, a method of
advancing a rigidizing device through a body
lumen includes: (1) inserting a rigidizing device into the body lumen while
the rigidizing device is in a
flexible configuration, where the rigidizing device includes an elongate
flexible tube having a
reinforcement element and a matrix, a braid layer, and an outer layer, and
where the reinforcement
element has a width to thickness aspect ratio of over 10:1; and (2) when the
rigidizing device has reached
a desired location in the body lumen, activating vacuum or pressure between
the flexible tube and the
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outer layer to transition the rigidizing device into a rigid configuration
that is stiffer than the flexible
configuration.
[0023] This and other embodiments can include or more of
the following features. The elongate
flexible tube can resist compression when vacuum or pressure is applied.
[0024] In general, in one embodiment, a rigidizing device includes an
elongate flexible tube, a braid
layer positioned over the elongate flexible tube, an outer layer over the
flexible tube and the braid layer,
and an inlet between the elongate flexible tube and the outer layer and
configured to attach to a source of
vacuum or pressure. The braid layer has a plurality of strands braided
together. The rigidizing device is
configured to have a rigid configuration when vacuum or pressure is applied
through the inlet and a
flexible configuration when vacuum or pressure is not applied through the
inlet. Ends of the strands are
embedded in or surrounded by an annular ring that allows relative movement of
the ends when the
rigidizing device is in the flexible configuration.
[0025] This and other embodiments can include one or more
of the following features. The annular
ring can include a coating of material. The annular ring can include silicone
or urethane. The annular
ring can be approximately 0.005-0.250 inches thick.
[0026] In general, in one embodiment, a method of
advancing a rigidizing device through a body
lumen includes: (1) inserting a rigidizing device into the body lumen while
the rigidizing device is in a
flexible configuration, where the rigidizing device includes an elongate
flexible tube, a braid layer having
a plurality of strands braided together, and an outer layer; and (2) when the
rigidizing device has reached
a desired location in the body lumen, activating vacuum or pressure between
the flexible tube and the
sheath to transition the rigidizing device into a rigid configuration that is
stiffer than the flexible
configuration. Ends of the strands are embedded in or surrounded by an annular
ring such that the ends
move relative to one another while the rigidizing device is in the flexible
configuration. The ends are
substantially fixed relative to one another while the rigidizing device is in
the rigid configuration.
[0027] In general, in one embodiment, a rigidizing device includes an
elongate flexible tube, a braid
layer positioned over the elongate flexible tube, an outer layer sealed over
the flexible tube and the braid
layer, and an inlet between the elongate flexible tube and the outer layer and
configured to attach to a
source of vacuum. The braid layer has a plurality of strands braided together
and a plurality of hoop
fibers woven into the braid. The rigidizing device is configured to have a
rigid configuration when
vacuum is applied through the inlet and a flexible configuration when vacuum
is not applied through the
inlet.
[0028] In general, in one embodiment, a method of
advancing a rigidizing device through a body
lumen includes: (1) inserting a rigidizing device into the body lumen while
the rigidizing device is in a
flexible configuration, where the rigidizing device includes an elongate
flexible tube, a braid layer and an
outer layer; and (2) when the rigidizing device has reached a desired location
in the body lumen,
activating vacuum between the flexible tube and the outer layer to transition
the rigidizing device into a
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rigid configuration that is stiffer than the flexible configuration. The braid
layer has a plurality of strands
braided together and a plurality of hoop fibers woven into the braid.
[0029] In general, in one embodiment, a rigidizing device
includes an elongate flexible tube, a
bladder layer positioned over the elongate flexible tube, a braid layer
positioned over the bladder layer, an
outer layer positioned over the flexible tube and the braid layer, a pressure
inlet between the bladder layer
and the elongate flexible tube, and a vent outlet between the bladder layer
and the outer layer. The
pressure inlet configured to attach to a source of pressure. The braid layer
includes a plurality of strands
braided together. The rigidizing device is configured to achieve a rigid
configuration when pressure is
supplied through the pressure inlet and a flexible configuration when pressure
is not supplied through the
pressure inlet. Fluid or gas surrounding the strands moves out of the vent
outlet as the rigidizing device
transitions from the flexible configuration to the rigid configuration.
[0030] This and other embodiments can include one or more
of the following features. The
rigidizing device can further include a handle attached to the elongate
flexible tube. The handle can
include a vent port in communication with the vent outlet.
[0031] In general, in one embodiment, a method of advancing a rigidizing
device through a body
lumen includes: (1) insetting a rigidizing device into the body lumen while
the rigidizing device is in a
flexible configuration, where the rigidizing device includes an elongate
flexible tube, a bladder layer, a
braid layer having a plurality of strands braided together, and an outer
layer, and (2) when the rigidizing
device has reached a desired location in the body lumen, providing pressure
through an inlet between the
elongate flexible tube and the bladder layer and venting gas or fluid
surrounding the strands out of a vent
outlet to transition the rigidizing device into a rigid configuration that is
stiffer than the flexible
configuration.
[0032] In general, in one embodiment, a rigidizing device
includes an elongate flexible tube, a braid
layer positioned over the elongate flexible tube, an outer layer over the
flexible tube and the braid layer, a
channel extending between the outer layer and the elongate flexible tube, and
an inlet. The inlet is
between the elongate flexible tube and the outer layer and configured to
attach to a source of vacuum or
pressure. The channel includes a working channel, a steering cable channel, or
an inflation lumen. The
rigidizing device is configured to have a rigid configuration when vacuum or
pressure is applied through
the inlet and a flexible configuration when vacuum or pressure is not applied
through the inlet
[0033] In general, in one embodiment, a method of advancing a medical
tool through a body lumen
includes: (1) inserting a rigidizing device into the body lumen while the
rigidizing device is in a flexible
configuration, where the rigidizing device includes an elongate flexible tube,
a braid layer, and an outer
layer; (2) when the rigidizing device has reached a desired location in the
body lumen, activating vacuum
or pressure between the flexible tube and the outer layer to transition the
rigidizing device into a rigid
configuration that is stiffer than the flexible configuration; and (3) passing
a medical tool through a sealed
working channel that is positioned between the elongate flexible tube and the
outer layer.
[0034] In general, in one embodiment, a method of
advancing a medical tool through a body lumen
includes: (1) inserting a rigidizing device into the body lumen while the
rigidizing device is in a flexible
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configuration, where the rigidizing device comprises an elongate flexible
tube, a braid layer, and an outer
layer; (2) when the rigidizing device has reached a desired location in the
body lumen, activating vacuum
or pressure between the flexible tube and the outer layer to transition the
rigidizing device into a rigid
configuration that is stiffer than the flexible configuration; and (3)
activating at least one cable that is
positioned between the elongate flexible tube and the outer layer to orient a
distal end of the rigidizing
device.
[0035] In general, in one embodiment, a method of
advancing a medical tool through a body lumen
includes: (1) inserting a rigidizing device into the body lumen while the
rigidizing device is in a flexible
configuration, where the rigidizing device includes an elongate flexible tube,
a braid layer, and an outer
layer; (2) when the rigidizing device has reached a desired location in the
body lumen, activating vacuum
or pressure between the flexible tube and the outer layer to transition the
rigidizing device into a rigid
configuration that is stiffer than the flexible configuration; and (3)
inflating a balloon on the rigidizing
device by passing an inflation medium through a sealed inflation lumen that is
positioned between the
elongate flexible tube and the outer layer.
[0036] In general, in one embodiment, a rigidizing device includes an
elongate flexible tube having a
central lumen, a braid layer positioned over the elongate flexible tube, an
outer layer over the flexible
tube and the braid layer, a plurality of sealed working channels extending
within the central lumen, and an
inlet between the elongate flexible tube and the outer layer and configured to
attach to a source of vacuum
or pressure. The rigidizing device is configured to have a rigid configuration
when vacuum or pressure is
applied through the inlet and a flexible configuration when vacuum or pressure
is not applied through the
inlet.
[0037] In general, in one embodiment, a method of
advancing a plurality of medical tools through a
body lumen includes: (1) inserting a rigidizing device into the body lumen
while the rigidizing device is
in a flexible configuration, where the rigidizing device includes an elongate
flexible tube, a braid layer,
and an outer layer; (2) and when the rigidizing device has reached a desired
location in the body lumen,
activating vacuum or pressure between the flexible tube and the outer layer to
transition the rigidizing
device into a rigid configuration that is stiffer than the flexible
configuration; (3) passing a first medical
tool through a first sealed working channel of the rigidizing device, and (4)
passing a second medical tool
through a second sealed working channel of the rigidizing device.
[0038] In general, in one embodiment, an overtube includes an elongate
tube and a distal tip attached
to the elongate tube. The distal tip has an annular distal face with one or
more vacuum holes extending
therethrough. The one or more vacuum holes are configured to draw tissue
towards the annular distal
face upon application of vacuum therethrough.
[0039] This and other embodiments can include one or more
of the following features. The elongate
tube can be a rigidizing device, and the rigidizing device can be configured
to have a rigid configuration
when vacuum or pressure is applied to a wall thereof and a flexible
configuration when vacuum or
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pressure is not applied to the wall. The elongate tube can include a braid
layer and an outer layer
thereover. The annular distal face can be angled relative to a longitudinal
axis of the elongate tube.
[0040] In general, in one embodiment, a rigidizing device
includes an elongate flexible tube, a braid
layer positioned over the elongate flexible tube, an outer layer over the
flexible tube and the braid layer,
and a distal tip attached to the elongate flexible tube. The braid layer has a
plurality of strands braided
together at a first braid angle relative to a longitudinal axis of the
elongate flexible tube when the elongate
flexible tube is straight. The distal tip includes a second braid layer having
a plurality of strands braided
together at a second braid angle that is different from the first braid angle.
An inlet between the elongate
flexible tube and the outer layer is configured to attach to a source of
vacuum or pressure. The rigidizing
device is configured to have a rigid configuration when vacuum or pressure is
applied through the inlet
and a flexible configuration when vacuum or pressure is not applied through
the inlet.
[0041] This and other embodiments can include one or more
of the following features. The second
braid angle can be greater than the first braid angle. The first and second
braid layers can be bonded to
one another.
[0042] In general, in one embodiment, a rigidizing device includes an
elongate flexible tube
including a plurality of reinforcement elements therein. The elongate flexible
tube includes a proximal
section and a distal section. A braid layer is positioned over the proximal
section and not the distal
section. The braid layer has a plurality of strands braided together at a
first braid angle relative to a
longitudinal axis of the elongate flexible tube when the elongate flexible
tube is straight. An outer layer
is positioned over the braid layer. A plurality of steerable linkages extend
over the distal section and not
the proximal section_ An inlet is between the elongate flexible tube and the
outer layer and is configured
to attach to a source of vacuum or pressure. The rigidizing device is
configured to have a rigid
configuration when vacuum or pressure is applied through the inlet and a
flexible configuration when
vacuum or pressure is not applied through the inlet.
[0043] This and other embodiment can include one or more of the following
features. The rigidizing
device can further include a plurality of cables attached to the steerable
linkages. The cables can extend
between the elongate flexible tube and the outer layer.
[0044] In general, in one embodiment, a rigidizing device
includes a rigidizing assembly and
plurality of linkages. The rigidizing assemble includes an elongate flexible
tube, a braid layer positioned
over the elongate flexible tube, an outer layer over the flexible tube and the
braid layer, and an inlet. The
inlet is between the elongate flexible tube and the outer layer and is
configured to attach to a source of
vacuum or pressure. The plurality of steering linkages are mounted over a
distal portion of the rigidizing
assembly. The rigidizing assembly is configured to have a rigid configuration
when vacuum or pressure
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is applied through the inlet and a flexible configuration when vacuum or
pressure is not applied through
the inlet.
[0045] This and other embodiments can include one or more
of the following features. The
rigidizing device can further include a plurality of cables attached to the
steerable linkages. The cables
can extend between the elongate flexible tube and the outer layer.
[0046] In general, in one embodiment, a rigidizing device
includes an elongate flexible tube, a
plurality of steerable linkages and an outlet. The elongate flexible tube
includes a proximal section and a
distal section. The elongate flexible tube includes a plurality of
reinforcement elements therein, a braid
layer positioned over the proximal section the distal section, an outer layer
including a plurality of
reinforcement elements. The plurality of steerable linkages extends over the
distal section and not the
proximal section. The inlet is between the elongate flexible tube and the
outer layer and configured to
attach to a source of vacuum or pressure. The braid layer has a plurality of
strands braided together at a
first braid angle relative to a longitudinal axis of the elongate flexible
tube when the elongate flexible tube
is straight. The outer layer is positioned over the proximal section and not
the distal section. The
rigidizing device is configured to have a rigid configuration when vacuum or
pressure is applied through
the inlet and a flexible configuration when vacuum or pressure is not applied
through the inlet.
[0047] This and other embodiments can include one or more
of the following features. The
rigidizing device can further include a plurality of cables attached to the
steerable linkages. The cables
can extend between the elongate flexible tube and the outer layer.
[0048] In general, in one embodiment, a rigidizing device includes a
rigidizing assembly and a
plurality of linkages. The rigidizing assembly includes an elongate flexible
tube, a braid layer positioned
over the elongate flexible tube, an outer layer over the flexible tube and the
braid layer, and an inlet
between the elongate flexible tube and the outer layer and configured to
attach to a source of vacuum or
pressure. A spine extends through a distal section of the rigidizing assembly.
The spine is configured to
provide bending of the rigidizing assembly in a set direction. The plurality
of steering linkages are distal
to the rigidizing assembly. The rigidizing assembly is configured to have a
rigid configuration when
vacuum or pressure is applied through the inlet and a flexible configuration
when vacuum or pressure is
not applied through the inlet.
[0049] This and other embodiments can include one or more
of the following features. The
rigidizing device can further include a pullwire configured to bend the device
at the spine when activated.
The rigidizing device can further include a plurality of cables attached to
the steerable linkages. The
cables can extend between the elongate flexible tube and the outer layer.
[0050] In general, in one embodiment, a rigidizing device
includes a rigidizing assembly and a distal
tip. The rigidizing assembly includes an elongate flexible tube, a braid layer
positioned over the elongate
flexible tube, an outer layer over the flexible tube and the braid layer, and
an inlet between the elongate
flexible tube and the outer layer and configured to attach to a source of
vacuum or pressure. The distal tip
is attached to the elongate flexible tube. The distal tip includes a plurality
of linkages connected together
at pivot points. The rigidizing assembly and the distal tip are configured to
assume a rigid configuration
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when vacuum or pressure is applied through the inlet and a flexible
configuration when vacuum or
pressure is not applied through the inlet.
[0051] In general, in one embodiment, a handle for use
with a rigidizing device includes a handle
body configured to attach to a rigidizing device, a vacuum feed line attached
to the handle body and
configured to connect to a source of vacuum, a vacuum port in communication
with a wall of the
rigidizing device, and an activation element on the handle body. The
activation element is configured to
move between a first position and a second position. The activation element in
the first position connects
the vacuum feed line with the vacuum port to provide vacuum to the wall of the
rigidizing device, and the
activation element in the second position disconnects the vacuum feed line
from the vacuum port to vent
the wall of the rigidizing device.
[0052] This and other embodiments can include one or more
of the following features. The
activation element can include a magnetic element thereon. The magnetic
element can be configured to
hold the activation element in the first position or the second position. The
vacuum feed line can be
coiled within the handle.
[0053] In general, in one embodiment, a method of advancing a rigidizing
device through a body
lumen includes: (1) holding a handle of the rigidizing device; (2) inserting
an elongate body of the
rigidizing device into the body lumen while the rigidizing device is in a
flexible configuration; (3) when
the rigidizing device has reached a desired location in the body lumen, moving
an activation element in a
first direction to connect a vacuum feed line of the handle with a vacuum port
to a wall of the elongate
body such that vacuum flows into the wall of the elongate body to transition
the elongate body to a rigid
configuration; and (4) moving the activation element in a second direction to
disconnect the vacuum feed
line from the vacuum port such that the elongate body vents to transition the
elongate body to the flexible
configuration.
[0054] In general, in one embodiment, a handle for use
with a rigidizing device includes a handle
body configured to attach to a rigidizing device, a fluid chamber within the
handle body, an outlet in fluid
communication with the fluid chamber and with a wall of the rigidizing device,
and an activation element
configured to move between a first position and a second position. The
activation element is configured
to transfer fluid from the fluid chamber to the wall of the rigidizing device
when moving from the first
position to the second position and to transfer fluid back into the fluid
chamber when moving from the
second position to the first position.
[0055] This and other embodiments can include one or more
of the following features. The handle
can further include an overflow chamber within the handle body and a pressure
relief valve between the
fluid chamber and the overflow chamber. The pressure relief valve can be
configured to open to allow
fluid to flow into the overflow chamber when pressure in the fluid chamber
reaches a predetermined
maximum pressure. The handle can further include a piston and rolling
diaphragm within the handle
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body. The piston can be configured to push on the rolling diaphragm as the
activation element is moved
between the first position and the second position.
[0056] In general, in one embodiment, a method of
advancing a rigidizing device through a body
lumen includes: (1) holding a handle of the rigidizing device, (2) inserting
an elongate body of the
rigidizing device into the body lumen while the rigidizing device is in a
flexible configuration; (3) when
the rigidizing device has reached a desired location in the body lumen, moving
an activation element in a
first direction to move fluid from a fluid chamber of the handle into a wall
of the rigidizing element to
transition the rigidizing device to a rigid configuration; and (4) moving the
activation in a second
direction to move fluid from the wall of the rigidizing element back into the
handle to transition the
rigidizing device to the flexible configuration.
[0057] In general, in one embodiment, a nested system
includes a first rigidizing device and a second
rigidizing device positioned radially within the first rigidizing device. The
second rigidizing device is
axially slideable relative to the first rigidizing device. The first and
second rigidizing devices are
configured to be alternately rigidized by vacuum or pressure.
[0058] This and other embodiments can include one or more of the
following features. The pressure
can be greater than 1 atm. The first rigidizing device can be configured to be
rigidized by vacuum and the
second rigidizing device can be configured to be rigidized by pressure of
greater than! atm. Each of the
first and second rigidizing devices can include a plurality of layers. The
vacuum or pressure can be
configured to be supplied between the plurality of layers. At least one of the
plurality of layers can be a
braid layer.
[0059] In general, in one embodiment, a method of
advancing through a body lumen includes: (1)
inserting a first rigidizing device into the body lumen while the first
rigidizing device is in a flexible
configuration; (2) supplying vacuum or pressure to the first rigidizing device
to transition the first
rigidizing device into a rigid configuration that is stiffer than the flexible
configuration; (3) inserting a
second rigidizing device in a flexible configuration through the first
rigidizing device while the first
rigidizing device is in the rigid configuration such that the second
rigidizing device takes on a shape of
the first rigidizing device in the rigid configuration; and (4) supplying
vacuum or pressure to the second
rigidizing device to transition the second rigidizing device from the flexible
configuration to a rigid
configuration,
[0060] This and other embodiments can include one or more of the
following features. Each
rigidizing device can include an elongate flexible tube and a braid layer.
Supplying vacuum or pressure
can compress the braid layer to transition the rigidizing device to the rigid
configuration.
[0061] In general, in one embodiment, a method of
advancing through a body lumen includes: (1)
moving a first rigidizing device in a flexible configuration until the first
rigidizing device reaches a
desired location; (2) after the first rigidizing device has reached the
desired location, transitioning the first
rigidizing device into a rigid configuration by supplying vacuum or pressure
to the first rigidizing device;
(3) after the first rigidizing device is rigidized, moving a second rigidizing
device in a flexible
configuration over the first rigidizing device in the rigidized configuration;
(4) transitioning the second
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rigidizing element into a rigid configuration by supplying vacuum or pressure
to the second rigidizing
device; (5) transitioning the first rigidizing device into a flexible
configuration by removing the vacuum
or pressure; and (6) moving the first rigidizing device in the flexible
configuration through the second
elongate rigidizing device until the first rigidizing device reaches a desired
location.
[0062] This and other embodiments can include one or more of the
following features. The method
can further include periodically moving both the first and second rigidizing
devices into a flexible
configuration to allow a curvature of the first and second rigidizing devices
to increase to match
surrounding anatomy.
[0063] In general, in one embodiment, a rigidizing rod
includes an inner bladder layer, a braid layer
positioned over the inner bladder layer, an outer sheath sealed over the inner
bladder layer and the braid
layer, and an inlet between the outer sheath and the inner bladder layer
configured to attach to a source of
vacuum. The rigidizing rod is configured to have a rigid configuration when
vacuum is applied through
the inlet and a flexible configuration when vacuum or pressure is not supplied
through the inlet. The
rigidizing rod does not have a through-lumen extending therethrough_
[0064] In general, in one embodiment, a method of advancing a rigidizing
device through a body
lumen includes: (1) advancing the rigidizing device through the body lumen;
(2) inserting a rod having an
elongate flexible tube, a braid layer, and a bladder into a lumen of the
rigidizing device while the rod is in
a flexible configuration; (3) when the rod has reached a desired location in
the lumen of the rigidizing
device, supplying pressure of greater than 1 atm to a central sealed lumen of
the rod to force the braid
layer against the elongate flexible tube to transition the rigidizing device
into a rigid configuration that is
stiffer than the flexible configuration; and (4) further advancing the
rigidizing device over the rod while
the rod is in the rigid configuration.
[0065] In general, in one embodiment, a method of
performing cholangioscopy includes: (I)
inserting an overtube into colon while the overtube is in a flexible
configuration, where the overtube
includes an elongate flexible tube, a braid layer having a plurality of
strands braided together, and an
outer layer; (2) steering a distal end of the overtube towards a papilla; (3)
activating vacuum or pressure
between the flexible tube and the outer layer to transition the overtube into
a rigid configuration that is
stiffer than the flexible configuration; (4) while the overtube is in the
rigid configuration, advancing a
guidewire through the overtube and into a bile duct or pancreatic duct; and
(5) advancing a scope over the
guidewire to the bile duct or pancreatic duct.
[0066] In general, in one embodiment, a method of
accessing the cardiac anatomy includes: (1)
inserting a sheath into the cardiac anatomy while the sheath is in the
flexible configuration, where the
sheath includes an elongate flexible tube, a braid layer having a plurality of
strands braided together, and
an outer layer; (2) steering a distal end of the sheath towards a desired
final location; (3) activating
vacuum or pressure between the flexible tube and the outer layer to transition
the overtube into a rigid
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configuration that is stiffer than the flexible configuration; and (4) passing
a cardiac device through the
rigid sheath.
[0067] This and other embodiments can include one or more
of the following features. The desired
final location can be the aortic valve. The cardiac device can be a
transcatheter aortic valve replacement.
The desired final location can be the mitral valve. The cardiac device can be
a mitral valve replacement
or a mitral valve repair element.
[0068] Any of the devices described here can include one
or more of the following. The rigidizing
device can further include a slip layer adjacent to the braid layer. The slip
layer can have a lower
coefficient of friction than the braid layer. The rigidizing device in the
rigid configuration can be at least
two times stiffer than the rigidizing device in the flexible configuration.
The rigidizing device in the rigid
configuration can be at least 5 times stiffer than the rigidizing device in
the flexible configuration. The
braid layer can have a plurality of strands braided together at a braid angle
of 5-40 degrees relative to a
longitudinal axis of the elongate flexible tube when the elongate flexible
tube is straight. The braid angle
can be between 10 and 35 degrees. The elongate flexible tube can include a
reinforcement element
extending therein. The reinforcement element can include a coil or plurality
of hoop elements. The braid
layer can include a plurality of strands braided together at 4-60 picks per
inch. The braid layer can
include a plurality of strands braided together. The stands can include
polyethylene terephalate or
stainless steel. The braid layer can provide a coverage of 30-70% relative to
the elongate flexible tube.
The braid layer can include 96 strands or more strands braided together. The
inlet can be configured to
attach to a source of pressure. The rigidizing device can further include a
bladder layer therein. The
bladder layer can be configured to be pushed against the braid layer when
pressure is supplied through the
inlet. The outer layer can further include a plurality of reinforcement
elements therein. The inlet can be
configured to attach to a source of vacuum. The outer layer can be a thin
flexible sheath. The rigidizing
device can further include a radial gap between the braid layer and the outer
layer The gap can have a
thickness of 0.00002" ¨ 0.04". The rigidizing device can further include a
steerable distal end. The
rigidizing device can further include a sealed channel between the elongate
flexible tube and the outer
layer. The sealed channel can include a working channel, a cable guide, or an
inflation lumen.
[0069] In general, in one embodiment, a handle for use
with a rigidizing device includes a handle
body configured to attach to a rigidizing device, a vacuum input configured to
be connected to a source a
vacuum, a vacuum port in communication with a wall of the rigidizing device,
and a ring activation
element configured to rotate between a first position and a second position.
The activation element in the
first position connects the vacuum input with the vacuum port to provide
vacuum to the wall of the
rigidizing device. The activation element in the second position disconnects
the vacuum input from the
vacuum port to vent the wall of the rigidizing device.
[0070] This and other embodiments can include one or more of the
following features. The handle
can further include a vent port in fluid communication with the vacuum input.
The activation element in
the first position can seal the vent port against a seal element. The ring
activation element can include
one or more magnets configured to hold the activation element in the first
position or the second position.
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The handle body can include a valve body about which the ring activation
element is configured to rotate.
The valve body can include one or more additional magnets configured to mate
with the one or more
magnets of the ring activation element. The handle can further include an
indicator element configured to
indicate whether the rigidizing device is in a flexible or a rigid
configuration. The handle can further
include a plurality of indicator elements positioned around a circumference of
the handle.
[0071] In general, in one embodiment, a catheter system
includes a rigidizing catheter having a
central lumen therein, and a wire configured to be placed within the central
lumen. The rigidizing
catheter is configured to alternate between a rigidized configuration and a
flexible configuration. The
wire is configured to have a preformed shape. The wire is stiffer than the
rigidizing catheter when the
rigidizing catheter is in the flexible configuration. The wire is more
flexible than the rigidizing catheter
when the rigidizing catheter is in the rigid configuration.
[0072] This and other embodiments can include one or more
of the following features. The catheter
system can further include a vacuum input configured to provide vacuum to a
wall of the rigidizing
catheter to rigidize the catheter. The catheter system can further include a
pressure input configured to
provide pressure to a wall of the rigidizing catheter to rigidize the
catheter. The wire can include a
superelastic material. The wire can include nitinol. A wall of the catheter
can include a plurality of
layers. At least one layer of the plurality of layers can include a braid.
[0073] In general, in one embodiment, a method of using a
rigidizing catheter includes (1) inserting
a rigidizing catheter into a body lumen in a flexible configuration, (2)
converting the rigidizing catheter to
a rigid configuration, (3) inserting a wire having a preformed shape into the
catheter while the rigidizing
catheter is in the rigid configuration such that the wire takes on a shape of
the rigidizing catheter in the
rigidizing configuration, and (4) converting the rigidizing catheter to the
flexible configuration while the
wire is positioned within the rigidizing catheter such that the rigidizing
catheter takes on a preformed
shape of the wire.
[0074] This and other embodiments can include one or more of the
following features. Converting
the rigidizing catheter to a rigid configuration can include supplying
pressure to a wall of the rigidizing
catheter. Converting the rigidizing catheter to a flexible configuration can
include releasing pressure
from the wall of the rigidizing catheter. Converting the rigidizing catheter
to a rigid configuration can
include supplying vacuum to a wall of the rigidizing catheter. Converting the
rigidizing catheter to a
flexible configuration can include releasing vacuum from the wall of the
rigidizing catheter. The wire can
include a superelastic material. The wire can include nitinol. The method can
further include converting
the rigidizing catheter to a rigid configuration while the rigidizing catheter
is in the preformed shape of
the wire. The method can further include removing the wire by pulling the wire
proximally through the
rigidizing catheter while the rigidizing catheter is in the rigid
configuration and in the preformed shape of
the wire. The method can further include performing coronary catheterization
through the rigidizing
catheter while the rigidizing catheter is in the rigid configuration and in
the preformed shape of the wire.
The method can further include accessing head and neck vessels from an aortic
arch through the
rigidizing catheter while the rigidizing catheter is in the rigid
configuration and in the preformed shape of
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the wire. The method can further include accessing a bile or pancreatic duct
through the rigidizing
catheter while the rigidizing catheter is in the rigid configuration and in
the preformed shape of the wire.
The method can further include performing Endoscopic Retrograde Cholangio-
Pancreatography.
[0075] In general, in one embodiment, a system for
manufacturing a coil wound tube includes an
outer tube, an inner tube concentric with the outer tube and having a
plurality of holes therein, an air
chamber between the outer tube and the inner tube, a thin tubular membrane
lining an inner
circumference of the inner tube, and an open lumen formed within the thin
tubular membrane. When
vacuum is supplied to the air chamber, the thin tubular membrane is configured
to expand radially
outwards towards the inner tube to increase a diameter of the lumen. When
vacuum is released from the
air chamber, the thin tubular member is configured to move away from the inner
tube to decrease a
diameter of the lumen.
[0076] This and other embodiments can include one or more
of the following features. The outer
tube, inner tube, and thin tubular membrane can be held together with a female
endcap and a male
endear. The female endcap and male endcap create a seal in the air chamber.
The thin tubular membrane
can include silicone. The inner tube can include perforated metal, perforated
plastic, a braid, a woven
cloth, or a textured tube. The outer tube comprises metal, polyetherimide, or
polyetheretherketone.
[0077] In general, in one embodiment, a method of
manufacturing a coil wound tube includes (1)
supplying vacuum to an air chamber formed between an inner breather tube and a
concentric outer tube so
as to pull a thin tubular membrane towards the inner breather tube, (2)
inserting a mandrel into a lumen
formed by the thin membrane while the thin membrane is pulled towards the
inner circumference of the
inner breather tube, the mandrel having a matrix and reinforcement element
thereon, and (3) releasing the
vacuum from the air chamber so as to shrink the thin tubular membrane against
the matrix and
reinforcement element, wherein pressure from the shrinking forms a composite
tube of the matrix and
reinforcement element.
[0078] This and other embodiments can include one or more of the
following features. The method
can further include supplying pressure to the air chamber to compress the thin
tubular membrane against
the matrix and reinforcement element. The method can further include supplying
heat to the matrix and
reinforcement element while the thin tubular membrane is pressed against the
matrix and reinforcement
element. The method can further include providing vacuum to the lumen. The
thin membrane can
include silicone.
[0079] In general, in one embodiment, a method of
performing a cardiac procedure includes (1)
inserting a first cannula in a flexible configuration into or proximate to the
cardiac anatomy, (2)
transitioning the first cannula to a rigid configuration when the first
cannula has reached a first cardiac
location, (3) inserting a second cannula in a flexible configuration into or
proximate to the cardiac
anatomy, (4) transitioning the second cannula to a rigid configuration when
the second cannula has
reached a second cardiac location, wherein distal tips of the first and second
cannulas are substantially
coaxial and positioned opposite one another when the first and second cannulas
are in the first and second
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cardiac locations, and (5) performing a cardiac procedure with both a first
cardiac tool extending through
the first rigidized cannula and a second cardiac tool extending through the
second rigidized cannula.
[0080] This and other embodiments can include one or more
of the following features. The method
can be performed in a closed heart and without cardiopulmonary support. The
method can further include
steering a tip of the first cannula to the first cardiac location or steering
a tip of the second cannula to the
second cardiac location. Transitioning the first cannula to a rigid
configuration comprises activating
vacuum or pressure within a wall of the first cannula, and wherein
transitioning the second cannula to a
rigid configuration comprises activating vacuum or pressure within a wall of
the second cannula. The
wall of the first cannula or the wall of the second cannula can include a
plurality of strands braided
together. The first cardiac location can be within a left atrium, and the
second cardiac location can be
within a left ventricle. The cardiac procedure can be a mitral valve repair or
replacement. The first
cardiac location can be within a right atrium, and the second cardiac location
can be within a right
ventricle. The cardiac procedure can be a tricuspid valve repair or
replacement. The first cannula can be
inserted through a vein and the second cannula is inserted through an artery.
The vein can be a femoral
vein, and the artery can be a femoral artery. The procedure can include
annuloplasty. The procedure can
include manipulating a suture across cardiac tissue. The first cardiac
location or the second cardiac
location can be the chamber of a heart. Inserting the first cannula or the
second cannula can include
inserting antegrade. Inserting the first cannula or the second cannula
comprises inserting retrograde.
[0081] In general, in one embodiment, a method of
performing a cardiac procedure includes (1)
inserting a first cannula in a flexible configuration into the cardiac anatomy
through a vein, (2)
transitioning the first cannula to a rigid configuration when the first
cannula has reached a first cardiac
location, (3) inserting a second cannula in a flexible configuration into the
cardiac anatomy through an
artery, (4) transitioning the second cannula to a rigid configuration when the
second cannula has reached
a second cardiac location, and (5) performing a cardiac procedure with both a
first cardiac tool extending
through the first rigidized cannula and a second cardiac tool extending
through the second rigidized
cannula.
[0082] This and other embodiments can include one or more
of the following features. The method
can be performed in a closed heart and without cardiopulmonary support. The
method can further include
steering a tip of the first cannula to the first cardiac location or steering
a tip of the second cannula to the
second cardiac location. Transitioning the first cannula to a rigid
configuration can include activating
vacuum or pressure within a wall of the first cannula. Transitioning the
second cannula to a rigid
configuration can include activating vacuum or pressure within a wall of the
second cannula. The wall of
the first cannula or the wall of the second cannula can include a plurality of
strands braided together. The
first cardiac location can be within a left atrium, and the second cardiac
location can be within a left
ventricle. The cardiac procedure can be a mitral valve repair or replacement.
The first cardiac location
can be within a right atrium, and the second cardiac location can be within a
right ventricle. The cardiac
procedure can be a tricuspid valve repair or replacement. The vein can be a
femoral vein, and the artery
can be a femoral artery. The procedure can include annuloplasty. The procedure
can include
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manipulating a suture across cardiac tissue. The first cardiac location or the
second cardiac location can
be the chamber of a heart Inserting the first cannula or the second cannula
can include inserting
antegrade. Inserting the first cannula or the second cannula can include
inserting retrograde.
[0083] k general, in one embodiment, a tip for a medical
device includes an outer conical housing
and an inner housing flush with the outer housing. The outer conical housing
has a proximal end and a
distal end. The inner housing has an annular member and a plurality of
protrusions extending distally
from the annular member to the distal end.
[0084] This and other embodiments can include one or more
of the following features. A material of
the inner housing can be stiffer than a material of the outer conical housing.
A material of the inner
housing can be harder than a material of the outer conical material. The outer
conical housing can include
a thermoplastic elastomer or silicone. The outer conical housing can include a
material having a
duronaeter of 50A or less. The inner housing can include a material having a
durometer of greater than
50A. The outer conical housing can include polypropylene,
polytetrafluoroethylene, high-density
polyethylene, or low-density polyethylene. Each of the protrusions can taper
from the annular member to
the distal end. Each of the protrusions can include a living hinge. The living
hinge can be configured to
enable the protrusion to bend radially outwards at the living hinge. The tip
can further include a lumen
extending from the proximal end to the distal end. The distal end can be
configured to abut a scope
extending through the lumen. A gap between an outer diameter of the scope and
an inner diameter of the
distal end can be less than 0.04 inches. The gap can be less than 0.01 inches.
[0085] In general, in one embodiment, a robotic system includes an inner
elongate cannula, an outer
elongate cannula concentric with the first inner elongate cannula, and a
cassette at a proximal end of the
first elongate cannula and the second cannula The cassette is configured to
alternately advance and
retract the outer elongate cannula relative to the inner elongate cannula.
[0086] This and other embodiments can include one or more
of the following features. The robotic
system can further include a drive unit configured to actuate a mechanism on
the cassette to advance and
retract the outer elongate cannula relative to the inner elongate cannula. The
cassette can be further
configured to steer the inner elongate cannula or the outer elongate cannula.
The cassette can include one
or more disks configured to rotate to activate cables of the inner elongate
cannula or the outer elongate
cannula to steer the inner elongate cannula or the outer elongate cannula. The
cassette can include a disk
configured to rotate to advance and retract the outer elongate cannula
relative to the inner elongate
cannula. The outer elongate cannula can include a rack at a proximal end
thereof, and the rack can be
configured to engage with the disk to advance and retract the outer elongate
cannula relative to the inner
elongate cannula. The inner elongate cannula and the outer elongate cannula
can be configured to
rigidize with the application of vacuum or pressure to a wall of the inner
elongate cannula or the outer
elongate cannula. The cassette can include an eccentric cam configured to
actuate the vacuum or
pressure. The robotic system can further include bellows configured to actuate
the vacuum or pressure.
[0087] In general, in one embodiment, a robotic system
includes an inner elongate cannula, an outer
elongate cannula concentric with the first inner elongate cannula, a cassette
at a proximal end of the first
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elongate cannula and the second cannula, and a drive unit configured to couple
with the cassette. The
drive unit is further configured to actuate a mechanism on the cassette to
rigidize the inner elongate
cannula and the outer elongate cannula.
[0088] This and other embodiments can include one or more
of the following features. The cassette
can be further configured to alternately advance and retract the outer
elongate cannula relative to the inner
elongate cannula. The drive unit can be further configured to actuate a
mechanism on the cassette to
advance and retract the outer elongate cannula relative to the inner elongate
cannula. The cassette can be
further configured to steer the inner elongate cannula or the outer elongate
cannula. The cassette can
include one or more disks configured to rotate to activate cables of the inner
elongate cannula or the outer
elongate cannula to steer the inner elongate cannula or the outer elongate
cannula. The cassette comprises
a disk configured to rotate to advance and retract the outer elongate cannula
relative to the inner elongate
cannula. The outer elongate cannula can include a rack at a proximal end
configured to engage with the
disk to advance and retract the outer elongate cannula relative to the inner
elongate cannula. The inner
elongate cannula and the outer elongate cannula can be configured to rigidize
with the application of
vacuum or pressure to a wall of the inner elongate cannula or the outer
elongate cannula. The mechanism
on the cassette can include an eccentric cam. The mechanism on the cassette
can include bellows.
[0089] hi general, in one embodiment, a rigidizing device
includes an elongate flexible tube, an
outer layer over the flexible tube, an inlet between the elongate flexible
tube and the outer layer, a
plurality of linkages coextensive with a distal end of the rigidizing device,
and a plurality of cables
configured to activate the plurality of linkages. The inlet is configured to
provide vacuum or pressure
between the elongate flexible tube and the outer layer to transition the
rigidizing device from a flexible
configuration to a rigid configuration. The distal end is configured to be
steered by the plurality of cables
when the rigidizing device is in the flexible configuration. The distal end is
configured to have a fixed
orientation when the rigidizing device is in the rigid configuration.
[0090] This and other embodiments can include one or more of the
following features. The plurality
of linkages can be positioned radially inwards of the elongate flexible tube.
The rigidizing device can
further include a braid layer between the elongate flexible tube and the outer
layer. The inner layer can
include a reinforcement element therein. The reinforcement element can include
a coil. The inner layer
can have a first thickness proximal to the plurality of linkages and a second
thickness coextensive with
the plurality of linkages. The first thickness can be greater than the second
thickness.
[0091] In general, in one embodiment, a method of
advancing a medical tool through a body lumen
includes (1) inserting a rigidizing device into the body lumen while the
rigidizing device is in a flexible
configuration, (2) steering the rigidizing device in the flexible
configuration to a desired location, and (3)
activating pressure or vacuum between layers of the rigidizing device to
transition the rigidizing device
into a rigid configuration and to hold the distal end in a fixed orientation.
Steering comprises activating
cables connected to a plurality of linkages at a distal end of the rigidizing
device
[0092] This and other embodiments can include one or more
of the following features. The plurality
of linkages can be positioned radially inwards of the layers of the rigidizing
device. The layers of the
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rigidizing device can include a braid layer. The layers of the rigidizing
device can include an inner layer.
The inner layer can include a reinforcement element therein. The reinforcement
element can include a
coil.
[0093] In general, in one embodiment, a rigidizing device
includes an elongate flexible tube, a braid
layer positioned over the elongate flexible tube, an outer layer positioned
over the flexible tube and the
braid layer, a balloon sealed around the outer layer, a fitting positioned
within the balloon and around the
elongate flexible tube, and an inflation lumen. The braid layer or the outer
layer terminate in the fitting.
The inflation lumen extends from a proximal end of the rigidizing device to
the fitting and is configured
to provide inflation fluid to the balloon.
[0094] This and other embodiments can include one or more of the
following features. The fitting
can include an anti-block element at a distal end of the inflation lumen. The
anti-block element can be a
fabric, breather, or permeable material.
[0095] In general, in one embodiment, a rigidizing device
includes an elongate body and a handle.
The elongate body includes an inner bladder layer, a braid layer positioned
over the inner bladder layer,
and an outer layer positioned over the inner bladder layer and the braid
layer. The handle is attached to
the elongate body and includes an annular bladder adaptor having an interior
surface and an exterior
surface. The inner bladder layer is bonded to the interior surface, and the
braid layer is bonded to the
exterior surface.
[0096] Any of the methods described here can include one
or more of the following. The method
can further include releasing vacuum or pressure after activating the vacuum
or pressure to transition the
rigidizing device back to the flexible configuration. The method can be
performed in the gastrointestinal
tract. The method can be performed in the heart. The method can be performed
in the kidneys. The
method can be performed in the lungs. The method can be performed in the
brain.
BRIEF DESCRIPTION OF THE DRAWINGS
[0097] The novel features of the invention are set forth
with particularity in the claims that follow.
A better understanding of the features and advantages of the present invention
will be obtained by
reference to the following detailed description that sets forth illustrative
embodiments, in which the
principles of the invention are utilized, and the accompanying drawings of
which:
[0098] Figure 1 shows a rigidizing device.
[0099] Figures 2A-2B show portions of a braid layer of a
rigidizing device.
[0100] Figure 3 is a graph of bend force vs braid angle
when a rigidizing device is placed under
vacuum.
[0101] Figures 4A-4D show exemplary braid formations.
[0102] Figures 5A-5B show exemplary braid formations.
[0103] Figures 6A-6D various designs for the termination
of braid layers of a rigidizing device.
[0104] Figure 7 shows an inner layer of a rigidizing
device.
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[0105] Figures 8A-8F show different coil designs for a
layer of a rigidizing device.
[0106] Figures 9A-9B show undulating reinforcement
elements for a layer of a rigidizing device.
[0107] Figures 10A-10E show notch and pocket
reinforcement elements for a layer of a rigidizing
device.
[0108] Figures 11A-11B show a cut tubing reinforcement element for a
layer of a rigidizing device.
[0109] Figures 12A-12B show exemplary rigidized shapes of
a rigidizing device.
[0110] Figures 13A-13D show an exemplary vacuum
rigidizing device_
[0111] Figures 14A-14B show an exemplary pressure
rigidizing device.
[0112] Figure 15 is a graph of bending strength vs
pressure for a rigidizing device.
[0113] Figure 16A-160 show various examples of pressure rigidizing
devices.
[0114] Figures 17A-17D show a rigidizing device with an
incorporated working channel.
[0115] Figures 18A-18B show a rigidizing device with a
spiraled working channel.
[0116] Figures 19A-19B show a rigidizing device with a
plurality of spiraled working channels.
[0117] Figures 20A-20B show a rigidizing device with a
plurality of working channels extending
down the central lumen.
[0118] Figure 21 shows a rigidizing device with a working
channel extending out the side thereof.
[0119] Figure 22 shows a tool that can be used with a
working channel of a device, such as a
rigidizing device.
[0120] Figure 23 shows a rigidizing device with a distal
end section.
[0121] Figure 24 shows a rigidizing device with a distal end section
having a separate braid pattern
from the proximal section of the device.
[0122] Figure 25 shows a rigidizing device with a distal
end section having a plurality of passive
linkages.
[0123] Figure 26 shows a rigidizing device with a distal
end section having a plurality of actively
controlled linkages.
[0124] Figures 27A-27E shows a plurality of actively
controlled linkages_
[0125] Figure 28 shows one embodiment of a rigidizing
device including cables extending within the
layered wall.
[0126] Figure 29 shows one embodiment of a rigidizing
device including cables extending within the
layered wall.
[0127] Figure 30 shows one embodiment of a rigidizing
device including cables extending within the
layered wall_
[0128] Figure 31 shows one embodiment of a rigidizing
device including cables extending within the
layered wall.
[0129] Figure 32 shows one embodiment of a rigidizing device including
cables extending within the
layered wall_
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[0130] Figure 33 shows one embodiment of a rigidizing
device including cables extending within the
layered wall.
[0131] Figure 34 shows one embodiment of a rigidizing
device including cables extending within the
layered wall.
[0132] Figure 35 shows a rigidizing device including cables extending
down the central lumen.
[0133] Figure 36 shows an embodiment of rigidizing device
including a cable spiraled therearound.
[0134] Figure 37 shows an embodiment of a rigidizing
device with a cable spiraled therearound.
[0135] Figures 38A-38B show an embodiment of a rigidizing
device with a cable spiraled
therearound.
[0136] Figures 39A-39B show a rigidizing device with a cable spiraled
therein.
[0137] Figures 40A-40D show exemplary linkages for a
distal end section.
[0138] Figures 41A41B show a rigidizing device with a
distal end section having linkages over a
rigidizing section.
[0139] Figure 42A shows a rigidizing device with a distal
end section having linkages within a
rigidizing section.
[0140] Figure 42B shows a rigidizing device with a
steering cable attached to a wall near the distal
end thereof.
[0141] Figures 43A-43C show a rigidizing device having an
actively deflected distal end section.
[0142] Figures 44A-44C show a rigidizing device with
separate rigidizing chambers along the length
thereof.
[0143] Figures 45A-45D show a rigidizing device with a
balloon and inflation lumen.
[0144] Figures 46A-46B show an embodiment of a suction
tip for a device such as a rigidizing
device.
[0145] Figures 47A47B show an embodiment of a suction tip
for a device such as a rigidizing
device.
[0146] Figures 48A48B show an embodiment of a suction tip
for a device such as a rigidizing
device.
[0147] Figures 49A49D show an embodiment of a handle for
use with a rigidizing device.
[0148] Figures 50A-50B show an embodiment of an
activation element for a handle of a rigidizing
device.
[0149] Figures 51A-51C show an embodiment of an
activation element for a handle of a rigidizing
device.
[0150] Figures 52A-52C show an embodiment of an
activation element with a coupling for a handle
of a rigidizing device.
[0151] Figures 53A-53D show an embodiment of a handle for use with a
rigidizing device.
[0152] Figures 54A-54B show an embodiment of a handle for
use with a rigidizing device.
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[0153] Figures 55A-55C show an embodiment of an
activation element for a handle of a rigidizing
device.
[0154] Figures 56A-56G show an embodiment of a handle for
use with a vacuum rigidizing device.
[0155] Figures 57A-57C show an embodiment of a handle for
use with a pressure rigidizing device.
[0156] Figures 58A-58E show a pre-filled handle for use with a pressure
rigidizing device.
[0157] Figure 59 shows a rigidizing device with imaging
elements mounted on a side thereof.
[0158] Figure 60 shows a rigidizing introducer.
[0159] Figures 61A-61B show a rigidizing device with a
side-access mechanism.
[0160] Figure 62 shows a nested rigidizing system.
[0161] Figure 63 shows a nested rigidizing system with a cover between
the inner and outer
rigidizing devices.
[0162] Figures 64A-64B show a nested rigidizing system
where the outer rigidizing device includes
steering and imaging.
[0163] Figures 65A-65H show exemplary use of a nested
rigidizing system.
[0164] Figure 66 shows a rigidizing rod.
[0165] Figure 67 shows a rigidizing rod in use with a
colonoscope.
[0166] Figures 68A-68B show an exemplary rigidizing
device with a scope therein.
[0167] Figures 69A-69B show use of a rigidizing device in
the gastrointestinal tract.
[0168] Figures 70A-70B show a method of use of a
rigidizing device for ERCP.
[0169] Figures 71A-71B show a method of use of a rigidizing device for
ERG'.
[0170] Figures 72A-72D show a method of use of a
rigidizing device for ERCP.
[0171] Figures 73A-73B show a method of use of a
rigidizing device in the heart to create access to
the left atrium.
[0172] Figures 74A-74B show a method of use of a
rigidizing device in the heart to perfortn
treatment of a branching vessel.
[0173] Figures 75A-75C show a method of use of a
rigidizing device in the heart for mitral valve
repair.
[0174] Figures 76A-76B show a method of use of a dual
rigidizing device in the heart.
[0175] Figure 77 shows a rigidizing device used as a
trocar.
[0176] Figure 78 shows a rigidizing device in use at the aortic
bifurcation.
[0177] Figure 79 shows a rigidizing device for mitral
valve repair.
[0178] Figure 80 shows a rigidizing device with a distal
payload for mitral valve repair.
[0179] Figures 81A-81F show a method of using a
rigidizing device to control a working tool.
[0180] Figures 82A-82J show a handle for using with a
rigidizing device.
[0181] Figures 83A-83E show the use of a dual rigidizing system to pass
sutures to secure an
annuloplasty ring.
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[0182] Figures 84A-84E show another method of attaching
an annuloplasty ring using two rigidizing
cannulas.
[0183] Figures 85A-85B show a compression system for
forming a composite tube.
[0184] Figures 86A-86F show a method of using a
rigidizing device and preformed wire.
[0185] Figures 87A-87C show torsional layers for a rigidizing device.
[0186] Figure 88 is a cross-section of an exemplary
reinforced layer.
[0187] Figure 89 shows a steerable rigidizing tip.
[0188] Figures 90A-90B show a rigidizing device with a
balloon therearound.
[0189] Figure 91 shows a handle and proximal end of a
pressure rigidizing device.
[0190] Figure 92 shows a cross section of a distal tip of a rigidizing
device.
[0191] Figures 93A-93D show a robotically controlled
rigidizing system.
[0192] Figures 94A-94B show mechanisms of actuating a
robotically controlled rigidizing system.
[0193] Figure 95 shows a drive unit for a robotically
controlled rigidizing system.
[0194] Figure 96 shows a guide for a robotically
controlled rigidizing system.
[0195] Figures 97-97B show another embodiment of a guide for a
robotically controlled rigidizing
system.
[0196] Figure 98 shows another embodiment of a guide for
a robotically controlled rigidizing
system.
[0197] Figure 99 shows a tool for use with a robotically
controlled rigidizing system.
[0198] Figure 100 shows a slide for use with a robotically controlled
rigidizing system.
[0199] Figures 101A-101B show a robotically controlled
rigidizing system.
[0200] Figure 102 shows a pivoting arm for a robotically
controlled rigidizing system.
[0201] Figures 103A-103B show an exemplary distal tip for
a rigidizing device.
DETAILED DESCRIPTION (DEVICE)
[0202] In general, described herein are rigidizing
devices (e.g., overtubes) that are configured to aid
in transporting a scope (e.g., endoscope) or other medical instrument through
a curved or looped portion
of the body (e.g., a vessel). The rigidizing devices can be long, thin, and
hollow and can transition
quickly from a flexible configuration (i.e., one that is relaxed, limp, or
floppy) to a rigid configuration
(i.e., one that is stiff and/or holds the shape it is in when it is
rigidized). A plurality of layers (e.g., coiled
or reinforced layers, slip layers, braided layers, bladder layers and/or
sealing sheaths) can together form
the wall of the rigidizing devices. The rigidizing devices can transition from
the flexible configuration to
the rigid configuration, for example, by applying a vacuum or pressure to the
wall of the rigidizing device
or within the wall of the rigidizing device. With the vacuum or pressure
removed, the layers can easily
shear or move relative to each other. With the vacuum or pressure applied, the
layers can transition to a
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condition in which they exhibit substantially enhanced ability to resist
shear, movement, bending, and
buckling, thereby providing system rigidization.
[0203] The rigidizing devices described herein can
provide rigidization for a variety of medical
applications, including catheters, sheaths, scopes (e.g., endoscopes), wires,
or laparoscopic instruments.
The rigidizing devices can function as a separate add-on device or can be
integrated into the body of
catheters, sheaths, scopes, wires, or laparoscopic instruments. The devices
described herein can also
provide rigidization for non-medical structures.
[0204] An exemplary rigidizing device system is shown in
Figure!. The system includes a
rigidizing device 300 having a wall with a plurality of layers including a
braid layer, an outer layer (part
of which is cut away to show the braid thereunder), and an inner layer. The
system further includes a
handle 342 having a vacuum or pressure inlet 344 to supply vacuum or pressure
to the rigidizing device
300. An actuation element 346 can be used to turn the vacuum or pressure on
and off to thereby
transition the rigidizing device 300 between flexible and rigid
configurations. The distal tip 339 of the
rigidizing device 300 can be smooth, flexible, and atrautnatic to facilitate
distal movement of the
rigidizing device 300 through the body. Further, the tip 339 can taper from
the distal end to the proximal
end to further facilitate distal movement of the rigidizing device 300 through
the body.
[0205] A portion of an exemplary braid layer 209 for a
rigidizing device similar to device 300 is
shown in Figures 2A-2B. The braid layer 209 can included braided strands 233.
The braid layer 209 can,
for example, be a tubular braid.
[0206] The braid angle a of the strands 233 relative to the longitudinal
axis 235 of the rigidizing
device when the rigidizing device (e.g., device 300) is in a straight (unbent)
configuration can be less than
45 degrees, such as less than or equal to 40 degrees, less than or equal to 35
degrees, or less than or equal
to 25 degrees. Referring to Figure 3, the bending strength of the rigidizing
device decreases as the braid
angle a (when the rigidizing device is straight or unbent) increases. That is,
the bending strength under
vacuum of the rigidizing device with a braid angle of 45 degrees (a typical
minimum angle for a torque or
torsion braid. Still larger angles are typically used for catheter shaft
reinforcement) under vacuum is 27%
of the bending strength under vacuum of a rigidizing device with a braid angle
of 25 degrees.
Accordingly, having a lower braid angle (e.g., less than 45 degrees, such as
40 degrees or less or 35
degrees or less) advantageously ensures that the rigidizing device (e.g.,
device 300) remains stiff in
bending (resistant to a change in configuration) under vacuum (and similarly
under pressure).
Additionally, the braid angle a when the rigidizing device is in a straight
(unbent) configuration can be
greater than 5 degrees, such as greater than 8 degrees, such as greater than
10 degrees, such as 15 degrees
or greater. Having a braid angle a within this range ensures that the braid
remains flexible enough to
bend when in the flexible configuration (i.e., when not rigidized under vacuum
or pressure). Thus, the
braid angle a of the strands 233 relative to the longitudinal axis 235 of the
rigidizing device when the
rigidizing device is in a straight configuration can be 5 to 40 degrees, such
as 10 to 35 degrees, such as 15
to 25 degrees, such as approximately 5, 10, 15, 20, 25, 30, 35, or 40 degrees.
The braid angle ct of the
strands 233 relative to the longitudinal axis 235 of the rigidizing device
when the rigidizing device is in a
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straight (unbent) configuration of 5-40 degrees ensures that the rigidizing
device is flexible enough to
bend in the flexible configuration (e.g., when not under vacuum/pressure) yet
stiff when in the rigid
configuration (e.g., when placed under vacuum or pressure). Additionally, it
should be understood that
the strands 233 are configured to slide over one another, and therefore that
the braid angle a will change
the rigidizing device flexes and bends. Having an angle a that is between 5
and 40 degrees also
advantageously ensures that the strands 233 can move freely relative to one
another without causing the
fibers to collide with one another and prevent further angular change.
[0207] Further, the braid for braid layer 209 can be
between 4-60 picks per inch, such as 8, 10, 12,
14, 16, 18, 20, or 25 picks/inch. In one embodiment, the tube formed by the
layer 209 has a diameter of
0_578", and the braid is 12-14 picks per inch.
[0208] In some embodiments, the braid layer 209 (or any
braid layer described herein) can be
configured such that the rigidizing devices described herein have a high
stiffness ratio (i.e., the ratio of
the stiffness in the rigid configuration, such as when vacuum or pressure is
applied, to stiffness in the
flexible configuration, such as when vacuum or pressure is not applied). For
example, the stiffness ratio
can be greater than 5, such as greater than 6, greater than 9, greater than 9,
or greater than 10. Referring
to Table 1 below, six vacuum rigidizing devices (samples A-F) were built and
tested over a length of 4"
and a deflection of " for cantilevered bending stiffnesses at atmospheric
pressure (flexible
configuration) and under vacuum (rigid configuration). As shown, lowering the
braid angles raises the
stiffness of the rigidized devices. Samples E and F show, in particular, the
stiffness difference between a
braid at a typical torque angle (sample E, 47.7 degrees and rigid stiffness of
0.5291bf) and a braid with a
lower angle (sample F, 27.2 degrees, and a rigid stiffness of 1.455 lbf). As
is also shown in Table 1,
rigidizing devices with lower angles (e.g., angles under 45 degrees or 35
degrees, such as samples A-D
and F) can have a much higher stiffness ratio (e.g., ratio of greater than 5,
greater than 6, greater than 9, or
greater than 10) than rigidizing devices with higher angles (e.g., angles of
45 degrees or above, such as
sample F), which can have a stiffness ratio of under S. It can also be
observed from Table 1 that both
samples A and B have a stiffness ratio above 5. Sample B, at a 14.9 degree
braid angle, has a lower
stiffness ratio but a higher absolute stiffness than sample because the
strands of sample B are oriented
close to the longitudinal axis (and therefore sample B has a higher stiffness
in the flexible configuration).
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Table 1¨ Vacuum Rigidizing Devices
-=_õ).;-..:0.:0;ea
---4,..--fa,,,
.......... ":::::::::
....rA:.:.-: ... :.,""""4 A.:.0:1-,= = = = ::. = =."."'`+' .NN,.N1/4 ,:-
,N.1/4:-.1/4:-.1/4:-.1/4\:õ.
..(.4A;A:A....A.,.A.,Ma \µµ..'.. \
A....A;A:A....A.;:=V1/4.: = .,...N..N..w.A,A-N.
N.. NN :: :.: SA µANANANN. A; 'N.N.:µ,:µ,: : NNN:N. \NN,N., S N,N,AN
AA...A-N.-Now,. A ::,;::,=,A : MA: .N.µ
MAMAR -A. '11/4t., atAAAMAA:k N.A.MAA.:=A:::,..A
Mr5AN..N..N..N..=.NeN.. .-. "N , ;(54 ,A..5.*:.:N5o,
.1/4. AFEA2A.1/4AVA:1/4. 't k;ENMKAN ',3%...Zii: ii. in. 1,...P.Ci n;l:.
;1"Q = :-A.`tncA
RI.1.,....7-,,,,,<...r.-..\\\.nnnnn \,.. ?,.......\\--nnnn \ - \ \ \
Nrananar,-,,,,_
¨
-..:..\\:.\\n-T-S ''',v%>-an.:7\\NMIMP,,s1..--,-,-,2:-.\--,w ,-,-,>,õ
.. õ..
yak.. .. õõõ..10,-aka =-- ¨ ^s, =
..---. ::::::::::4......4....,i
OMM
Inata 1 Sanra; 1110 ; 03.."-R-R-Zi .4.- MAMMA \i-kmoa .1 ' '
kkt:k ! ighzzAI itgi
0.010"
A
0.37 20.4 PET 14.3 0.046 0.441
9.6 0.395
0.010"
B
0.37 14.9 PET 12.8 0.097 0.653
6.7 0.556
0.010"
C
0.576 32.8 PET
16.2 0.099 0.661 6.7 0.562
0.010"
D
0.576 20 PET
11.5 0.115 1.102 9.6 0.987
0.010"
E
0.77 47.7 PET 19.8 0.115 0.529
4.6 0.414
0.010"
F
0.77 27.2 PET 12.2 0.137 1.455
10.6 1.318
[0209] Referring to Table 2 below, three pressure
rigidizing devices (samples G-I) were built and
tested over a length of 4" and a deflection of 1/2"for cantilevered bending
stiffnesses at atmospheric
pressure atmospheric pressure (flexible configuration) and under 4atm pressure
(rigid configuration). The
samples all included a coverage of 35-45% and a braid with 96 strands and one
filament per strand. As
shown, lowering the braid angles raises the stiffness of the rigidizing
devices. As is also shown in Table
2, rigidizing devices with lower angles can have a higher stiffness ratio than
rigidizing devices with
higher angles. In some embodiments, the pressure rigidizing devices described
herein have a stiffness
ratio of greater than 10, such as greater than 15, such as greater than 20.
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Table 2¨ Pressure Rigidizing Devices
N.... = = ;==
;;;:tt:tt:tt:tt = , -1 ,nta
ZW.T.Z4.1""=;..=
'''''''''''''' """''''"''''''' 'ttktµt'nw.-
't-L=tt unz zzznzmuzlz,z,z;;;;;õ:d zzµõõztzzzttttrt,tnt,t
µla Lk:k:t:k")"'
flz:z:z:z:z1z1z1z111111tIbt.:1:1:z:zzrzzztz ttttztztttrt.t::::::::znµn
z=ztzt:::=m= zz=zziztztzt;z:z,z,znut
z:z:z:z1z1c1c1:1:1:tzt'znz:z:z:z:z:ztztttttztktkt" nztzttztttttttttunt:u,::
zzmzzzzzzzz:z:z.z.znz:z
zzzzzztzzztzizzlizity
izzz.....k.,zzzzttzzlzz
zrz:unzr:muutzt,z_uuz,,,,,,,z1z1z1zInIzz
ntztt:: tztz.
zzz.:::,,z,rrtutti=t1t.
zrn."st:=:;!::Y
ttttttttZMUllitiliZIZ;Zz
'''''''''''''''''''' Z;Zzkzkktmwk
tnniniUMM:Mt:MMW
zaaE.zE.zzzzzaakkkkmtztz,,.:.z,.z
Ask .ykr..5 am , aft:zazamazzaatizt
zb?;:Wk:;:t":Za'
" LILL: RPIP.P.P.Migti;;;;;;L:Mtitititi
;NtigSafgaggfatii; iLiLiii:t :?,
-
ztzt:11
zzuzzzzzzz:zii
:z:z:z. :z:z:z:z:z:z:zt"tt:ttrIztztzt--=:z:z:z:z :z;z:z ¨rm:zr.:= =-
=-rm:::::::nx.-rz zr,.1,,n,L,õzzztzzrzrzz___, ..,:mtztztz.n.,tztzt
zz:z:z:
0.35 30 0.005" 24.1 0.044 0.448
10.2 0.404
stainless
steel
0.35 22.7 0.005" 17.5 0.037 0.611
16.5 0.574
stainless
steel
0.35 15.6 0.005" 11.7 0.051 1.091
21.4 1.04
stainless
steel
[0210]
Further, in some embodiments, the braid
of braid layer 209 can have a coverage of 30%-70%,
such as 40%-60%, e.g., 30%, 40%, 50%, 60%, or 70%, where the coverage area is
the percentage of an
underlying surface that is covered or obstructed by the braid.
[0211] In some embodiments, the braid layer 209 can be
formed by running each individual strand
around an inner tube or the rigidizing device and/or a separate mandrel in a
helix such that the strands 233
are interlaced with one another. In one embodiment, the braid layer 209 can be
heat formed over a 0.50"-
0.60", e.g., 0.56" mandrel. Further, in some embodiments, the braid layer
during manufacturing can be
mounted over a tube or mandrel to a diameter that is smaller than the core
diameter (i.e., smaller than the
diameter at which the braid was originally manufactured). Compressing the
braid radially in this way can
decrease the braid angle in the range that provides a high rigidization
multiple (while also decreasing the
PPI, increasing the total length of the tubular braid layer, and increasing
the braid coverage percentage).
[0212] The strands 233 can be rectangular/flat (e.g.,
with a long edge of 0.001"-0.060", such as
0.005", 0.007", 0.010", or 0.012", and a short edge of 0.0003"-0.030", such as
0.001", 0.002", or 0.003"),
round (e.g., with a diameter of 0.001"-0.020", such as 0.005", 0.01", or
0.012"), or oval. In some
embodiments, some of the strands 233 can be flat and some of the strands 233
can be round.
[0213] In some embodiments, the strands 233 can be made of metal
filaments (e.g., stainless steel,
aluminum, nitinol, tungsten, or titanium), plastic (nylon, polyethylene
terephthalate, PEEK,
polyetherimide), or high strength fiber (e.g., aranaids, ultra-high molecular
weight UHMW polyethylene,
or liquid crystal polymers such as Vectran). In some embodiments, the strands
233 can be made of a
multi-layer composite, such as a metal core with a thin elastomeric coating.
In one specific example, the
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strands 233 can include round nylon having a diameter of 0.010" (or metal
filaments having a diameter of
0.003") intertwined with flat aluminized PET with cross-sectional dimensions
of 0.002" by 0.002". In
some embodiments, the material for the strands 233 of the braid can be a
material with a known high
coefficient of friction. For example, the strands 233 can be a monolithic
structure or have a coating such
that the strands include aluminum on aluminum, copper on copper, silver on
silver, or gold on gold. As
another example, the strands 233 can be coated with an elastomeric material
(e.g., lower durometer
elastomers can be coated on top of a higher modulus substrate). As another
example, the strands 233 can
be made of styrene co-polymer, polycarbonate, or acrylic.
[0214] There can be between 12-800 strands 233, such as
24, 48, 96, 120, 144 or more strands 233
extending within braid layer 209. In some embodiments, there are 96 strands or
more, 120 strands or
more, 200 strands or more, or 240 strands or more. A higher number of strands
may advantageously help
rigidize the braid due to the increased interaction between strands.
[0215] Referring to Figures 4A-4D, the braid of any of
the rigidizing devices described herein can be
in a variety of different braid patterns. For example, referring to Figure 4A,
the braid of layer 1709 can
be a diamond full load pattern in which two neighboring strands 1733a,b extend
over two strands and
then under two strands. Referring to Figure 4B, the braid of layer 1709 can be
a full load pattern, in
which each strand 1733a extends over two strands and under two strands in a
manner that is opposite to
the neighboring strand 1733k Referring to Figure 4C, the braid of layer 1709
can be a diamond half load
pattern in which each strand 1733a extends over one strand and under one
strand opposite to the
neighboring strand 1733b. Referring to Figure 4D, the braid of layer 1709 can
include one or more
longitudinal strands 1733c running through the crossed strands 1733a, 1733b.
[0216] Referring to Figures 5A-5B, each strand 1833 can
include a single filament 1818 (Figure 5A)
or multiple filaments 1818a-c (three filaments 1818a-c are shown in each
strand 1833 in Figure 5B). The
filaments 1818 can be chosen (i.e., diameter, spacing, and modulus can be
specifically tailored) to reduce
crimp (the waviness or bending of the filaments). Reduced crimp can help the
system provide enhanced
compression buckling resistance, which can translate to enhanced system
stiffness.
[0217] Exemplary specific braid layer embodiments J-N are
shown in Table 3.
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Table 3- Exemplary braids
:::::7-----::.::;:;:z.::::::Rm . õ,::::::-;:---:::::::-,...:-,--::::------..--
;-;:z: :::::;:----:-7.--....7-tzz.õ-:-.;-::-::;-::;:-.....;77.-=:-..-.-:,:-
,t...;
.ir...t...:,11....1.......-..P._Ent....*::.t...1.11,--n rs.r.....rir, ...--
1...r.stfn :1:111- In...:*÷...n.ra: ri.-LI ...m. .-.1.-,
,
zz-zzzz,zzzzunt:z:zalz .1 L':,- z = z Is zz zz:z:z: z= %: .-1,33:::
ztztzz:zzuz:z:z:z:z1z1z1z zn:::: iz,,,iiiTi
iTiiilitib,õiiiiiiii:Li iiiiiiiiTi ,i,..i:p-iiiiii ii-i-ii ,-Lii,,,
i...,:..1...... r.:t...=,...,:rm-ymõ,,,,õ.m...1-.1.:.:nt
-.4k.`41-.0-.`1,1:::::Ititzrzkat'tktiStIt.it: irizIf't ."":"."4"t,t-
tlii:2".11.-Rrart'aMign WISIIRra Wilt:WLSMi-t.i
=Ftrsikr'Skr':::$3414:1;*1/4"..".'1"-Z:cl= z=-=-=:vzz
v$1..:Mt::::::*=1:1f:AxiMt::::::::::::VA*
.A=AA=AASA=lAslAz.A;;Az.-00',S=Sx; A -A, ..."..k. .:" . .z.' ;As: A=,,-A`t: i
= .1.A A. ...,RA;;;;;;;AAAAAAAAAIASASAS.A.kAtz:kz ;A:AA:, V.AA ;AAA kAA.A ' :
:::: ....: =.` ."- ::;..A :AAA - A ØA. - = k`" .kk:',...kkA",:c:.:......A..
=kz...AkiASAkAkkt-kt;;;;;;=:'=:: MA, kA":õ.=Wes.MAIr-
iiiiiz.-;;;;;;::::::::;ASW=MmAnznel-Rk.:::::::;.-t:.;=EIR-zrz*R-
MR:;::;::;:::::::::::A.S..tif=;:f0A-MSSR:::;;::;::::=1.-;:kf=t
zn.r.;:f=&;;;;;;SS'AS= ::::;S:S:f=tf=tf(A-UE:=:E
Actzf=Rz:;;;;;;ASS::;:e=tf=nkik-&-Atl...-Rsz:::;AINEZZ:ZZ:i.tq: 1 z.=....-.4-
:::.nzb.s.Annz..k.z.k.z..
-::.-::-:"..c..c..4":::::::**Aara:Sra:::::::::::::::::=M::=::::::;::;;;
;;ActWAc..:::::"..c..
z..c..c....z...k.S.:=:::::.Wffa'az.=:::::::::::::::::=:;:k:k.:::
:::::::::?;;;;;:::::.=:::.=:::.=:: :;=.,..:;:::::::::;:::::=Ay:::
::::ZZZ:.;:t;',Z.1...a."..t:Z:M41.1.:..isza.z..;:mmz:EkE i
kLaikftkiz,ciz:tm...;:n:::
iialare:MIFALTAtkift;:=1:akPO:::: :re-Sta:Salkitti:
Z:ti:ti.4;4;4:Mcf.FSM;;;:".=rnitlknk.".11ZSAIM;;;;;;;;;
,...a...z.1.1ztzt..ztsta :ikst::::.;;;;;;;;:nk,kkt,ta-3.4 ;;;;;;;;;;;;;,, :
,....,:nc.za,;;;;;;;;;;
;;;;;;.õ......-----------::::.-rn ..:yrt---el-nre., ,:,:,,,,,::::.::-
....ny:,...., ,ar.::-,--,,,Tirin ti,:i;:,õõõõõõ, ;,--;;;;;it, s ;: ;;;;;;
,;;;;;;;;;;;;;;;;;,,,,L;;:;;:;,,,,õõõõõ:õ , zdnnt:.3.,E:zzzzzzztzt=
1.:=:=:=:=:=:S:SrmIzrz=ztztzta.:=:=:=:====ncr.cm: :=:===z;t:=:=:=
=:=:=::=1.tta.a.z1z1z=z=z=z= =z;t:=:====ttntz ztknetzt=z=z=z=z====ntnt'vt'n¨s-
:z=z;,tj 'flfl,=,=M=:--ij:ij:ri'MM--j: NirrEIT:r:in
Itz:z:z:z:z:z3Szz-zz-zrzz:z:zuntz:z:z.:znz--=:Itazz: nunz:z:z:z:z.
z:z:z1z1z1z:1::1;z:z:z:z:z:z. z:z:z.::;inPiiii iii8tiiiiiPii-iiPii-in-i--
Aiirthittm.: iiiin -.;;;;;;;;;;;;;;;;;:ttnnt:Rcrrymnntnnt-_. nutntr:r:nymntzt
'...z...:...:::::::::::$;-:..r...r.v.v..:::-.:-.::::::.r.-- ;tr..-- :.?:;N:::-
.F.F.:=--F.F.:::::::...;:tuu=r(i-zp.p.r.f.F.F. z..F..:::-...,,,,, -,:-
....:Nr..:-.:-:-:-:----,........,,,,,,s,sk-N-N-: ,-;-;-;... . -
......................skp.,,,,,,,,,,,-..,- ,..,-.....¨.-
...............r.,%,:kr.r.z.z.z.
MEtititititiz 0.576 20 PET, 12 120
1 Full 56.7% Vacuum
:-taminfvz:ziz
nn-n-y:yrdltd- i-
,õõõõõ,:,:õõ, round,
load
::::::::::::::::::::
if--,:i.,ii..e--i-
::::::::::::::::::::::
:::::::::::::::::::: 0.010"
:::::::::::::::::..:..
=TffiiiHN
:-..:õ..:õ..:õ.:...;,..:.s...,..,:µ,..
0.21 15.1 Stainless 18.7 96
1 Full 59% Pressure
J.,nn
nnwinnnmnn steel,
load
round,
z:A.A.Z..A.M.A.kAitttkp=p=
EMMM
zra.Z...R-WA.:::::
;;;;;;;alla 0.005"
Te".1mvfeftftft=
0.35
25.7 Stainless 20.45 96 1 Full load 42%
Pressure
::::::.::.=:........
............õ:õõ,
=nzanwsannitam
=azaziiminn....nm steel,
enc-fpniesst
round,
inninna
0.005"
ilaiiiiiIMMT
.,=-k=-,,,,N.Z;;;;;:k:k:
ift::.:Ni=ZA :::z:::zNN 0.21 15.1 Stainless 18.7
96 1 Full 50% Pressure
makikaii'aw
:{geni@d-zi:z
;;;;;;;;;;;;;;;;;;;; steel,
load
,õõõõõ,:,:,:z:z
;;;;;;;;;;;;;;;;;;;;
,õõõõõ,:,:,,,,,
:::::::::::::::::::: round,
.;:;1,TArAisAisAisArAtAtA
zA:zi.:z:3::::::::::::::.--M
"z:z:n....t:::::::::::::::
einkThksiksinnµv=c" 0.004"
nztazizi.ewst
0.33
14 Stainless 11.7 96 1 Full 42% Pressure
inninnni i nin
inninninn:nnn
nz:zrz::::::::::::rn:
=AWAKAWAtzt3:3AW
steel, load
'1:::::::::AA'aft-ftzkzkz
kt:AM:Niz'a
.t'inzazazniti:t round,
!!...
aft-1...
z=nzt:=
zrzurumnizim 0.005"
- õõõ._
[0218] In use, vacuum or pressure can be supplied between
the walls of the rigidizing devices
described herein, causing the braided layer and neighboring layer(s) to
constrict and/or separate to
transition between flexible and rigid configurations. The rigidizing devices
described herein can thus
advantageously transition from very flexible to very stiff upon activation by
the user. When a vacuum or
pressure is applied, the braids or strands can radially constrict or expand to
become mechanically fixed or
locked in place relative to one another. As a result, the rigidizing device
can go from a flexible
configuration to a rigid configuration when vacuum or pressure is applied
(thereby fixing the rigidizing
device in the shape that the rigidizing device was in just prior to
application of the vacuum or pressure).
[0219]
Referring to Figures 6A-6D,
in some embodiments, one or both ends of the braid layer 5609
of a rigidizing device 5600 as described herein can be bonded to another layer
of the device 5600 to
prevent the strands 5633 of the braid from coming unbraided. Further, the ends
of the strands 5633 can
be bonded in such a way so as to allow relative movement of the stands 5633
during flexing of the
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rigidizing device 5600 when it is in the flexible configuration (La, so as to
prevent rigidity or buckling of
the device 5600, which in turn can lead to drag at the tip 5629, that might
otherwise occur if the strands
5633 were constrained).
[0220] For example, as shown in Figure 6A, the tip 5629
of the braid layer 5609 can include a
coating 5634 thereover of low durometer material, such as silicone or
urethane, that is stretchable and/or
flexible. As a result, the ends of the strands 5633 can be encapsulated by the
coating 5634 (and therefore
prevented from unbraiding) while still moving with coating 5634 as it
stretches and/or flexes. The
coating 5634 can be thin, such as between 0.005-0.250 thick (e.g.,
approximately 1/32" thick).
[0221] As another example, as shown in Figure 6B, the tip
5629 of the braid layer 5609 can include
an annular ring 5601z therearound. In some embodiments, the ring 5601z can be
formed by melting the
lips of the strands 5633. In other embodiments, the ring 5601z can be a
separate element that is bonded to
the strands 5633 (e.g., bonded to less than 20%, less than 10%, or less than
5% of the strands 5633). In
some embodiments, there can be two bonding positions approximately 180 degrees
apart from one
another. The ring 5601z can advantageously ensure that the strands 5633 do not
unwind and yet can
substantially move relative to one another underneath the ring 5601z. The ring
5601z can be made, for
example, of rubber, Kapton, PTFE, silicone, urethane, latex, or ePTFE.
[0222] As another example, as shown in Figure 6C, the tip
5629 of the braid layer 5609 can have a
varying pick count along the tip 5629 with a greater pick count at the tip and
a lower pick count towards
the center. As a result, the strands 5633 can have a greater angle relative to
the longitudinal axis at the tip
5629 than in the rest of the layer 5609. For example, while the strands 5633
in the central portion of the
device 5600 can have an angle of 45 or less relative to the longitudinal axis
of the device 5600 (for
example, 40 degrees or less, 35 degrees or less, 25 degrees or less, or 20
degrees or less), the strands
5633 at the tip 5629 can have an angle of greater than 45 , such as between 45
and 60 , relative to the
longitudinal axis (for example, 35 degrees, 45 degrees, or 55 degrees). The
change in braid angle can be
a continuous change at the tip 5629 and/or can be created by joining two
separate braids together. The
strands 5633 of greater angle can be glued down to the innermost layer at the
tip 5629. By having a braid
with a greater angle at the tip 5629, the tip 5629 can remain flexible as it
curves or bends even when the
strands 5633 are fixed to the inner layer 5615. In some embodiments, the
increasing braid angle at the tip
5629 can be created by changing the speed of pulling the core inside the
tubular braid during
manufacturing.
[0223] As another example, as shown in Figure 6D, the tip
5629 of the braid layer 5609 can be
everted and bonded to the innermost layer 5615 (and/or other layer that is
radially inwards of the braid
layer 5609). The tip 5629 can be more flexible relative to a non-everted tip
5629 because it includes an
extra (everted) length within which to allowed the strands 5633 to move.
[0224] In some embodiments, the proximal and distal ends of the braid
layer 5609 can have different
treatments (e.g., the distal end may have a first treatment as described in
Figures 6A-6D while the
proximal end may have a second treatment as described in Figures 6A-6D).
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[0225] In some embodiments, the braid layer described
herein can be braided with a diameter that
enables the braid layer to be inherently biased against a first adjacent layer
and biased away from a
second (opposite) adjacent layer. For example, the braid layer can be formed
with a diameter that is
smaller than the diameter of the innermost layer, and then the braid layer can
be stretched to fit thereover
(so as to bias the braid layer against the innermost layer). As another
example, the braid layer can be
formed with a diameter that is larger than a diameter of the outermost layer,
and the braid layer can be
compressed to fit therein (so as to bias the braid layer against the outermost
layer). In other
embodiments, the braid layer can be formed with a diameter similar to the
diameter of the adjacent layers
(or between the two adjacent layers). These diameter options can be used to
modulate the performance of
the rigidizing system, particularly the initial baseline flexibility and the
pressurized/vacuum stiffness.
[0226] In some embodiments, the rigidizing devices
described herein (e.g., rigidizing device 300)
can include one or more slip layers bordering the braid layer (e.g., braid
layer 209). The slip layer can be
configured to reduce friction between the braid and the bordering layers to
allow the bordering layers
(and in particular the braid layer) to more easily shear or move relative to
each other, particularly when no
vacuum or pressure is applied to the rigidizing device, to maximize
flexibility in the flexible
configuration. The slip layer can advantageously enhance the baseline
flexibility of the rigidizing device
to allow the layers to move relative to one another. In one embodiment, the
slip layer can include a
powder, such as talcum or cornstarch. In particular, a powder slip layer can
advantageously reduce
friction without adding significant thickness to the device, thereby enhancing
flexibility of the rigidizing
device in the flexible configuration. The slip layer can be made of a low
coefficient of friction material,
such as a thin film fluoropolymer (FEP, Chemfilm, PTFE, with thicknesses from
2-50 microns). In one
embodiment, the slip layer can be a coating. In one embodiment, the slip layer
can be a slip additive
added to an elastomer. In one embodiment, the slip layer can be a sheath of
thin plastic film that is
inherently lubricious, such as low-density polyethylene (LDPE). In one
embodiment, the slip layer can
be made of a thin spiral-wrapped film, such at .0005" FEP or .00025" Chemfilm
(St. Gobain). In one
embodiment, the slip layer can be made of a grease, oil or other liquid.
[0227] The rigidizing devices described herein can
include an innermost layer configured to provide
an inner surface against which the additional layers (e.g., braid layer) can
be consolidated, for example,
when a vacuum or pressure is applied within the walls of the rigidizing
device. The layer can further
provide a seal for the wall (Le., can be leak-proof) and can be strong enough
to provide resistance to
diametrical collapse even during bending of the rigidizing device and/or
compression of the rigidizing
device during rigidization_ Referring to Figure 7, in some embodiments, the
innermost layer 8815 can
include a reinforcement element 8850z or coil within a matrix 8851z. The
reinforcement element 8850z
can be a continuous spiral coil or closed rings with gaps in between them
(which may exhibit more
resistance to collapse than a spiral coil). Additionally, the inner layer 8815
can include an inner film
8852z and an outer film 8853z on one or both sides thereof In some
embodiments, each of the elements
8853z, 8852z, 8850z/8851z can have a thickness of 0.0002" ¨ 0.015".
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[0228] The reinforcement element 8850z can be, for
example, a metal wire, such as a metal wire
made of stainless steel, nitinol, or Tungsten. The reinforcement element 8850z
can be, for example, a
high strength fiber (e.g., Kevlar, Dyneema, Vectran, Technora, or carbon
fiber). The reinforcement
element 8850z can be, for example, a stent, a structure cut from a tube, or a
braid. In some embodiments,
the reinforcement element 8850z can be a round wire (e.g., 0.0005"-0.030" in
diameter, such as 0.001",
01)03", 0.005", 0.007" or 0.009" in diameter). In some embodiments, the
reinforcement element 8850z
can be a rectangular wire (e.g., having a width of 0.001" to 0.100" inch, for
instance, 0.010", 0.020",
0.030", 0.040", 0.050", 0.060", 0.070", 0.080", 0.090", or 0.100" and/or The
rectangular wire can have a
thickness from 0.0003" to 0.020", for instance, 0.001", 0.003", 0.005", 0.007"
or 0.010"). In other
embodiments, the reinforcement element 8850z can have an oval cross-section
and/or can include a
plurality of individual strands and/or can have a rectangular cross section in
which the four sharp corners
are rounded. In some embodiments, the reinforcement element 8850z can be cut
from a single tube using,
for instance, a laser to create the gaps. In some embodiments, no
reinforcement element is used.
[0229] In some embodiments, the reinforcement element
8850z can be an element with a high aspect
ratio (e.g., have a high RE width relative to RE height, such as an aspect
ratio of over 5:1, such as over
10:1, such as over 11:1, such as approximately 12:1). Note that in Figure 7,
RE width is the width of
reinforcement element 8850z, RE height is height or thickness of reinforcement
element 8850z, and RE
Gap is distance between reinforcement elements 8850z. The high ratio of width
to height of the
reinforcement element 8850z can advantageously help prevent external pressure
caused
parallelogramming-type collapse of the reinforcement elements 8850z within the
innermost layer 8815.
Parallelogramming-type collapse occurs when the spirals of the coil move from
being approximately
normal to the axis of the center of the coil towards being parallel to the
axis of the center of the coil (the
spirals essentially "tip over"). Further, it may be advantageous in preventing
parallelogranuning if the RE
gap between the reinforcement elements 8850z is no more than 3 times the RE
height, such as no more
than 2 times the RE height, such as no more than 1.5 times the RE height.
Additionally, a ratio of the
inner diameter of a hollow tube with an innermost layer 8815 to the width of
the reinforcement layer
8850z in the innermost layer 8815 of less than 5, such as less than 4.5, such
as approximately 4.3, can
likewise help prevent parallelogramming-type collapse.
[0230] The matrix 8851z may be a very low durometer, for
example a TPU or TPE, with a
durometer equal to or less than 60A, 50A, 40A, 30A, 20A or 10A. hi some
embodiments, the matrix
8851z can be TPU, TPE, PET, PEEK, Mylar, urethane, or silicone. Inner and
outer films 8852z, 8853z
can similarly include TPU, TPE, PET, PEEK, Mylar, urethane, or silicone_ In
some embodiments, the
inner and outer films 8852z, 8853z can be applied by spraying, dipping,
wrapping as a sheet or tube,
pulling through a bath of solvent, melted, and/or consolidated. In some
embodiments, the layer 8815
does not include inner and/or outer films 8852z, 8853z and/or additional films
can be included. The inner
and/or outer films 8852z, 8853z can create a smooth inner and outer surface.
[0231] In a specific example of an innermost layer 8815
for a pressure system, the layer is made at
0_260" inside diameter as a hollow tube with an RE width of 0_050", an RE
height of 0.008", and an RE
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Gap of 0.010". Film 8853z is omitted on both sides. Film 8852z (on both sides
of the matrix 8851z and
reinforcement elements 8850z) are all made of urethane (600psi to 100%
strain). The thickness of both
the matrix 8851z and each film 8852z is about 0.006", giving a total wall
thickness of 0.018". This
structure can resist collapse at over lOatm of external pressure.
[0232] In a second specific example of an innermost layer 8815 for a
pressure system, film 8853z is
omitted on both sides. The RE width is 0.050", the RE height is 0.008", and
the RE Gap is 0.010". The
film 8852z is a higher durometer elastomer, for example an elastomer that has
a stress of 2000psi@100%
strain and has a thickness of about 0.001" thick. The matrix 8851z can be an
50A urethane. The matrix
8851z can be deposited as thermoplastic elastomer cord stock, for example at
.008" rectangular cross
section or .010" round cross section. This cord stock can also be deposited
with increased axial modulus
(but not transverse modulus) by co-extruding the stock with a wire (for
example, .001" diameter) or fiber
at its core.
[0233] In a third specific example of an innermost layer
8815 for a pressure system, the
reinforcement element 8850z can be a wire with a high aspect ratio. For
example, the layer 8815 can
have an RE height of 0.005", an RE width of 0.060" and an RE gap of 0.006" in
a square stainless steel
wire. The inner diameter of the tube formed with the innermost layer 8815 is
0.26". Elements 8852z and
8851z can be 80A urethane and can be approximately 0.002" thick. Further,
layer 8851 zcan be a 50A
urethane (e.g., deposited from a heated tank with melted urethane therein and
an orifice for precise
dispensing via pressure). The structure of this exemplary innermost layer 8815
can resist collapse at
over lOatm of external pressure, such as over 12atm of pressure, such as over
13atm of pressure.
[0234] In a specific example of an innermost layer 8815
for a vacuum system, the outer film 8853z
on one side (e.g., the outer or top side) is omitted, the film 8852z above
(outside of) the
reinforcement/matrix includes a 0.005" 50A urethane, the matrix 8851z is made
of 0.005" thick 50A
urethane, the reinforcement element 8850z is a stainless steel wire, the film
8852z below (inside of) the
reinforcement/matrix includes 0.0025" thick 50A urethane, and the bottom outer
film 8853z is a 0.004"
thick 80A urethane. The RE width is 0.020", the RE height is 0.005", and the
RE Gap is 0.010". The
bottom outer film 8853z is hydrophilically coated. The inner diameter of the
tube formed by layer 8815
is 0.551".
[0235] Although shown in Figure 7 as symmetrical, it
should be understood that the innermost layer
8815 need not have a symmetrical arrangement of films 8852z, 8853z. For
example, neither layer may be
on the bottom (inside of the matrix/reinforcement) while both layers are
present on top. Additionally, it
should be understood that the material for both innermost films 8852z need not
be the same, nor need the
material for the both of the outermost films 8853z be the same.
[0236] The reinforcement elements of the innermost layer
can be in a variety of configurations. As
shown in Figures 8D-8F, the reinforcement element 9205z can be a multi-start
coil winding (e.g., 2 starts
as shown in Figure 8F, three starts as shown in Figure 8E, or four starts as
shown in Figure 8D). When
multi-start coil windings are used the gap between reinforcement elements
along the longitudinal axis can
be the same as with a single coil, but number of starts can be 2, 3, 4, 5, 6,
7, 8,9 or even more. While a
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single start creates a wire angle that is nearly vertical (for example, 2
degrees off of vertical), a multi-start
approach creates a wire angle that biases the coils to tilt in one direction,
much further away from vertical
(for example, 4, 6, 10, 15, or even 20 degrees). This larger angle may serve
to make the innermost layer
less likely to tilt or structurally collapse under pressure, as the coils with
the larger pitch tend to brace
against one another for stability. Figures 8A-8C show individual starts
(coils) from the multistart
reinforcement elements 9205Z. Figure 8C shows one coil from Figure 8F, Figure
8B shows one coil from
Figure 8E and Figure 8A shows one coil from Figure 8D.
[0237] In some embodiments, referring to Figures 9A-9B,
the reinforcement elements 8950z can be
a series of wavy or undulated wires (or an undulated wire that is coiled as
described herein). As shown in
Figure 98, when the device is loaded, the undulated reinforcement elements
8950z moves toward
colliding with itself, compressing the matrix 8851Z in between the wires and
resisting a parallelogram-
type collapse. In one specific embodiment, an innermost layer with such an
undulating wire can have an
RE height of 0.005", an RE width of 0.060" and an RE gap of just 0.006". The
undulating wave can vary
0.03" from a centerline (that is, have a wave amplitude of 0.060"). The wave
can repeat every 03"
(that is, have a wavelength of 03").
[0238] In some embodiments, referring to Figures 10A-10C,
the reinforcement elements 9050z can
include alternating pocket wires 9052z and notched wires 9053z. When unloaded,
the pockets and
notches of each respective element can be separate (as shown in Figure 10D).
However, when loaded, the
notch of wire 9053z moves toward colliding with the pocket of wire 9052z (as
shown in Figure 10E)
compressing the matrix 8851z in between the wires and resisting a
parallelogram-type collapse.
[0239] In some embodiments, referring to Figures 11A-118,
the reinforcing elements 9150z can be a
flexure design, e.g., cut from a laser tube.
[0240] In some instances, the reinforcement element can
be separate from the inner layer. For
instance, the reinforcement element can be positioned diametrically inside or
outside the inner layer. The
innermost layer can have a hardness, for example, of 30A to 80A. Further, the
innermost layer can have a
wall thickness of between 0.0005" and 0.060". In some embodiments, the
innermost layer can include
lubrication or a coating (e.g., hydrophilic coating) on the inner surface
thereof to improve sliding of an
endoscope or other instrument theretlwough. The coating can be hydrophilic
(e.g., a Hydromer coating
or a Surmodics coating) or hydrophobic (e.g., a fluoropolymer). The coating
can be applied, for
example, by dipping, painting, or spraying the coating thereon. The innermost
layer can be a laminated
layer with a low frictional coefficient.
[0241] For any of the reinforced layers described herein
(e.g., innermost layer 8815), the matrix
surrounding the reinforcement element can be comprised of a material with high
hydrolytic stability.
That is, it is advantageous for the rigidizing devices described herein to
maintain their structural integrity
when exposed to an immersive fluid environment, such as water, saline, gastric
fluids, or blood. If the
matrix material is hygroscopic and thus absorbs fluid, the fluid may act as a
plasticizer and soften the
matrix, which can result in a reduction in resistance to pressurized (or
vacuum-based) structural collapse
and therefore a reduction in the rigidization of the device. As such, in some
embodiments, the matrix can
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be made of a hydrophobic material, thereby absorbing little to no fluid and
advantageously maintaining
its structural integrity even when immersed in fluid. For example, the matrix
can be made of
polyethylene, polypropylene, polystyrene, thermoplastic elastomers (such as
ChronopreneTM and Teknor
Apex MedallistTm), or polyvinyl chloride.
[0242] For any of the reinforced layers described herein (e.g.,
innermost layer 8815), the
reinforcement element and the matrix can be bonded together with an adhesive.
For example, the
reinforcement element can have the adhesive dipped, sprayed, or immersively
applied thereto, and then
the reinforcement element can be positioned within the matrix so as to co-join
the matrix and the
reinforcement element. In some embodiments, the reinforcement element and
matrix can have a resulting
bond strength of up to 50 pounds per square inch. The adhesive can be, for
example, ChemlokTm
adhesive. By using an adhesive to adhere the reinforcement elements to the
matrix, the reinforced layer
can remain intact to resist pressure and/or vacuum collapse.
[0243] For any of the reinforced layers described herein
(e.g., innermost layer 8815), the reinforced
layer can be manufactured such that the layer has a final diameter (i.e.,
within the rigidizing device) that
is at or near its net (i.e., manufactured) diameter, thereby ensuring that the
matrix is not required to hold
the reinforcement element to a specific diameter. For example, the final
diameter of the reinforced layer
can be within 10% of the net diameter, such as within 5%, such as within 2% of
the net diameter.
Having a final diameter near the net diameter can advantageously ensure that
the internal stresses of the
reinforced layer are reduced, thereby reducing creep and/or failure of the
reinforced layer. In some
embodiments, the reinforcement element can be manufactured, for example, by
yielding the
reinforcement element as it is being applied to the matrix, such as by running
the reinforcement element
through a series of deformation rollers.
[0244] Any of the reinforced layers described herein
(e.g., innermost layer 8815) can be configured
to include alternating types of material along the longitudinal axis of the
device. For example, referring
to Figure 88, the layer 18815 can include alternating sections 18807y and
18806y of high durometer
material and low durometer material, respectively. Further, the section 18807z
of high durometer
material can include the reinforcement element 18850z embedded therein. In
some embodiments, the
alternating sections 18807y and 18806y can be formed by spiraling section
18807y, but leaving gaps
between the spirals that are subsequently filled with the lower durometer
material of section 18806y.
This design can advantageously enable the layer 18815 to have high stiffness
at sections 18807y while
enabling flexibility and bending at hinge points created by sections 18806y.
Accordingly, the device
incorporating layer 18815 can have a high stiffness and resistance to
pressure/vacuum collapse while still
maintaining high baseline flexibility.
[0245] For any of the reinforced layers described herein
(e.g., innermost layer 8815), the layer can
be a composite tube. Referring to Figures 85A-85B, in some embodiments, the
composite tube can be
produced or manufactured by supplying radial compression to the tube in order
to laminate the
reinforcement element (e.g., coil) into the matrix. As shown, a compression
system 8590z can include an
outer metal tube 8591z and a concentric inner breather tube 8592z (with holes
8596z therein). An air
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chamber 8593z can extend between the outer metal tube 8591z and the inner
breather tube 8592z, which
can be connected to a source of vacuum or air via fitting 8597z. A silicone
extrusion tube 8594z can line
the inner breather tube 8592z and create a lumen 8595z therein. The layers of
the compression system
8590z can be held together at a first end 8502y by a female end cap 8598z and
a male end cap 8599z.
The outer metal tube 8591z and the inner breather tube 8592z can be mated with
the female end cap
8598z. Further, the silicone extrusion tube 8594z can be sandwiched between
the female end cap 8598z
and the male end cap 8599z, and the female end cap 8598z and the male end cap
8599z can be held
together with a fastener 8501y, such as a screw. The second end 8503y of the
compression system 8590z
can be open so as to allow the mandrel and tube (with matrix and reinforcement
element) to be placed
therethrough. The various tubes can be sealed together to maintain a seal in
the air chamber 8593z (e.g.,
with male and female endcaps at the second end 8503y).
[0246] In use, vacuum can be applied to the air chamber
8593z via fitting 8597z. The vacuum can
pull the silicone extrusion tube 8594z against the inner breather tube 8592z,
thereby widening the
diameter of the lumen 8595z to allow the mandrel and tube of matrix and
reinforcement element to be
placed therein. Once the mandrel and tube of matrix and reinforcement element
have been inserted, the
vacuum can be removed, and the silicone extrusion tube 8594z can shrink around
the composite tube to
laminate the reinforcement element into the matrix, resulting in formation of
the composite tube. In some
embodiments, heat (e.g., 120 C to 220 C) can further be applied to ensure
embedding of the
reinforcement element into the matrix.
[0247] In some embodiments, vacuum can be applied to lumen 8595z once the
mandrel and tube of
matrix and reinforcement element have been inserted and before removing vacuum
to the air chamber
8593z. This vacuum in lumen 8595z can be maintained throughout the remainder
of the process and can
provide a number of benefits, including reducing likelihood of air being
trapped when the silicone
extrusion tube 8594z compresses onto the mandrel after the outside vacuum is
removed, facilitating
removal of trapped air throughout the heat cycle, and/or increasing the
compression force of the silicone
extrusion tube 8594z since the pressure differential in higher when the inside
is under vacuum. In some
embodiments, to provide additional compression for formation of the composite
tube, pressure can be
supplied to the air chamber 8593z through the fitting 8597z while the mandrel
and the tube of matrix and
reinforcement element are positioned within the lumen 8595z.
[0248] The inner breather tube 8592z can provide for the even
distribution of vacuum along the
length of the compression system 8590z and can be made for example, of a
perforated metal, a perforated
high temperature plastic, a braid (e.g., plastic or metal), woven cloth, or
textured tubing_ Although
described herein as a silicone extrusion tube 8594z, it should be understood
that the extrusion tube 8594z
can additionally or alternatively be made of other materials. For example, the
extrusion tube 8594z can
be made of any material (e.g., elastomer) that is heat resistant (i.e., up to
temperatures of 120 C-220 C),
can stretch outward with vacuum and compress back down, and is biocompatible.
Similarly, the outer
metal tube 8591z can alternatively or additionally be made of a rigid material
other than metal, such as
polyetherimide or polyetheretherketone.
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[0249] In some embodiments, the amount of radial
compression supplied to the silicone extrusion
tube 8594z can be optimized by optimizing the thickness of the silicone
extrusion tube 8594z (higher
thickness may result in greater compression), stiffness of the silicone
extrusion tube 8594z (higher
stiffness may result in greater compression), outer pressure on the silicone
extrusion tube 8594z (higher
pressure may result in greater radial compression), inner vacuum on the
silicone extrusion tube 8594z
(higher vacuum may result in greater radial compression), and/or natural
diameter of the silicone
extrusion tube 8594z (smaller natural diameter may result in a higher
compression force). Additionally,
in some embodiments, the axial tension on the silicone extrusion tube 8594z
can be optimized (high axial
tension can result in creep while low compression can result in wrinkling
and/or trapped air).
[0250] In some embodiments, the braid layer can be integrated with or
embedded into the matrix of
any of the reinforced layers (e.g., innermost layer 8815).
[0251] Any of the rigidizing devices described herein can
further include one or more torsional
layers configured to enhance torsional stiffness. For example, the inner layer
(e.g., innermost layer 8815)
can include a torsional layer thereover. The torsional layer can include, for
example, one or more ribbons
or wires that are spiraled around at an angle (e.g., at an angle of 45-75
degrees, such as 50-70 degrees,
relative to the longitudinal axis of the rigidizing device). For example, as
shown in Figures 87A-87C, the
innermost layer 8715 can include a first torsional layer 8702a wrapped in a
first direction and a second
torsional layer 8702b wrapped in a second opposite direction (e.g., the first
layer 8702a can be wrapped at
70 degrees, and the second layer 8702b can be wrapped at -70 degices). In some
embodiments, the two
layers 8702a, 8702b can shear or slide relative to one another. There can be,
for example, a slip layer
between the two layers 8702a, 8702k The torsional layer can be made of a
material that exhibits both
tensile and compressive loads (such as sheet metal or wire) or a material that
exhibits a high tensile load
but poor compressive load (such as a plurality of small diameter wires or
fibers). Further, the torsional
layer can include ribbons or wires or fibers that have an equivalent cross-
section (e.g., round cross-
section) or that have a flattened cross-section (e.g., a flat wire having a
width to thickness of between 10:1
and 200:1). In some embodiments, them can be a slip layer between the
torsional layer(s) and other
layers of the device (e.g., the innermost layer). In some embodiments, the
torsional layer can be part of or
interwoven with another layer (e.g., a braid layer).
[0252] Exemplary rigidizing devices in the rigidized
configuration are shown in Figures 12A and
12B. As the rigidizing device is rigidized, it does so in the shape it was in
before vacuum or pressure was
applied, i.e., it does not straighten, bend, or otherwise substantially modify
its shape (e.g., it may stiffen in
a looped configuration as shown in Figure 12A or in a serpentine shape as
shown in Figure 12B). This
can be because the air stiffening effect on the inner or outer layers (e.g.,
made of coil-wound tube) can be
a small percentage (e.g., 5%) of the maximum load capability of the rigidizing
device in bending, thereby
allowing the rigidizing device to resist straightening. Upon release of the
vacuum or pressure, braids or
strands can unlock relative to one another and again move so as to allow
bending of the rigidizing device.
Again, as the rigidizing device is made more flexible through the release of
vacuum or pressure, it does so
in the shape it was in before the vacuum or pressure was released, i.e., it
does not straighten, bend, or
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otherwise substantially modify its shape. Thus, the rigidizing devices
described herein can transition
from a flexible, less-stiff configuration to a rigid configuration of higher
stiffness by restricting the
motion between the strands of braid (e.g., by applying vacuum or pressure).
[0253] The rigidizing devices described herein can toggle
between the rigid and flexible
configurations quickly, and in some embodiments with an indefinite number of
transition cycles. As
interventional medical devices are made longer and inserted deeper into the
human body, and as they are
expected to do more exacting therapeutic procedures, there is an increased
need for precision and control.
Selectively rigidizing devices (e.g., overtubes) as described herein can
advantageously provide both the
benefits of flexibility (when needed) and the benefits of stiffness (when
needed). Further, the rigidizing
devices described herein can be used, for example, with classic endoscopes,
colonoscopes, robotic
systems, and/or navigation systems, such as those described in International
Patent Application No.
PCT/US2016/050290, filed September 2, 2016, titled "DEVICE FOR ENDOSCOPIC
ADVANCEMENT
THROUGH THE SMALL INTESTINE," the entirety of which is incorporated by
referenced herein.
[0254] The rigidizing devices described herein can be
provided in multiple configurations, including
different lengths and diameters. In some embodiments, the rigidizing devices
can include working
channels (for instance, for allowing the passage of typical endoscopic tools
within the body of the
rigidizing device), balloons, nested elements, and/or side-loading features.
[0255] Referring to Figures 13A-13D, in one embodiment, a
tubular rigidizing device 100 can
include a wall having a plurality of layers positioned around the lumen 120
(e.g., for placement of an
instrument or endoscope therethrough). A vacuum can be supplied between the
layers to rigidize the
rigidizing device 100.
[0256] The innermost layer 115 can be configured to
provide an inner surface against which the
remaining layers can be consolidated, for example, when a vacuum is applied
within the walls of the
rigidizing device 100. The structure can be configured to minimize bend force
/ maximize flexibility in
the non-vacuum condition. In some embodiments, the innermost layer 115 can
include a reinforcement
element 150z or coil within a matrix, as described above.
[0257] The layer 113 over (i.e., radially outwards of)
the innermost layer 115 can be a slip layer.
[0258] The layer 111 can be a radial gap (i.e., a space).
The gap layer 111 can provide space for the
braided layer(s) thereover to move within (when no vacuum is applied) as well
as space within which the
braided or woven layers can move radially inward (upon application of vacuum).
[0259] The layer 109 can be a first braid layer including
braided strands 133 similar to as described
elsewhere herein. The braid layer can be, for example, 0.001" to 0.040" thick.
For example, a braid layer
can be 0.001", 0.003", 0.005", 0.010", 0.015", 0.020", 0.025" or 0.030" thick.
[0260] In some embodiments, as shown in Figure 13B, the
braid can have tensile or hoop fibers 137.
Hoop fibers 137 can be spiraled and/or woven into a braid layer. Further, the
hoop fibers 137 can be
positioned at 2-50, e.g., 20-40 hoops per inch. The hoop fibers 137 can
advantageously deliver high
compression stiffness (to resist buckling or bowing out) in the radial
direction, but can remain compliant
in the direction of the longitudinal axis 135 of the rigidizing device 100.
That is, if compression is
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applied to the rigidizing device 100, the braid layer 109 will try to expand
in diameter as it compresses.
The hoop fibers 137 can resist this diametrical expansion and thus resist
compression. Accordingly, the
hoop fiber 137 can provide a system that is flexible in bending but still
resists both tension and
compression.
[0261] The layer 107 can be another radial gap layer similar to layer
111_
[0262] In some embodiments, the rigidizing devices
described herein can have more than one braid
layer. For example, the rigidizing devices can include two, three, or four
braid layers. Referring to
Figure 13C, the layer 105 can be a second braid layer 105. The second braid
layer 105 can have any of
the characteristics described with respect to the first braid layer 109. In
some embodiments, the braid of
second braid layer 105 can be identical to the braid of first braid layer 109.
In other embodiments, the
braid of second braid layer 105 can be different than the braid of the first
braid layer 109. For example,
the braid of the second braid layer 105 can include fewer strands and have a
larger braid angle a than the
braid of the first braid layer 109. Having fewer strands can help increase the
flexibility of the rigidizing
device 100 (relative to having a second strand with equivalent or greater
number of strands), and a larger
braid angle a can help constrict the diameter of the of the first braid layer
109 (for instance, if the first
braid layer is compressed) while increasing/maintaining the flexibility of the
rigidizing device 100. As
another example, the braid of the second braid layer 105 can include more
strands and have a larger braid
angle a than the braid of the first braid layer 109. Having more strands can
result in a relatively tough
and smooth layer while having a larger braid angle a can help constrict the
diameter of the first braid
layer 109.
[0263] The layer 103 can be another radial gap layer
similar to layer 111_ The gap layer 103 can
have a thickness of 0.0002-0.04", such as approximately 0.03". A thickness
within this range can ensure
that the strands 133 of the braid layer(s) can easily slip and/or bulge
relative to one another to ensure
flexibility during bending of the rigidizing device 100.
[0264] The outermost layer 101 can be configured to move radially inward
when a vacuum is
applied to pull down against the braid layers 105, 109 and conform onto the
surface(s) thereof. The
outermost layer 101 can be soft and atraumatic and can be sealed at both ends
to create a vacuum-tight
chamber with layer 115. The outermost layer 101 can be elastomeric, e.g., made
of urethane. The
hardness of the outermost layer 101 can be, for example, 30A to WA_ Further,
the outermost layer 101
can be have a thickness of 0.0001-0.01", such as approximately 0.001", 0.002,
0.003" or 0.004".
Alternatively, the outermost layer can be plastic, including, for example,
LDPE, nylon, or PEEK.
[0265] In some embodiments, the outermost layer 101 can,
for example, have tensile or hoop fibers
137 extending therethrough. The hoop fibers 137 can be made, for example, of
aramids (e.g., Technora,
nylon, Kevlar), Vectran, Dyneema, carbon fiber, fiber glass or plastic.
Further, the hoop fibers 137 can
be positioned at 2-50, e.g., 20-40 hoops per inch. In some embodiments, the
hoop fibers 137 can be
laminated within an elastomeric sheath. The hoop fibers can advantageously
deliver higher stiffness in
one direction compared to another (e.g., can be very stiff in the hoop
direction, but very compliant in the
direction of the longitudinal axis of the rigidizing device). Additionally,
the hoop fibers can
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advantageously provide low hoop stiffness until the fibers are placed under a
tensile load, at which point
the hoop fibers can suddenly exhibit high hoop stiffness.
[0266] In some embodiments, the outermost layer 101 can
include a lubrication, coating and/or
powder (e.g., talcum powder) on the outer surface thereof to improve sliding
of the rigidizing device
through the anatomy. The coating can be hydrophilic (e.g., a Hydromer0 coating
or a Surmodics0
coating) or hydrophobic (e.g., a fluoropolymer). The coating can be applied,
for example, by dipping,
painting, or spraying the coating thereon.
[0267] The innermost layer 115 can similarly include a
lubrication, coating (e.g., hydrophilic or
hydrophobic coating), and/or powder (e.g., talcum powder) on the inner surface
thereof configured to
allow the bordering layers to more easily shear relative to each other,
particularly when no vacuum is
applied to the rigidizing device 100, to maximize flexibility.
[0268] In some embodiments, the outermost layer 101 can
be loose over the radially inward layers.
For instance, the inside diameter of layer 101 (assuming it constitutes a
tube) may have a diametrical gap
of 0"-0.200" with the next layer radially inwards (e.g., with a braid layer).
This may give the vacuum
rigidized system more flexibility when not under vacuum while still preserving
a high rigidization
multiple. In other embodiments, the outermost layer 101 may be stretched some
over the next layer
radially inwards (e.g., the braid layer). For instance, the zero-strain
diameter of a tube constituting layer
101 may be from 0-0.200" smaller in diameter than the next layer radially
inwards and then stretched
thereover. When not under vacuum, this system may have less flexibility than
one wherein the outer
layer 101 is looser. However, it may also have a smoother outer appearance and
be less likely to tear
during use.
[0269] In some embodiments, the outermost layer 101 can
be loose over the radially inward layers.
A small positive pressure may be applied underneath the layer 101 in order to
gently expand layer 101
and allow the rigidizing device to bend more freely in the flexible
configuration. In this embodiment, the
outermost layer 101 can be elastomeric and can maintain a compressive force
over the braid, thereby
imparting stiffness. Once positive pressure is supplied (enough to nominally
expand the sheath off of the
braid, for example, 2 psi), the outermost layer 101 is no longer is a
contributor to stiffness, which can
enhance baseline flexibility. Once rigidization is desired, positive pressure
can be replaced by negative
pressure (vacuum) to deliver stiffness.
[0270] A vacuum can be carried within rigidizing device 100 from minimal
to full atmospheric
vacuum (e.g., approximately 14.7 psi). In some embodiments, there can be a
bleed valve, regulator, or
pump control such that vacuum is bled down to any intermediate level to
provide a variable stiffness
capability. The vacuum pressure can advantageously be used to rigidize the
rigidizing device structure by
compressing the layer(s) of braided sleeve against neighboring layers. Braid
is naturally flexible in
bending (i.e. when bent normal to its longitudinal axis), and the lattice
structure formed by the interlaced
strands distort as the sleeve is bent in order for the braid to conform to the
bent shape while resting on the
inner layers. This results in lattice geometries where the corner angles of
each lattice element change as
the braided sleeve bends. When compressed between conformal materials, such as
the layers described
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herein, the lattice elements become locked at their current angles and have
enhanced capability to resist
deformation upon application of vacuum, thereby rigidizing the entire
structure in bending when vacuum
is applied. Further, in some embodiments, the hoop fibers through or over the
braid can carry tensile
loads that help to prevent local buckling of the braid at high applied bending
load.
[0271] The stiffness of the rigidizing device 100 can increase from 2-
fold to over 30- fold, for
instance 10-fold, 15-fold, or 20-fold, when transitioned from the flexible
configuration to the rigid
configuration. In one specific example, the stiffness of a rigidizing device
similar to rigidizing device
100 was tested. The wall thickness of the test rigidizing device was 1.0mtn,
the outer diameter was
17mm, and a force was applied at the end of a 9.5cm long cantilevered portion
of the rigidizing device
until the rigidizing device deflected 10 degrees. The forced required to do so
when in flexible mode was
only 30 grams while the forced required to do so in rigid (vacuum) mode was
350 grams.
[0272] In some embodiments of a vacuum rigidizing device
100, there can be only one braid layer.
In other embodiments of a vacuum rigidizing device 100, there can be two,
three, or more braid layers_ In
some embodiments, one or more of the radial gap layers or slip layers of
rigidizing device 100 can be
removed. In some embodiments, some or all of the slip layers of the rigidizing
device 100 can be
removed.
[0273] The braid layers described herein can act as a
variable stiffness layer. The variable stiffness
layer can include one or more variable stiffness elements or structures that,
when activated (e.g., when
vacuum is applied), the bending stiffness and/or shear resistance is
increased, resulting in higher rigidity.
Other variable stiffness elements can be used in addition to or in place of
the braid layer. In some
embodiments, engagers can be used as a variable stiffness element, as
described in International Patent
Application No. PCT/US2018/042946, filed July 19, 2018, titled "DYNAMICALLY
RIGIDIZ1NG
OVERTUBE," the entirety of which is incorporated by reference herein.
Alternatively or additionally,
the variable stiffness element can include particles or granules, jamming
layers, scales, rigidizing axial
members, rigidizers, longitudinal members or substantially longitudinal
members.
[0274] In some embodiments, the rigidizing devices
described herein can rigidize through the
application of pressure rather than vacuum. For example, referring to Figures
14A-14B, the rigidizing
device 2100 can be similar to rigidizing device 100 except that it can be
configured to hold pressure (e.g.,
of greater than 1 atm) therein for rigidization rather than vacuum. The
rigidizing device 2100 can thus
include a plurality of layers positioned around the lumen 2120 (e.g., for
placement of an instrument or
endoscope therethrough). The rigidizing device 2100 can include an innermost
layer 2115 (similar to
innermost layer 115), a slip layer 2113 (similar to slip layer 113), a
pressure gap 2112, a bladder layer
2121, a gap layer 2111 (similar to gap layer 111), a braid layer 2109 (similar
to braid layer 109) or other
variable stiffness layer as described herein, a gap layer 2107 (similar to
layer 107), and an outermost
containment layer 2101.
[0275] The pressure gap 2112 can be a sealed chamber that
provides a gap for the application of
pressure to layers of rigidizing device 2100. The pressure can be supplied to
the pressure gap 2112 using
a fluid or gas inflation/pressure media. The inflation/pressure media can be
water or saline or, for
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example, a lubricating fluid such as soil or glycerin. The lubricating fluid
can, for example, help the
layers of the rigidizing device 2100 flow over one another in the flexible
configuration. The
inflation/pressure media can be supplied to the gap 2112 during rigidization
of the rigidizing device 2100
and can be partially or fully evacuated therefrom to transform the rigidizing
device 2100 back to the
flexible configuration. In some embodiments, the pressure gap 2112 of the
rigidizing device 2100 can be
connected to a pre-filled pressure source, such as a pre-filled syringe or a
pre-filled insufflator, thereby
reducing the physician's required set-up time.
[0276] The bladder layer 2121 can be made, for example,
of a low durometer elastomer (e.g., of
shore 20A to 70A) or a thin plastic sheet. The bladder layer 2121 can be
formed out of a thin sheet of
plastic or rubber that has been sealed lengthwise to form a tube The
lengthwise seal can be, for instance,
a butt or lap joint. For instance, a lap joint can be formed in a lengthwise
fashion in a sheet of rubber by
melting the rubber at the lap joint or by using an adhesive. In some
embodiments, the bladder layer 2121
can be 0.0002-0.020" thick, such as approximately 0.005" thick. The bladder
layer 2121 can be soft,
high-friction, stretchy, and/or able to wrinkle easily. In some embodiments,
the bladder layer 2121 is a
polyolefin or a PET. The bladder 2121 can be formed, for example, by using
methods used to form heat
shrink tubing, such as extrusion of a base material and then wall thinning
with heat, pressure and/or
radiation. When pressure is supplied through the pressure gap 2112, the
bladder layer 2121 can expand
through the gap layer 2111 to push the braid layer 2109 against the outermost
containment layer 2101
such that the relative motion of the braid strands is reduced.
[0277] The outermost containment layer 2101 can be a tube, such as an
extruded tube. Alternatively,
the outermost containment layer 2101 can be a tube in which a reinforcing
member (for example, metal
wire, including round or rectangular cross-sections) is encapsulated within an
elastomeric matrix, similar
to as described with respect to the innermost layer for other embodiments
described herein. In some
embodiments, the outermost containment layer 2101 can include a helical spring
(e.g., made of circular or
flat wire), and/or a tubular braid (such as one made from round or flat metal
wire) and a thin elastomeric
sheet that is not bonded to the other elements in the layer. The outermost
containment layer 2101 can be a
tubular structure with a continuous and smooth surface. This can facilitate an
outer member that slides
against it in close proximity and with locally high contact loads (e.g., a
nested configuration as described
further herein). Further, the outer layer 2101 can be configured to support
compressive loads, such as
pinching. Additionally, the outer layer 2101 (e.g., with a reinforcement
element therein) can be
configured to prevent the rigidizing device 2100 from changing diameter even
when pressure is applied.
[0278] Because both the outer layer 2101 and the inner
layer 2115 include reinforcement elements
therein, the braid layer 2109 can be reasonably constrained from both
shrinking diameter (under tensile
loads) and growing in diameter (under compression loads).
[0279] By using pressure rather than vacuum to transition from the
flexible state to the rigid state,
the rigidity of the rigidizing device 2100 can be increased. For example, in
some embodiments, the
pressure supplied to the pressure gap 2112 can be between 1 and 40
atmospheres, such as between 2 and
atmospheres, such as between 4 and 20 atmospheres, such as between 5 and 10
atmospheres. In some
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embodiments, the pressure supplied is approximate 2 atm, approximately 4
atmospheres, approximately 5
atmospheres, approximately 10 atmospheres, approximately 20 atmospheres. In
some embodiments, the
rigidizing device 2100 can exhibit change in relative bending stiffness (as
measured in a simple
cantilevered configuration) from the flexible configuration to the rigid
configuration of 2-100 times, such
as 10-80 times, such as 20-50 times. For example, the rigidizing device 2100
can have a change in
relative bending stiffness from the flexible configuration to the rigid
configuration of approximately 10,
15, 20, or 25, 30, 40, 50, or over 100 times. Figure 15 shows a graph of
bending strength vs pressure for
a rigidizing device as described herein. As shown, the bending strength of the
rigidizing device increases
as the pressure supplied to the wall increases.
[0280] Simplified versions of a wall of various pressurized rigidizing
devices similar to rigidizing
device 2100 are shown in Figures 16A-160. For example, rigidizing device 2200a
of Figure 16A
includes the innermost layer 2215a, pressure gap 2212a, bladder layer 2221a
that is sealed to the
outermost layer 2201a, braid layer 2209a, and outer containment layer 2201a
(similar as described with
respect to rigidizing device 2100). The rigidizing device 2200a further
includes end caps 2292a at the
proximal and distal ends thereof to seal the pressure therein. When pressure
is supplied to the pressure
gap 2212a via inlet 2293a, the bladder layer 2221a is pressed against the
braid layer 2209a, which in turn
is pressed against the outermost layer 2201a, preventing the strands of the
braid from moving relative to
one another.
[0281] Referring to Figure 16J, rigidizing device 2200j
is similar to rigidizing device 2200a except
that slip layer 2213j and stiffening layer 2298j are added. Layer 2213j can be
a slip layer as described
herein, for example comprising a coating film or powder. Layer 2298j can be a
stiffening layer that,
similar to layers 2201j and 2215j, can include a reinforcement element 2250z
as described elsewhere
herein. The additional stiffening layer 2298j can work in concert with the
inner layer 2215j. For
example, the two layers 2215j and 2298j can easily slip past one another (via
slip layer 2213j) in the
flexible configuration and stick to one another to form a stiff composite
structure in the rigid
configuration (i.e., when pressure is applied). Layer 2298j can be a high
durometer elastomeric rubber,
for example a TPU or TPE with a durometer greater than or equal to 60A, 70A,
80A or 90A. When the
tube is in a flexible state, layers 2215j and 2298j may easily shear or move
with respect to each other
(e.g., due to slip layer 2213j) such that the flexibility of the system is
lower than it would be if the layers
were bonded together. When the tube is in a rigid state (for example, when
pressure is applied), layers
2215j, 2298j and 2213j may lock to each other and act like a single bonded
layer in order to resist
collapse of the wall of the rigidizing device 2200j. Similar to other
embodiments, the braid layer 2205j
can push against the outer layer 2201j when pressure is supplied to gap 2212j
to rigidize the device 2200j.
[0282] Referring to Figure 16B, rigidizing device 2200b
is similar to rigidizing device 2200a except
that the pressure gap 2212b is surrounded by an everted bladder layer 2221b
(or a double-layered
bladder), i.e., such that the bladder layer 2221b includes one side that
borders the braid layer 2205b and
one side that borders the innermost layer 2215b. As pressure is supplied to
the pressure gap 2212b (inside
of the two sides of the bladder layer 2221b), the bladder layer 222113 can
expand both against the
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innermost layer 2215b and against the braid 2209b (which in turn can be pushed
against the outermost
layer 2201b).
[0283]
Referring to Figure 16C,
rigidizing device 2200c is similar to rigidizing device 2200a except
that the bladder layer 2221c is sealed to the innermost layer 2215c rather
than the outermost layer 2201c.
When pressure is supplied to the pressure gap 2212c via inlet 2293c, the
bladder layer 2221c is pressed
against the braid layer 2209c, which in turn is pressed against the outermost
layer 2201c.
[0284]
Referring to Figure 16D,
rigidizing device 2200d is similar to rigidizing device 2200b except
that the innermost layer 2215d is a spring element rather than a coil-wound
tube. Because the pressure is
in the everted bladder layer 2221d, the inner layer 2215d need not be sealed
itself.
[0285]
Referring to Figure 16E, rigidizing device
2200e is similar to rigidizing device 2200a except
that the innermost layer 2215a is replaced with an inner payload 2294e that is
sealed at both the proximal
and distal ends and can include a plurality of lumens therein (e.g., a working
channel 2291e, a pressure
channel 2292e, and a rinse channel 2293e).
[0286] Referring to Figure 16F, rigidizing device 22001
is similar to rigidizing device 2200a except
that the braid layer 2209f is inside of the pressure gap 2212f and the bladder
layer 22211 such that
pressure supplied to the pressure gap 2212f causes the bladder layer 2221f to
push inwards against the
braid layer 2209f, which in turn pushes against innermost layer 2215f.
[0287]
In some embodiments, a
pressure rigidizing device can include two braid layers (e.g., of the
same or different braid characteristics). For example, an exemplary rigidizing
device 2200m with two
braid layers 2209m and 2205m is shown in Figure 16M. The two braid layers
2209m and 2205m
sandwich two bladders 2221m and 2217m (and/or a single annular bladder)
therebetween. When pressure
is supplied to the pressure gap 2212m between the two bladders, the outer
braid layer 2205m will be
pushed radially outwards against the outer layer 2201m while the inner braid
layer 2209m will be pushed
radially inwards against the inner braid layer 2215m to rigidize the device
2200m.
[0288]
Another exemplary rigidizing device 2200n
with two braid layers 2209n, 2205n is shown in
Figure 16N. The two braid layers 220%, 2205n are positioned adjacent to one
another between the
bladder layer 2221n (not labeled in figure) and the outer tube 2201n. When
pressure is supplied to the
pressure gap 2212n, the bladder 2221n forces the two braid layers 2209n, 2205n
together and against the
outer tube 2201n. The braid layers 2209n, 2205n may interdigitate with one
another when pressurized,
thereby strengthening the rigidity of the device 2200n.
[0289]
Referring to Figure 16K,
rigidizing device 2200k is similar to rigidizing device 2200a except
that an annular ring 2219k, e.g., including fibers and adhesive, is positioned
around each of the ends of
the braid layer 2209k and bladder layer 2221k to attach the bladder layer
2221k to the innermost layer
2215k (and thereby hold pressure within the pressure gap 2212k when pressure
is supplied through the
inlet 2293k). The annular ring 2219k can, for example, include a high strength
fiber, such as Kevlar or
Dyneema. Further, the adhesive can be, for example, a cyanoacrylate. In some
embodiments, adhesive
can also be placed at the ends between the innermost layer 2215k and the
bladder layer 2221k and also
encompassing the inlet tube.
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[0290] Figure 16G shows a rigidizing device 2200g with
gap inlet 2293g and vent inlet 2223g. Inlet
2293g connects to pressure gap 2212g (via pressure line 2294g). Inlet 2223g
connects to gap 2206g
around the braid layer 2209g (between bladder 2221g and outermost layer
2201g). The device 2200g can
be rigidized in one or more different configurations. In a first rigidizing
configuration, pressure can be
applied to inlet 2293g while the vent inlet 2223g can be open or vented to
atmospheric pressure. The
pressure supplied to the pressure gap 2212g through the inlet 2293g can thus
push the braid 2209g against
the outermost layer 2201g, which in turn can force any air in the gap 2206g
out through the vent inlet
2223g. Allowing the air to escape through the vent inlet 2223g can enable a
tighter mechanical fit
between the braid layer 2209g and the outer layer 2201g, thereby strengthening
the rigidization of the
device 2200g. In a second rigidizing configuration, pressure can be applied to
inlet 2293g and a vacuum
can be applied to vent inlet 2223g. This may cause the rigidizing device 2200g
to become even stiffer
than in the first configuration, as the vacuum can assist in moving the braid
layer 2209g towards the outer
layer 2201g. The device 2200g can likewise be made flexible in one or more
different configurations. In
a first flexible configuration, both inlet 2293g and vent inlet 2223g can be
opened to atmospheric
pressure_ This will loosen the braid layer 2209g relative to the outer layer
2201g and cause the rigidizing
device 2200g to be flexible as the braid layer 2209g moves freely relative to
the outer layer 2201g. In a
second flexible configuration, a low pressure (e.g., 5-10% above atmospheric
pressure) can be provided
to both inlet 2293g and vent inlet 2223g. This may cause the outermost layer
2201g and the innermost
layer 2215g to separate slightly, which can provide additionally area for the
braid layer 2209g to move
freely. As a result, this may cause the rigidizing device 2200g to become even
more flexible than in the
first rigidizing configuration. Additionally, providing a low pressure above
atmospheric pressure in the
flexible configuration can allow the rigidizing device 2200g to be introduced
into the body with a very
small diameter (e.g., such that the pressure gap 2212g is essentially zero)
and then the low pressure can be
provided to both inlet 2293g and vent inlet 2223g to slightly expand the
pressure gap 2212g to provide
more room for the braid layer 2209g to move freely.
[0291] Figure 16H shows a rigidizing device 2200h with
bellows 2243h connected to pressure line
2294h. Pressure gap 2212k pressure line 2294h, and bellows 2243h can all be
configured to be filled
with a sealed pressure transmitting medium,, such as distilled water or saline
solution or an oil. The
pressure transmitting medium may be a radiopaque fluid that advantageously
will show the rigidized
device more clearly during a procedure using fluoroscopy. The pressure
transmitting medium can be
added to the rigidizing device immediately before use and/or when the device
is being manufactured. In
use, activating the actuator 2288h can compress bellows 2243h, thus reducing
the volume of pressure
medium in the bellows 2243h, which flows through the pressure line 2294h to
the pressure gap 2212h,
causing a rise in pressure in the pressure gap 2212h and movement of the braid
layer 2209h against the
outer layer 2201h. The vent inlet 2223h can be open to the atmosphere to allow
gas to escape from the
space 2206h around the braid layer 2209k Further, reversing the action of the
actuator 2288h can cause
the pressure in the pressure gap 2212h to fall as the pressure medium moves
back to the bellows 2243h.
Actuator 2288h can be, for example, a solenoid, a voice coil, a lead screw, a
valve, or a rotary cam. In
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some embodiments, the pressure line 2294h can be pinched or flattened to raise
the pressure in pressure
gap 2212h rather than using bellows 2243k
[0292] Figure 161 shows a rigidizing device 2200i
including sumps 2230i and 2228i respectively.
Sumps 2230i and 2228i may comprise a fluid medium, such as water and a gaseous
medium such as air.
Pressure or vacuum or combinations thereof may be applied to inlets 2293i,
2223i. Using the sump
configuration shown may mean that there is no air or gas in the rigidizing
device regardless of the
pressurization state of each gap 2206i or 2212i (increased pressure, vacuum or
atmospheric pressure). In
the event that the gaps leaks during a procedure, this may mean that only the
fluid medium enters into the
patient. This may offer patient protection from gaseous (e.g. air)
embolization.
[0293] In some embodiments, the rigidizing devices described herein can
include a plurality of
individual bladders running longitudinally down the length of the device. For
example, referring to Figure
160, device 2200o includes four different circumferential bladders 2221
surrounding pressure gaps
2212o. In this embodiment, the braid layer is likewise divided into four
longitudinal flat braids 2209o,
each of which is positioned radially outwards from a bladder 2221o. In other
embodiments, the braid
layer can include tubular braids wrapped around the bladders 22210 (similar to
as described with respect
to Figure 67 below). Further, the outer and inner layers 2201o, 2215o are
connected by dividers 2236o.
In some embodiments, the dividers 2236o can be formed by elements of the outer
or inner layers 2201o,
2215o (e.g., be continuous elements of one or both layers 2201o, 2215o). In
some embodiments, the
dividers 2236o can be configured to help maintain the thickness of the wall.
When pressure is supplied to
the pressure gaps 2212o, the bladders 22210 expand to push the flat braids
22090 against the outer layer
2201o.
[0294] In some embodiments, referring to Figure 16L, the
pressure rigidizing devices described
herein do not include an innermost layer (e.g., do not include an innermost
layer with a reinforcement
element therein). Rather, the rigidizing device 22001 can include an outer
layer 22011, gap layer 22061,
braid layer 22091, and an everted or tubular bladder 22211 (with a pressure
gap 22121 therein). The
tubular bladder 22211 can be configured to be positioned around the inner
device (such as a scope 2291).
As the pressure gap 22121 is fated with pressurizing medium, the bladder 22211
can expand against the
scope 2291 and the braid layer 22091.It should be understood that any of the
features described herein
with respect to vacuum rigidizing devices can be substituted or replaced with
any of the features
described with respect to pressure rigidizing devices.
[0295] In some embodiments, referring to Figure 92, the
distal tips 9229 of the braid layer 9209 can
be bonded with the bladder layer 9221 of a pressure rigidizing device such
that the tips of the braids are
part of the same bond as the bladder layer 9221. This can advantageously
ensure that sharp ends of the
braid do not puncture the bladder layer 9221. In some embodiments, the distal
tips 9229 of the braid
layer 9209 can extend further distally than the end of the bladder layer 9221
to further ensure that the
sharp ends do not interfere with the bladder layer 9221.
[0296] In some embodiments, the rigidizing devices
described herein can incorporate a tool or
working channel therein. The working channel can be designed so as to not
significantly add to the
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rigidizing device's bending stiffness. Referring to Figures 17A-17C, in one
embodiment, a rigidizing
device 500 can include a working channel 555 extending therethrough. The
working channel 555 can
include a central lumen 571z (e.g., for passage of a working element
therethrough) formed by alternating
telescoping tubular sections that are locally necked or tapered from a larger
diameter end 569z to a
smaller diameter end 570z. Each of the sections can be connected to the
underlying layer of the wall
(e.g., the slip layer 513 over the innermost layer 515) at a discrete location
or anchor point 568z and can
be otherwise free to move. As the rigidizing device 500 bends, the smaller
diameter end 570z can move
within the larger diameter end 559z of a neighboring section so as to allow
for bending of the working
channel 555. The working channel 555 can be positioned within the wall of the
rigidizing device 500,
such as in the radial gap 511 between the slip layer 513 and the first braid
layer 509 (and can therefore
also be positioned underneath the radial gap layer 507, the second braid layer
505, the radial gap layer
503, and the outermost layer 501). The working channel 555 can thus be
positioned within the sealed
vacuum (or pressure chamber) of the rigidizing device 500. In some
embodiments, the working channel
555 can itself be positioned within a sealed bag or layer 572z so as to ensure
that there is no vacuum or
pressure leak path. In other embodiments, the sections can include sliding
seals therebetween to ensure
that there is no vacuum or pressure leak path. In some embodiments, as shown
in Figure 17D, rather than
having tapered sections, there can be alternative large diameter sections 525a
and small diameter sections
525b. The smaller diameter sections 525b can move within the large diameter
sections 525a during
bending over the rigidizing device 500. The working channel can be placed
within the sealed volume
formed by layers 501 and 515 or it can be placed outside of this sealed
volume, such as on top of layer
501.
[0297] Referring to Figures 18A-18B, in some
embodiments, a rigidizing device 7800 can include a
working channel 7855 spiraled around a portion of the elongate body 7803z of
the rigidizing device 7800.
For example, the working channel 7855 can be spiraled at a 40-50 degree angle,
such as approximately a
45 degree angle, relative to the longitudinal axis of the device 7800. A
spiraled working channel 7855
can advantageously deform into a curved path as the rigidizing device 7800
bends without resisting
bending and/or without forcing path length adjustments along its length. The
working channel 7855 can
include a proximal port 7844)z integrated into the handle 7831 and a distal
port 7841z (through which a
working tool may exit) molded onto end of the tip 7833z of the rigidizing
device 7800. The spiraled
working channel 7855 can be positioned over the outermost layer 7801, under
the outer layer 7801 (as
shown in Figures 18A-18B where the outer layer 7801 has been removed for
clarity), or further within the
layers of the wall (.e., under the braid layer).
[0298] Referring to Figures 19A-19B, in some
embodiments, a rigidizing device 4500 can include a
plurality of working channels 4555 spiraled around the outside thereof. As
shown in Figures 19A-19B,
the working channels 4555 can, for example, form a spiral shield around the
rigidizing device 4500. In
some embodiments, the working channels 4555 can be configured together to form
a second rigidizing
element that can be rigidized separately from the inner rigidizing device
4500. The second rigidizing
element can advantageously be highly flexible due to the relative movement of
the individual spiraling
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working channels 4555. In some embodiments, the working channels 4555 can
include a thin flexible
ring and/or thin flexible sheath to contain the working channels 4555 in a
circular cross section_ In some
embodiments, the device 4500 can further include a steerable distal tip 4547,
e.g., to help with placement
of the tools that extend through the working channels 4555.
[0299] Referring to Figures 20A-20B, in some embodiments, a rigidizing
device 8000 can include a
rigidizing elongate body 8003z with a plurality of working channels 8055a-d
(such as 1-10, 3-5, or 4-5
working channels) extending down the central lumen 8020 thereof to the tip
8033z. The working
channels 8055a-d can be used for a plurality of different tools throughout a
procedure. For example, one
of the working channels 8055a-d can be used for a catheter with a camera and
lighting, another could be
used for traction, another could be used for cutting, another could be used
for suction, etc_ The elements
extended down the working channels 8055a-d can be interchanged throughout the
procedure. In some
embodiments, the rigidizing elongate body 8003z can be disposable while the
tools can be cleanable
and/or sterilizable. In some embodiments, the rigidizing device 8000 can
further include passive or active
linkages 8004z.
[0300] Referring to Figure 21, in some embodiments, a rigidizing device
8100 can include a first
working channel 8155a and a second working channel 8155b. The first working
channel 8155b can
extend down the central lumen 8120 (or within the walls of the elongate body
8103z) to the distal end
8133z. The second working channel can similarly extend down the central lumen
8120 or within the
walls of the elongate body 8103z, but can exit the side of the elongate body
8103z proximal to the distal
section 8102z (e.g., prior to the linkages 8104z). Having tool channel 8155b
exit proximal to the distal
section can advantageously limit interference with steering or bending of the
linkages 8104z.
[0301] Referring to Figure 22, in some embodiments, a
tool 7942z can be specifically designed for
use with a working channel of a rigidizing device as described herein. The
tool 7942z can include a
flexible shaft 7943z and an expandable atraumatic tip 7944z. The atraumatic
tip 7944z can be an
expandable balloon or a nitinol cage with foam therearound. In some
embodiments, the expandable tip
7944z can be configured to be collapsed (e.g., sheathed) for delivery through
the working channel and to
self-expand after sheath withdrawal and placement through the working channel.
The atraumatic tip
7944z can be sized, for example, so as to not fill the lumen of the
gastrointestinal tract and therefore so as
to not contact the walls of the gastrointestinal tract. The tool 7942z can
further have a flexible loop 7945z
that is attached to the tip 7944z or to the shaft 7943z. In some embodiments,
the loop 7945z can be
attached to an endoscopic clip (often used to close a variety of defects in
the GI tract) to provide traction
during an ESD procedure_ By sliding the shaft 7943z longitudinally, the user
can provide traction to the
clip. The expandable atraumatic tip 7944z can advantageously allow the tool
7942z to be advanced freely
ahead of the rigidizing device without being concerned that it will cause
trauma or get caught in the GI
tract. By hooking the flexible loop 7945z onto the clip, the tool 7942z can
get good traction with a simple
back and forth motion of the flexible shaft 7943z.
[0302] Any of the rigidizing devices described herein can
have a distal end section or sections with a
different design that the main elongate body of the rigidizing device. As
shown in Figure 23, for
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example, rigidizing device 5500 can have a main elongate body 5503z and a
distal end section 5502z.
Only the distal end section 5502z, only the main elongate body 5503z, or both
the distal end section
5502z and the main elongate body 5503z can be rigidizing as described herein
(e.g., by vacuum and/or
pressure). In some embodiments, one section 5502z, 5503z is activated by
pressure and the other section
5502z, 5503z is activated by vacuum. In other embodiments, both sections
5502z, 5503z are activated by
pressure or vacuum, respectively.
[0303] Referring to Figure 24, in some embodiments, the
distal section 5702z can include a
rigidizing braid that differs from the braid of the main elongate section
5703z. For example, in one
embodiment, the braid angle relative to the longitudinal axis in the distal
end section 5702z can be greater
than the braid angle of the main elongate body 5703z. For instance, the braid
angle in distal section may
be 40 degrees while the braid angle in the main elongate body may be 20
degrees. The braids may overlap
somewhat and be joined with a flexible adhesive. These designs may give the
distal end section 5702z
more bending flexibility in a non-rigidized state than the main elongate
section 5703z. Having a more
flexible distal tip can, for example, advantageously prevent buckling and drag
at the tip (caused by fixing
the braid ends) and/or can advantageously provide flexibility during
navigation through a body lumen to
prevent trauma to the anatomy. In another embodiment, the braid angle relative
to the longitudinal axis in
the distal end section 5702z can be less than the braid angle of the main
elongate body 5703z. This may
give distal end section 5702z more stiffness in the rigidized state relative
to the main elongate body
5703z. Having more stiffness in the distal end section 5702z can, for example,
advantageously provide a
stable platform for movement or delivery of a medical device through the
central lumen and out the distal
end of the rigidizing device 5700.
[0304] Referring to Figure 25, in some embodiments, the
distal end section 5802z can include a
plurality of linkages 5804z that are passively activated. The linkages 5804z
can be connected together at
one or more pivot points and can advantageously provide deterministic bending
(Le., bending in a specific
and predetermined direction). Additionally, the linkages 5804z can
advantageously provide torsional
rigidity to the distal end section 5802z while providing high flexibility for
bending. The linkages 5804z
can be activated passively, e.g., via flexing as the device 5800 is moved
through the anatomy. The distal
end section 5802z may, for example, include 1-100 linkages 5804z, such as 1,
2, 4, 6, 8, 10, 16, 20, 30, or
40 links 5504z. In some embodiments, the linkages 5804z can be formed by
passively cut flexures, such
as laser cut tubes or stents.
[0305] Referring to Figure 26, in other embodiments, the
distal end section 7602z can include a
plurality of linkages 7604z that are actively controlled, such as via cables
7624, for steering of the
rigidizing device 7600. The device 7600 is similar to device 5800 except that
it includes cables 7624
configured to control movement of the device. While the passage of the cables
7624 through the
rigidizing elongate body 7603z (i.e., with outer wall 7601, braid layer 7609,
and inner layer 7615) is not
shown in Figure 26, the cables 7624 can extend therethrough in any manner as
described elsewhere
herein. In some embodiments, one or more layers of the rigidizing elongate
body 7603z can continue into
the distal end section 7602z. For example, and as shown in Figure 26, the
inner layer 7615 can continue
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into the distal end section 7602z, e.g., can be located radially inwards of
the linkages 7604z. Similarly,
any of the additional layers from the rigidizing proximal section (e.g., the
braid layer 7609 or the outer
layer 7601 may be continued into the distal section 7602z and/or be positioned
radially inwards of the
linkages 7604z). In other embodiments, none of the layers of the rigidizing
elongate body 7603z continue
into the distal section 7602z. The linkages 7604z (and any linkages described
herein) can include a
covering 7627z thereover. The covering 7627z can advantageously make the
distal section 7602z
atraumatic and/or smooth. The covering 7627z can be a film, such as expanded
PTFE. Expanded PTFE
can advantageously provide a smooth, low friction surface with low resistance
to bending but high
resistance to buckling.
[0306] Figures 27A-E show another exemplary distal end section 4302z that
includes a plurality of
linkages 4304z that are actively controlled, such as via cables 4324, for
steering of the rigidizing device.
In some embodiments, the pivots for the linkages 4304z can be involutes,
similar to gear teeth, as shown
in Figures 27A-E, to reduce the local contact drag. The cables 4324 can be
positioned within cable
guides (e.g., jackets or coil pipes) that extend the length of the rigidizing
device. In some embodiments,
the cables 4324 (and cable guides) can extend within the wall of the
rigidizing device. The cable guides
can advantageously ensure that tensile load is carried through the cable
guide, rather than through the wall
of the rigidizing device, so that the structure of the wall is not adversely
deflected as the load is applied to
the linkages 4304z. In some embodiments, the cable guides and cables 4324 can
have excess length to
account for bending of the rigidizing device. This excess length can, for
example, be woven or curled
within the wall of the rigidizing device. Further, the cables 4324 can run
through apertures and/or
grooves in the linkages 4304z (see, e.g., Figure 27C) while remaining
otherwise free to float within the
wall (and thereby to account for bending of the rigidizing device. As the
cables 4324 are activated, the
linkages 4304z pivot relative to one another, thereby providing steering for
the distal end section of a
rigidizing device. Articulation of the linkages 4304z and cables 4324 for
steering can be achieved by
actuators (e.g., local motors, current-activated (heat) nitinol wires,
proximal actuators (typically stainless
steel, tungsten, or composites), hydraulics, and/or EAP (electro-active
polymers)). Such steering
mechanisms can advantageously provide increased clinical utility. Further,
such steering allows the
device that is positioned through the central lumen (for example, an endoscope
or a guidewire) be steered
towards and more easily reach the desired anatomical location.
[0307] When cables are used for steering the distal end section, the
cables (which can be in cable
guides or not) can be routed through the wall of the rigidizing devices
described herein in a number of
different ways. Figures 28-39B show exemplary configurations of rigidizing
devices with cable guides
(some wall layers have been omitted in Figures 28-39B for clarity). For
example, Figure 28 shows a
rigidizing device 6200 having cables 6224 extending in cable guides 6299
within the outer radial gap
layer 6207 (and thus between the braid layer 6209 and the outer layer 6201).
In some embodiments, each
of the cables 6224 and cable guides 6299 can be positioned approximately
equidistant around the
circumference (i.e., approximately 90 degrees away from neighboring cables
when four cables are used).
In other embodiments, one or more of the cables 6224 and cable guides 6299 can
be grouped closely
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together (e.g., within the same quadrant) rather than spaced apart. Further,
in some embodiments, the
cables 6224 and/or guides 6299 can be asymmetrically positioned around the
circumference of the
rigidizing device 6200.
[0308] Figure 29 shows a rigidizing device 6300 in which
the cables 6324 and cable guides 6399
are positioned within the inner radial gap layer 6311 (and thus between the
braid layer 6309 and the inner
layers of the rigidizing device, such as the bladder 6321). When, for example,
pressure is supplied to
pressure gap 6312, the bladder 6321 can push against the braid layer 6309, and
the braid layer and
correspondingly push against the outer layer 6301 without the braid layer 6309
squeezing or otherwise
impacting the cables 6324. Again, the cables 6324 and cable guides can be
positioned equidistant or
asymmetrically about the circumference of the rigidizing device 6300.
[0309] Referring to Figure 30, in some embodiments, the
rigidizing device 6400 can have cables
6424 and cable guides 6499 at least partially separated from the pressurized
or vacuum zone. For
example, as shown in Figure 30, a tubular bladder layer 6421 can surround the
pressure gap 6412. Some
or all of the cables 6424 and cable guides 6499 can be positioned in the gap
6407 between the inner layer
6415 and the braid layer 6409 and circumferentially adjacent to the tubular
bladder layer 6421.
Advantageously, in this configuration, the cables 6424 and cable guides 6499
can both be minimally
impacted by pressurization of the bladder layer 6421 and provide substantially
no additive stack height or
thickness to the wall.
[0310] Referring to Figure 31, in some embodiments, the
rigidizing device 6500 can include a
plurality of tubular bladders 6521 spaced circumferentially apart such that
each cable 6524 and cable
guide 6599 can fit in the gap 6507 between adjacent tubular bladders 6521.
[0311] Referring to Figure 32, rigidizing device 6600 is
similar to device 6500 except that cables
6624 and guides 6699 are grouped in pairs to reduce the number of tubular
bladders 6621 necessary (e.g.,
there can be two tubular bladders 6621 and a two pair of cables 6624 and
guides 6699 positioned
therebetween).
[0312] Referring to Figure 33, rigidizing device 6700 is
similar to device 6500 except that each
tubular bladder 6721 includes a tubular braid layer 6709 therearound (i.e.,
rather than having a single
braid layer 6509 as with device 6500). As pressurizing medium is provided to
pressure gaps 6712, the
bladder 6721 can expand to press each individual tubular braid 6709, which can
expand to press against
the inner and outer layers 6715, 6701. Alternately, not all of the bladders
can be pressurized at the same
time (for instance, just 1 or 2) such that the device is only stiffened
partway around the circumference.
This may create stiffness along only a portion of the device, while still
enabling flexibility amongst the
other portion, which may create preferential motion should the device be
imparted with a deflection load.
[0313] Referring to Figure 34, in some embodiments, a
rigidizing device 6800 can include strips of
braid layer 6809 (La, flat braid rather than tubular braid). Each strip of
braid layer 6809 and each cable
6824 and cable guide 6899 can be positioned in the radial gap 6807. Further,
the strips of braid layer
6809 can alternate with the cables 6824/6899 so as to minimize the thickness
of the wall of the rigidizing
device 6800. The bladder 6821can be positioned radially outwards of the strips
of braid layer 6809 and
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cables 6824 / guides 6899. When pressure medium is supplied to the pressure
gap 6812, the bladder 6821
can push the strips of braid layer 6809 radially inwards against the innermost
layer 6815 to rigidize the
device 6800. In other embodiments, the bladder 6821 can be radially inwards of
the strips of braid layer
6809 (and cables 6824 / guides 6899) and be configured to push the strips of
braid layer 6809 against the
outer layer 6801.
[0314] In some embodiments, referring to Figure 35, the
cables 6924 and cable guides 6999 can be
positioned so as to extend down the central lumen 6920 of the rigidizing
device 6900.
[0315] In some embodiments, referring to Figure 36, the
cables 7024 and cable guides 7099 can be
positioned radially outwards of the outer layer 7001. The cables 7024 and
guides 7099 can, for example,
be positioned in a sheath 7009z that can extend only over the cables 7024 or
that can fully encompass the
outer layer 7001. The guides 7099 can be only minimally constrained within the
sheath 7009z so as to
freely bend during movement of the device 7000 (e.g., so as to curl or extend
to full length depending on
whether the guides 7099 are positioned on the inside or outside of the cure of
the rigidizing device 7000
as it bends).
[0316] Referring to Figure 37, in some embodiments, a cable guide 7199
(with one or more cables
therein) can be spiraled around the outside of the outer layer 7101 of the
rigidizing device 7100.
Additional cable guides can likewise be spiraled therearound. In some
embodiments, the cable guide
7199 can be spiraled around other layers of the rigidizing device 7100, such
as around the inner layer.
[0317] Referring to Figures 38A-38B, in some
embodiments, a cable guide 7299 (with one or more
cables therein) and a tubular element 7210z can be alternately spiraled around
the inner layer 7215 (La,
such that the cable guide 7299 and the tubular element 7210z form
approximately a single layer down the
length of the rigidizing device 7200. The tubular element 7210z can include an
outer tubular braid 7209
with an inner tubular bladder 7221. As pressurizing medium is provided to
pressure gap 7212, the
bladder 7221 can expand to press outwards on the tubular braid 7209, which can
push outwards on the
outer layer (not shown for clarity).
[0318] Referring to Figures 39A-39B, a rigidizing device
7300 can be similar to device 7200 except
that only the cable guide 7399 and a tubular bladder 7321 can be spiraled
around the inner layer 7315
within gap 7311 (note that cable guide 7399 and tubular bladder 7321 are not
shown in Figure 39B for
clarity). A braid layer 7309 can then be wrapped radially around the gap 7311.
When a pressure medium
is supplied to the tubular bladder 7321, the bladder 7321 can expand to push
the braid layer 7309 against
the outer layer 7301 (not shown in Figure 39A for clarity).
[0319] It should be understood that the cable
configurations described with respect to Figures 28-
39B can be used with any number of cables (such as 1, 2, 3, 4, 5, 6,8, 12, or
16 cables). Further, the
cables can be used to steer any tip or a rigidizing device and/or to steer any
distal end section (e.g.,
sections with linkages or different braid angles). Further, the cable guides
described herein can be round
with round cables, flat, rectangular with flat ribbon tensile elements, or a
combination thereof. Further, in
some embodiments, other steering elements can be used in addition to or in
place of the cables (e.g.,
pneumatics, hydraulics, shape memory alloys, EAP (electro-active polymers), or
motors). Intentionally
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separating the elements required for steering and the elements required for
rigidization can enable the
structure to exhibit a continuously high rigidization performance as a
function of length, even if the forces
available for steering are demonstrably lower than the forces required for
nested system rigidization.
[0320] Additionally, it should be understood that the
cable configurations and placement described
with respect to Figures 28-39B can similarly be used for the placement of
working channels or other
lumens (for example, inflation lumens for balloons) within the rigidizing
devices.
[0321] Referring to Figures 40A-40D, in some
embodiments, the distal end section 5902z may
include a series of linkages 5904z (either active or passive) that are
specifically designed to rigidize via
the application of pressure or vacuum. For example, the linkages 5904z can be
connected to each other
through a pivot point 5928z (which can, for example, be wire pivot points).
Each pivot point 5928z can
allow bending with one degree of freedom between linkages_ Further, the
linkages 5904z can be arranged
in alternating fashion with every other linkage connected with the pivot
points 5928z positioned 90
degrees away from the previous linkage. Each linkage 5904z can have cut-outs
5975z at the proximal
and distal ends thereof extending from the pivot-points 5928z to as to allow
bending of the linkages
5904z relative to one another. Further, each linkage 5904z can be connected to
a neighboring linkage
5904z by a respective tensile member 5930z. The tensile member 5930z can be
fixed relative to one
linkage and at least partially movable within a track 5931z of the neighboring
linkage (e.g., within track
5931z of linkage 5904z). Movement of the linkages 5904z allows the tensile
member 5930z to lengthen
when on the outside of the curve and shorten when on the inside of the curve
during bending of the
rigidizing device. Further, the proximal end section 5902z can include two
sliding clamps 5932z attached
to tensile member 5930z along opposite axis (i.e., 90 degrees away from one
another). The two tensile
members 5930z extend from each of the sliding clamps 5932z to the distal-most
end of the distal section
5902z. As the distal end section 5902z is bent, one cable element of each
sliding clamp 5932z gets
shorter and one cable element of each sliding clamp 5932z gets longer,
resulting in circumferential
movement of the sliding clamps 5932z. When vacuum or pressure is applied, the
outer sleeve can
compress the sliding clamps 5932z to the track 5931z surface. The sliding
clamps 5932Z and the track
5931z surface may be smooth, rough or have teeth. This compression force may
case the sliding clamps
5932Z to lock in place with respect to the links 5904z, thereby fixing the
position of tensile members
5930z and making the distal end section stiffer in its current shape.
Additional rigidizing linkages and/or
engages are described in International Patent Application No.
PCT/US2018/042946, filed July 19, 2018,
tided "DYNAMICALLY RIG1DIZING OVERTUBE," now Pa Publication No. WO
2019/018682, the
entirety of which is incorporated by reference herein.
[0322] Referring to Figures 41A-41B, in some
embodiments, the distal end section 6002z can
include linkages 6004z (either active or passive) that are placed over a
section 6007z that rigidizes via
vacuum or pressure as otherwise described herein (i.e., over a rigidizing wall
with inner layer 6015,
pressure gap 6012, bladder 6021, braid layer 6009, and outer layer 6001).
Placing the linkages 6004z
over the rigidizing section can provide the advantages of a linked system
(e.g., flexibility in bending and
torsional stiffness) together with a steering or deterministic bending tip
that can be rigidized when the
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remaining structure is rigidized. Alternatively, linkages can be positioned
radially inwards of a rigidizing
section. As shown in Figure 41B, cables 6024 in cable guides 6099 can extend
through linkages 6004z to
provide optional active steering of the linkages 6004z.
[0323] Referring to Figure 89, in some embodiments, the
distal end section 8907z can include
linkages 8904z that are positioned radially inwards of a section 8907z that
rigidizes via vacuum or
pressure as otherwise described herein. For example, the linkages 8904z (and
corresponding cables 8924)
can be placed radially inwards of the inner layer 8915 (and thus also bladder
8921, braid layer 8909, and
outer layer 8901). When radially inwards of the inner layer 8915, the linkages
8904z can help the inner
layer 8915 (e.g., coil wound tube) resist collapse. Further, in such an
embodiment, the distal portion of
the inner layer 8915 that is coextensive with the linkages 8904z can be
thinner and/or more flexible than
the proximal portion of the inner layer 8915 that is not coextensive with the
linkages 8904z. Having a
thinner and/or more flexible distal portion of the inner layer 8915 can
provide enhanced maneuverability,
flexibility and bendability at the tip.
[0324] In one exemplary use of distal end section 8907z
(or distal end section 6002z of Figures
41A-41B), the linkages 8904-z and cables 8924 can be used to steer the
rigidizing device when the
rigidizing section 8907z is in the flexible configuration. Conversely, when
the rigidizing section is in the
rigid configuration, the linkages 8904z can be prevented from moving, thereby
holding the linkages
8904z in a fixed shape. In some embodiments, section 8907z can be separately
rigidizable relative to the
proximal portion of the rigidizing device.
[0325] Referring to Figure 42A, in some embodiments, the distal end
section 6102z can include a
series of linkages 6104z (either active or passive) sealed within a thin layer
of material 6108z(e.g., made
of an elastomer, PVC, or PEEK). The linkages 6104z and thin layer of material
6108z can, for example,
be positioned over (i.e., radially outwards from) the braid layer 6109 and can
be continuous with the coil
wound tube 6101 of the main elongate body 6103z. In this embodiment, when
pressure or vacuum is
supplied to the gap 6112, the braid layer 6109 can be compressed by the
bladder 6121 against the coil
wound tube 6101 in the main elongate body 6103z and against the linkage sheath
6108z in the distal end
section 6102z to rigidize. The linkage sheath 6108z is supported by the
linkages 6104z such that it can
resist the pressure of the braid expanding. This design advantageously
provides both rigidization and
linkages while maintaining a low wall thickness and/or diameter. The distal
end section 6102z can, for
example, include cables 6124 extending within cable guides to activate the
linkages 6104z.
[0326] In some embodiments, the rigidizing structure can
be steered from within the wall of the
rigidizing structure and optionally without any links. Figure 42B shows a
cross section of a pressure
rigidizing structure 2500 where a cable guide 2599 is placed in the pressure
gap 2512 and can be attached
to the inner layer 2515. The cable 2524 extends from the cable guide 2599 into
the distal end section
2502z and is anchored to the inner layer 2515 at anchor point 2568. Pulling on
the cable 2524wi11 cause
the distal end section 2502z (distal to the end of the cable guide 2599) to
deflect. In some embodiments,
the cable guide 2599 can be omitted, and the rigidizing device 2500 will bend
along its entire length when
the cable 2524 is pulled. In some embodiments, the device 2500 can be built
with a distal end section
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2502z that has a lower bending stiffness than the proximal elongate body 2503z
(as described herein, for
instance by varying the braid angle or using a more flexible reinforcement
element in either the inner or
outer layer) so that the distal end section 2502z bends more than the body
2503z. The cable guide 2599
and cables 2524 can be located between the bladder 2521 and the braid 2509 or
between the braid 2509
and outer layer 2501. The cable guide 2599 and/or the cables 2524 can be
attached to the outer wall 2501.
Alternately, in a vacuum rigidized structure, the cable guide 2599 and cables
2524 can be located between
the inner layer and the braid or between the braid and the outer layer. In
some embodiments, the bladder
2521 and the braid of the braid layer 2509 can be omitted in the section where
the cable 2524 is not inside
the cable guide 2599, leaving only inner and outer layers 2515, 2501, or just
an outer layer or just an inner
layer.
[0327] Referring to Figures 43A-43C, in some embodiments,
the distal end section 4602z can
include active deflection segment 4646. The deflection segment 4646 can
include a ribbon or spine
extending therethrough that provides bending only in one or more predetermined
directions upon
activation. The active deflection segment 4646 can be deflected, for example,
using one or more cables,
bladders, pullwires, and/or introduction of a guide wire, to a predetermined
shape. The active deflection
segment 4646 can thus provide bending of the rigidizing device 4600 at a fixed
location and in a fixed
direction. In some embodiments, markers (e.g., radiopaque markers) can be
positioned within or
proximate to the active deflection segment 4646 to indicate where the bend
will occur and/or in which
direction the active deflection segment 4646 will bend. Bending of the
rigidizing device 4600 using the
active deflection segment 4646 can be advantageous, for example, where bending
is required without
assistance from the anatomy (i.e., when the anatomical path for the rigidizing
device 4600 is not
predefined or constrained by the anatomy). For example, such bending might be
useful to create a bend
across the open or relatively unconstrained space between the inferior vena
cava (PVC) and the atrial
septum during transseptal procedures in the mitral valve. The active bending
segment 4646 can be
configured to be rigidized (i.e., via pressure or vacuum) as described herein
to fix or lock the active
deflection segment 4646 in the bent configuration. Further, the rigidizing
device 4600 can include a
steerable distal section 4647 (e.g., with linkages) in addition to the active
deflection segment 4646. The
steerable distal section 4647 can be used to point or orient the distal end of
the rigidizing device 4646 in
the desired direction (e.g., via cables and/or along four axes), as described
elsewhere herein.
[0328] In some embodiments, the rigidizing devices described herein can
be configured to assume a
predetermined shape without the use of an internal steering mechanism (e.g.,
without cables, bladders, or
pullwires). Referring to Figures 86A-86F, a system 8604y includes a preformed
wire 8605y (e.g., a
superelastic nitinol wire) and a rigidizing device 8600. The preformed wire
8605y can be pre-formed
with a variety of shapes, such as a preformed shape for use in specific
cerebral, visceral, or cardiac
indications. The preformed wire 8605y can be stiffer than the rigidizing
device 8600 in the flexible
configuration, but less stiff than the rigidizing device 8600 in the rigidized
configuration. Thus, the
preformed wire 8605y can bend the rigidizing device 8600 to the shape of the
preformed wire 8605y
when the rigidizing device 8600 is in the flexible configuration, but can take
on the shape of the rigidizing
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device 8600 when the rigidizing device is in the rigid configuration. Because
the preformed wire 8605y
is superelastic, it can easily change shape (e.g., when the rigidizing device
8600 is in the rigidized
configuration) while still returning to its preformed shape (e.g., when the
rigidizing device 8600 is in the
flexible configuration).
[0329] An exemplary method of using the system 8604y is shown in Figures
86B-86F. As shown in
Figure 86B, the rigidizing device 8600 can be placed in the body (in any
shape) and rigidized (e.g., by the
application of pressure or vacuum). As shown in Figure 86C, the preformed wire
8605y can then be
inserted into the central lumen of the rigidizing device 8600. Because the
rigidizing device 8600 is in the
rigid configuration, the preformed wire 8605y will take on the shape of the
rigidizing device 8600. As
shown in Figure 86D, the rigidizing device 8600 can then be made flexible
(e.g., by releasing the pressure
or vacuum), allowing the preformed wire 8605y to return to its preformed
shape. As shown in Figure
86E, the rigidizing device 8600 will take on the shape of the preformed wire
8605y as the preformed wire
8605y resumes its shape. The rigidizing device 8600 can then be rigidized in
that preformed shape. At
step 86F, the preformed wire 8605y can be removed by pulling it proximally
back though the device
8600 while it is in the rigidized configuration_
[0330] Advantageously, a single rigidizing device 8600
can be configured to take on a plurality of
different predetermined shapes in situ through the use of a plurality of
different preformed wires 8605y.
In some embodiments, multiple preformed wires 8605y can be tried until the
shape is just right for the
desired indication without removing the rigidizing device 8600 from the body.
In some embodiments, the
preformed wire 8605y can be reusable (e.g., via autoclaving after use) while
the rigidizing device 8600
can be disposable.
[0331] The system 8604y can advantageously be used, for
example, for coronary catheterization, for
accessing the head and neck vessels from the aortic arch, or for accessing
bile and pancreatic ducts
during, for example, ERCP (Endoscopic Retrograde Cholangio-Pancreatography).
[0332] Any of the rigidizing devices described herein can include one or
more separately rigidizing
sections. For example, referring to Figures 44A-44C, in some embodiments, a
rigidizing device 900 can
have separate vacuum/pressure chambers 975a-d (e.g., four vacuum or pressure
chambers) along the
length thereof. Each chambers 975a,b,c,d can have its own vacuum/pressure line
927a-d extending
thereto for individual rigidization of the chambers 975a,b,c,d. Pressure seals
929 can extend between
each chamber and/or at the distal end. The rigidizing device 900 with
separately rigidizing chambers
975a,b,c,d can, in some embodiments, include a steerable distal section 902z
(e.g., with linkages as
otherwise described herein). The cables 924a-d to control the steerabk distal
section 902z can be
managed using cable guides 999 (e.g., there can be at least one, such as 1-4
cable guides 999 in each
vacuum chamber 975). In some embodiments, shown in Figure 44B, the cables 924a-
d, cable guides
999a-d, and/or vacuum/pressure lines 927a-d can extend within a radial gap 911
between the innermost
layer 915 and the braid layer 909 (and thus also beneath the outermost layer
901). In other embodiments,
shown in Figure 44C, the cables 924a-d, cable guides 999a-d, and/or
vacuum/pressure lines 927a-d can
extend within the central lumen 920 of the rigidizing device 90(1 In use of
the rigidizing device 900, any
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of the chambers 975a-d that are in the flexible state can be steered or
deflected in the direction of cable
tension while the chambers 975a-d that are rigidized will remain in their
position and not be deflected.
Advantageously, this design allows alternating which chambers 975a-d arc under
vacuum/pressure and/or
direction of steering to form a variety of complex shapes and provide
navigation through the anatomy
with minimal looping.
[0333] Any of the rigidizing devices or distal end
sections described herein can have a distal tip
thereon that is configured to closely follow a diameter of a scope of device
inserted therethrough without
creating substantial drag or friction. For example, Figures 103A-103B show an
exemplary distal tip
10332y that is axially reinforced and radially expandable. As shown, the tip
10332y can include a conical
outer housing 10333y. Additionally, the tip 10332y can include an inner
housing 10334y that includes an
annular ring 10335y and a plurality of protrusions 10336y extending distally
from the annular ring
10335y. There can be, for example, 10-40 protrusions 10336y, such as 15-30
protrusions 10336y. The
protrusions 10336y can taper so as to have a wider proximal end 10337y and a
narrower distal end
10338y. Additionally, the proximal ends 10337y of the protrusions 10336y can
have a cut-out 10339y
therein (e.g., on the outer surface) so as to create a living hinge at each
protrusion 10336y. The living
hinges can advantageously allow the protrusions 10336y to bend radially
outwards.
[0334] In some embodiments, the outer housing 10333y can
be made of a low durometer material
while the inner housing 10334y can be made of a high durometer material. For
example, the outer
housing 10333y can be made of a thermoplastic elastomer or silicone and/or can
have a durometer of 50A
or less while the inner housing 10334y can made of polypropylene,
polytetrafluoroethylene, high-density
polyethylene, or low-density polyethylene. In some embodiments, the material
for the inner housing
10334y can be a low friction material to allow it to slide easily relative to
the scope.
[0335] The tip 10332y can be configured to mate with the
layers of the rigidizing device at a
proximal end and to conform to a scope body at the distal end. In use, the
protrusions 10336y can move
between a variety of diameters at the distal end (e.g., at the living hinges).
This can advantageously allow
the tip 10332y to conform closely to a variety of scope diameters or features
and/or to conform to the
scope as it bends, thereby reducing the gap between the scope and the tip
10332y and lessening the
chance that tissue can get caught in the gap between the distal end of the tip
10332y and the scope. In
some embodiments, the resulting gap when the tip 10332y is used with a scope
can be less than 0.04",
such as less than 0.01". Additionally, the stiffness of the protrusions 10336y
can further advantageously
prevent inversion of the distal end of the rigidizing device.
[0336] In some embodiments, the tip 10332y can be
injection molded. For example, the stiff
material of the inner housing 10334y can be molded first, and then the
flexible material of the outer
housing 10333y can be molded thereover.
[0337] In some embodiments, the lower durometer material for the outer
housing 10333y can
additionally or alternatively be placed along the inside of the inner housing
10334y.
[0338]
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[0339] In some embodiments, the distal end section of the
rigidizing devices described herein can
include an element for local tissue stabilization, such as suction, a balloon
or a cage element. For
example, referring to Figures 45A-45D, in one embodiment, a rigidizing device
600 can include a balloon
666 and a balloon inflation lumen or tube 667 extending thereto. As shown in
Figures 45B-45D (the
outer layers have been removed in 6B-6C for clarity), the balloon inflation
tube 667 can extend alongside
the working channel 655 (and thus within the radial gap 611 between the slip
layer 613 and the first braid
layer 609). As shown in Figures 45B-45C, the inflation tube 667 can be
configured to include a service
loop 668 that can change lengths (i.e., straighten as in Fig 4513 or obtain a
greater bend as in 45C) to
accommodate bending of the rigidizing device 600. In some embodiments, the
balloon inflation tube can
be spiraled about its axis to accommodate bending. In some embodiments, a
vacuum rigidizing device
can include a balloon inflation tube between the innermost layer and the
braid, between the braid and the
outer layer, radially inwards of the inner layer, or radially outwards of the
outer layer. In some
embodiments, a pressure rigidizing device can include an inflation lumen in
the pressure gap, between the
bladder and braid, between the braid and outer layer, radially inwards if the
inner layer, or radially
outwards of the outer layer. For example, the inflation lumen can be
positioned similar to as described
herein with respect to working channels and/or cables.
[0340] Another exemplary rigidizing device 9000 including
a balloon 9066 and a hollow inflation
tube or tubes 9067 is shown in Figures 90A-9013 (the outer sheath, braid, and
anti-block element have
been removed from 90A for clarity). The hollow inflation tube 9067 extends
between the braid layer 9009
and the inner layer 9015. Further, the device 9000 includes a tip fitting
9008y positioned within the
balloon 9066 and proximal to the overtube distal ring or tip 9009y. The outer
layer 9001 and braid 9009
can terminate in the tip fitting 9008y and can be attached to the tip fitting
9008y, for example, with an
adhesive, thermal bond, or compression fitting. The inner layer 9015 can
extend radially inwards of the
tip fitting 9008y to the overtube distal ring or tip 9009y. Further, the inner
layer 9015 and the proximal
end of the balloon 9066 can be connected to the overtube distal ring 9009y
(e.g., with an adhesive,
thermal bond, or compression fitting). The tip fitting 9008y can include a
slot 9010y or hole therein
configured to allow the lumen of the hollow inflation tube 9067 to pass
therethrough to the interior of the
balloon 9066. The slot 9010y can include an anti-block element 9011y, such as
a piece of fabric, breather
or other permeable material, at the distal end thereof to prevent the balloon
9066 from blocking flow in or
out of the inflation lumen 9067 even if the balloon wall collapses.
[0341] As another example, Figures 46A-4613 show an
exemplary vacuum tip 5354 for use with a
rigidizing device. The vacuum tip 5354 can include a circumferential array of
vacuum holes 5358 on the
distal-most face 5359. Further, the array of vacuum holes 5358 can be
connected to a vacuum line 5356
that runs along the rigidizing device (e.g., within or alongside the layered
walls of the rigidizing device).
The vacuum line 5356 can be connected to a source of vacuum such that, when
activated, vacuum is
provided through the vacuum line 5356 to each of the holes 5358 of the array
(e.g., through an annular
inlet 5319z). As a result, suction can be provided on the distal-most face
5359 of the tip 5354 (and thus
the distal-most face of the rigidizing device). Such suction can be useful,
for example, to suction tissue
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thereto (e.g., for stabilization during interventional procedures such as for
cannulation of the papilla, e.g.,
for access to the pancreatic duct or bile duct). The suction can also be
useful, for example, for
Endoscopic Submucosa Dissection (ESD), or Endoscopic Full Thickness Resection
(EFTR).
[0342] In some embodiments, the vacuum tip 5354 can be
positioned just distal to a steering section
of the rigidizing device, which can advantageously be used to orient the
vacuum tip 5354 in the desired
direction. Further, in some embodiments, a tool (e.g., guidewire or scope) can
pass through the central
lumen 5320z of the tip 5354 and between the array of vacuum holes 5358 to
allow for procedures to be
performed while suction is activated.
[0343] Referring to Figures 47A-47B, in some embodiments,
the vacuum tip 5254 can include a
semi- annular array of holes 5238 at the distal-most face 5259 rather than a
circumferential array of holes.
[0344] Referring to Figures 48A-48B, in some embodiments,
the vacuum tip 5454 can have an
angled distal face 5459 (e.g., angled at 30-80 degrees relative to the
longitudinal axis of the tip 5454, such
as 30, 45, 60, 70, or 80 degrees). The angled distal face can advantageously
help approach angled
anatomy to more easily adhere to the local surface.
[0345] The vacuum tips described herein can advantageously provide
suction without causing "red-
out" of the endoscopic lens, as the suction can occur locally (e.g., at the
holes 5358) and not at the lens of
the scope. Accordingly, the scope can provide visualization of the tissue even
when suction is applied.
[0346] In some embodiments, the vacuum tips described
herein can include a metallized portion
and/or have co-joined wires such that the vacuum tips can conduct current.
Such current can be used, for
example, to cut or coagulate the suctioned tissue.
[0347] In some embodiments, the vacuum tips described
herein can be used with a standard
endoscope or endoscopic type device that does not include rigidization.
[0348] Any of the rigidizing devices described herein can
be used with a handle configured to allow
manual manipulation and/or activation of the device.
[0349] An exemplary handle 1031 is shown in Figures 49A-49D. The handle
1031 includes an
activation element 1048 in the form of a button configured to activate the
vacuum or pressure (the button
is shown off in Figures 49A and 49C and on in Figures 4913 and 49D). Further,
a flow path within the
handle 1031 can include a vacuum or pressure inlet port 1049 configured to be
attached to the vacuum or
pressure source, a rigidizing device port 1050 that connects to the rigidizing
device via output 1073z, and
a vent port 1051 that connects to atmosphere. As shown in Figure 49A, when the
activation element 1048
is in a distal "off' position (Le., such that vacuum or pressure for
rigidization to the rigidizing device is
off), the vent port 1051 and rigidizing device port 1050 are in communication
with one another, thereby
venting any rigidizing pressure or vacuum to the air and allowing the
rigidizing device to be in a flexible
configuration. As shown in Figure 49B, when the activation element 1048 is in
a proximal "on" position
(i.e., such that vacuum or pressure to the rigidizing device is on), the
rigidizing device port 1050 and the
vacuum or pressure inlet port 1049 are in communication with one another,
thereby supplying pressure or
vacuum to the rigidizing device to allow the device to rigidize. In some
embodiments, the handle 1031
can be configured to be bonded to the rigidizing device (e.g., to an inner
coil wound tube over the
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rigidizing device) at bonding region 1053. As shown in Figures 49C-D, the
handle includes a status
indicator element 1067z to indicate whether the rigidizing device is in the
flexible or rigid configuration.
In this embodiment, the status indicator 1067z is such that the word "on"
shows when the button is placed
in the "on" position, and the word "off' shows when the button is placed in
the "off" position. In other
embodiments, the status indicator can be a symbol, color, light, or moving
indicator.
[0350] The activation element for a rigidizing device
handle as described herein can be a button,
switch, toggle, slider, screwed connection, squeeze handle, or stop-cock.
Further, the activation element
can be planar, a sector, or omnidirectional. The indicator element can include
words, lights, or an
element that spins with flow of vacuum or pressure. For example, referring to
Figures 50A-50B, in some
embodiments, the activation element 1548 can be a slider element. The
activation element 1548 can
include a connection element 1574z (e.g., a hollow tube or snap-fit element)
configured to slide over a
handle. The indicator element 1567z can be built into the slider (e.g.,
indicate "rigid" when the slider is
in one position and "flexible" when the slider is in another position). A
similar slider actuation element
1648 (this one orthogonal) can be seen in Figures 51A-51C.
[0351] In some embodiments, rather than including the activation element
and indicator element on
the handle, one or both can be on separate elements. For example, the
activation element can be
positioned along the vacuum or pressure line between the handle and the vacuum
or pressure pump, can
be actuated by a foot pedal, can be on the scope umbilical, on the scope
shaft, or can be clipped on the
patient's bed. In some embodiments, the actuation element can be separate from
the handle, but can clip
onto the handle during part of the procedure. For example, Figures 52A-52C
show an activation element
1448 that includes an attachment mechanism 1452 (e.g., a c-shaped clip) for
detachable coupling to a
handle 1431. Having the indicator element and/or activation element separate
from the handle can
advantageously allow the actuator and indicator to be seen more clearly (i.e.,
not be obstructed by the
person's anatomy) and/or can allow the actuator and indicator to be
controlled/used more easily by an
additional person (e.g., a procedural assistant).
[0352] Figures 53A-D show a handle 1131 that is designed
to allow manipulation of a rigidizing
device, but that does not include an activation element or an indicator
element. The handle 1131 includes
a large stopper or flange 1161 at the distal end thereof that can act as an
insertion blocker for the handle
1131 (i.e., to stop the handle 1131 from moving into the anatomy) and to act
as a face against which the
operator can push during use. The rigidizing device can connect at bond region
1151 Further, the handle
1131 can include an input 1165 from the remote activation element connected to
an output 1173z to the
rigidizing device.
[0353] In some embodiments, a handle for use with a
vacuum rigidizing device can include a vent
port to vent the rigidizing device when vacuum is not supplied (i.e., when the
rigidizing device is in the
flexible configuration). For example, Figures 54A-54B show a handle 1231
having spool valve
activation element 1248 that is shuttled in one direction to activate the
vacuum in the rigidizing device
and can be shuttled in the opposite direction to deactivate the vacuum or
pressure. When deactivating
vacuum or pressure to the rigidizing device, the activation element 1248 can
provide venting via vent port
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1251. The activation element 1248 can be positioned on the vacuum or pressure
line 1232 leading to the
handle, such as 4"-8", e.g., 6" away from the handle. As shown in Figure 54A,
the spool valve with end
button indicator element 1267z can indicate that the rigidizing device is in
the flexible configuration (as
shown) or the rigid configuration (when pushed in the opposite direction).
[0354] Referring to Figures 55A-55C, the activation element 1348 can be
a rotary valve (e.g.,
connected to the handle or elsewhere as described herein), and a sliding
indicator 1367z on the rotary
valve activation element 1348 can show that the vacuum or pressure is on (as
shown in Figures 55A and
55C) or off and vented (as shown in Figure 55B).
[0355] In some embodiments, a handle for use with a
vacuum rigidizing device can include a
mechanism configured to automatically lock the handle in the vacuum or vented
configuration. For
example, handle 7531 for use with a vacuum rigidizing device 7500 is shown in
Figures 56A-56G. The
handle 7531 includes a handle body 7515z configured to attach to the
rigidizing device 7500. The handle
7531 further includes an activation element 7548 in the form of a switch ring
for supplying vacuum to the
rigidizing device 7500. The switch ring activation element 7548 can include a
magnet 7522z that is
configured to mate with either a proximal magnet 7523z (as shown in Figure
56D) or a distal magnet
7524z (as shown in Figure 56E). When the switch ring magnet 7522z is mated
with the proximal magnet
7523z, the vacuum feed line 7532 in the handle 7531 is disconnected from the
vacuum port 7550 to the
rigidizing device, and both the rigidizing device and the vacuum are vented or
open to the atmosphere (as
shown in Figure 56F). When the switch ring magnet 7522z is mated with the
distal magnet 7523z, the
vacuum feed line 7532 in the handle 7531 is connected to the vacuum port 7550
to the rigidizing device
so as to supply vacuum thereto (as shown in Figure 56G). Advantageously, the
magnets 7522z, 7523z,
7524z can lock the switch ring 7548 in the vacuum or vent configurations,
thereby preventing harm to the
patient that could result if in the unintended configuration (e.g., attempted
movement of the device 7500
through the anatomy when in a rigid configuration when it could damage the
anatomy). In some
embodiments, the magnet 7522z can be a ferrous material while the magnets
7523z, 7524z can be
magnets or vice versa. As shown in Figures 56A-56B, the handle 7531 can
further include a user grip
7521z for the user's hand with a grip cover 7525z configured to cover the
vacuum feed tube line 7532 in
the handle 7531. Further, the vacuum feed tube line 7532 can connect directly
to the switch ring
activation element 7548. The vacuum feed line 7532 may have a spiral or
winding shape under the grip
cover 7525z, which can allow the switch ring activation element 7548 to move
proximally and distally
without restricted motion caused by the vacuum feed line 7532. The spiraling
of the vacuum feed line
7532 may be from 30 to about 1440 degrees. For instance, 90 degrees (as shown
in Figure MC where the
grip cover is removed for clarity) 180, 364) and 720 degrees. The grip cover
7525z may be designed such
that it covers the whole vacuum feed line 7532 even when the spiral goes all
the way around the handle
7531. The handle 7531 can further include a stopper flange 7561 to prevent the
handle 7531 from
moving into the anatomy (for instance, the stopper flange may prevent the
device from passing through
the anus or through an oral bite guard), a proximal handle port 7526z for
insertion of a scope or other
working tool therethrough, and/or an indicator element 7567z. The indicator
element 7567z is a band that
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is visible only when the switch ring activation element 7548 is in the distal
position. The indicator
element 7567z may have a different color and or value than the rest of the
handle, preferably a color that
contrasts sharply and is visible in reduced lighting configurations. For
instance, the handle 7531 may be
white and the indicator element 7567z may be a medium to dark blue. The
indicator element 7567z band
may also have a different texture than the rest of the handle 7531. For
instance, it may have raised bumps
or a crosshatching. This may allow a physician to easily feel the state of the
handle 7531.
[0356] Another exemplary handle 8231 for a vacuum
rigidizing device with a mechanism configured
to automatically lock the handle in the vacuum or vented configuration is
shown in Figures 82A-J. The
handle 8231 includes a handle body 8215z configured to attach to a rigidizing
device. The handle body
8215z can include a distal connector 8281z, a valve body 8280z, a switch ring
activation element 8248,
and a proximal end 8282z. The distal connector 8281z is configured to attach
to the rigidizing device and
includes a stopper flange 8261 thereon. The proximal end 8282z includes a port
8226z for passage of a
scope or other working tool therethrough. The switch ring activation element
8248 can be configured to
rotate about the valve body 8280z in a first direction (shown in Figure 82G)
to set the rigidizing device in
a rigid configuration and in a second direction (shown in Figure 82H) to set
the rigidizing device in the
flexible configuration.
[0357] The ring activation element 8248 can include a
pair of switch ring magnets 8222z configured
to engage with a first magnet 8223z or a second magnet 8224z of the valve body
8280z, depending on the
rotational position of the ring activation element 8248. When one of the
switch ring magnets 8222z is
mated with the first magnet 8223z, a vent port in the vacuum feed 8232 is
sealed (against seal 8297z), and
the vacuum feed 8232 is fluidically connected to the vacuum port 8250, causing
the rigidizing device to
take on the rigid configuration (as shown in Figure 82G). When the other
switch ring magnet 8222z is
mated with the second magnet 8224z, the vacuum feed line 8232 and the vacuum
port 8250 are open to
the atmosphere, and the rigidizing device is in a flexible configuration (as
shown in Figure 82H). In some
embodiments, the vacuum port 8250 can be formed entirely within the valve body
8280z, thereby
preventing the need for separate tubing.
[0358] Similar to the handle 7531, the magnets 8222z,
8223z, 8224z can lock the switch ring 8248 in
the vacuum or vented configuration, thereby preventing harm to the patient
that could result if the
rigidizing device is positioned in the unintended and/or partial configuration
(i.e., the handle can be bi-
stable so as to only allow the activation element 8248 to be set fully in the
vacuum/rigid configuration or
fully in the vented/flexible configuration). Additionally, because the
rotational movement of the ring
8248 is orthogonal to the linear motion used to perform a procedure with the
rigidizing device, the two
motions (activation and movement of the rigidizing device within the body) can
be decoupled, further
decreasing the chance of unintentional activation (and thereby improving
safety). Further, by having the
switch ring 8248 rotate between positions, the user can easily hold the handle
body 8215z and activate
and deactivate vacuum with a single hand, leaving the other hand free.
[0359] In some embodiments, the actuation can be locked
by using only a pair of magnets on the
valve body 8280z and using a magnetic material on or for the ring activation
element 8248 (i.e., in place
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of the pair of switch ring magnets 82224. In this embodiment, the magnetic
material on the ring
activation element 8248 can be configured to interact with both the first
magnet 8223z and the second
magnet 8224z depending on the positioning of the ring 8248.
[0360] The switch ring activation element 8248 can
further include an indicator element 8267z that
can indicate whether the activation element 8248 is rotated so as to be in the
rigid (Figure 821) or the
flexible (Figure 821) configuration. Further, in some embodiments, there can
be an indicator element
8267z at varying locations around the circumference (e.g., every 180 degrees)
so as to ensure that the user
can visualize the state of the rigidizing device regardless of the rotational
position of the handle 8231 in
the user's hand. The switch ring activation element 8248 can thither include a
plurality of radially
extending projections 8283z (see Figures 8I-8J) configured to enhanced grip
for the user.
[0361] In some embodiments, a handle for use with a
pressure rigidizing device can include a
pressure gap inlet and a vent gap inlet. An exemplary handle 6231 attached to
a pressure rigidizing
device 6200 is shown in Figures 57A-57C. The handle includes a gap inlet 6293
and a vent gap inlet
6223. Pressure gap inlet 6293 connects to pressure gap 6212 (via pressure line
6294). Vent gap inlet
6223 (which can extend all the way through the handle to exit on both sides
thereof) connects to gap 6206
around the braid layer 6209 (between the bladder 6221 and the outermost layer
6201). The vent inlet
6223 can be open to atmosphere while the gap inlet 6293 can be connected to a
pressure source (e.g., and
activated with an activation element). The handle 6231 can, for example, be
used to operate the device
2200g described with respect to Figure 16G. In some embodiments, a fitting can
be added to the gap inlet
6293 so that the handle 6231 can be used to operate the device 2200i as
described with respect to Figure
161.
[0362] In some embodiments, shown in Figure 91, a handle
9131 for use with a pressure rigidizing
device can include an annular bladder adapter 9112y with an annular outer
adapter 9113y positioned
around the bladder adaptor 9112y. The adaptors 9112y, 9113y can be configured
to fix the layers of the
rigidizing device within the handle 9131 and may be attached (e.g., bonded or
thermally welded) to
handle 9131. Thus, as shown in Figure 91, the outer surface of the innermost
layer 9115 can be bonded to
the inner surface of the handle body 9115z, which can advantageously ensure
that the handle body 9115z
does not extend into the lumen 9114y of the handle 9131. The outside surface
of the bladder 9121, in
turn, can be bonded to the inside surface of the bladder adaptor 9112y, which
can advantageously provide
the maximum annular area for inflation fluid or gas to flow between the
bladder 9121 and the innermost
layer 9115 and thereby increase/decrease activation/deactivation speeds.
Having the outside surface of
the bladder 9121 bonded to the bladder adaptor 9112y can further ensure that,
when pressure is supplied
to the pressure gap 9112, it compresses the bonded region and thereby
increases the strength of the bond.
Additionally, the inside surface of the braid 9109 can be bonded to the
outside surface of the bladder
adaptor 9112y, which can advantageously ensure that any sharp ends of the
braid 9109 are kept away
from the bladder 9121. Finally, the outside surface of the outer layer 9101
can be bonded to the inside
surface of the outer layer adapter 9113y.
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[0363] In some embodiments, a handle for use with a
pressure rigidizing device can include a pre-
filled pressure medium therein. For example, an exemplary handle 7431 attached
to a pressure rigidizing
device 7400 is shown in Figures 58A-58E. The handle 7431 includes a handle
body 7415z and a
grip/lever 7411z that can be activated to provide pressure medium to the
rigidizing device 7400, such as
pressure medium pre-filled or stored in the fluid chamber 7412z of the handle
7431_ The chamber 7412z
can, for example, be bordered by a rolling diaphragm 7416z. The grip/lever
7411z can include teeth
7476z that mate with a rack 7414z of a piston 7413z. As the grip/lever 7411z
is moved towards the
handle body 7415z, the piston 7413z can move distally towards the rolling
diaphragm 7416z of the fluid
chamber 7412z. As the rolling diaphragm 7416z is pushed distally, it forces
the pressure medium from
the chamber 7412z through the gap inlet 7493 to the pressure gap 7412 outside
of the bladder 7421 for
stiffening (and air or other fluids can likewise escape from around the braid
layer via vent 7423). In some
embodiments, the handle 7431 can include a locking mechanism (e.g., via a
click on/click off mechanism,
such as that found in a ball point pen) with spring and feeler 7778z
configured to lock the grip/lever
7411z against the body 7415z so as to lock the rigidizing device 7400 in the
rigid configuration.
Similarly, when the grip/lever 7411z is pushed against the body again, the
grip/lever 7411 can be
released, and the fluid can move back into the fluid chamber 7412z via inlet
7493.
[0364] In some embodiments, the handle 7431 can further
include a pressure relief valve 7417z
between the chamber 7412z and an overflow chamber 7418z. When the pressure in
the fluid chamber
7412z reaches a predetermined maximum pressure (e.g., 5atm), the pressure
relief valve 7417z can open
to allow fluid to be channeled into the overflow chamber 7418z. The fluid
chamber 7412z can be
overfilled during manufacturing such that the valve 7417 always opens upon the
first activation of the
grip/lever 7411z, which can ensure calibration of the handle 7431 to the
desired pressure. One exemplary
method of filling the fluid chamber 7412z can include: (1) attaching the
handle 7431 to a filling fitting
that attaches to a tube leading to the pressure system; (2) drawing a vacuum
on the handle to remove air
through that filling fitting; (3) while maintaining vacuum, introducing water,
DI, Saline, an oil or another
incompressible fluid into the system through the filling fitting; and (4)
crimping and sealing the tube (via
a mechanical crimp, via melting the tube, etc.) distal to the pressure fitting
and then removing the
pressure fitting, leaving the crimped/sealed tube in the handle.
[0365] Any of the handles described herein can have a
pressure indicating feature built in. For
instance, the handles may have a pressure gauge. The handles may include a
feature, such as a piston, that
is displaced to give a visual indication that the device is pressurized. The
handles may have a feature that
flips or turns such that it displays a different color; for instance, it may
display a green dot at atmospheric
pressure and red dot when rigidized. In some embodiments, the visual
indication can be seen on
fluoroscopy.
[0366] Any of the pressure rigidizing handles described may have an
emergency venting feature if,
for some reason, the handle passageways became clogged. The emergency venting
feature can, for
example, allow for incising of the device, thereby breaking its pressure
cavity. The emergency venting
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feature can, for example, be a valve distal to the handle (for example, a
swabable valve), such that should
the valve be actuated, the device would vent pressure and therefore de-
rigidiza
[0367] Any of the rigidizing devices described herein can
include built-in cameras, lighting, etc. to
provide for on-board imaging. In some embodiments (and as shown below in
Figure 63), the cameras and
lighting can be positioned at the distal tip of the device. In other
embodiments, and as shown in Figure
59, a rigidizing device 8200 can include a camera 8234z and lighting 8235z
mounted on the elongate
body 8203z proximal to the distal end 8202z of the device (e.g., proximal to
steering linkages 8204z).
[0368] In some embodiments, the rigidizing devices
described herein can be configured as an
introducer (i.e., an instrument for introduction of a flexible device, such as
an introducer sheath for
interventional cardiology). For example, referring to Figure 60, a rigidizing
device 8700 can include a
rigidizing elongate body 8703z with a tapered distal tip 8733z. The device
8700 can further include a
hemostatic valve 8749z and/or a flush line 8748z.
[0369] The braid described herein can include or be
replaced by a mesh, a woven material, a ribbon
or a cloth. In some embodiments, the braid can be non-woven (La, fibers at
different angles may not go
over and under each other but instead be on separate layers that do not cross
each other). Similarly, the
braid can be replaced by a stent or a structure (e.g., metal structure) cut
from a hypodermic tube.
[0370] In some embodiments, the rigidizing devices
described herein can be configured to be loaded
over the side of the scope or other instrument (e.g., rather than requiring
insertion of the scope/instrument
into the proximal end of the rigidizing device). For example, as shown in
Figures 61A-61B, the
rigidizing device 400 can be split along the length thereof (i.e., split
longitudinally through the wall from
the proximal end to the distal end). Further, a connection feature 444 can
connect the split wall together.
In some embodiments, the connection feature 444 can be reusable. For example,
the connection feature
444 can be a series of magnets that can engage (Figure 61A) to hold the
rigidizing device 400 together
and disengage (Figure 61B) to provide side access for the scope/instrument.
Other exemplary reusable
connection features include zippers, interlocking zip-lock male and female
configuration, or reusable
tape. In some embodiments, the connection feature 444 can be permanent and not
reusable, such as
permanent tape or adhesive.
[0371] In some embodiments, the vacuum and pressure multi-
layered systems described herein can
be used to create stiffness for non-cylindrical or non-tubular structures. For
example, the systems
described herein could be used to create a balloon that assumes the desired
shape when pressurized and/or
rigidized. Such a structure can be a flexible structure that nevertheless
contains elements that exhibit high
hoop stiffness, such as wire (tension or compression) or thin fiber strands
(tension).
[0372] In some embodiments, the rigidizing devices
described herein can include proximal and distal
seals within the innermost layer to create a space between the scope or
instrument and the innermost layer
to hold lubrication.
[0373] In some embodiments, the rigidizing devices
described herein can be used in conjunction
with other versions of the product. For example, an endoscope can include the
rigidizing mechanisms
described herein, and a rigidizing device can include the rigidizing
mechanisms described herein. Used
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together, they can create a nested system that can advance, one after the
other, allowing one of the
elements to always remain stiffened, such that looping is reduced or
eliminated (i.e., they can create a
sequentially advancing nested system).
[0374] An exemplary nested system 2300z is shown in
Figure 62. The system 2300z can include an
outer rigidizing device 2300 and an inner rigidizing device 2310 (here,
configured as a rigidizing scope)
that are axially movable with respect to one another either concentrically or
non-concentrically. The
outer rigidizing device 2300 and the inner rigidizing device 2310 can include
any of the rigidizing
features as described herein. For example, the outer rigidizing device 2300
can include an outermost
layer 2301a, a braided layer 2309a, and an inner layer 2315a including a coil
wound therethrough. The
outer rigidizing device 2300 can be, for example, configured to receive vacuum
between the outermost
layer 2301a and the inner layer 2315a to provide rigidization. Similarly, the
inner scope 2310 can include
an outer layer 230 lb (e.g., with a coil wound therethrough), a braid layer
2309b, a bladder layer 2321b,
and an inner layer 2315b (e.g., with a coil wound therethrough). The inner
scope 2310 can be, for
example, configured to receive pressure between the bladder 2321 b and the
inner layer 2315b to provide
rigidization. Further, an air/water channel 2336z and a working channel 2355
can extend through the
inner rigidizing device 2310. Additionally, the inner rigidizing scope 2310
can include a distal section
2302z with a camera 2334z, lights 2335z, and steerable linkages 2304z. A cover
2327z can extend over
the distal section 2302z. In another embodiment, the camera and/or lighting
can be delivered in a
separate assembly (e.g., the camera and lighting can be bundled together in a
catheter and delivered down
the working channel 2355 and/or an additional working channel to the
distalmost end 2333z).
[0375] An interface 2337z can be positioned between the
inner rigidizing device 2310 and the outer
rigidizing device 2300. The interface 2337z can be a gap, for example, having
a dimension d (see Figure
62) of 0.001"-0.050", such as 0.0020", 0.005", or 0.020" thick. In some
embodiments, the interface
2337z can be low friction and include, for example, powder, coatings, or
laminations to reduce the
friction. In some embodiments, there can be seals between the inner rigidizing
device 2310 and outer
rigidizing device 2300, and the intervening space can be pressurized, for
example, with fluid or water, to
create a hydrostatic bearing. In other embodiments, there can be seals between
the inner rigidizing device
2310 and outer rigidizing device 2300, and the intervening space can be filled
with small spheres to
reduce friction.
[0376] The inner rigidizing device 2310 and outer rigidizing device 2300
can move relative to one
another and alternately rigidize so as to transfer a bend or shape down the
length of the nested system
2300z. For example, the inner device 2310 can be inserted into a lumen and
bent or steered into the
desired shape. Pressure can be applied to the inner rigidizing device 2310 to
cause the braid elements to
engage and lock the inner rigidizing device 2310 in the configuration. The
rigidizing device (for instance,
in a flexible state) 2300 can then be advanced over the rigid inner device
2310. When the outer rigidizing
device 2300 reaches the tip of the inner device 2310, vacuum can be applied to
the rigidizing device 2300
to cause the layers to engage and lock to fix the shape of the rigidizing
device. The inner device 2310 can
be transitioned to a flexible state, advanced, and the process repeated_
Although the system 2300z is
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described as including a rigidizing device and an inner device configured as a
scope, it should be
understood that other configurations are possible. For example, the system
might include two overtubes,
two catheters, or a combination of overtube, catheter, and scope.
[0377] Figure 63 shows another exemplary nested system
2700z. System 2700z is similar to system
2300z except that it includes a cover 2738z attached to both the inner and
outer rigidizing device 2710,
2700. The cover 2738z may be, for example, low-durometer and thin-walled to
allow elasticity and
stretching. The cover 2738z may be a rubber, such as urethane, latex, or
silicone. The cover 2738z may
protect the interface / radial gap between the inner and outer devices 2710,
2700. The cover 2738z may
prevent contamination from entering the space between the inner and outer
tubes. The cover 2738z may
further prevent tissue and other substances from becoming trapped in the space
between the inner and
outer tubes. The cover 2738z may stretch to allow the inner device 2710 and
outer device 2700 to travel
independently of one another within the elastic limits of the material. The
cover 2738z may be bonded or
attached to the rigidizing devices 2710, 2700 in such a way that the cover
27381 is always at a minimum
slightly stretched. This embodiment may be wiped down externally for cleaning.
In some embodiments,
the cover 2738z can be configured as a "rolling" seal, such as disclosed in
US6447491, the entire
disclosure of which is incorporated by reference herein.
[0378] Figures 64A-64B show another exemplary nested
system 9400z. In this system 9400z, the
outer rigidizing device 9400 includes steering and imaging (e.g., similar to a
scope) while the inner device
includes only rigidization (though it could include additional steering
elements as described elsewhere
herein). Thus, outer device 9400 includes linkages or other steering means
disclosed herein 9404z,
camera 9434z, and lighting 9435z. The outer device 9400 can further include a
central passageway 9439z
for access to the inner device 9410 (e.g., lumens such as working channels
therein). In some
embodiments, bellows or a loop of tubing can connect the passageway 9439z to
lumens of the inner
device 9410_ Similar to the other nested systems, at least one of the devices
9410, 9400 can be rigidized
at a time while the other can conform to the rigidization and/or move through
the anatomy. Here, the
outer device 9400 can lead the inner device 9410 (the inner device 9410 is
shown retracted relative to the
outer device 9400 in Figure 64A and extended substantially even with the outer
device 9400 in Figure
MB). Advantageously, system 9400z can provide a smooth exterior surface to
avoid pinching the
anatomy and/or entrance of fluid between the inner and outer devices 9410,
9400. Having the steering on
the outer device 9400 can also provide additional leverage for steering the
tip. Also, the outer device can
facilitate better imaging capabilities due to the larger diameter of the outer
device 9400 and its ability to
accommodate a larger camera.
[0379] Figures 65A-65H show the exemplary use of a nested
system 2400z as described herein. At
Figure 65A, the inner rigidizing device 2410 is positioned within the outer
rigidizing device 2400 such
that the distal end of the inner rigidizing device 2410 extends outside of the
outer rigidizing device 2400.
At Figure 65B, the distal end of the inner rigidizing device 2410 is bent in
the desired
direction/orientation and then rigidized (e.g., using vacuum or pressure as
described herein). At Figure
65C, the outer rigidizing device 2400 (in the flexible configuration) is
advanced over the rigidized inner
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rigidizing device 2410 (including over the bending distal section). Once the
distal end of the outer
rigidizing device 2400 is sufficiently advanced over the distal end of the
inner rigidizing device 2410,
then the outer rigidizing device 2400 can be rigidized (e.g., using vacuum or
pressure as described
herein). At Figure 65D, the inner rigidizing device 2410 can then be
transitioned to the flexible state
(e.g., by removing the vacuum or pressure as described herein and by allowing
the steering cables to go
slack such that tip can move easily) and can be advanced and
directed/oriented/steered as desired.
Alternately, in Figure 65D, the inner rigidizing device 2410 can be actively
steered (either manually or
via computational control) as it emerges such that is minimizes the load on
the rigidized outer tube.
Minimizing the load on the outer rigidizing device 2400 makes it easier for
this tube to hold the rigidized
shape. Once the inner rigidizing device 2410 is rigidized, the outer
rigidizing device 2400 can be
transitioned to the flexible state and advanced thereover (as shown in Figure
65E). The process can then
be repeated as shown in Figures 65F-H.
[0380] In some embodiments, at the completion of the
sequence shown in Figures 65A-H, a third
rigidizing device can be slid over the first two rigidizing devices (2400,
2410) and rigidized. Rigidizing
devices 2400 and 2410 can then be withdrawn. Finally, a fourth rigidizing
device can be inserted through
the inner lumen of the third tube. This fourth rigidizing device may have a
larger diameter and more
features than rigidizing device 2410. For instance, it may have a larger
working channel, more working
channels, a better camera, or combinations thereof. This technique can allow
two smaller tubes, which
tend to be more flexible and maneuverable, to reach deep into the body while
still ultimately deliver a
larger tube for therapeutic purposes. Alternately, in the example above, the
fourth rigidizing device can be
a regular endoscope as is known in the art.
[0381] In some embodiments, at the completion of the
sequence shown in Figures 65A-H, outer
rigidizing device 2400 may be rigidized and then the inner rigidizing device
2410 may be removed. For
example, the rigidizing device 2410 may be a "navigation" device comprising a
camera, lighting and a
distal steering section. The "navigation" device 2410 may be well, sealed such
that it is easy to clean
between procedures. A second inner device may then be placed inside the
rigidized outer device 2400 and
advanced past the distal end of the outer device 2400. The second inner device
may be a "therapeutic"
tube comprising such elements as a camera, lights, water, suction and various
tools. The "therapeutic"
device may not have a steering section or the ability to rigidize, thereby
giving additional room in the
body of the therapeutic tube for the inclusion of other features, for example,
tools for performing
therapies. Once in place, the tools on the "therapeutic" tube may be used to
perform a therapy in the body,
such as, for example, a mucosa' resection or dissection in the human GI tract.
[0382] In another embodiment, after or during the
completion of the sequence shown in Figures
65A-H, a third device may be inserted inside inner tube 2410. The third device
may be rigidizing and/or
an endoscope.
[0383] Although the outer rigidizing device for the
nested systems described herein is often referred
to as rigidizing via vacuum and the inner scope rigidizing device as
rigidizing via pressure, the opposite
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can be true (La, the outer rigidizing device can rigidize via pressure and the
inner rigidizing device via
vacuum) and/or both can have the same rigidizing source (pressure and/or
vacuum).
[0384] Although the inner and outer elements of the
nested systems are generally described as
including integrated rigidizing elements, the rigidizing elements can be
separate (e.g., so as to allow
relative sliding between the imaging scope elements and the rigidizing
elements).
[0385] The rigidizing devices of the nested systems
described herein can be designed such that inner
rigidizing device can't rotate substantially within outer rigidizing device
when they are assembled. For
instance, the outer surface of the inner rigidizing device can have
longitudinal ridges and grooves that
form a spline. The inner surface of the outer rigidizing device can have
corresponding ridges and grooves
that mate with the same features in the outer rigidizing device.
[0386] Either or both of the rigidizing devices of the
nested systems described herein can be
steerable. If both rigidizing devices are steerable, an algorithm can be
implemented that steers whichever
rigidizing device is flexible and moving longitudinally. The algorithm can
steer the flexible rigidizing
device to anticipate the shape of the rigidized device thus minimizing the
tendency for the moving,
flexible rigidizing device to straighten the rigid device.
[0387] If one rigidizing device of the nested systems
described herein requires vacuum and the other
rigidizing device requires pressure, user controls can be constructed in which
moving one vs. the other
(outer and inner) involves flipping a switch, with the switch toggling between
a fffst condition in which,
for example, one is pressurized for rigidity when the other is vented for
flexibility and a second condition
in which one is vented for flexibility and the other is vacuumed for
stiffness. This, for example, could be
a foot pedal or a hand switch.
[0388] In some embodiments, the alternate movement of the
nested systems described herein can be
controlled manually. In other embodiments, the alternate movement can be
controlled automatically, via
a computer and/or with a motorized motion control system.
[0389] The nested systems described herein can advantageously be of
similar stiffness. This can
ensure that the total stiffnesses of the nested system is relatively
continuous. The nested systems
described herein can be small so as to fit in a variety of different
anatomies. For example, for neurology
applications, the outside diameter of the system can be between 0.05"-0.15",
such as approximately 0.1".
For cardiology applications, the outside diameter of the system can be between
0.1"-0.3", such as
approximately 0.2". For gastrointestinal applications, the outside diameter of
the system can be between
0.3"-1.0", such as 0.8". Further, the nested systems described herein can
maintain high stiffness even at a
small profile. For example, the change in relative stiffness from the flexible
configuration to the rigid
configuration can be multiples of 10x, 20x, 30x, and even larger.
Additionally, the nested systems
described herein can advantageously move smoothly relative to one another.
[0390] The nested systems described herein can advantageously navigate an
arbitrary path, or an
open, complex, or tortuous space, and create a range of free-standing complex
shapes. The nested
systems can further advantageously provide shape propagation, allowing for
shape memory to be
imparted from one element to another. In some embodiments, periodically, both
tubes can be placed in a
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partially or fully flexible state such that, for instance, the radii or
curvature of the system increases, and
the surrounding anatomy provides support to the system. The pressure or vacuum
being used to rigidize
the tubes can be reduced or stopped to place the tubes in a partially or fully
flexible state. This
momentary relaxation (for instance, for 1-10 seconds) may allow the system to
find a shape that more
closely matches the anatomy it is travelling through. For instance, in the
colon, this relaxation may gently
open tight turns in the anatomy.
[0391] In some embodiments, the stiffness capabilities of
the inner or outer rigidizing devices may
be designed such that tight turns formed by the inner rigidizing device at its
tip, when copied by the outer
rigidizing device, are gradually opened up (made to have a larger radius) as
the shape propagates
proximally down the outer tube. For instance, the outer rigidizing device may
be designed to have a
higher minimum radius of curvature when rigidized.
[0392] The nested systems are continuous (i.e., non-
segmented) and therefor provide smooth and
continuous movement through the body (e.g., the intestines). The nested
systems can be disposable and
low-cost.
[0393] In some embodiments, the outer rigidizing device can be a
dynamically rigidizing overtube
(e.g., as described in PCT/US18/42946, the entirety of which is incorporated
by reference herein). In
some embodiments, the inner rigidizing device can be a rigidizing system or a
commercially available
scope, for example a 5 mm diameter nasal scope. Utilizing rigidization and a
nested system enables the
utilization of a smaller scope that delivers, compared to a duodenoscope, more
flexibility if desired, more
stiffness if desired, enhanced maneuverability, and the ability to articulate
at a much smaller radius of
curvature_
[0394] In some embodiments, upon reaching the target
destination, the inner rigidizing device of a
nested system can be withdrawn. The outer rigidizing device can remain
rigidized and contrast can be
injected through the inner element's space to fluoroscopically image.
[0395] RF coils can be used in any of the nested systems described herein
to provide a 3-D
representation of whatever shape the nested system takes. That representation
can be used to re-create a
shape or return to a given point (e.g., for reexamination by the doctor after
an automated colonoscopy).
[0396] In some embodiments, the nested systems described
herein can be useful as a complete
endoscope, with the internal structure carrying the payload of working
channels, pressurization lines,
vacuum lines, tip wash, and electronics for lighting and imaging (vision
systems, ultrasound, x-ray, MM).
[0397] The nested systems described herein can be used,
for example, for colonoscopy. Such a
colonoscopy nested system can reduce or eliminate looping. It could eliminate
the need for endoseopic
reduction. Without looping, the procedure can combine the speed and low cost
of a sigmoidoscopy with
the efficacy of a colonoscopy. Additionally, colonoscopy nested systems can
eliminate conscious
sedation and its associated costs, time, risks, and facility requirements.
Further, procedural skill can be
markedly reduced for such colonoscopy procedures by using the nested systems
described herein. Further,
in some embodiments, the nested systems described herein can provide automated
colonoscopy, wherein
a vision system automatically drives the nested system down the center of the
colon while looking for
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polyps. Such an automated system would advantageously not require sedation nor
a doctor for the basic
exam while allowing the doctor to follow up for further examination if
required.
[0398] In some embodiments, the rigidizing devices (e.g.,
nested systems) described herein can be
robotically controlled. Figures 93A-93D show an exemplary use of a nested
system 9300z, like that
shown in Figures 65A-65H, that can be robotically controlled or manipulated
(e.g., for rigidization,
steering, movement, etc.). As shown in Figures 93A-93D, the outer rigidizing
device 9300 and the inner
rigidizing device 9310 may be terminated together into a common structure,
such as a cassette 9357. The
outer rigidizing device 9300 can be movable with respect to the inner
rigidizing device 9310 by rotation
of a disk 9389 that is mounted to the cassette 9357. For example, the disk
9389 can be a pillion, and the
outer rigidizing device 9300 may have a rack 9382 including a plurality of
small teeth on the outside
thereof. Rotating the disk 9389 against teeth 9382 may cause outer rigidizing
device 9300 to advance
forward or backward relative to the inner rigidizing device 9310. In some
embodiments, the possible
movement or translation of the rigidizing devices 9300, 9310 is limited by the
size or design of the
cassette 9357.
[0399] The cassette 9357 can further include additional disks 9371a, 937
lb that may connect to
cables 9363a,b respectively, to steer (e.g., bend or deflect) the tip of the
inner rigidizing device 9310
(and/or outer rigidizing device 9300). Other steering mechanisms (e.g.,
pneumatics, hydraulics, shape
memory alloys, EAP (electro-active polymers), or motors) are also possible.
Again, in embodiments with
different steering mechanisms, one or more disks in the cassette 9357 (e.g.,
disks 9371a, 9371b) may be
used to actuate the steering.
[0400] The cassette 9357 can further include bellows
9303a, 93036 that may connect to the pressure
gap of the inner rigidizing device 9310 and the outer rigidizing device 9300,
respectively. Compressing
bellows 9303a, 93036 may drive fluid through pressure lines 9305z, causing the
pressure in the pressure
gap of the inner rigidizing devices 9310, 9300 to rise, causing the rigidizing
devices 9310, 9300 to
become rigid. Activation of the bellows 9303a, 9303b may be applied
sequentially and/or
simultaneously. As shown in Figures 93A-93D, the cassette 9357 can include
eccentric cams 9374a,b to
control bellows 9303a,b. Alternatively, as shown in Figure 94A, one or more
linear actuators 9316y (e.g.,
on cassette 9357 or on drive unit 9517y) can be configured to actuate the
bellows 9303a,b. As another
alternative, the devices 9300, 9310 can be rigidized and de-rigidized through
one or more sumps (as
described herein) or pressure sources 9306z (e.g., via pressure line 9305z),
as shown in Figure 948.
Other mechanisms causing rigidization of the inner and outer rigidizing
devices 9310, 9300 are also
possible. For example, in some embodiments, cassette 9357 can include a
syringe or other container
comprising a fluid that can be delivered to the inner and outer rigidizing
devices 9310, 9300 to add
pressure for rigidization. In some embodiments, a syringe or other container
can be used to draw fluid
within the cassette 9357, creating a vacuum that can be applied to the inner
and outer rigidizing devices
9310, 9300.
[0401] Referring back to Figures 93A-93D, the cassette
9357 can include a connector 9315y for
connecting to additional lumens and/or wiring in the inner rigidizing device
9310. The connector 9315y
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may include a connection for the delivery of both suction and water to the tip
of the inner rigidizing
device 9310. The connector 9315y may include electrical connector to connect
to a camera mounted to
the tip of inner rigidizing device 9310 to an external monitor and/or video
processing unit. The connector
9315y may include a mechanical connector that connects to a hollow tube (e.g.,
working channel) leading
all the way to the tip of the inner rigidizing device 9310. By including the
connector 9315y, the control of
all components of the system 9300z can be performed with the cassette 9357.
[0402] Disks 9389, 9371a, 9371b and cams 9374a, 9374b (or
the corresponding bellows) may be
accessible from the bottom of the cassette 9357, as best shown in the side
perspective view of Figure 93B.
Disks 9389, 9371a, 9371 b and/or cams 9374a, 9374b may have features, such as
splines, pins or teeth, to
transmit torque. These features can allow the disks 9389, 9371a, 9371b and/or
cams 9374a, 9374b to be
manipulated (e.g., by a drive unit).
[04413] Figure 95 shows an exemplary a drive unit 9517y
that may be used to drive the disks 9389,
9371a, 9371b and/or cams 9374a, 9374b. For example, the drive unit 9517y can
include drive paddles
9519y that may align with disks 9389, 9371a, 9371b and/or cams 9374a, 9374b of
the cassette 9357. The
drive paddles 9519y can be driven (i.e., rotated) by one or more motors of the
drive unit 9517y so as to
deliver torque to the disks 9389, 9371a, 937 lb and/or cams 9374a, 9374b of
the cassette 9357. The drive
paddles 9519y can includes features 9518y (e.g., splines, pins, teeth, or the
like) to transmit torque to the
disks 9389, 9371a, 937 lb and/or cams 9374a, 9374b of the cassette 9357. The
drive unit 9517y may
attach to the cassette 9357, for example, with clips, screws, or magnets.
[04414] Referring to Figure 96, in some embodiments, a robotically
controlled nested system as
described herein (e.g., system 9300z) can include a guide 9621y extending
along the outer diameter of the
outer rigidizing device 9600 to allow the advancement of tools, such as
surgical or laparoscopic tools,
therethrough. That is, the guide 9621y can allow a tool to be guided along the
outside of the outer
rigidizing device 9600 until the distal end of the tool advances distally past
the distal end of the outer
rigidizing device 9600. The guide 9621y may be, for example, a series of
atraumatic rings 9622y. The
rings 9622y may be spaced apart from each other along the longitudinal axis
such they do not touch each
other even when the outer rigidizing device 9600 is deflected to its maximum
bend radius. In some
embodiments, the rings 9622y can have an inner diameter of about 2-9 mm.
[04415] Referring to Figures 97A-97B, the guide 9721y can
be, for example, a layflat tube that is
adhered along one side to the outer rigidizing device 9700. In a first
configuration (shown in Figure
97A), the layflat tube guide 9721y can be flat against the outside of the
outer rigidizing device 9700. In a
second configuration, the guide 9721y can be can be expanded to its tubular
shape. The inner diameter of
the guide 9721y can be, for example, between 2nun and 9mm. The layflat tube
guide 9721y may assume
the second configuration, for example, when a tool is passed through the
layflat tube guide 9721y. The
layflat tube guide 9721y may have a series of perforations along its length to
allow a tool to be inserted
into the lumen of the tube guide 9721y at any perforation along the length of
the rigidizing device 9700.
In another embodiment, the guide can be a series of telescoping rigidizing
devices, shaped like a bellows
or combinations thereof.
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[0406] In some embodiments, the robotically controlled nesting system can
include more than one guide
so as to provide for differing placement and/or the use of multiple tools. For
example, as shown in Figure
98, an outer rigidizing device 9800 can include two guides 9821y on opposite
sides thereof The guides
9821y can comprise the same or a different design. More than two guides and
associated tools are also
possible. In some embodiments, guides may be located within the volume of
inner rigidizing device (e.g.,
rigidizing device 9310).
[0407] As is further shown in Figure 98, in some
embodiments, the robotically controlled nesting
system can include a fitting 9823y at the distal end thereof. The guide(s)
9821y can terminate in fitting
9823y at port(s) 9824y (or if rings are used for the fitting, the rings may
align concentrically with port
9824-y when the outer rigidizing device 9800 is in the straight
configuration). When a tool is passed
through a guide 9821y, it can also pass through the corresponding port 9824y
and, in some embodiments,
lock to the port 9824y. In some embodiments, two, three or more tools maybe
locked into fitting 9823y.
Further, in some embodiments, the fitting 9823y can include additional ports
that may connect to
additional tubular structures to provide suction, water, imaging and/or an
additional tool channel. These
additional tubular structures may extend proximally to or past the cassette
(e.g., cassette 9357). In some
embodiments, these additional tubular structures may be omitted from the
inside of inner rigidizing
device 9310 due to their incorporation into the fitting 9823y. In some
embodiments, the fitting 9823y can
be permanently attached the outer rigidizing device 9800 but temporarily
attached to the inner rigidizing
device (e.g., rigidizing device 9310) for use during a particular procedure.
The fitting 9823y can include
a disposable sheath attached thereto. The disposable sheath may be, for
instance, a thin plastic rigidizing
device, such as an inexpensive layflat rigidizing device. The disposable
sheath may cover the inner
rigidizing device (e.g., device 9310) and the outer rigidizing device 9800 and
connect to the cassette (e.g.,
cassette 9357). The disposable sheath may include tubular structures that
provide features such as suction,
water and an additional tool channel as described herein. In some embodiments,
the fitting 9823y may be
configured to rotate about the outer rigidizing device 9800. For instance, a
Bowden cable may be fitted
external to outer rigidizing device 9800 and terminated at the distal end in
the fitting 9823y and at the
proximal end of the rigidizing device, such as in the handle. Rotating the
Bowden cable may impart a
torque in fitting 9823y, causing the fitting 9823y to rotate. The fitting
9823y may have a limited range of
motion; for instance, +1-90 degrees or +/-60 degrees.
[0408] An exemplary tool 9980 for use with a robotic nested system (e.g.,
system 9300z) is shown in
Figure 99. The tool 9980 can include a cassette 9925y, a flexible shaft 9926y,
a bending section 9927y
and an end effector 9928y (e.g., forceps, a grasper, or scissors). The
cassette 9925y, like the nested
system cassette (e.g., cassette 9357) may have disks that can be rotated to
control aspects of the tool 9980.
For instance, rotating a disk may cause the bending section 9927y to deflect.
Another disk may be used
to control the end effector 9928y. Additionally, the tool 9980 can include a
locking feature 9929y
configured to engage with a fitting port (e.g., port 9824y) to lock the tool
9980 in place relative to the
outer rigidizing device (e.g., rigidizing device 9800). The locking feature
9929y can include, for
example, a spring pin configured to engage a corresponding slot or hole on the
end fitting 3060. Other
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locking mechanisms are also possible (e.g., magnetic lock, electronic lock,
twist lock, breach lock,
bayonet lock, and the like).
[0409] In one exemplary use, when tool 9980 is inserted
into guide 9821y, it can be moved distally
until it passes through the port 9824y and the locking feature 9929y is
aligned with the inside diameter of
port 9824y. In some embodiments, a control on the tool 9980 can be reversibly
engaged to longitudinally
lock tool 9980 with end fitting 9823y. Alternately, the tool 9980 may
automatically lock into place in
fitting 9923y. Except for the lock at fitting 9823y, the tool 9980 may be
otherwise loosely held or float
longitudinally in guide 9821y.
[0410] Referring to Figure 100 and back to Figures 93A-
93D, in some embodiments, the robotic
system (e.g., system 9300z including the inner and outer rigidizing devices
9310, 9300 and cassette 9357)
may be positioned on a linear slide 10020y. The linear slide 10020y can
further include a drive unit
10017y (similar to drive unit 9517y) configured to control the inner and outer
rigidizing devices 9310,
9300. The slide 10020y can allow the inner and outer rigidizing devices 9310,
9300 to be translated
together (i.e., simultaneously). In some embodiments, in order to effect
relative movement between of
the inner rigidizing device 9310 with respect to the outer rigidizing device
9300, the system 9300z can be
translated in a first direction (forwards or backwards along the slide 10020y)
while simultaneously using
the disk 9389 and rack 9382 on the outer rigidizing device 9300 to move the
outer rigidizing device 9300
in a second direction, opposite to the first direction. That is, to advance
the inner rigidizing device 9310
relative to the outer rigidizing device 9300, the system 9300z including both
rigidizing devices 9300,
9310 is advanced along the slide 10020y while simultaneously retracting the
outer rigidizing device 9300
using the disk 9389 and rack 9382. Conversely, to retract the inner rigidizing
device 9310 relative to the
outer rigidizing device 9300, the system 9300z including both rigidizing
devices 9300, 9310 can be
retracted along the slide 10020y while simultaneously advancing the outer
rigidizing device 9300.
[0411] Referring to Figure 100, the linear slide 10020y
can further include a second drive unit
10030y configured to control a tool or tools (e.g., tool 9980) used with the
inner and outer rigidizing
devices. In some embodiments, the first drive unit 10017y and the second drive
unit 10030y can
independently translate along linear slide 10020y. One, two or more tools 9980
may attach to drive unit
10030Y. The linear slide 10020y can advantageously ensure that the tool(s)
used with the nested
rigidizing system stay in place at the distal end of the outer rigidizing
device despite any translation by
the outer rigidizing device. For example, the tool drive unit 10030y can be
configured to translate the
tool forward when the outer rigidizing device advances relative to the slide
10020y. Similarly, the tool
drive unit 10030y can be configured to retract the tool when the outer
rigidizing device retracts relative to
the slide 10020y. This may ensure, for example, that the tool stays locked
into the fitting (e.g., fitting
9823y).
[0412] Figures 101A and 101B show top perspective and top views,
respectively, of an exemplary
robotic system 10100z positioned on a slide 10120y with cassette 10157
attached to a drive unit 10117y
for control of the nested rigidizing devices 10100, 10110. Two cassettes
10125y for the control of two
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different tools 10180, are mounted to drive unit 10130y. The tools 10180 are
inserted through guide
10121y and locked in fitting 10123y at ports 10124y.
[0413] Figure 102 shows an exemplary pivoting arm 10231y
that can be connected to the linear slide
10120y so as to orient the slide 10120y and thus the rest of the robotic
system (including nested rigidizing
devices 10100, 10110 and/or tools 10180) relative to the patient As such, the
linear slide 10120y may be
positioned vertically, horizontally or at an angle in between.
[0414] The system 10100z may be used in the following
exemplary manner_ Cassette 10157 is
attached to the inner and outer rigidizing devices 10110, 10100, and the inner
and outer rigidizing devices
10110, 10100 are advanced into the patient's body (e.g., as detailed in
Figures 65A-H). In some
embodiments, the inner and outer rigidizing devices 10110, 10100 are advanced
into the patient's colon
or upper GI tract. Reciprocating motion of the inner rigidizing device 10110
and outer rigidizing device
10100 is provided by the motion of disk a disk within the cassette 10157 and
the translation of the
rigidizing devices 10110, 10100 along the slider 10120y_ Rigidization is
provided by compressing
bellows in cassette 10157. Steering is provided by disks in cassette 10157.
When a medical practitioner
has reached the place in the body where the procedure is to be performed, a
tool can be inserted through
guide 10121y and locked to ports 10124y. The cassettes 10125y are then
attached to drive unit 10130y for
control of the tool.
[0415] The drive units described herein may be connected
to a computer (e.g., computer, tablet,
laptop, etc.) for control. The computer in communication with the drive units
may comprise software
providing a user interface for a clinician to interact with to control the
system and any tools being used.
Automation, such as via computer controls of the cassettes and/or drive units
described herein, can be
used to make repetitive tasks easier to perform. For instance, a program can
be developed that
automatically moves the distal end of the rigidizing device in an arc while
emitting water. A second arc
can then be made to suction water and material from the GI tract. This may be
useful in cleaning the GI
tract. A program can be developed to perform the rigidization steps outlined
herein in sequence such that
the operator needs only to provide input, with, for example, a joystick, to
direct the distal end of the
device.
[0416] In some embodiments, the inner rigidizing device
and the outer rigidizing device may be
advanced by the robotic system described herein using small steps (e.g., less
than 1 inch steps). Small
steps may advantageously allow for more precise control of the placement and
orientation of the
rigidizing devices_ For example, the user may steer the inner tube in the
desired direction and, as the
inner tube advances ahead of the outer tube by a small amount (for instance,
1/2, 3/4 or just under 1 inch),
the sequence of rigidization and advancement or retraction of the outer tube
can be triggered
automatically. In some embodiments, the present sequence of small steps can be
overridden when
desired. In some embodiments, the inner rigidizing device and outer rigidizing
device may be advanced
by the robotic system using medium steps (e.g., 1-3 inch steps) or large steps
(e.g., greater than 3 inch
steps).
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[0417] The cassettes and/or tools described herein may be
disposable or reusable or used and cleaned
for a limited number of cycles.
[0418] The linear slides described herein can, in some
embodiments, be U-shaped with a
corresponding U-shaped tact. Alternatively, the linear slides can, in some
embodiments, be circular with
a corresponding circular shaped tract.
[0419] In some embodiments, the tip of the outer
rigidizing device can include one or more cameras
to view the end effector of the tool used with a robotic system. This can
allow a controller of the robotic
system to calculate the relation between the control inputs and effector
outputs and adjust accordingly to
give the same effector motion regardless of the tooth path (e.g., regardless
of drag placed on the tool
control cables during bending).
[0420] In some embodiments, the nested rigidizing devices
can include one or more expansive
member (e.g., cage or balloon) on the distal end thereof. Exemplary expansive
members are described in
PCT/US2017/047591 and PCT/US2019/034881, the entireties of which are
incorporated by reference
herein. The expansive member can help center the rigidizing devices for
simplified relative motion and
also move tissue away from any camera lenses. In some embodiments, the
expansive member can be
expanded when the rigidizing device to which it is attached is stationary and
decreased in size or
collapsed when the rigidizing device to which it is attached is moving. In
other embodiments, the
expansive member can remain expanded throughout the procedure.
[0421] In some embodiments, a rigidizing device as
described herein can be configured as a
rigidizing rod. Referring to Figure 66, the rod 4900 can include an outer
layer 4901, a braid layer 4909,
and an inner bladder layer 4921. Further, the gap 4912 within the bladder
layer can be sealed and filled,
for example, with air or water (e.g., to push the bladder layer 4921 radially
outwards). The outer layer
4901 can be a wire-reinforced layer, such as a coil reinforced urethane tube.
The braid layer 4901 can
include braided strands 4933 and can include any of the features of other
braid layers described herein.
The inner bladder layer 4921 can be made of a low durometer elastomer. The rod
4900 can further
include an atraumatic tip that is soft and/or tapered_
[0422] In some embodiments, the distal end of the inner
bladder layer 4921 can be sealed to the
outer layer 4901, and the rod 4900 can include an inlet between the outer
layer 4901 and the inner bladder
layer 4921 to provide vacuum for rigidization. In other embodiments, the
distal end of the inner bladder
layer 4921 can be sealed to itself or to the atraumatic distal tip and the
proximal end can be configured to
have an inlet to the inside of the inner bladder layer 4921 (i.e., radially
inward of the inner bladder layer
4921) to provide pressure rigidization. When pressure rigidization is used,
the rod 4900 can further
include a vent on the distal and/or proximal end to allow venting of air from
between the inner bladder
layer 4921 and outer layer 4901 (thereby allowing the bladder 4921 to fully
push the braid layer 4909
against the outer layer 4901).
[0423] In some embodiments, the outer surface of the
outer layer 4901 can be coated to provide a
low friction surface including a hydrophilic coating. In some embodiments, the
outer diameter of the rod
4900 can be less than 5nun, less than 4mm, or less than 3mm. For example, the
outer diameter can be
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between 2trun and 5nun, such as between 2.5nun and 3trun, such as
approximately 2.8tmn. In some
embodiments, an angle of the braid of the braid layer 4909 can be less than 25
degrees relative to a
longitudinal axis of the tube, such as approximately 5-15 degrees. In some
embodiments, there can be
between 10 and 50 strands, such as 20-40 strands, extending within the braid
layer 4909.
[0424] Referring to Figure 67, the rod 4900 can be used, for example, as
a stiffening wire for
colonoscopy. In use as such, the colonoscope 5091 can be inserted into the
patient's colon. If looping
occurs (thereby hindering advancement of the colonoscope), the scope 5091 can
be left in place, the
working channel 5055 of the scope 5091 can be flushed, water can be applied to
the outer surface of the
rod 4900 to activate the hydrophilic coating, and the rod 4900 can be inserted
in the flexible state (i.e., un-
rigidized) through the working channel 5055. Once the rod 4900 is fully
inserted into the endoscope
such that the distal end of the rod 4900 is flush with the distal end of the
colonoscope 5091 vacuum or
pressure can be applied to the rod 4900 (e.g., via pressure inlet and/or
connector 5063z), thereby
rigidizing the rod. In some embodiments, the pressure or vacuum can be
supplied to the rod 4900 through
a syringe or locking insufflator The colonoscope 5091 can be advanced over the
rod 4900 and relative to
the patient while holding the rod 4900 stationary relative to the patient. The
vacuum or pressure can be
removed to advance or remove the rigidizing rod 4900.
[0425] Advantageously, the rod 4900 can thus be inserted
into the scope 5091 in a flexible
configuration so as to navigate around turns easily relative to a standard
stiffening wire (i.e.., relative to a
stiffening wire of fixed rigidity). Further, the rod 4900 can conform to the
shape of the looped colon in
the flexible configuration while providing a rigid track for the scope to ride
along in the rigid
configuration. Dynamic transitions of the rod 4900 between flexible and stiff
configurations can prevent
unwanted straightening of the scope 5091 (which can otherwise occur with
standard stiffening wires).
Further, the atraumatic tip of the rod 4900 can prevent damaging of the
working channel 5055. The
rigidizing rod 4900 can further be relatively long (e.g., longer than the
scope) without prohibiting
navigation of the scope because the scope moves over and along the rigidizing
rod 4900, and thus the rod
4900 can work with a variety of scopes regardless of length of the scope.
Similarly, the rod 4900 can have
a diameter of 3.2nam or less and can thus work with a variety of endoscopes
regardless of diameter (as
most endoscopes have a working channel that is 3.2mm or larger).
[0426] The rigidizing systems and devices described
herein can be used to treat or access a number
of different anatomical location&
[0427] In one method of use, during a surgical procedure,
a rigidizing device as described herein can
be introduced to the patient in the flexible configuration. Once the distal
end of the rigidizing device is
positioned past the challenging anatomy (e.g., a portion of the anatomy that
would cause looping or is
otherwise difficult to pass with a standard instrument), the rigidizing device
can be transitioned to the
rigid configuration. An instrument (e.g., a scope) can then be passed over or
through the rigid device.
[0428] For example, the devices described herein can be
used to navigate the gastrointestinal tract, to
reach anatomical locations in the stomach, for abdominal access to anatomical
locations otherwise
blocked by other organs, for interventional endoscopic procedures (including
ESD (Endoscopic
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Submucosal Dissection) and EMR (Endoscopic Mucosal Resection)), for direct
cholangioscopy, for
endoscopic retrograde eholangiopancreatography, for cardiac applications, for
resection or snaring of a
lesion in the gastrointestinal tract, for enteroscopy, for EUS, to access the
lungs, to access the kidneys, for
neuro applications, for treatment of chronic total occlusions, for
laparoscopic manual tools, for
contralateral leg access, for ear nose and throat applications, during
esophagogastroducxlenoscopy, for
transoral robotic surgery, for flexible robotic endoscopy, for natural orifice
transluminal endoscopic
surgery, or for altered anatomy cases_ Specific examples are further described
below,
[0429] Further, the rigidizing devices described herein
can have different dimensions depending
upon the desired application. For example, a rigidizing device can have an
inner diameter of
approximately 0.3"-0.8" (e.g., 0.5"), an outer diameter of 0.4"-LO" (e.g.,
0.6"), and a length of 50-200cm,
such as 75-150 cm, when designed, for example, for use in the gastrointestinal
tract. The rigidizing
device can have an inner diameter of, for example, 0.04"-0.3" (e.g., 0.2"), an
outer diameter of 0.06"-
0.4", and a length of 30-130cm when designed, for example, for use in the
cardiac vessels.
[0430] The rigidizing devices described herein can be
used as overtubes for scopes in at least three
different manners: (I) placement of the overtube after the scope has reached
the destination; (II) overtube
follows the scope closely, but remains proximal to the tip of the scope until
the scope has reached its
destination; or (III) the point and shoot method. An exemplary rigidizing
device 2000 and scope 2091 is
shown in Figures 68A-68B
[0431] For method I, the scope 2091 can be placed in the
body at the desired location using standard
technique, and then the rigidizing device 2000 can be advanced from the
proximal end until the rigidizing
device 2000 is sufficiently supporting the scope 2091_ For instance, in order
to perform a resection in the
colon, a doctor may advance a colonoscope to the target site and then advance
a rigidizing device almost
or completely to the tip of the endoscope. The rigidizing device 2000 may then
be rigidized. The rigidized
device 2000 can, for example, advantageously enhance control during resection
of a colon by providing
a stable surgical platform. The rigidized device 2000 can also advantageously
facilitate a good connection
between the doctor's hand motion of the shaft of the scope 2091 external to
the patient and motion of the
tip of the scope 2091 (so called "1 to 1" motion).
[0432] For method II, the scope 2091 may lead the
rigidizing device 2000 (for example, the distal
end of the scope 2091 and the distal end of the rigidizing device 2000 may
never approximately align)
with the rigidizing device repeatedly being switched between a flexible and
rigid state to aid advancement
of the scope. For example, when advancing the scope 2091, the rigidizing
device 2000 may be rigid,
helping to prevent scope looping and aiding in scope force transmission. Once
the scope 2091 has been
advanced, the rigidizing device may be made flexible again and advanced
distally on the scope. The
process may be repeated.
[0433] Method III may include the following steps: (1) rigidizing device
2000 can be in a flexible
state with the distal end of the rigidizing device 2000 approximately aligned
with the distal end of the
scope 2091; (2) scope 2091 can be steered with the distal end of the
rigidizing device 2000 positioned
thereover and therefore being steered by the scope 2091; (3) rigidizing device
2000 can be placed in a
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rigid state that minors the steering position of the scope 2091; (4) the
distal end of scope 2091 can be
advanced. This point and shoot method can advantageously allow the scope 2091
to be advanced in the
direction to which the tip of the scope 2091 is pointing. In some embodiments,
the steps can be repeated
to advance the rigidizing device 2000 and scope 2091 within a body cavity or
lumen.
[0434] It should be understood that methods I-III can be used in
combination with one another.
Further, in some embodiments, the rigidizing device can be steerable to
further provide direction for the
scope.
[0435] The three different manners of control can be used
in the digestive tract. For example, these
techniques may allow an endoscope 2691a to be positioned in the upper
digestive tract 2646z with a
rigidizing device 2600a as shown in Figure 69A. As another example, a
rigidizing device 2600b may be
used to position an endoscope 2691b in the lower digestive tract 2647z as
shown in Figure 698. The
described manners of control may make the positioning shown in Figures 69A and
69B easier and faster
to achieve, while minimizing risk of complications (such as GI tract
perforation) and reducing or
eliminating patient discomfort form endoscopic looping.
[0436] The rigidizing devices and systems described herein can be used
for endoscopic retrograde
cholangiopancreatography (ERCP) and/or direct cholangioscopy (DC). The goal of
endoscopic
retrograde cholangiopancreatography is to diagnose and treat disease in the
bile and pancreatic ducts. This
is most commonly performed with a side viewing duodenoscope by navigating a
guidewire into the bile
and pancreatic ducts, injecting contrast into the ducts, viewing under
fluoroscopy, and passing various
tools through the ducts over the wire. It is desirable to directly visualize
the ducts with a camera rather
than using radiation and contrast injections. By passing a small endoscope
into the bile ducts, one can
directly visualize the ducts without radiation. However, it is very difficult
to navigate such a small
endoscope through the stomach and into the bile duct as the scope will tend to
loop.
[0437] Cannulation of the bile or pancreatic duct is made
difficult due to two reasons. First, the
endoscope must be small in order to fit inside the small ducts which means it
is very flexible and buckles
inside the stomach when trying to exit the stomach. Second, the duct entrance
(papilla) is on the side of
the duodenum wall which means the endoscope must bend and advance at an angle
relative to the long
axis of the endoscope which cannot be done without a surface to deflect
against. The rigidizing devices
described herein can be used to create more optimal access and stabilization
during ERCP and DC,
including the kinematically and clinically challenging tasks of cannulating
the papilla. For example, the
devices described herein can be used both for getting to the papilla (which is
typically performed with a
duodenoscope) and to cannulate the biliary and pancreatic trees.
[0438] Referring to Figures 70A-72D, the rigidizing
devices described herein can be used for ERCP
and direct visualization of the pancreatic or bile duct (cholangioscopy) in a
variety of ways. For example,
as shown in Figures 70A-70B, a rigidizing device 8300 (which can be similar to
the rigidizing device of
Figure 25) with a steerable distal end 8302z may be used over a cholangioscope
8391. The
cholangioscope 8391 can be a flexible endoscope with a camera, lighting, and
optionally a tool channel
designed to achieve the bend radius and diameter necessary to navigate into
the bile ducts. The bend
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radius of the cholangioscope 8391 can be 0.5" with a distal tip and insertion
tube diameter of 2 mm- 6
mm. The cholangioscope 8391 can be placed inside the rigidizing device 8300,
and the rigidizing device
8300 can begin in the flexible condition. The two devices 8300, 8391 may be
navigated together through
the upper gastrointestinal tract to the duodenum 8354z (or the cholangioscope
8391 may be advanced
ahead of the rigidizing device 8300 with the rigidizing device 8300 following
it when deemed necessary
by the operator). Once in the duodenum 8354z, the rigidizing device 8300 can
be rigidized and steered to
angle the cholangioscope 8391 towards the entrance to the ducts (papilla
8355z). The rigidizing device
8300 steering can be locked in place and the cholangioscope 8391 can be
advanced towards the papilla
8355z. A guidewire 8385 can be pushed through the cholangioscope 8391 and
aimed at the entrance to
the papilla 8355z and pushed through into the bile duct 8357z or the
pancreatic duct 8356z (positioning in
the bile duct 8355z is shown in Figure 70A). As shown in Figure 70B, the
cholangioscope 8391 can be
advanced into the bile duct 8357z over the wire 8385 to achieve direct
cannulation. This rigidizing device
8300 in this method can advantageously support the small cholangioscope 8391
to keep it from buckling
in the stomach, and the steering section 8302z of the rigidizing device 8300
can advantageously deflect
the cholangioscope 8391 and direct it towards the papilla. As a result, direct
visualization can be
achieved, reducing the amount of radiation required during ERCP.
[0439] Another exemplary ERCP method is shown in Figures
71A-7113. In this embodiment, a
rigidizing device 8400 without a steerabk distal end can be used. The
cholangioscope 8491 can be used
to steer the rigidizing device 8400 while in the flexible configuration to
point the rigidizing device 8400
towards the papilla 8455z. Once pointed in the correct direction, the
rigidizing device 8400 can be
rigidized. The cholangioscope 8491 can then be advanced in the same manner as
described above with
respect to Figures 70A-70B. This method can be referred to as the "point and
shoot" method of direct
cholangioscopy.
[0440] Another exemplary ERCP method is shown in Figures
72A-'72D. In this embodiment, the
rigidizing device 8500 includes at least two working channels therein (e.g.,
similar to the device of
Figures 20A-2013 and 21A-21B). The cholangioscope 8591 is placed down the
first tool channel initially
for navigation and cannulation of the papilla 8555z. Once the guidewire 8585
has been crossed into the
bile duct 8557z (as shown in Figure 7213) or pancreatic duct (8556z), the
cholangioscope 8591 can be
removed from the first tool channel with the wire 8585 remaining in place
inside the duct 8557z (as
shown in Figure 72C). The cholangioscope 8591 can then be placed into the
second tool channel (e.g.,
which may extend sideways out of the wall of the device 8500 as shown in
Figure 81) such that the
duodenal side of the papilla 8555z can be seen (as shown in Figure 72D). The
first tool channel can be
used to place larger instruments therethrough, such as a stent 8558z to be
placed into the duct 8557z. In
some embodiments, it may be useful to have to have exterior (duodenal)
visualization of the papilla 8555z
during stent placement since the stent 8558z takes up most of the diameter of
the duct 8557z and a portion
of the stent 8558z remains inside the duodenum 8554z.
[0441] In another exemplary ERCP method, a rigidizing
device similar to the device of Figure 59
includes a single tool channel running the entire length of the device. The
rigidizing device includes a
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camera attached to the outside of the rigidizing device just proximal to the
steering section. Cannulation,
ERCP, and direct cholangioscopy can be performed similar to the methods
described above. When a stent
or larger tools are to be used, the cholangioscope can be removed from the
tool channel and the rigidizing
device camera can be used to view the exterior of the papilla while larger
instruments or stents are used.
[0442] In another exemplary ERCP method, the rigidizing device includes
a suction tip on the distal
end thereof as described in Figures 46A-46B. The suction tip can surround the
papilla, and suction can be
applied at the tip. This action can stabilize the papilla and make it easier
for the cholangioscope to aim to
the appropriate location to cross the wire. Holding the surrounding tissue of
the papilla can also provide
some counter-tension when pushing on the papilla with the wire or
cholangioscope. Providing counter
tension to the compression force of the cholangioscope or other tools could
decrease the number of
sphincterotomies (cutting open the papilla) required.
[0443] Advantageously, the rigidizing devices used for
ERCP as described herein can be disposable
and sterile, reducing risk of infection or cross-patient contamination_ The
methods further result in less
radiation and easy of navigation to the papilla with steering capabilities on
the rigidizing device and/or
the scope.
[0444] The rigidizing devices and systems described
herein can be used for cardiology and cardiac
surgery, including the heart valves (e.g., aortic and mitral heart valves).
[0445] Typically, in transcatheter, percutaneous
procedures, the clinician affects motion from the
access site (e.g., an artery or vein in the groin, arm, etc.) using a flexible
rod or shaft that has adequate
stiffness to advance the catheter to the treatment site but is flexible enough
to conform to the anatomy.
This means that all the force or leverage is developed at the remote access
site and may be reflected off of
more local anatomy to: (a) bend the flexible rod or shaft to navigate to the
procedure site; and to (b)
provide localized forces (linear and torque) at the procedure site. In
contrast, a dynamically rigidizing
device as described herein effectively moves the access site to the treatment
site by providing a means to
both navigate (e.g. advance) through tortuous anatomy to the treatment site in
a flexible state and
subsequently rigidized to form a stable port at the treatment site independent
of anatomical reflections.
[0446] One of the advantages of the rigidizing devices
described herein is the ability to conform to
surrounding anatomy (e.g., the vasculature). Devices such as guide catheters
need to provide a certain
amount of stiffness to be advanced through the anatomy (e.g. vasculature) and
perform the functions
required. Stiff systems, however, can prevent the device from being advanced
to the target anatomy due,
at least in part, to highly tortuous paths, forcing the anatomy to conform to
the device, which can interfere
with passing and potentially lead to trauma to surrounding tissues and
vessels. In contrast, the rigidizing
devices described herein can be flexible enough to be moved through the
vasculature, conforming to the
vasculature instead of remodeling the vasculature. In some embodiments, the
inch-worming allowed by a
rigidizing device or nested system as described herein allows for this
flexible forward movement. Once
the device has advanced to a target site, the rigidization allows for
preservation and utilization of the
created path through the vasculature. The rigidizing devices described herein,
for example, can be 1/10 as
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stiff as a typical guide catheter when in a flexible state and 5 times stiffer
than a typical guide catheter
when in a rigid state.
[0447] In some embodiments, a rigidizing device as
described herein can be used during
percutaneous procedures in the heart or vasculature. The rigidizing device can
both conform to the
cardiac anatomy and provide a local distal fulcrum for instrument
manipulation_ Currently, when
performing a percutaneous procedure, the mechanical fixation and stabilization
occurs at the access site
(e.g., femoral vein, radial artery, iliac vein, etc.). As described above,
this fixation point creates a long
moment artn extending from the access site to the procedure site. Further, as
described in further detail
below, the mechanical linkage created by typical stiff catheter systems
between the access site and target
anatomy relies on anatomical reflections to direct the catheter tip and
transmit force to the tools being
used. Stiff catheter systems create potential energy along the access route
when they are bent to conform
to the anatomy. This energy can be released when there is voluntary or
involuntary patient movement or
unintentional movement by the operator at the access site. In contrast, the
rigidizing devices described
herein conform to the anatomical pathway prior to rigidization, eliminating
stored energy associated with
stiff catheter systems. Once rigidized, the mechanical fixation is achieved
independently of anatomical
reflections, greatly reducing the moment arm and increasing a physician's
control over the procedure
tools leading to more predictable results. In some embodiments, the rigidizing
device can comprise an
integrated hemostasis valve, obviating the need for a separate access sheath.
[0448] In some embodiments, the rigidizing devices
described herein can be used to stiffen a guide
sheath in interventional cardiology or structural heart cases. For example,
the rigidizing devices can be
used to provide a "rail" for the transcatheter aortic valve replacement (TAVR)
device, thereby keeping
the tip of the TAVR catheter from scraping and skiving the top of the aortic
arch where there is often
thrombus burden (current systems tend to ride the outside of the arch, rubbing
against plaques, creating
embolic debris). The rigidizing devices can help enable superior alignment and
placement as well as
lower paravalvular leakage and optimal placement relative to pacing nodes.
Providing a separate "rail" for
TAVR devices can advantageously permit in situ rotation of the prosthetic
heart valve for superior
alignment.
[0449] In some embodiments, the rigidizing devices
described herein can be used as a delivery
system that may be passed from the venous circulation through the right atrium
and atrial septum into the
left atrium through the mitral valve and antegrade into the left ventricular
outflow tract and aortic valve.
In this manner, a transcatheter aortic valve implantation (TAVI) may be
facilitated avoiding contact with
the aortic arch and ascending aorta typical with retrograde deployment
[0450] In some embodiments, the rigidizing devices
described herein can be used to deliver a mitral
valve replacement. That is, crossing the septal wall during mitral valve
replacement can be particularly
difficult, as it involves multiple curves, a beating heart, and the need for
precisely aligned entry and
stabilization before delivery of the implant. Current valve delivery platforms
can be quite rigid, which
can be dangerous for anatomy that it straightens (such as the femoral artery,
which can be highly calcified
and friable). The rigidizing devices described herein can advantageously
create a conduit that goes in
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flexibly, then rigidizes in whatever shape the particular person's anatomy
provided, such that the
rigidizing device conforms to the entire anatomical track As a result, the
rigidizing devices described
herein can allow the clinician to create a stable mechanical lumen leading
directly to the anatomy, to
locate it without significant local anatomical load, then to stabilize rigidly
in that shape as a device is
delivered through it.
[0451] Figure 73A depicts an embodiment of a rigidizing
device 3700 advanced through the right
atrium RA to the left atrium of the heart. A guidewire or other piercing
member and dilator can be used
to puncture the atrial septum 3704 to create access to the left atrium LA. The
rigidizing device 3700 can
be advanced to the treatment site using the methods described herein. A
cardiac tool 3787 (which may or
may not be rigidizing) can be advanced within with the rigidizing device 3700.
For example, the cardiac
tool 3787 and rigidizing device 3700 can be advanced as described with respect
to the nested system
shown herein, such as in Figures 65A-H,. The dynamic nature of the
rigidization allows the device 3700
and tool 3787 to be advanced through tortuous anatomy. The rigidizing device
3700 can be rigidized
once at the treatment site to provide a stable base for the treatment.
Optionally, the rigidizing device
3700 may comprise an anchoring balloon 3778 near its distal tip to anchor the
rigidizing device 3700 to
chambers in the heart, e.g., to the atrial septum 3704 to maintain the tip of
the tube 3700 in the left atrium
LA. The detailed view of Figure 73B shows the balloon 3778. The balloon 3778
can be positioned at
any location around a circumference of the tube 3700. In some embodiments, the
balloon is annular and
surrounds a circumference of the tube 3700. The rigidizing device 3700 may
include an echogenic tip.
Other tips allowing real time visualization are also possible (e.g.,
radiographic tip, a scope within a saline
filled bag, etc.).
[0452] Figures 74A-74B show an exemplary method for use
of a dynamically rigidizing device in
performing treatment of a in a small branching vessel, such as the coronary
arteries. When navigating to
these smaller vessels, oftentimes, applying force in these areas can cause the
guide catheter or other
advanced devices to be pushed out of the area. Sometimes, guiding catheters
are used in such situations
to provide a bit of local mechanical advantage. Still, using such an guiding
catheters, when applying
force, for example, to push through an occlusion, the whole device can be
pushed out of the area. HG.
74A-74B compare the use of a standard guide catheter to a rigidizing device as
described herein. In
Figure 74A, a standard guide catheter 3886 is used to navigate to the ostium
3845 of one of the main
coronary arteries 3842. A guidewire 3885 extends from the tip of the guide
catheter 3886 and can be
used to perform a procedure (e.g., placing a sten . The guide catheter 3886
can, in some embodiments,
reflect off of adjacent anatomy 3873 to achieve mechanical advantage, prevent
catheter push back, and/or
provide more local force_ In contrast, Figure 74B show a rigidizing device
3800 as described herein
advanced through the ostium 3845 and into the coronary artery 3842. Because of
the rigidization
capability of the device 3800, it does not need to reflect off local anatomy
and can instead provide
inherent stabilization at the treatment site. Additionally, because of the
dynamic rigidization capabilities
of the rigidizing device, it can be advanced past the ostium 3845 and into the
coronary artery 3842.
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[0453] Figure 75A shows an exemplary method of using a
dynamically rigidizing overtuhe system
for performing a mitral valve repair. This method illustrates how the
rigidizing device 3900 can be
positioned in the left atrium LA such that it independently maintains axial
alignment with the treatment
site, in this example, the mitt-al valve. As shown in Figure 75A, the
rigidizing device 3900 is advanced
through the vasculature to the right atrium RA, through the atrial septum, and
into the left atrium LA_
The end of the rigidizing device can be steered such that a longitudinal axis
3983 extending through the
end 3969 of the tube aligns with the desired treatment area (e.g., portion of
the valve). The steering,
dynamically rigidizing, and tip visualization capabilities can allow for
precise positioning of the
rigidizing device. For example, the axis 3983 extends through the mitral valve
MV into the left ventricle
LV. Another position 3964 of the rigidizing device 3900 is shown in phantom
with the axis extending
through a leaflet of the mitral valve MV. Current methods of mitral valve
repair utilize a separate
steerable guide sheath to navigate into the left atrium LA, and often reliable
axial alignment is not
possible. The presently disclosed method of using the rigidizing device 3900
to achieve axial alignment
in a flexible state prior to rigidization provides a significant benefit over
currently used methods of
positioning during procedures such as mitral valve repair. This sort of
precise alignment can be beneficial
in other areas of the anatomy as well (e.g., across other valves, in
transseptal access sites, within a vessel
lumen, etc.), including the ability to place sutures, clips and other devices
within the heart with equivalent
precision normally reserved for open heart surgery.
[0454] Referring to Figure 75B, the rigidizing device
3900 used in a procedure such as that shown
in Figure 75A can comprise various configurations. In some embodiments, the
rigidizing device 3900
can be steered and positioned using a guidewire 3985. In some embodiments, the
rigidizing device 3900
can comprise a nested system comprising an inner rigidizing device 3910.
[0455] As shown in Figure 75C, in one embodiment, at
needle-tipped catheter 3958z can be
advanced through the rigidizing device 3900 and positioned within the cardiac
anatomy, such as above a
mitral valve leaflet. In some embodiments, the needle-tipped catheter 3958z
can contain an anchoring
device 3962z (pledget, stainless steel pledget, etc.) attached to a length of
suture 3959z that can be passed
through the tissue creating an anchor for the suture_ Suture and anchors
delivered through the rigidizing
device can be used to sew tissue structures together, such as leaflet
plication for antral valve repair.
[0456] It will be appreciated that a system comprising
one or more rigidizing devices as described
herein can be used in heart procedures other than mitral valve repair. For
example, the system may be
used in complex mitral valve procedures where the goal may be to effect
leaflet repair and mitral
annuloplasty during the same procedure. The system can be used to perform
transseptal delivery of an
aortic prosthesis (e.g., TAVI). In some embodiments, the system is used to
perform aortic valve repair
via transseptal access. A combination of dynamically rigidizing overtubes can
used in synchrony to pass
suture or other instruments from one heart chamber to another. In any of these
procedures, the
dynamically rigidizing systems described herein can advantageously provide a
cannula or access sheath
providing universal access to the various chambers of the heart.
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[0457] Figure 76A shows an exemplary dual rigidizing
cannula system that can be simultaneously
placed in multiple chambers of the heart. The two rigidizing cannulas 4000a,
4000b can be axially
aligned and provide the capability for clinicians to pass instruments from one
cannula to the other. In use,
the first rigidizing cannula 4000a can be navigated through the right atrium
RA to the left atrium LA (e.g.
via the femoral vein and transseptal crossing). Advantageously, the rigidizing
cannula 4000a can move
through the open transseptal space without the presence of an intrinsic
pathway (such as an artery or vein)
or pathway created with a separate guide catheter due to the inherent
steerability and/or rigidization of the
cannula 4000a. The cannula 4000a can then be oriented such that the tip 4004
of the cannula faces
towards the mitral valve 4081 and rigiclized in this position. The cannula
4004a may comprise a bending
section near the tip 4004 to properly position the tip and steer the device.
The second cannula 4000b can
be navigated retrograde through the aorta 4066z into the left ventricle LV
(e.g., via the femoral artery).
The cannula 4000b can be steered and positioned such that a tip 4039 is
positioned below the mitral valve
and facing the tip 4004 of the first cannula 4000a. The cannula 400% can be
rigiclized in this position.
Once in place, the tips 4004, 4039 of the first and second cannula 4000a,b can
be substantially aligned or
coaxial with one another such that a central axis 4014 extends through the
center of each tip 4004, 4039
and substantially perpendicular to the plane of each tip 4004, 4039. Further,
the axis 4014 extending
between the tip 4004 of the first cannula and the tip 4039 of the second
cannula can be aligned with the
area to be treated. The cannulas 4000a,b can thus be configured to work
together or in unison to perform
a cardiac procedure. For example, this dual access can allow a suture to be
passed from one cannula to
the other and/or to allow tools to be passed therebetween. Using two cannulas
can also allow the
procedure to be performed with a greater degree of precision and accuracy (for
example, the treatment
site can be approached from the top, or bottom, or both). Examples of
procedures that can be performed
with two such rigidizing cannulas 4000a, 400b include leaflet plication with
standard suture techniques
and annuloplasty with conventional rings. Each cannula 4000a, 4000b can
include multiple working
channels and provide fixed access sites within the heart. The provision of
these dual fixation sites can
allow for replication of standard open heart surgical procedures through far
less invasive percutancous
access.
[0458] Figure 7613 shows the dual rigidizing cannula
system of Figure 76A being used to pass
suture through a tissue. The first rigidizing cannula 4000a is positioned on a
first side of tissue 4061z to
be sutured. The second rigidizing cannula 4000b is positioned on an opposite
side of the tissue 4061z. A
needle catheter 4058z positioned by the first cannula 4000a can be used in
combination with a tool 4065z
such as a grasper, snare, or the like positioned by the second cannula 4000b
to pass suture through the
tissue 4061z. In some embodiments, the rigidizing cannula 4000a, 4000b can
include one or more
proximity sensors on the tips 4004, 4039 thereof so as to help maintain
alignment of the tips 4004, 4039.
[0459] Referring to Figures 83A-83E, a dual rigidizing system (e.g.,
such as that shown in Figures
76A-76B) can be used to pass sutures to secure an annuloplasty ring 8384z. For
example, and as shown
in Figures 83A-83E, the rigidizing cannulas 8300a,b can complete a square knot
around an annuloplasty
ring 8384z. That is, referring to Figure 83A, the first rigidizing cannula
8300b can be placed on the
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ventricular side LV of the mitral valve (e.g., similar to device 4000b of
Figure 76A). For example, the
first rigidizing cannula 8300b can navigate the medial and lateral trigones
and the perimeter of the
posterior annulus. A needle 8388z with two loops of suture 8385z, 8386z (e.g.,
positioned relative to one
another as a partially completed square knot as shown in Figure 83A) can be
placed through the first
rigidizing cannula 8300b, and the needle 8388z can puncture tissue of the
mitral valve annulus MA.
Referring to Figure 83B, the second rigidizing cannula 8300a can be placed on
the atrial side LA of the
mitral valve (e.g., similar to device 4000a of Figure 76A). For example, the
rigidizing cannula 8300a can
navigate an entire perimeter of the mitral valve annulus MA. The tips of the
cannula 8300a,b can be
substantially aligned or coaxial as described with respect to Figures 76A-76B.
A hook or grasping
mechanism 8387z can be used to pull the ends of the first loop 8385z through
the second loop 8386z.
Referring to Figure 83C, tension can then be applied from both the first
rigidizing device and the second
rigidizing device 8300a,b to tighten the knot around the annuloplasty ring
8384z. The final knot is shown
in Figure 83D. Further, in some embodiments and as shown in Figure 83E, clips
8389z can be attached to
the ends of the knot to terminate and hold the knot in place. The process can
then be repeated to attach
additional sutures (e.g., a total of 8-12 pairs of sutures can be used to
ensure that the annuloplasty ring
8384z is secure and free of para-annular leak). The entire process for
attaching the annuloplasty ring can
advantageously take place in situ, as the rigidizing devices 8300a,b can
provide direct access to the mitral
valve from both sides of the valve_ Further, the rigidizing devices 8300a,b
advantageously provide stable
rigid ports from which to tie sutures around the annuloplasty ring 8384z.
[0460] Another exemplary method of attaching an annuloplasty ring using
the rigidizing cannulas
described herein is shown in Figures 84A-84E. As shown in Figure 84A, the
annuloplasty ring 8484z can
be affixed to the sutures 8485z external to the body. The sutures 8485z may
periodically pierce the mitral
annulus MA as they are passed from cannula 8400b to cannula 8400a. The sutures
8485z may be suture
pairs. As shown in Figure 8413, the annuloplasty ring 8484z may be aligned
such that it can travel down a
rigidizing cannula 8400a to reach the atrial side of the mitral annulus. The
annuloplasty ring 8484z may
then be place against the mitral annulus MA by, for instance, using a pushing
device. Figure 84C shows
the annuloplasty ring 8484z placed on the mitral annulus MA with suture pairs
8485z passing through
both the mitral annulus MA and the annuloplasty ring 8484z. Figure 84D shows a
suture pair 8485z that
has been tightened to form a mattress suture holding annuloplasty ring 8484z
in place on the mitral
annulus MA. Figure 84E shows a side vide of figure 84D. The mattress suture
can then be secured in the
left atrium LA using conventional suture, knotting or crimping techniques
[0461] In some embodiments, and as described above,
sutures can be introduced through the
rigidizing cannula(s) described herein as interrupted sutures (i.e. a suture
in which each stitch is made
from a separate piece of material and fixed by tying or otherwise attaching
the ends together).
Alternatively, fixation of a suture through a rigidizing cannula can be
achieved with a continuous or
running suture that is created from a single length of suture in which
stitches are made in a serial pattern.
In one example, a length of suture can be threaded within a hollow tube or
needle. The first end of the
suture may be introduced, for example, through the annulus of a valve and
secured. The needle may be
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partially withdrawn with an additional length of suture advanced through the
needle or piercing device.
The next stich can be secured, and so on. This procedure can be repeated until
desired surgical fixation
pattern is achieved.
[0462] In some embodiments, the sutures used herein can
have features thereon to aid in snaring
suture ends and/or to aid in visualization. In one embodiment, small ferrules
can be crimped onto the
suture creating additional purchase for the snare. In one embodiment, ferrules
(e.g., balls) can be fixed at
specified lengths on a continuous length of suture and/or the ferrules can be
crimped in place as needed.
[0463] Combinations of the above techniques may be
employed. For instance, the techniques
shown in Figures 84A-E may be employed to initially seat an annuloplasty ring.
Then the techniques
shown in Figures 83A-E may be employed to more firmly seat the annuloplasty
ring.
[0464] Referring to Figure 77, in some embodiments, a
rigidizing device as described herein can be
used as a trocar during endoscopic procedure& Figure 77 shows a dynamically
rigidizing trocar 4141 and
a standard trocar 4138. Typically, when using a standard trocar 4138, the
initial placement of the trocar
4138 can be incorrect, requiring removal and repositioning. In contrast, the
dynamically rigidizing trocar
4141 can allow for minor adjustments during or after placement of the trocar.
The dynamically rigidizing
trocar 4141 can have steering capability, as described with respect to other
dynamically rigidizing devices
disclosed herein. Using this capability, the trocar 4141 can be bent or
deflected in a desired direction and
then rigidizecl, allowing far greater control than standard trocars. The
dynamically rigidizing trocar 4141
can be used in cardiac applications and/or elsewhere in the body.
Additionally, the trocar 4141 can be
provided in different sizes or shapes depending on the application.
[0465] Referring to Figure 78, a dynamically rigidizing
device 4200 can be used at the aortic
bifurcation 4297. This area of the vasculature can commonly become diseased
and require complex
repair based on the extreme tortuous anatomy at this site. Currently, many
catheters or other delivery
devices used to teat this area travel up to the apex of the bifurcation and
then deploy tools down from
there. As shown in Figure 78, a dynamically rigidizing device 4200 can use a
combination of steering
and dynamic (e.g., periodic) rigidization to navigate around the bifurcation
4297 and be able to reach any
treatment site in the area. For example, the system shown in Figure 78 can be
used to treat a CTO
(chronic total occlusion) in one leg by making percutaneous access in the
other leg.
[0466] Referring to Figure 79, a rigidizing device 4700
with an active deflection segment 4746 and a
steerable distal section 4747 can be used in the heart to perform tnitral
valve repair. The rigidizing device
4700 can be positioned in the left atrium LA such that it independently
maintains axial alignment with the
treatment site, in this example, the tnitral valve MV. The rigidizing device
4700 can thus be advanced
through the vasculature to the right atrium RA, through the atrial septum, and
into the left atrium LA.
The end of the rigidizing device can be steered such that a longitudinal axis
4783 extending through the
end 4769 of the tube aligns with the desired treatment area (e.g., portion of
the valve). To achieve the
desired positioning, the active deflection segment 4746 can be bent in the
relatively unconstrained space
between the IVC and the atrial septum while the distal steerable section 4747
can be positioned within the
left atrium LA and steered or oriented towards the mitral valve MV. In such a
position, the rigidizing
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device 4700 can have a bend with an arc radius of approximately 4-6cm, such as
5cm, at an angle of 90
degrees or more.
[0467] Referring to Figure 80, a rigidizing device 4800
for use in mitral valve repair (with active
deflection segment 4846 and steerable distal section 4847) can include a
distal payload 4848 (e.g., a
mitral clip, mitral valve replacement, or annuloplasty ring) attached thereto.
Having the distal payload
4848 attached thereto while still incorporating the active deflection segment
4846 and steerable distal
section 4847 can advantageously reduce or eliminate the need for an outer
large-bore guide catheter
during such procedures. The catheter 4800 (or 4700) for use in mitral valve
procedures can, for example,
be 14-40Fr with a length of 80-120cm.
[0468] A method of using the rigidizing device 4700 01 4800 can include:
(1) introducing the device
into the distal circulation; (2) advancing the device to the target anatomy
(e.g. heart valve); (3) making a
Fast bend with the active deflection segment (e.g., negotiating the bend
between the IVC and septal wall,
which is approximately 900); (4) locking the active deflection segment in the
bent configuration using
pressure or vacuum; and (5) using the steerable distal section to get to the
mitral plane and mitral valve;
and (6) delivering a therapy or payload.
[0469] Advantageously, the rigidizing devices described
herein can be used to perform cardiac
procedures in a closed beating heart. These procedures therefore
advantageously do not require
cardiopulmonary bypass or a sternotomy, providing enhanced safety for the
patient. In some
embodiments, the cardiac procedures can be performed using imaging, such as
fluoroscopic and/or
echocardiographic imaging.
[0470] A rigidizing device with an active deflection
section and a steerable distal section as
described herein can also be used, for example, for placement of fenestrated
grafts for thoracic artery or
for abdominal aneurysm repair that involves critical branch vessels that
require treatment.
[0471] The rigidizing devices and systems described
herein can be used for resection or snaring of a
lesion in the gastrointestinal tract.
[0472] Referring to Figures 81A-81F, in some embodiments,
the rigidizing device 700 can be
configured so as to control the directionality of a working tool 777 that
extends through the working
channel 755. For example, the rigidizing device 700 can include a flexible
distal section 702z that is
highly flexible relative to the proximal rigidizing elongate body 703z (which
can include rigidizing
features as described herein) extending proximally thereof. Referring to
Figure 81A, the endoscope 791
with a scope steering section 776 can be placed within the rigidizing device
700 in vessel 760z.
Referring to Figure 81B, the rigidizing device 700 can be moved distally such
that the flexible distal
section 702z is positioned over the steering section 776 of the endoscope 791.
As shown in Figure 81C,
as the steering section 776 bends, the flexible distal section 702z and the
connected working channel 755
can bend with it, thereby providing steering of the tool 777 in the working
channel 755 (e.g., towards the
lesion 779 in the vessel 736). As shown in Figure 81D, the tool 777 can then
be advanced out of the
working channel 755 to the desired location (e.g., the lesion 779). Referring
to Figure 81E, the rigidizing
device 700 can then be pulled proximally to move the flexible distal portion
702z off of the steerable
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section 776 and to move the working channel 755 further proximally as well. As
shown in Figure 81F,
this can allow the scope 791 to be steered (with the steerable section 776)
without disturbing the
placement or direction of the working tool 777.
[0473] The rigidizing devices and systems described
herein can be used for enteroscopy to navigate
substantially all of the small intestine to diagnose and/or treat disease_
[0474] Enteroscopy is kinematically challenging for
several reasons, including because the scopes
are relatively small diameter (9 mm), they are very long (2 meters), and they
frequently loop as they
navigate the gastrointestinal tract to get to the beginning or end of the
small intestine (the pylorus or the
ileocecal valve, respectively).
[0475] The rigidizing devices and systems described herein can be used
for IEUS_
[0476] The rigidizing devices and systems described
herein can be used to access the lungs. For
example, a rigidizing device 2100 and a scope 2191 can be assembled
concentrically (the scope inside the
rigidizing device) and then placed through the mouth down the trachea to the
carina. As detailed herein, a
"Point and Shoot" method may be employed at the carina to advance the scope
into the left main or right
main bronchus. The "Point and Shoot" method may be repeatedly used to select
additional, deeper
branches in the lungs.
[0477] The rigidizing devices and systems described
herein can be used to access the kidneys. For
example, a rigidizing device 2100 and a scope 2191 can be assembled
concentrically (the scope inside the
rigidizing device) and then placed through the urethra into the bladder. As
detailed herein, a "Point and
Shoot" method may be employed in the bladder to advance the scope into the
left or right ureter_ The
"Point and Shoot" method may be repeatedly used to help the scope reach the
kidneys
[0478] The rigidizing devices and systems described
herein can be used to navigate through
neurological anatomy.
[0479] Systems described herein may be used to access the
carotid arteries or the distal vessels
leading to or in the brain.
[0480] For example, a guidewire may be placed into the
carotid artery. A rigidizing device or sheath
may be placed over the guidewire and directed into the carotid artery. Once
the overtube or sheath is
placed at the target site, it may be rigidized to decrease the likelihood of
the catheter or g-uidewire
prolapsing into the aortic arch during the procedure.
[0481] The rigidizing devices and systems described herein can be used
for access and/or treatment
of chronic total occlusions (CTO).
[0482] Thus, in some embodiments, the rigidizing devices
can be incorporated into catheters for
interventional cardiology, such that they track very easily (flexible), then
can be rigidized for instances
when the device is used to push through locally anatomy, such as for instance
when treating a CTO.
[0483] The rigidizing devices and systems described herein can be used
with laparoscopic manual
tools.
[0484] The rigidizing devices and systems described
herein can be used for contralateral leg access.
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[0485] The rigidizing devices and systems described
herein can be used for ear, nose, and throat
(ENT) applications.
[0486] The rigidizing devices and systems described
herein can be used to perform therapies during
esophagogastroduodenoscopy (EGD), for example, on the roof of the stomach.
[0487] The rigidizing devices and systems described herein can be used
for TORS (transoral robotic
surgery).
[0488] The rigidizing devices and systems described
herein can be used for NOTES (Natural Orifice
Transluminal Endoscopic Surgery).
[0489] The rigidizing devices and systems described
herein can be used for altered anatomy cases,
including Roux-en-Y.
[0490] It should be understood that any feature described
herein with respect to one embodiment can
be combined with or substituted for any feature described herein with respect
to another embodiment.
For example, the various layers and/or features of the rigidizing devices
described herein can be
combined, substituted, and/or rearranged relative to other layers.
[0491] Additional details pertinent to the present invention, including
materials and manufacturing
techniques, may be employed as within the level of those with skill in the
relevant art. The same may
hold true with respect to method-based aspects of the invention in terms of
additional acts commonly or
logically employed. Also, it is contemplated that any optional feature of the
inventive variations
described may be set forth and claimed independently, or in combination with
any one or more of the
features described herein. Likewise, reference to a singular item, includes
the possibility that there are a
plurality of the same items present. More specifically, as used herein and in
the appended claims, the
singular forms "a," "and," "said," and "the" include plural referents unless
the context clearly dictates
otherwise. It is further noted that the claims may be drafted to exclude any
optional element. As such,
this statement is intended to serve as antecedent basis for use of such
exclusive terminology as "solely,"
"only" and the like in connection with the recitation of claim elements, or
use of a "negative" limitation.
Unless defined otherwise herein, all technical and scientific terms used
herein have the same meaning as
commonly understood by one of ordinary skill in the art to which this
invention belongs. The breadth of
the present invention is not to be limited by the subject specification, but
rather only by the plain meaning
of the claim terms employed.
[0492] When a feature or element is herein referred to as being "on"
another feature or element, it
can be directly on the other feature or element or intervening features and/or
elements may also be
present. In contrast, when a feature or element is referred to as being
"directly on" another feature or
element, there are no intervening features or elements present. It will also
be understood that, when a
feature or element is referred to as being "connected", "attached" or
"coupled" to another feature or
element, it can be directly connected, attached or coupled to the other
feature or element or intervening
features or elements may be present. In contrast, when a feature or element is
referred to as being
"directly connected", "directly attached" or "directly coupled" to another
feature or element, there are no
intervening features or elements present. Although described or shown with
respect to one embodiment,
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the features and elements so described or shown can apply to other
embodiments. It will also be
appreciated by those of skill in the art that references to a structure or
feature that is disposed "adjacent"
another feature may have portions that overlap or underlie the adjacent
feature.
[0493] Terminology used herein is for the purpose of
describing particular embodiments only and is
not intended to be limiting of the invention. For example, as used herein, the
singular forms "a", "an" and
"the" are intended to include the plural forms as well, unless the context
clearly indicates otherwise. It
will be further understood that the terms "comprises" and/or "comprising,"
when used in this
specification, specify the presence of stated features, steps, operations,
elements, and/or components, but
do not preclude the presence or addition of one or more other features, steps,
operations, elements,
components, and/or groups thereof. As used herein, the term "and/or" includes
any and all combinations
of one or more of the associated listed items and may be abbreviated as "/".
[0494] Spatially relative terms, such as "under",
"below", "lower", "over", "upper" and the like, may
be used herein for ease of description to describe one element or feature's
relationship to another
element(s) or feature(s) as illustrated in the figures. It will be understood
that the spatially relative terms
are intended to encompass different orientations of the device in use or
operation in addition to the
orientation depicted in the figures. For example, if a device in the figures
is inverted, elements described
as "under" or "beneath" other elements or features would then be oriented
"over" the other elements or
features. Thus, the exemplary term "under" can encompass both an orientation
of over and under. The
device may be otherwise oriented (rotated 90 degrees or at other orientations)
and the spatially relative
descriptors used herein interpreted accordingly. Similarly, the terms
"upwardly", "downwardly",
"vertical", "horizontal" and the like are used herein for the purpose of
explanation only unless specifically
indicated otherwise.
[0495] Although the terms "first" and "second" may be
used herein to describe various
features/elements, these features/elements should not be limited by these
terms, unless the context
indicates otherwise. These terms may be used to distinguish one
feature/element from another
feature/element. Thus, a first feature/element discussed below could be termed
a second feature/element,
and similarly, a second feature/element discussed below could be termed a
first feature/element without
departing from the teachings of the present invention.
[0496] As used herein in the specification and claims,
including as used in the examples and unless
otherwise expressly specified, all numbers may be read as if prefaced by the
word "about" or
"approximately," even if the term does not expressly appear. The phrase
"about" or "approximately" may
be used when describing magnitude and/or position to indicate that the value
and/or position described is
within a reasonable expected range of values and/or positions. For example, a
numeric value may have a
value that is +/- 0.1% of the stated value (or range of values), +/- 1% of the
stated value (or range of
values), +/- 2% of the stated value (or range of values), +/- 5% of the stated
value (or range of values), +/-
10% of the stated value (or range of values), etc. Any numerical range recited
herein is intended to
include all sub-ranges subsumed therein.
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