U.S. patent application number 14/515324 was filed with the patent office on 2015-02-12 for tissue expansion devices, systems and methods.
This patent application is currently assigned to Fractyl Laboratories, Inc.. The applicant listed for this patent is Fractyl Laboratories, Inc.. Invention is credited to Jay Caplan, Andrew Coats, J. Christopher Flaherty, Christopher James Kadamus, Philip S. Levin, Mark A. Manasas, Harith Rajagopalan.
Application Number | 20150045825 14/515324 |
Document ID | / |
Family ID | 49384132 |
Filed Date | 2015-02-12 |
United States Patent
Application |
20150045825 |
Kind Code |
A1 |
Caplan; Jay ; et
al. |
February 12, 2015 |
TISSUE EXPANSION DEVICES, SYSTEMS AND METHODS
Abstract
A device for expanding tissue comprises at least one fluid
delivery tube and at least one fluid delivery element in fluid
communication with the at least one fluid delivery tube. The at
least one fluid delivery tube comprises a proximal end, a distal
end, and a lumen therebetween. The device is constructed and
arranged to perform a near full circumferential expansion of
luminal wall tissue. Systems and methods are also provided,
including a system for expanding tissue layers and treating tissue
proximate to the expanded tissue layers.
Inventors: |
Caplan; Jay; (Belmont,
MA) ; Rajagopalan; Harith; (Brookline, MA) ;
Manasas; Mark A.; (Lexington, MA) ; Kadamus;
Christopher James; (Jamaica Plain, MA) ; Coats;
Andrew; (Somerville, MA) ; Levin; Philip S.;
(Storrs, CT) ; Flaherty; J. Christopher;
(Auburndale, FL) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Fractyl Laboratories, Inc. |
Waltham |
MA |
US |
|
|
Assignee: |
Fractyl Laboratories, Inc.
Waltham
MA
|
Family ID: |
49384132 |
Appl. No.: |
14/515324 |
Filed: |
October 15, 2014 |
Related U.S. Patent Documents
|
|
|
|
|
|
Application
Number |
Filing Date |
Patent Number |
|
|
PCT/US2013/037485 |
Apr 19, 2013 |
|
|
|
14515324 |
|
|
|
|
61635810 |
Apr 19, 2012 |
|
|
|
Current U.S.
Class: |
606/191 |
Current CPC
Class: |
A61B 2018/1472 20130101;
A61B 5/6847 20130101; A61B 17/12186 20130101; A61M 25/00 20130101;
A61M 25/0084 20130101; A61M 2025/0089 20130101; A61B 18/1477
20130101; A61M 2025/009 20130101; A61B 18/1492 20130101; A61B
5/4836 20130101; A61M 2025/0092 20130101; A61M 29/00 20130101; A61M
25/0074 20130101; A61B 5/0036 20180801; A61M 2025/0087 20130101;
A61M 25/04 20130101; A61B 5/00 20130101; A61M 29/02 20130101 |
Class at
Publication: |
606/191 |
International
Class: |
A61M 29/00 20060101
A61M029/00 |
Claims
1. A device for expanding tissue comprising: at least one fluid
delivery tube comprising a proximal end, a distal end and a lumen
therebetween; and at least one fluid delivery element in fluid
communication with the at least one fluid delivery tube lumen;
wherein the device is constructed and arranged to perform a near
full circumferential expansion of luminal wall tissue.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application is a continuation of PCT Application No.
PCT/US2013/037485 (Attorney Docket No. 41714-705.601), filed Apr.
19, 2013, which claims the benefit of U.S. Provisional Application
No. 61/635,810 (Attorney Docket No. 41714-705.101), filed Apr. 19,
2012, the entire content of which is incorporated herein by
reference; this application is also related to PCT Application
Serial Number PCT/US2012/01739 (Attorney Docket No. 41714-703.601),
filed Jan. 18, 2012; and PCT Application Serial Number
PCT/US2013/28082 (Attorney Docket No. 41714-704.601), filed Feb.
27, 2013; the contents of each are incorporated herein by reference
in their entirety.
TECHNICAL FIELD
[0002] The embodiments disclosed herein relate generally to
systems, devices and methods for expanding tissue, particularly one
or more layers of gastrointestinal tissue.
BACKGROUND OF THE INVENTION
[0003] The field of gastrointestinal endoscopy has for many years
focused on diagnostic and therapeutic techniques to observe, modify
and remove tissues located in the digestive tract. For example,
prior to a procedure to remove or otherwise modify tissue, a method
referred to in the art as "lift and cut" involves the injection of
saline or other biocompatible solution beneath the submucosa in an
attempt to elevate and/or expand the submucosa, thereby changing
the geometry to make it suitable for treatment, for example
resection of tissue. In some cases, an injection catheter is used
to deliver the fluid within the submucosal layer, which does not
readily dissipate, throughout the target area, and once the target
resection area has been elevated and/or expanded, the tissue can be
treated.
[0004] However, the current devices, systems and methods for
expanding submucosal and other tissue layers are cumbersome,
inaccurate, and have a limited effected tissue area. Therefore,
there is a need for improved devices, systems and methods for
expanding submucosal and other tissue layers that provide
simplified use, larger expansion areas, and reduced procedure
time.
SUMMARY OF THE INVENTION
[0005] According to one aspect of the present inventive concepts, a
device for expanding tissue comprises at least one fluid delivery
tube comprising a proximal end, a distal end and a lumen
therebetween; and at least one fluid delivery element in fluid
communication with the at least one fluid delivery tube lumen where
the device is configured to expand one or more tissue layers, such
as a to perform a near full circumferential expansion of luminal
wall tissue.
[0006] In some embodiments, the device is configured to perform
near full circumferential expansion of luminal wall tissue. The
near circumferential expansion can be performed with a single
operator step of fluid delivery, for example where the at least one
fluid delivery element comprises two or more fluid delivery
elements and fluid delivery from the two or more fluid delivery
elements occurs simultaneously or sequentially. Alternatively, the
near circumferential expansion can be performed with multiple
operator steps of fluid delivery.
[0007] In some embodiments, the device is configured to narrow a
lumen surrounded by luminal wall tissue, for example narrowed to a
diameter 85% or less of the diameter prior to luminal wall tissue
expansion, or in some cases 75% or less
[0008] In some embodiments, the device is configured to smooth the
inner surface of luminal wall tissue, for example plicae of the
gastrointestinal tract.
[0009] In some embodiments, the device is configured to deliver a
pre-determined volume of fluid into tissue. The volume of fluid
delivered can range from approximately 0.5 ml to 4.0 ml which can
be delivery between 2 and 10 times. The volume of fluid delivered
can range from approximately 1.0 ml to 3.0 ml which can be
delivered between 2 and 10 times.
[0010] In some embodiments, the device is configured to provide
pressure-controlled delivery of fluid into tissue. The device can
deliver fluid until a maximum pressure is reached, or until the
pressure is above a minimum level.
[0011] In some embodiments, the device is configured to expand a
first layer of tissue while avoiding expansion of a second, deeper
layer of tissue. Conversely, the device can be configured to expand
a first layer of tissue while avoiding expansion of a second, more
shallow layer of tissue.
[0012] In some embodiments, the device is configured cause the at
least one fluid delivery element to initially penetrate the plicae
of the gastrointestinal tract.
[0013] The one or more tissue layers to be expanded can comprise
luminal wall tissue. The one or more tissue layers to be expanded
can comprise submucosal tissue, for example duodenal submucosal
tissue. The device can be configured to avoid expansion of tissue
selected from the group consisting of: mucosal layer tissue;
muscularis layer tissue; serosal layer tissue; and combinations of
these. Other types of tissue that can be expanded by the device are
selected from the group consisting of: a gastrointestinal tissue
layer; a duodenal tissue layer; an esophageal tissue layer; a
jejunum tissue layer; an ileum tissue layer; a colon tissue layer;
a stomach tissue layer; a bladder tissue layer; an oral cavity
tissue layer; a uterus tissue layer; and combinations of these.
[0014] The at least one fluid delivery element can comprise two or
more fluid delivery elements, for example a first and a second
fluid delivery element. The first and the second fluid delivery
elements can be similar or dissimilar. The first fluid delivery
element and the second fluid delivery element can be configured to
deliver fluid simultaneously and/or sequentially. The at least one
fluid delivery tube can comprise a single fluid delivery tube where
the first fluid delivery element and the second fluid delivery
element are fluidly connected to the single fluid delivery tube.
Alternatively, the at least one fluid delivery tube can comprise at
least two fluid delivery tubes where the first fluid delivery
element is fluidly connected to a first fluid delivery tube and the
second fluid delivery element is fluidly connected to a second
fluid delivery tube.
[0015] The at least one fluid delivery element can comprise three
or more fluid delivery elements positioned in a relatively
circumferential array. In some embodiments, the device comprises a
support assembly where the three or more fluid delivery elements
are positioned on and/or in the support assembly. The support
assembly can comprise a support structure selected from the group
consisting of: at least one balloon; two or more support arms; a
radially deployable structure; and combinations of these. The
support assembly can comprise two or more support arms where a
first fluid delivery element is positioned proximate a first
support arm and wherein a second fluid delivery element is
positioned proximate a second support arm. The at least one
delivery element can comprise at least four fluid delivery elements
where the support assembly comprises at least four support arms,
and where a fluid delivery element is positioned proximate each of
the four support arms. The support assembly can comprise a radially
expandable support assembly that is expandable via a retractable
shaft. The support assembly can comprise a support assembly
configured to be biased in a radially expanded state, and also
configured to be radially compacted. The support assembly can
comprise two or more tubes where each of the two or more tubes
surrounds a fluid delivery element, for example where the two or
more tubes slidingly engage a fluid delivery element. Each of the
two or more tubes can comprise an exit port through which a fluid
delivery element can be advanced. Each of the two or more tubes can
comprise a vacuum port configured to apply tension to tissue. Each
of the two or more tubes can comprise an entry port configured to
allow tissue to pass through. The support assembly can comprise two
or more exit ports through which a fluid delivery element can be
advanced and a vacuum can be applied to the two or more exit ports.
The support assembly can comprise at least one vacuum port.
[0016] The device can further comprise at least one exit port where
the at least one fluid delivery element is configured to be
operably advanced out of the at least one exit port. The device can
be configured to apply a vacuum to the at least one exit port. The
device can further comprise an elongate shaft which slidingly
receives the at least one fluid delivery tube, and where the at
least one exit port is positioned at a side portion of the elongate
shaft, and the device can be configured to allow an operator to
adjust the trajectory of the at least one fluid delivery element
out of the at least one exit port.
[0017] The at least one fluid delivery element can comprise an
advanceable fluid delivery element. For example, the fluid delivery
element can be advanced by an operator. The device can comprise a
control configured to advance the at least one fluid delivery
element where the control can be positioned on a handle of the
device. The control can be configured to allow an operator to
modify the advancement of the at least one fluid delivery element.
The device can comprise a guide surface configured to cause and/or
maintain a predetermined trajectory for the at least one fluid
delivery element. The device can comprise a surface positioned such
as to limit the advancement of the at least one fluid delivery
element. The at least one fluid delivery element can be advanced a
fixed distance, for example a distance set by an operator. The
distance can range from approximately 1 mm to 10 mm, or from
approximately 3 mm to 7 mm. The device can comprise an elongate
shaft comprising a recess portion surrounding the at least one
fluid delivery tube where the at least one fluid delivery element
is configured to advance into the recess portion. The device can
comprise an elongate shaft with a distal end surrounding the at
least one fluid delivery tube where the at least one fluid delivery
element is configured to advance out of the shaft distal end. The
at least one fluid delivery element can be resiliently biased in a
retracted state, for example via a spring element. The at least one
fluid delivery element can comprise a first fluid delivery element
and a second fluid delivery element where each of the fluid
delivery elements are biased in a retracted state.
[0018] The at least one fluid delivery element can comprise at
least two fluid delivery elements, each comprising advanceable
fluid delivery elements. For example, a first fluid delivery
element can be independently advanceable from a second fluid
delivery element. Alternatively, the first and second fluid
delivery elements can be advanced simultaneously.
[0019] The device can further comprise a spring-loaded fluid
delivery advancement assembly. The assembly can be configured to be
activated by an operator. The assembly can be configured to advance
multiple fluid delivery elements, and in some cases, the multiple
fluid delivery elements can be advanced independently of one
another.
[0020] The at least one fluid delivery element can be configured to
move laterally as the tissue is expanded.
[0021] The at least one fluid delivery element can comprise at
least one element selected from the group consisting of; a needle;
a water jet; an iontophoretic element; a porous element; and
combinations of these. In an embodiment where the at least one
fluid delivery comprises a needle, the device can comprise an
elongate shaft with a recess where the needle is constructed and
arranged to be maintained within the elongate shaft recess. The
needle diameter can range from approximately 20 to 35 gauge, for
example from approximately 23 to 27 gauge. The needle can comprise
a solid tip needle comprising an exit port selected from the group
consisting of: at least one side hole; a porous section; and
combinations of these. The needle can comprise at least one side
hole. The needle can be configured to penetrate through mucosal
tissue and into submucosal tissue but not penetrate muscularis
tissue. The needle can be configured to penetrate through mucosal
tissue and into submucosal tissue but not penetrate serosal tissue.
The needle can comprise an exposed length of less than or equal to
10 mm, for example an exposed length less than or equal to 7 mm.
The needle can extend from an expandable support, for example an
expandable support selected from the group consisting of: a
balloon; a cage; one or more radially extending arms; and
combinations of these.
[0022] The at least one fluid delivery element can comprise a
sharpened distal end. The at least one fluid delivery element can
comprise a beveled distal end, for example where the bevel angle
ranges from 10.degree. and 60.degree. such as a bevel angle of
approximately 30.degree..
[0023] The at least one fluid delivery element can comprise a water
jet where the water jet can comprise a nozzle configured to cause
fluid to penetrate one or more tissue layers.
[0024] The device can further comprise fluid configured to be
delivered to the tissue through the at least one fluid delivery
element. The fluid can be a fluid selected from the group
consisting of: a liquid; a gas; and combinations of these. For
example, the fluid can be selected from the group consisting of:
water; saline such as hypertonic saline; air; CO.sub.2; one or more
hydrogels; epinephrine; hypertonic dextrose water; hyaluronic acid;
glycerol solutions; and combinations of these. The fluid can be one
that provides a visual image corresponding to the amount of tissue
expansion, for example a fluid selected from the group consisting
of: methylene blue; dye; radiopaque fluid; MR visualizable fluid;
ultrasonically visualizable fluid; and combinations of these. The
fluid can comprise a magnetic fluid. The fluid can change color as
the fluid temperature changes. The fluid can comprise at least two
fluids, for example a first fluid with a first reflectance color
and a second fluid with a second reflectance color where the device
is configured to deliver the first fluid through a first fluid
delivery element and the second fluid through a second fluid
delivery element. The fluid can comprise a fluid that is heated
prior to delivery into tissue. The fluid can comprise a fluid
configured to change viscosity after delivery into tissue, for
example the fluid can increase or decrease in viscosity after
delivery into tissue. The fluid can comprise a fluid of similar
osmolarity to the tissue. The fluid can comprise a fluid configured
as an insulator. The fluid can comprise glycerol and saline, for
example heated glycerol and saline. The fluid can be configured to
provide a bioactive function, for example a function selected from
the group consisting of: sclerosant; an anti-inflammatory agent; an
antimicrotubule or other mitotic inhibitors; an alkylating agent;
an antimetabolite; an anthracycline; a plant alkaloids; a
topoisomerase inhibitor; an anti-proliferative; and combinations of
these.
[0025] The device can further comprise a manipulating assembly
configured to manipulate one or more of: tissue; fluid; delivered
fluid; and combinations of these. The manipulating assembly can
comprise a vacuum port. The vacuum port can comprise a width that
is less than or equal to 2.0 mm, or less than or equal to 1.5 mm,
or less than or equal to 1.0 mm. The vacuum port can comprise a
length that is less than or equal to 5.0 mm, or less than or equal
to 4.0 mm, or less than or equal to 3.0 mm. The vacuum port can
comprise a width of approximately 1.5 mm and a length of
approximate 4.0 mm. The device can further comprise a lumen in
fluid communication with the vacuum port. The device can further
comprise a vacuum generator in fluid communication with the vacuum
port. The vacuum port can be configured to move the tissue toward
the at least one fluid delivery element. The device can be
configured to apply a vacuum of approximately 5 cmHg to 45 cmHg
below atmospheric pressure to the vacuum port, for example a vacuum
of approximately 5 cmHg to 20 cmHg below atmospheric pressure to
the vacuum port. The device can be configured to allow an operator
to adjust the pressure applied at the vacuum port. The manipulating
assembly can be configured to prevent motion of a portion of tissue
as the at least one fluid delivery element penetrates into that
portion of tissue. The manipulating assembly can be configured to
prevent motion of a portion of tissue as the at least one fluid
delivery element delivers fluid into that portion of tissue. The
manipulating assembly can be configured to move fluid previously
delivered into tissue, for example via a vacuum and/or via the
application of a translating force across the tissue. The
manipulating assembly can be configured to direct the flow of fluid
being delivered into tissue. The manipulating assembly can comprise
one or more components selected from the group consisting of: a
balloon; an expandable ring; a vacuum port; a grasper such as a
pair of articulating jaws; a radially expandable cage; a radially
deployable arm; and combinations of these.
[0026] The device can further comprise a luminal sealing element
configured to at least partially occlude the lumen of the at least
one fluid delivery tube surrounded by the tissue. For example, the
luminal sealing element can comprise a balloon positioned proximal
to or distal to the at least one fluid delivery element.
[0027] The device can further comprise a pressure monitoring
assembly configured to monitor pressure prior to, during and/or
after expansion of the tissue.
[0028] The device can further comprise a diagnostic assembly
configured to perform an assessment of the tissue expansion. For
example, the diagnostic assembly can assess the amount of tissue
expansion; the thickness of one or more tissue layers; the
penetration of the at least one fluid delivery element into tissue;
and combinations of these. The diagnostic assembly can comprise a
visualization assembly. The visualization assembly can be
configured to monitor the color density of fluid delivered into
tissue. The visualization assembly can comprise a component
selected from the group consisting of: a visible light camera; an
ultrasound imager; an OCT device; an OCDR device; confocal
endomicroscopy via either scanning or structured illumination; and
combinations of these. The visualization assembly can further
comprise a light emitting source configured to monitor the depth of
penetration of the at least one fluid delivery element into tissue.
The diagnostic assembly can comprise a tissue analyzer, for example
an ultrasonic tissue analyzer configured to provide tissue
thickness information. The diagnostic assembly can comprise an
impedance measurement element. The diagnostic assembly can be
configured to deliver heated and/or chilled fluid and to assess
tissue expansion based on a measured change in temperature.
[0029] The device can further comprise at least one sensor. The at
least one sensor can comprises a sensor selected from the group
consisting of: temperature sensor; impedance sensor; optical
sensor; pressure sensor; strain gauge; force sensor; and
combinations of these. The sensor can be configured to perform a
function selected from the group consisting of: quantify or
otherwise assess one or more of: amount of tissue expansion;
current tissue thickness (e.g. pre, during and/or post expansion);
tissue layer thickness; penetration distance of a fluid delivery
element; color density of a delivered fluid; impedance of tissue;
temperature of tissue such as temperature of tissue that has
received a heated or chilled fluid via needle; and combinations of
these.
[0030] The device can further comprise an expanding element. The
expanding element can be configured to minimize migration of fluid
delivered to tissue. For example, the expanding element can
comprise a balloon. The expanding element can comprise a first
balloon and a second balloon where the at least one fluid delivery
element is positioned between the first and the second balloon. The
expanding element can comprise a tapered profile. The expanding
element can comprise a dog-bone profile. The expanding element can
comprise at least one recess. The at least one fluid delivery
element can be configured to be positioned and/or advanced in the
at least one recess. A vacuum port can be positioned in the at
least one recess.
[0031] The device can further comprise an elongate shaft
surrounding the at least one fluid delivery tube.
[0032] The at least one fluid delivery element can comprise a first
fluid delivery element and a second fluid delivery element where
the at least one fluid delivery tube comprises a first fluid
delivery tube in fluid communication with the first fluid delivery
tube and a second fluid delivery tube in fluid communication with
the second fluid delivery tube. The device can further comprise a
shaft surrounding the first fluid delivery tube and the second
fluid delivery tube and wherein the first fluid delivery tube and
the second fluid delivery tube are positioned in a side-by-side
arrangement.
[0033] The at least one fluid delivery element can comprise at
least three fluid delivery elements. The at least one fluid
delivery tube can comprise at least three fluid delivery tubes
singly connected to the at least three fluid delivery elements.
Alternatively, the at least one fluid delivery tube can comprise a
single fluid delivery tube where the device further comprises a
manifold configured to operably connect the single fluid delivery
tube to the first fluid delivery element, the second fluid delivery
element and the third fluid delivery element.
[0034] The at least one fluid delivery element can comprise at
least four fluid delivery elements. The at least one fluid delivery
tube can comprise at least four fluid delivery tubes singly
connected to the at least four fluid delivery elements.
Alternatively, the at least one fluid delivery tube can comprise a
single fluid delivery tube where the device further comprises a
manifold configured to operably connect the single fluid delivery
tube to the first fluid delivery element, the second fluid delivery
element, the third fluid delivery element and the fourth fluid
delivery element.
[0035] In some embodiments, the device is configured to be inserted
through an endoscope. In some embodiments, the device is configured
to be inserted through a lumen of 13 mm or less, or a lumen of 8 mm
or less, or a lumen of 6 mm or less.
[0036] In some embodiments, the device comprises a workable
insertion length of at least 25 cm, or at least 35 cm, or at least
100 cm, or at least 140 cm.
[0037] In some embodiments, the device is configured for
over-the-wire delivery into the gastrointestinal tract. The device
can comprise a lumen configured to slidingly receive a guidewire.
Additionally or alternatively, the device can comprise a sidecar
configured to rapid exchange delivery over a guidewire.
[0038] The device can further comprise an elongate shaft
surrounding the at least one fluid delivery tube wherein the at
least one fluid delivery element is configured to be advanced from
the elongate shaft, for example where the elongate shaft comprises
an endoscope shaft.
[0039] The device can further comprise an elongate shaft
surrounding the at least one fluid delivery tube and comprising a
distal portion and an opening positioned in the distal portion. The
at least one fluid delivery element can be positioned in the distal
portion opening. The at least one fluid delivery element can be
configured to be advanceable into the distal portion opening. The
device can be configured to apply a vacuum to the distal portion
opening. The distal portion opening can comprise a recess in the
elongate shaft distal portion.
[0040] According to another aspect of the present inventive
concepts, a method comprises providing a tissue expansion device
comprising at least one fluid delivery tube comprising a proximal
end, a distal end, and a lumen therebetween; and at least one fluid
delivery element in fluid communication with the at least one fluid
delivery tube lumen; and delivering fluid through the at least one
fluid delivery element into a first tissue location to expand one
or more layers of tissue.
[0041] Delivering fluid through the at least one fluid delivery
element into a first tissue location to expand one or more layers
of tissue can comprise delivering the fluid via at least two fluid
delivery elements simultaneously.
[0042] The one or more layers of tissue can be expanded to move an
inner layer of tissue toward a treatment element.
[0043] The method can further comprise delivering a second volume
of fluid. The second volume of fluid can be delivered to the first
tissue location, or to a second, different tissue location.
[0044] The method can further comprise moving delivered fluid
residing in the tissue. The fluid residing in the tissue can be
moved as fluid is being delivered through the fluid delivery
element.
[0045] The method can further comprise applying a force to tissue
prior to and/or during the delivering of fluid. The force can be
applied by two expandable elements, for example two expandable
balloons.
[0046] The method can further comprise manipulating the first
tissue location and/or tissue proximate the first tissue location
prior to delivering the fluid into the first tissue location. The
manipulating can comprise applying a vacuum. The at least one fluid
delivery element can be advanced into the vacuum manipulated
tissue, for example where the at least one fluid delivery element
comprises a needle. Alternatively or additionally, the manipulating
can comprise grasping the tissue with a tool.
[0047] The method can further comprise monitoring the expansion of
tissue. For example, the monitoring can comprise monitoring tissue
expansion for sufficiency.
[0048] The method can further comprise ablating tissue proximate
the expanded tissue.
BRIEF DESCRIPTION OF THE DRAWINGS
[0049] The advantages of the technology described above, together
with further advantages, may be better understood by referring to
the following description taken in conjunction with the
accompanying drawings. The drawings are not necessarily to scale,
emphasis instead generally being placed upon illustrating the
principles of the technology.
[0050] FIG. 1 is a side view of a tissue expanding device including
multiple fluid delivery elements in a retracted state, consistent
with the present inventive concepts.
[0051] FIG. 1A is a side view of the tissue expanding device of
FIG. 1, with the multiple fluid delivery elements advanced,
consistent with the present inventive concepts.
[0052] FIG. 2 is a flow chart of a method for tissue expansion,
consistent with the present inventive concepts.
[0053] FIGS. 3A, 3B and 3C are a series of sectional side and end
views of a segment of luminal wall tissue, prior to, during and
after full circumferential tissue expansion, respectively,
consistent with the present inventive concepts.
[0054] FIG. 4 is a side view of a distal portion of a tissue
expansion device, including a manually deployable expandable
assembly, consistent with the present inventive concepts.
[0055] FIG. 4A is a side view of the tissue expansion device of
FIG. 4, after radial expansion of the deployable assembly,
consistent with the present inventive concepts.
[0056] FIG. 4B is a side view of the tissue expansion device of
FIGS. 4 and 4A, after radial expansion of the deployable assembly
and advancement of fluid delivery elements, consistent with the
present inventive concepts.
[0057] FIG. 5 is a side and end view of a distal portion of a
tissue expansion device, including a self-expanding assembly,
consistent with the present inventive concepts.
[0058] FIG. 5A is a side sectional view of a segment of a support
arm of a tissue expansion device, including a support member for a
fluid delivery element, consistent with the present inventive
concepts.
[0059] FIG. 5B is a top view of an opening of a support arm of a
tissue expansion device, consistent with the present inventive
concepts.
[0060] FIG. 5C is a perspective view of an alternative opening of a
support arm, consistent with the present inventive concepts.
[0061] FIG. 6 is a side sectional view of a distal portion of a
fluid delivery element comprising a penetrator and an atraumatic
surrounding tube and positioned in a body lumen, consistent with
the present inventive concepts.
[0062] FIG. 6A is a side sectional view of the fluid delivery
element of FIG. 6 after the tube has been advanced over the
penetrator and into tissue, consistent with the present inventive
concepts.
[0063] FIG. 6B is a side sectional of the fluid delivery element of
FIGS. 6 and 6A after fluid has been injected into a layer of
tissue, consistent with the present inventive concepts.
[0064] FIG. 7 is a side sectional view of a fluid delivery element
comprising a needle with an internal lumen and positioned in a body
lumen, consistent with the present inventive concepts.
[0065] FIG. 8 is a side sectional view of a fluid delivery element
comprising a water jet including a nozzle and an internal lumen and
positioned in a body lumen, consistent with the present inventive
concepts.
[0066] FIG. 9 is a side sectional view of a fluid delivery element
comprising an iontophoretic fluid delivery assembly and positioned
in a body lumen, consistent with the present inventive
concepts.
[0067] FIG. 10 is a side sectional view of a distal portion of a
tissue expansion device comprising a side recess portion and
protected needle exit port, consistent with the present inventive
concepts.
[0068] FIG. 10A is a side sectional view of the tissue expansion
device of FIG. 10 after the device has been positioned proximate
tissue, consistent with the present inventive concepts.
[0069] FIG. 10B is a side sectional view of the tissue expansion
device of FIGS. 10 and 10A after a needle has been axially advanced
into the tissue, consistent with the present inventive
concepts.
[0070] FIG. 11 is a side sectional view of a distal portion of a
tissue expansion device comprising an end recess portion and
protected needle exit port, consistent with the present inventive
concepts.
[0071] FIG. 12 is a side sectional view of the distal portion of a
tissue expansion device comprising an endoscope and an advanceable
needle and positioned in a body lumen, consistent with the present
inventive concepts.
[0072] FIG. 13 is a side view of the distal portion of a tissue
expansion device comprising multiple needles and a fluid dispersion
manifold, consistent with the present inventive concepts.
[0073] FIG. 13A is a magnified view of the fluid dispersion
manifold of FIG. 13, consistent with the present inventive
concepts.
[0074] FIG. 13B is a magnified sectional view of a support arm of
FIG. 13, consistent with present inventive concepts.
[0075] FIG. 14 is a side sectional view of a distal portion of a
tissue expansion device comprising a spring-loaded needle injector,
consistent with the present inventive concepts.
[0076] FIG. 14A is a side sectional view of the distal portion of
the tissue expansion device of FIG. 14, after advancement of the
needle by the spring-loaded injector, consistent with the present
inventive concepts.
[0077] FIG. 15 is a side sectional view of a distal portion of a
tissue expansion device comprising a needle biased in a retracted
state, consistent with the present inventive concepts.
[0078] FIG. 15A is a side sectional view of the distal portion of
the tissue expansion device of FIG. 15, after advancement of the
needle, consistent with the present inventive concepts.
[0079] FIG. 16 is a side sectional view of a distal portion of a
tissue expansion device comprising a luminal occlusion assembly and
a fluid delivery element comprising a needle, each positioned in a
body lumen, consistent with the present inventive concepts.
[0080] FIG. 16A is a side sectional view of the luminal occlusion
assembly and fluid delivery element of FIG. 16, after the luminal
occlusion assembly has been brought into contact with tissue,
consistent with the present inventive concepts.
[0081] FIG. 16B is a side sectional view of the luminal occlusion
assembly and fluid delivery element of FIGS. 16 and 16A, after the
needle has been advanced into tissue, consistent with the present
inventive concepts.
[0082] FIG. 16C is a side sectional view of the luminal occlusion
assembly and fluid delivery element of FIGS. 16, 16A and 16B, after
a fluid has been advanced through an opening in the needle and into
the tissue, consistent with the present inventive concepts.
[0083] FIG. 17 is a side sectional view of a distal portion of a
tissue expansion device including a fluid delivery element with an
operator adjustable needle trajectory guide, consistent with the
present inventive concepts.
[0084] FIG. 17A is the tissue expansion device of FIG. 17 after the
adjustable guide has been rotated to cause the trajectory taken by
the needle to tend toward a distal end of the device, consistent
with the present inventive concepts.
[0085] FIG. 17B is the tissue expansion device of FIG. 17 after the
adjustable guide has been rotated to cause the trajectory taken by
the needle to tend toward a proximal end of the device, consistent
with the present inventive concepts.
[0086] FIG. 18 is a side sectional view of a fluid delivery element
comprising a needle with a side hole and positioned with the needle
penetrating into a second tissue layer of a body lumen, consistent
with the present inventive concepts.
[0087] FIG. 18A is a side sectional view of the fluid delivery
element of FIG. 18 after injected fluid has expanded the second
layer of tissue, consistent with the present inventive
concepts.
[0088] FIG. 18B is a side sectional view of the fluid delivery
element of FIGS. 18 and 18A, after the introduction into the body
lumen of a tissue manipulating assembly which has been brought into
contact with a luminal wall proximate the injection site,
consistent with the present inventive concepts.
[0089] FIG. 18C is a side sectional view of the fluid delivery
element and tissue manipulating assembly of FIG. 18B, after a force
has been applied to the luminal wall causing modification to the
tissue expansion, consistent with the present inventive
concepts.
[0090] FIG. 19 is a system for expanding tissue as well as for
ablating or otherwise treating target tissue, consistent with the
present inventive concepts.
DETAILED DESCRIPTION OF THE INVENTION
[0091] Reference will now be made in detail to the present
embodiments of the inventive concepts, examples of which are
illustrated in the accompanying drawings. Wherever practical, the
same reference numbers will be used throughout the drawings to
refer to the same or like parts.
[0092] It is an object of the present inventive concepts to provide
devices, systems, and methods to safely and effectively expand an
area of tissue, such as one or more layers of a portion of tubular
or solid tissue, such as tissue of an organ or tissue of the
gastrointestinal tract of a patient. The devices and systems of the
present inventive concepts include one or more fluid delivery
elements, such as needles or water jets configured to deliver one
or more fluids to the tissue to be expanded. Needles may comprise
hollow or partially hollow needles, such as needles with one or
more openings at the distal end and/or at a side wall location. One
or more visualization assemblies may be included, such as to allow
an operator to visualize or otherwise assess the tissue expansion
procedure. One or more tissue manipulation assemblies may be
included, such as to apply a force to enhance or otherwise modify
the tissue expansion.
[0093] In some embodiments, a vacuum or other negative pressure may
be used to manipulate tissue and/or to maintain proximity between a
portion of a tissue expansion device or assembly, and tissue. This
vacuum or other negative pressure can comprise a pressure below
another pressure, such as a pressure below the environment of the
patient, hereinafter referred to as a "vacuum" or "vacuum
pressure". The vacuum may be provided by one or more vacuum
sources, such as via one or more operator adjustable vacuum
sources.
[0094] In some embodiments, the tissue expansion is performed prior
to treatment of tissue, such as ablation of a target volume of
tissue. The devices and systems of the present invention may
further include one or more ablation devices, such as ablation
devices configured to treat a layer of tissue above a previously
expanded tissue layer, such as to prevent damage to one or more
tissue layers below the expanded tissue layer. In these
embodiments, the expanded tissue layer acts as a safety volume of
tissue, reducing the specificity of the ablation and/or protecting
the underlying tissue from damage.
[0095] Referring now to FIG. 1, a side view of a device for
expanding tissue is illustrated, including multiple fluid delivery
elements, consistent with the present inventive concepts. Device
100 includes handle 110, which is fixedly attached to a hollow
tube, outer sheath 109, typically a flexible tube made of one or
more biocompatible materials. Sheath 109 surrounds and slidingly
receives inner shaft 101, also typically a flexible tube made of
one or more biocompatible materials. Inner shaft 101 includes
distal end 102. In some alternative embodiments, device 100 does
not include sheath 109, and inner shaft 101 is fixedly attached to
handle 110. Attached on a distal portion of shaft 101 is expandable
assembly 130, typically a radially expandable and/or radially
compressible assembly such as an inflatable balloon, a flexible
basket or cage, or a series of radially deployable arms. In
alternative embodiments, assembly 130 can be directed or otherwise
brought to tissue through deflection, advancement or other
manipulation, with or without expansion, such as is described in
reference to FIGS. 6, 7, 8, 9, 10, 11, 12, 14, 15, 16, 17 and 18
herebelow. Expandable assembly 130 is configured to allow one or
more fluid delivery elements to be brought in proximity to tissue,
such as to penetrate tissue or otherwise be positioned to allow
fluid to be delivered to tissue and cause one or more layers of
tissues to expand. Expandable assembly 130 can include one or more
openings 131, such as openings 131a and 131b through 131n as shown.
Assembly 130 can be constructed and arranged to apply force to
tissue. Assembly 130 can be constructed and arranged to orient
fluid delivery elements 140 and/or openings 131, such as to
position openings 131 relatively perpendicular to luminal wall
tissue. The tissue may comprise one or more locations within a
patient's body, such as tissue comprising a body lumen such as one
or more portions of the gastrointestinal tract. Typical tissue
locations are described in detail in reference to FIGS. 3A, 3B and
3C herebelow.
[0096] Handle 110 can include a varied number of controls and/or
groups of controls configured to advance, deploy or otherwise
activate one or more assemblies or components of device 100.
Typical controls include one or more mechanical and/or electrical
controls such as knobs, levers, switches, solenoids and the like.
Controls may be connected to electrical wires such as to deliver
power to an assembly or component of device 100. Controls may be
connected to one or more mechanical linkages such as linkages
including advanceable and retractable shafts or cables, cams and
pivots. Controls can be configured to activate a hydraulic or
pneumatic supply.
[0097] Knob 114 is a control configured to be rotated to advance
and/or retract inner shaft 101 within outer sheath 109. In FIG. 1,
inner shaft 101 has been advanced such that expandable assembly 130
has exited sheath 109. Expandable assembly 130 may comprise an
assembly that is resiliently biased in the radially expanded
condition shown, such as an assembly comprising a Nitinol cage
biased in the radially expanded condition shown that expands at it
exits sheath 109. In these embodiments, retraction of shaft 101 can
be performed to draw expandable assembly 130 within sheath 109,
expandable assembly 130 being radially compressed during its
insertion into sheath 109. Alternatively, expandable assembly 130
may be deployable to the radially expanded condition after exiting
sheath 109, such as when expandable assembly 130 comprises a
balloon that can be inflated or a deployable cage or array of arms
that can be deployed by retraction of a shaft.
[0098] Handle 110 can include one or more controls 111, such as
controls 111a and 111b through 111n as shown, such as to
electrically and/or mechanically activate one or more components or
assemblies of device 100, such as to activate flow of fluid and/or
application of a vacuum, such as by activating one or more fluid
valves as described in reference to FIG. 19 herebelow. Handle 110
can include an array of knobs 112 and receiving slots 113, such as
knobs 112a and 112b through 112n and receiving slots 113a and 113b
through 113n. Knobs 112a and 112b through 112n are operably
connected to one or more linkages, not shown but configured to
individually or collectively control the advancement and retraction
of one or more fluid delivery elements 140, such as fluid delivery
elements 140a and 140b through 140n that advance through openings
131a and 131b through 131n, respectively. Alternatively or
additionally, one or more fluid delivery elements 140 may be
constructed and arranged to penetrate tissue by entering into an
opening 131, without exiting opening 131, such as when a vacuum is
applied to the opening 131 and tissue is drawn into opening 131, as
is described herebelow. A numerous range of vacuum pressure levels
can be applied, such as a vacuum of 5 to 45 cmHg below atmospheric
pressure, such as a vacuum between 5 and 20 cmHg below atmospheric
pressure. Fluid delivery elements 140 can be of numerous forms
configured to deliver fluid to tissue, including but not limited
to: a needle; a water jet comprising a nozzle; an iontophoretic
element; a porous element; and combinations of these. Knobs 112 can
be configured to allow axial travel of fluid delivery elements 140
through a range of distances, such as distances between 1 mm and 10
mm, or distances between 3 mm and 7 mm. In some embodiments, fluid
delivery extension is limited to a maximum of 10 mm or 7 mm. Fluid
delivery elements 140 can be advanced axially and/or radially. In
some embodiments, fluid delivery elements 140 are advanced axially
and radially, such as to radially advance to be proximate and/or
within (e.g. penetrating into) tissue. Alternatively, fluid
delivery elements 140 may be advanced into a protective recess,
such as the openings 131 described in reference to FIGS. 5, 5A, 5B,
5C, 10 and 11 herebelow, such as after tissue that has been drawn
via a vacuum into the recess.
[0099] In some embodiments, one or more adjustable mechanical stops
may be included, such as adjustable stop 118, configured to allow
an operator to limit the advancement of knob 112 to the right of
the page as shown. Handle 110 may include one or more markings
corresponding to the travel of fluid delivery elements 140 through
advancement of knobs 112, markings not shown. Magnitude of
advancement of fluid delivery elements 140, both linear distance as
well as radial displacement from a central axis, may be configured
to expand a first tissue layer, while avoiding expansion of a
second, deeper tissue layer. The fluid delivery elements 140 may be
constructed and arranged, and positioned, such as to expand a first
tissue layer, while avoiding expansion of a second, more shallow
tissue layer. The fluid delivery elements 140 may be configured to
penetrate (e.g. when in the form of a needle) and/or to cause fluid
to penetrate (e.g. when in the form of a water jet) tissue of
various properties and shapes. In some embodiments, a fluid
delivery element 140 is configured to penetrate the plicae of the
gastrointestinal tract.
[0100] Fluid delivery elements 140 may be of similar or dissimilar
types, such as in an embodiment in which fluid delivery element
140a is a needle and fluid delivery element 140b is a water jet.
Multiple fluid delivery elements 140 may be configured to deliver
fluid simultaneously and/or sequentially. Multiple fluid delivery
elements 140 may be connected to individual supplies of fluid, such
as fluid delivery tubes 121a and 121b through 121n, or one or more
fluid delivery elements 140 may be attached to a single supply of
fluid, such as is described in reference to FIG. 13 herebelow.
[0101] Fluid delivery elements 140 may comprise a symmetric
circumferential array of fluid delivery elements, such as an array
of 2, 3, 4, 5, 6, 7, 8, 9 or 10 fluid delivery elements 140. In
some embodiments, fluid delivery elements 140 can comprise a linear
or axial array of fluid delivery elements, such as an array of 2,
3, 4, 5, 6, 7, 8, 9 or 10 fluid delivery elements 140. In some
embodiments, multiple fluid delivery elements 140 can be in an
asymmetric pattern, along a single circumference or at varied axial
locations along device 100. Fluid delivery elements 140 may be
positioned singly, on or within two or more support arms of
expandable assembly 130, not shown but such as the support arms
described in detail in reference to FIGS. 4 and 5 herebelow.
Alternatively, multiple fluid delivery elements can be positioned
on or within a single support arm. Arrays of multiple fluid
delivery elements 140 may be arranged in a spiral pattern, and can
comprise a pre-deployment and/or post-deployment spiral pattern of
fluid delivery elements 140 that may be similar or different.
Spiral patterns of fluid delivery elements 140 can be positioned to
allow efficient compacting of an expandable assembly 130, such as
to be insertable into a small lumen of a body access device such as
an endoscope. Arrays of multiple fluid delivery elements 140 can be
configured to deliver fluid simultaneously or sequentially. Fluid
injections may comprise a single injection in a single location;
multiple injections in a single location (e.g. multiple injections
without repositioning assembly 130); or multiple injections in
multiple locations. Repositioning of assembly 130 between
injections can comprise axial advancement or retraction, as well as
rotation.
[0102] In some embodiments, a vacuum is applied to openings 131,
such as via a vacuum pump or other negative pressure source fluidly
attached to openings 131, such as via vacuum source 340 connected
to one or more internal components of handle 110 via connection 341
as shown. A vacuum can be applied to one or more lumens of handle
110 and/or shaft 101, not shown but lumens that are fluidly
connected to one or more lumens of connection 341, and then travel
distally to fluidly connect to one or more openings 131. Vacuum
applied to openings 131, or another opening of expandable assembly
130 or another component of device 100, can be used to maintain
contact with tissue and/or to manipulate tissue. In some
embodiments, the applied vacuum is constructed and arranged to
cause tissue to be drawn into openings 131, such as is described in
reference to FIGS. 5 and 10 herebelow. Alternatively or
additionally, vacuum source 340 can apply a vacuum to one or more
fluid delivery elements 140, such as vacuum intermittently applied
to one or more needles between fluid delivery periods. Vacuum
source 340 can provide a fixed vacuum and/or it may provide a
vacuum whose pressure or other performance parameter is adjustable
by an operator. In some embodiments, one or more of controls 111
may comprise a control configured to connect vacuum source 340 to
one or more of openings 131. In a particular embodiment, one or
more of controls 111 comprises a hole or other opening that is
fluidly connected to a lumen that fluidly connects vacuum source
340 and one or more openings 131. This opening of control 111
prevents any significant vacuum pressure from reaching the one or
more connected openings 131. However, covering of the opening of
control 111, such as by the finger of an operator, causes the
vacuum pressure to increase at the one or more associated openings
131, such as to cause tissue to be withdrawn into these one or more
openings 131.
[0103] In some embodiments, assembly 130, one or more fluid
delivery elements 140, and/or another component of device 100
comprise a flexibility and radial support that allow flexing
without luminal collapse, such that one or more fluid delivery
elements 140 can automatically translate radially (e.g. toward the
center of a lumen) as one or more tissue layers expand.
Alternatively or additionally, assembly 130, one or more fluid
delivery elements 140, and/or another component of device 100 may
be configured to manually be translated and/or radially compacted
to similarly translate radially as one or more tissue layers
expand.
[0104] In some embodiments, fluid delivery is performed during
advancement and/or retraction of one or more fluid delivery
elements 140. Alternatively or additionally, fluid delivery is
performed after one or more fluid delivery elements 140 are
positioned at a target tissue location. Fluid delivery elements 140
can comprise a component selected from the group consisting of: a
needle; a water jet; an iontophoretic element; and combinations of
these, such as those described in reference to FIGS. 7, 8 and 9 and
other figures described herebelow. Fluid delivery elements 140 are
shown in a retracted state in FIG. 1. The multiple fluid delivery
elements 140 and associated openings 131 may be distributed evenly
along a relatively singular axial location of shaft 101. For
example, two fluid delivery elements 140 may be separated by
180.degree., three fluid delivery elements 140 may be separated by
120.degree., four fluid delivery elements 140 may be separated by
90.degree., five fluid delivery elements 140 by be separated by
72.degree., and so on. In alternative embodiments, one or more
fluid delivery elements 140 and associated openings 131 can be
separated by different separation angles, and can be positioned at
a single axial position (i.e. a single circumferential pathway), or
along multiple axial locations.
[0105] Handle 110 may include or be attached to one or more sources
of fluid, such as reservoirs 125 including reservoir 125a and 125b
through 125n as shown. Reservoirs 125 may comprise a supply of
fluid, such as a liquid filled chamber, or they may comprise a
port, such as a luer, for attachment to a supply of fluid, such as
a fluid filled syringe. Fluid delivery elements 140a and 140b
through 140n are fluidly connected to fluid delivery tubes 121a and
121b through 121n respectively, such that fluid can be delivered
from each reservoir 125, through each associated fluid delivery
tube 121 to each respective fluid delivery element 140. While fluid
delivery tubes 121a and 121b through 121n are shown exiting the
side of handle 110, alternative exit points can be used including
exiting the distal end of handle 110 such as to ease in rotation of
handle 110.
[0106] Numerous forms of one or more fluids can be delivered
through fluid delivery elements 140 to expand tissue. The fluid may
comprise a liquid, a gas, or a combination of one or more liquids
and gases. In some embodiments, the injected fluid is selected from
the group consisting of: water; saline such as hypertonic saline;
air; CO.sub.2; one or more hydrogels; epinephrine; hypertonic
dextrose water; hyaluronic acid; glycerol solutions; and
combinations of these. In some embodiments, the injected fluid
comprises a colorant or is otherwise configured to be visible
during injection, such as via an endoscope camera or other
visualization device such that the tissue expansion can be
quantified or otherwise assessed. Typical fluids to be visualized
include but are not limited to: methylene blue; dye; radiopaque
fluid; MR visualizable fluid; ultrasonically visualizable fluid;
and combinations of these. The injected fluid may comprise a fluid
selected from the group consisting of: a magnetic fluid; a
hydrogel; a fluid configured to increase in viscosity after
injection; a fluid configured to decrease in viscosity after
injection; a fluid that is heated prior to injection such as a
mixture of glycerol and saline that is heated prior to injection; a
fluid with a similar osmolarity to the tissue in which it is being
injected; a fluid configured to act as an thermal or electrical
insulator; and combinations of these. Colored (e.g. non-clear)
fluids or fluids that change color may be injected. In some
embodiments, a liquid changes color due to a temperature change of
the fluid, such as to assess the presence or quantity of tissue
expansion. In some embodiments, a first color fluid is injected
during a first injection, and a second color fluid is injected
during a second injection, such as with the same or a different
fluid delivery element. In some embodiments, an injected fluid
provides a bioactive function, such as a bioactive function
selected form the group consisting of: sclerosant; an
anti-inflammatory agent; an antimicrotubule or other mitotic
inhibitors; an alkylating agent; an antimetabolite; an
anthracycline; a plant alkaloids; a topoisomerase inhibitor; an
anti-proliferative; and combinations of these.
[0107] Handle 110 may include or be attached to a functional
element, such as functional element 119 shown, which comprises a
functional element or assembly selected from the group consisting
of: a vacuum source; a hydraulic source; a pneumatic source; a
source of electrical energy such as a battery or a radiofrequency
energy generator; a rotating drive mechanism such as a drive
mechanism configured to rotate an imaging element such as an
ultrasound crystal or an optical fiber; and combinations of these.
Functional element 119 may be fluidly, electrically or otherwise
operably connected to one or more components of device 100, such as
an operably connection to fluid delivery elements 140, expandable
assembly 130, openings 131, and/or another component of device
100.
[0108] In some embodiments, device 100 comprises one or more
sensors 135, such as one or more sensors selected from the group
consisting of: a pressure sensor; a force sensor; a strain gauge;
an electrode; an impedance sensor; a visualization sensor such as
an ultrasound crystal, an optical visible light, OCT or OCDR fiber;
a light sensor array such as a CCD; a physiologic sensor; a
magnetic sensor; a light sensor; and combinations of these. In some
embodiments, a pressure sensor is included, such as to monitor
pressure of tissue expansion. Sensor 135 may be used to perform a
diagnostic, such as in a diagnostic assembly in combination with
one or more components integral to or external to handle 110, such
as one or more electronic components configured to analyze a signal
received from sensor 135 and produce a diagnostic output. Sensor
135 can be used to quantify or otherwise assess one or more of:
amount of tissue expansion; current tissue thickness (e.g. pre,
during and/or post expansion); tissue layer thickness; penetration
distance of a fluid delivery element; color density of an injected
fluid; impedance of tissue; temperature of tissue such as
temperature of tissue that has received a heated or chilled fluid
via a needle such as needle 141 of FIGS. 4-4B; and combinations of
these. Alternatively or additionally, sensor 135 may comprise a
transducer, such as a transducer selected from the group consisting
of: a heat transducer; a cooling transducer; a source of light such
as an LED; and combinations of these.
[0109] Device 100 may be configured to be advanced through a
separate body introduction device, such as an endoscope in which
device 100 is introduced through a lumen also known as a "working
channel" of the endoscope. In these embodiments, device 100 may not
include outer sheath 109, and shaft 101 may be fixedly attached to
handle 110. Expandable assembly 130 can be expanded automatically
or manually, as it exits or after it exits, respectively, the
distal end of the endoscope. Device 100 is introduced such that
fluid delivery elements 140 are in proximity to one or more tissue
layers to be expanded, such as the tissue described in reference to
FIGS. 3A, 3B and 3C herebelow. Shaft 101 may comprise a diameter
configured for insertion through lumen of a limited size, such as a
shaft with a maximum diameter or otherwise configured to be
inserted through a lumen with a diameter less than or equal to 6
mm. In some embodiments, shaft 101 is inserted into a patient's
anatomy along the side of an endoscope, such as when shaft 101 has
a relatively continuous diameter of approximately 8 mm or less. In
other embodiments, shaft 101 is inserted into the patient anatomy
void of an endoscope, such as when shaft 101 has a relatively
continuous diameter of approximately 13 mm or less.
[0110] Shaft 101 may comprise an insertable or "working" length
configured to provide access to one or more body locations such as
one or more gastrointestinal body locations. In some embodiments,
device 100 is configured to expand tissue in the esophagus and
shaft 101 is configured to be inserted through the mouth and have a
working length of greater than or equal to approximately 25 cm. In
some embodiments, device 100 is configured to expand tissue in the
stomach and shaft 101 is configured to be inserted through the
mouth and have a working length of greater than or equal to
approximately 35 cm. In some embodiments, device 100 is configured
to expand tissue in the duodenum and shaft 101 is configured to be
inserted through the mouth and have a working length of greater
than or equal to approximately 100 cm. In some embodiments, device
100 is configured to expand tissue in the jejunum and shaft 101 is
configured to be inserted through the mouth and have a working
length of greater than or equal to approximately 140 cm. In some
embodiments, device 100 is configured to expand tissue in the ileum
and shaft 101 is configured to be inserted through the mouth and
have a working length of less than or equal to approximately 300
cm. Device 100 may be configured for delivery over a guidewire,
such as via a lumen along the majority of length of shaft 101 (such
as is described in reference to FIG. 4 herebelow), or via a sidecar
lumen configured for rapid exchange guidewire delivery, such as is
described in reference to FIG. 10 herebelow. Device 100 can include
one or more markers, not shown, but typically comprising one or
more markers selected from the group consisting of: radiopaque
markers; electromagnetic markers; ultrasonically visible markers;
and combinations of these.
[0111] Referring now to FIG. 1A, knobs 112 have each been advanced
to the right of the page as shown, such as to individually cause
fluid delivery elements 140a and 140b through 140n to exit openings
131a and 131b through 131n, respectively. In an alternative
embodiment, one or more knobs 112 are configured to advance two or
more fluid delivery elements 140. The amount of extension of each
fluid delivery element 140 may be controlled manually and/or
automatically by the amount of advancement of knob 112, such as to
control depth of penetration of fluid delivery element 140 into
tissue. Handle 110 can include one or more markings, not shown but
delineated to indicate axial advancement and/or radial displacement
of each fluid delivery element 140. One or more needle stops can be
included to ensure precise advancement of each fluid delivery
element 140, needle stops not shown but such as those described in
reference to FIG. 10 herebelow.
[0112] In some embodiments, sheath 109, shaft 101, expandable
assembly 130 and/or another component of device 100 is constructed
and arranged to be displaced as tissue is expanded, such as a
radial displacement toward the center of a lumen such as a lumen of
the duodenum. Alternatively or additionally, expandable assembly
130 and/or another component of device 100 may be constructed and
arranged to radially compress as tissue is expanded.
[0113] Referring now to FIG. 2, a flow chart of a method for tissue
expansion is illustrated, consistent with the present inventive
concepts. In STEP 200, a tissue expansion device of the present
inventive concepts is inserted into a patient, such as a patient
receiving a gastrointestinal diagnostic or therapeutic procedure.
The tissue expansion device may be inserted through a lumen of a
body access device, such as an endoscope. Alternatively or
additionally, the tissue expansion device may be inserted over a
guidewire, such as a guidewire passing through a lumen of the
device, or a rapid exchange segment near the distal end of the
tissue expansion device.
[0114] In STEP 210, one or more fluid delivery elements of the
tissue expansion device are positioned in proximity to tissue to be
expanded. This positioning may be performed using a visualization
apparatus, such as a visualization apparatus selected from the
group consisting of: an imaging device integral to or inserted
through an endoscope; an imaging assembly integral to the tissue
expansion device; an imaging device external to the patient such as
a fluoroscope, a CT scanner, an MR scanner; an ultrasound imager;
an imaging device inserted into the patient, such as a visual
camera and/or an ultrasound probe or catheter; and combinations of
these.
[0115] In STEP 220, an optional step is performed in which one or
more fluid delivery elements of the tissue expansion device are
advanced, such as an advancement in which the one or more fluid
delivery elements make contact with tissue and/or penetrate an
outer layer of tissue. In some embodiments, the one or more fluid
delivery elements penetrate the mucosal layer of the
gastrointestinal tract and enter the submucosal layer, such as in a
segment of the duodenum. In some embodiments, an expandable
assembly including one or more fluid delivery elements may be
expanded, typically during or prior to the performance of STEP 220,
such as to contact luminal wall tissue such as luminal wall tissue
of the duodenum. The expandable assembly can be resiliently biased
in a radially expanded state, such as a resiliently biased basket
or cage supporting one or more fluid delivery elements and attached
fluid delivery tubes. Alternatively or additionally, STEP 220 may
include a tissue manipulation step in which tissue is moved, such
as a movement toward a fluid delivery element and/or into an
opening. In some embodiments, vacuum is applied to a port or other
opening, such as to draw tissue into the opening, such as is
described in reference to FIGS. 10, 10A and 10B herebelow. Once
positioned in the opening, a fluid delivery element can be advanced
and/or fluid delivered to the captured tissue. The applied vacuum
and opening size can be constructed and arranged to preferentially
move certain tissue into the opening, such as to preferentially
move one or more inner layers of tissue into the opening while
avoiding one or more deeper layers being moved into the opening. In
some embodiments, mucosal and submucosal tissue layers are drawn
into the opening while the muscularis layer remains outside the
opening or is otherwise positioned to avoid being expanded by the
fluid delivery element. After application of the vacuum, one or
more other tissue manipulations may be performed (e.g. to "tent"
the tissue), such as via advancement, retraction and/or rotation of
the tissue expansion device and/or a component of the device.
[0116] In STEP 230, one or more fluids are delivered by the one or
more fluid delivery elements, into tissue, to cause one or more
layers of the tissue to expand. In some embodiments, one or more
fluid delivery elements are moved (e.g. advanced or retracted),
during the fluid delivery of STEP 230. Fluid is delivered through
one or more fluid delivery tubes of the tissue expansion device, to
the one or more fluid delivery elements. The one or more fluid
delivery tubes can be attached to one or more sources of fluids,
such as one or more syringes, pumping assemblies and/or reservoirs
of fluids.
[0117] In STEP 240, an optional step of assessing tissue expansion
is performed. The tissue expansion assessment can be performed
using one or more visualization devices as has been described
above, such as a device used in a visualization procedure performed
at a time after fluid injection, such as 10, 20 or 30 seconds after
fluid injection has initiated or ceased. In some instances, a
visualization procedure may be performed at a time immediately
prior to the performance of an ablation procedure, such as 15, 30,
or 45 minutes after fluid injection has initiated or ceased. If
insufficient expansion is achieved, an optional STEP 245 may be
performed, in which one or more fluid delivery elements are
retracted, and one or more portions of the tissue expansion device
is repositioned. STEP 245 may include various repositioning
maneuvers including but not limited to: rotating a shaft of the
fluid delivery device and/or a support structure containing one or
more fluid delivery elements; advancing one or more fluid delivery
elements axially and/or radially; retracting one or more fluid
delivery elements axially and/or radially; and combinations of
these. STEP 245 may further include advancing fluid delivery
elements, such as the advancement described in reference to STEP
220 hereabove, such as when one or more fluid delivery elements
were previously retracted during STEP 245. STEP 230 is subsequently
repeated, with or without the retraction and/or repositioning of
STEP 245, in which one or more fluids are injected into tissue to
cause expansion of one or more layers of tissue. The optional step
of STEP 240 can be subsequently repeated, assessing the sufficiency
of tissue expansion.
[0118] STEP 250 is performed after the injection of fluid into
tissue in STEP 230, with or without the assessment performed in
STEP 240 and/or the repositioning performed in STEP 245. In STEP
250, the fluid delivery device can be removed, remain in place for
subsequent tissue expansion at a later time, or relatively
immediately be advanced to a new tissue expansion location, such as
by returning to STEP 210 and repeating STEPS 210 through 250 as
illustrated.
[0119] The tissue expansion methods of the present inventive
concepts may comprise a single step of injecting fluid, such as
from one or more fluid delivery elements. Alternatively, the tissue
expansion may be performed with multiple fluid injection steps,
such as a first injection at a first location, followed by a second
injection at a different location. The tissue expansion devices and
their assemblies are typically configured to be rotated, such as to
inject at multiple tissue locations along a relatively uniform
circumference of luminal wall tissue. Fluid may be injected by
multiple fluid delivery elements simultaneously and/or
sequentially.
[0120] The fluid injected to cause tissue expansion may be of a
pre-determined volume, such as a pre-determined volume per
injection and/or cumulative volume of multiple injections delivered
to a single site (e.g. a single injection of a needle or an amount
of fluid delivered by a water jet's nozzle to a single location).
In some embodiments, this pre-determined volume of fluid per
injection and/or site comprises a volume of 0.5 ml to 4.0 ml, or
1.0 ml to 3.0 ml. These pre-determined volumes may be injected at
different sites, such as between 2 to 10 sites along a relative
circumference of luminal wall tissue. Complete tissue expansion can
comprise one or more axial and/or circumferential injections,
performed simultaneously and/or sequentially. Injections may be
performed by one or more fluid delivery elements, such as two or
more fluid delivery elements delivering fluid simultaneously and/or
sequentially. Between injections, the tissue expansion device can
be axially advanced and/or retracted, and it can be rotated. In
some embodiments, fluid is delivered at a first location causing
tissue expansion in a first expansion location. A second injection
can be performed proximate the first expansion location, such as
proximate an edge of the first expansion location. Repeated
injections proximate previously expanded locations can be used to
ease injection as well as reduce likelihood of perforation or
failed tissue expansion.
[0121] Referring now to FIGS. 3A, 3B and 3C, sectional side and end
views of a segment of luminal wall tissue are illustrated, prior
to, during and after full circumferential tissue expansion,
respectively, consistent with the present inventive concepts. In
FIG. 3A, a side and end sectional view of a segment of luminal wall
tissue includes inner layer L1, mid layer L2 and outer layer L3,
prior to any expansion by a tissue expansion device of the present
inventive concepts. In FIG. 3B, a tissue expansion has occurred at
a single location toward the top of the page as shown, within
tissue layer L2. In FIG. 3C, a tissue expansion has occurred for a
full 360.degree. segment of layer L2. In some embodiments, a full
or near full circumferential expansion (e.g. greater than
approximately 300.degree. of tissue expansion, greater than
approximately 320.degree. of tissue expansion, or greater than
approximately 330.degree. of tissue expansion), is performed in a
relatively single step, such as from multiple fluid delivery
elements. In other embodiments, a full or near full circumferential
expansion is performed in multiple steps, such as from one or more
fluid delivery elements that are configured to inject fluid in a
first step and be rotated in one or more subsequent steps, each
rotation followed by an injection of fluid into tissue.
[0122] The expansion of a tissue layer, such as layer L2 of FIGS.
3A through 3C, may be performed to cause a reduction in cross
sectional area of the lumen, such as a reduction to 85% of the
pre-expansion cross sectional area (e.g. a 35 mm lumen reduced to a
30 mm lumen), or a reduction to 75% of the pre-expansion
cross-sectional area. Some body lumens comprise an inner layer
including a non-smooth surface, such as the lining of the duodenum
or jejunum including one or more folds known as the plicae. In some
embodiments, the tissue expansion causes folds such as plicae to be
smoothed and/or widened. This modification can be useful in
subsequent treatments of the lumen's inner lining, such as to
improve the results of one or more ablation procedures.
[0123] Numerous forms and locations of patient tissue can be
expanded by the devices, systems and methods of the present
inventive concepts. In some embodiments, the tissue to be expanded
comprises submucosal tissue, such as submucosal tissue of the
duodenum. The devices systems and methods of the present inventive
concepts may be constructed and arranged to avoid expanding one or
more layers of tissue, such as when the muscularis or serosal layer
of the duodenum is prevented from being expanded. Applicable tissue
may comprise luminal wall tissue or other tissue layers. Applicable
tissue locations to be expanded can include luminal wall tissue
selected from the group consisting of: a gastrointestinal tissue
layer; a duodenal tissue layer; an esophageal tissue layer; a
jejunal tissue layer; an ileal tissue layer; a colonic tissue
layer; and combinations of these. Alternatively or additionally,
tissue to be expanded may comprise tissue selected from the group
consisting of: a stomach tissue layer; a bladder tissue layer; an
oral cavity tissue layer; a uterine tissue layer; and combinations
of these.
[0124] Referring now to FIG. 4, a side view of a distal portion of
a tissue expansion device is illustrated, including a manually
deployable expandable assembly, consistent with the present
inventive concepts. A tissue expansion device, such as a tissue
expansion device similar to device 100 of FIG. 1, includes an
expandable assembly 130 in a pre-deployment (e.g. prior to radial
expansion) state. Expandable assembly 130 is shown to have been
axially advanced to exit sheath 109, such as via one or more
controls on a handle mounted on the proximal end of sheath 109. In
some embodiments, sheath 109 comprises an endoscope, such as when
expandable assembly 130 is advanced through a working channel of
the endoscope. Expandable assembly 130 comprises at least two
support arms, arms 132a and 132b typically a hollow or partially
hollow tube such as a metal tube or a plastic tube. Arms 132a and
132b include openings 131a and 131b, respectively. The distal ends
of arms 132a and 132b are attached to a control cable, cable 103,
typically a metal or non-metallic cable which travels proximally
and attaches to one or more controls on a proximal handle, such as
those described in reference to handle 110 of FIG. 1 and configured
to advance or retract cable 103. Cable 103 can comprise a hollow
tube, such as a cable including a guidewire lumen 105, configured
to allow over-the-wire delivery of expandable assembly 130 and
sheath 109.
[0125] Two fluid delivery elements, needles 141a and 141b are shown
positioned within arms 132a and 132b, respectively. Needles 141a
and 141b typically comprise metal needles, such as needles with a
gauge between 20 and 35 gauge, or between 23 and 27 gauge. Needles
141a and/or 141b may comprise a beveled end, such as an end with a
bevel angle between 10.degree. and 60.degree., such as a bevel
angle of approximately 30.degree.. Needles 141a and 141b are
fluidly attached to one or more fluid delivery tubes, such as fluid
delivery tubes 121 described in reference to FIG. 1, such that one
or more fluids can be delivered to needles 141a and 141b via the
fluid delivery tubes. Needles 141a and/or 141b may comprise a
particular sharpness or other penetration characteristic such as to
preferably penetrate one form of tissue, such as the submucosa,
while avoiding or minimizing penetration of a deeper layer of
tissue, such as the muscularis or serosal layers. Needles 141a
and/or 141b may be constructed and arranged to be advanced to an
exposed length of less than 10 mm, such as less than 7 mm. Needles
141a and 141b may be constructed and arranged to remain within
openings 131a and 131b, respectively, as is described in reference
to FIGS. 5 and 10 herebelow. Vacuum can be applied to openings 131a
and 131b such as to draw tissue toward and/or into openings 131a
and 131b. Alternatively or additionally, needles 141a and 141b may
be constructed and arranged to advance out of openings 131a and
131b, respectively, as is described in reference to FIG. 4B
herebelow.
[0126] Referring now to FIG. 4A, cable 103 has been retracted such
that the mid portions of arms 132a and 132b extend radially from
the axis of sheath 109. Openings 131a and 131b correspondingly
extend radially as shown. Needles 141a and 141b remain in the
pre-deployed position shown.
[0127] Referring now to FIG. 4B, needles 141a and 141b have been
advanced to exit openings 131a and 131b, such that when expandable
assembly 130 is positioned against tissue, such as luminal wall
tissue, needles 141a and 141b penetrate into one or more tissue
layers. Advancement of needles 141a and 141b may be done in
combination or independently, such as via one or more controls on a
proximal handle, not shown but such as is described in reference to
handle 110 of FIG. 1. In alternative embodiments, needles 141a and
141b do not exit openings 131a and 131b, respectively, during
advancement, such as is described in reference to the tissue
expansion devices of FIGS. 5 and 10 herebelow. In these
embodiments, a vacuum is applied to draw tissue into openings 131a
and 131b and needles 141a and 141b penetrate the captured tissue
when advanced.
[0128] Referring now to FIG. 5, a side and end view of a distal
portion of a tissue expansion device are illustrated, including a
self-expanding assembly, consistent with the present inventive
concepts. A tissue expansion device, such as a tissue expansion
device similar to device 100 of FIG. 1, includes an expandable
assembly 130 in a deployed (e.g. a radially expanded) state.
Expandable assembly 130 is attached to the distal end of shaft 101,
which has been axially advanced to exit sheath 109, such as via one
or more controls on a handle mounted on the proximal end of sheath
109. In some embodiments, sheath 109 comprises an endoscope, such
as when expandable assembly 130 is advanced through a working
channel of the endoscope. Expandable assembly 130 comprises at
least three support arms, such as three support arms comprising
proximal segments 133a, 133b and 133c, and attached distal segments
134a, 134b and 134c respectively. Proximal segments 133a, 133b and
133c are typically a hollow or partially hollow tube such as a
metal tube or a plastic tube, and configured to slidingly receive a
fluid delivery element and include openings 131a, 131b and 131c,
respectively. Distal segments 134a, 134b and 134c are typically
resiliently biased in the orientation shown in FIG. 5, such as to
cause expandable assembly 130 to be in a radially expanded
condition when not surrounded by a compressing tube, such as sheath
109. Expandable assembly may be constructed of a resiliently biased
metal, such as stainless steel and/or Nitinol that is resiliently
biased in an expanded or contracted geometry. In some embodiments,
assembly 130 is configured to transition to a radially compacted
state, such as when inserted within a lumen of a tube such as
sheath 109 and/or a working channel of an endoscope. Distal
segments 134a, 134b and 134c can comprise an elastic, biocompatible
material such as Nitinol or stainless steel formed in a curved
orientation. Distal segments 134a, 134b and 134c may comprise a
flat sheet material or a round tube. The distal end of distal
segments 134a, 134b and 134c are attached to tip 139 which
surrounds and maintains the position of the distal end of segments
134a, 134b and 134c. In alternative embodiments, distal segments
134a, 134b and 134c may be fabricated of a single sheet or
otherwise fabricated such that their distal ends are connected,
with or without a tip 139. Tip 139 may be covered by an atraumatic
material, such as silicone or other biocompatible polymer.
[0129] Each proximal segment 133a, 133b and 133c contains a single
fluid delivery element, needle 141a, 141b and 141c, respectively.
Needles 141a, 141b and 141c are each attached to a single fluid
delivery tube, 121a, 121b and 121c, respectively. In some
embodiments, each fluid delivery tube travels proximally to a
handle, such as to be attached to individual supplies of fluid for
injection into tissue, such as reservoirs 125a, 125b and 125c,
respectively described in reference to FIG. 1. In other
embodiments, one or more of fluid delivery tubes 121a, 121b and/or
121c fluidly attach to each other, such as to attach to a source of
fluid, such that fluid is simultaneously injected through one or
more of fluid delivery tubes 121a, 121b and/or 121c. In some
embodiments, a vacuum is applied, such as via a proximal handle
port, such as a vacuum applied at one or more of openings 131a,
131b and 131c, around needles 141a, 141b and 141c, respectively,
such as through a vacuum delivery tube, such as is described in
reference to FIGS. 5A and 5C herebelow. Applied vacuum may be
configured to maintain tissue position during penetration of tissue
by needles 141a, 141b and/or 141c, and/or to manipulate tissue into
openings 131a, 131b and 131c for subsequent needle advancement. In
some embodiments, a second opening is provided on one or more of
support arms 133a, 133b and/or 133c, openings not shown but
configured to be fluidly attached to a source of vacuum and to
apply one or more forces to tissue.
[0130] Referring now to FIG. 5A, a side sectional view of a segment
of a support arm of a tissue expansion device is illustrated,
consistent with the present inventive concepts. A fluid delivery
element is shown in an advanced position and a support member
surrounds the fluid delivery element. A segment of a support arm
133 is shown, such as a segment of proximal support arm 133a, 133b
and/or 133c of FIG. 5. Support arm 133 comprises two lumens, lumen
107 and lumen 108, and may be constructed of a rigid or flexible
material, such as a metal material such as stainless steel or
Nitinol, or a plastic material such as a Pebax.RTM. with a
durometer between 50 D and 80 D. Lumen 108 slidingly receives
needle 141. The distal end of fluid delivery tube 121 is fluidly
and mechanically attached to the proximal end of needle 141, such
as via a sealed bond and/or frictionally engaging interface (e.g.
the interface between a proximal outer diameter portion of needle
141 and a distal inner diameter portion of tube 121). This
attachment provides a fluid seal yet allows fluid to pass through
fluid delivery tube 121 into needle 141. Needle 141 is constructed
and arranged to be advanced into a recess in support arm 133,
opening 131, such as to the advanced position shown. Needle 141 can
comprise a needle between 25 and 30 gauge, such as a 27 gauge
stainless steel needle with a beveled tip. Fluid delivery tube 121
can comprise a flexible shaft, such as a shaft comprising a plastic
material including a braid, such as a polyimide shaft including a
stainless steel braid.
[0131] On its proximal end, lumen 107 is fluidly attached to an
operator activatable supply of vacuum, not shown but such as vacuum
source 340 of FIG. 1. Lumen 107 is fluidly attached on its distal
end to opening 131. Opening 131 can comprise sloped side walls 231,
such as to cause tissue drawn into opening 131 to have a preferred
shape and/or a preferred array of tensional force vectors imparted
on the tissue. In use, needle 141 is in a retracted state (e.g. not
entering opening 131), and a vacuum can be applied to opening 131.
After tissue is drawing into opening 131, needle 141 is advanced
(to the right of the page) to the position shown in FIG. 5A,
penetrating tissue and ready for fluid to be delivered through
fluid delivery tube 121 to expand one or more tissue layers drawing
the tissue into opening 131.
[0132] A support and/or guiding element, ferrule 149 may be
included to provide support to needle 141 as it penetrates tissue.
Ferrule 149 can be configured to prevent undesired rotation,
bending and or twisting to needle 141, such as when needle 141 is
advanced into tissue. Ferrule 149 can comprise a round tube that is
bonded to or frictionally engages a distal portion of needle 141.
Ferrule 149 can comprise an outer diameter that approximates the
inner diameter of lumen 108, such as when ferrule 149 comprises an
outer diameter between 0.020'' and 0.036'' (e.g. a diameter
approximating 0.028''), and lumen 108 comprises a diameter between
0.027'' and 0.043'' (e.g. a diameter approximating 0.035'').
Ferrule 149 can comprise a tubular construct with a length between
1.5 mm and 2.5 mm, such as a length approximating 2.0 mm. Ferrule
149 can comprise a rigid material such as a metal such as stainless
steel. Ferrule 149 can be axially positioned on needle 141 such
that a majority of ferrule 149 remains within lumen 108 as the
distal end of needle 141 travels axially to the position shown in
FIG. 5A.
[0133] Referring now to FIG. 5B, a top view of an opening of a
support arm of a tissue expansion device is illustrated, with a
fluid delivery element in an advanced position, consistent with the
present inventive concepts. A segment of a support arm 133 is
shown, such as a segment of proximal support arm 133a, 133b and/or
133c of FIG. 5, and/or a segment of support arm 133 of FIG. 5A.
Support arm 133 slidingly receives fluid delivery tube 121 and
needle 141. Needle 141 is constructed and arranged to be advanced
into a recess in support arm 133, opening 131, such as to the
advanced position shown. Opening 131 can comprise sloped walls 231
such as to cause tissue drawn into opening 131 to have a preferred
shape and/or a preferred array of tensional force vectors imparted
on the tissue. Needle 141 and support shaft 133 can be constructed
and arranged to maintain the relatively aligned position shown in
FIG. 5B (e.g. aligned to a central axis of support arm 133 and/or
opening 131), such as when needle 141 is advanced through tissue
drawn into opening 131. Alignment can be achieved through a needle
support and/or aligning component, such as ferrule 149 of FIG. 5A.
In some embodiments, one or more components of the tissue expansion
device, such as one or more of needle 141 and support arm 133, are
constructed and arranged such that when needle 141 is fully
advanced, the opening in the distal end of needle 141 is centered
in opening 131, as is shown in FIG. 5B. Control of this positioning
can be accomplished through the use of a needle stop, such as is
described in reference to FIG. 10 herebelow and/or via one or more
controls integral to a handle, such as handle 110 and associated
controls described in reference to FIG. 1 hereabove.
[0134] In some embodiments, opening 131 comprises an axial length
of approximately 4 mm, and needle 141 is constructed and arranged
such that 3 mm of length resides in opening 131 when needle 141 is
fully advanced, and the opening in the end of needle 141 is
centered in opening 131 as shown. In some embodiments, opening 131
comprises an axial length up to 5 mm. In some embodiments, opening
131 comprises a width up to 2 mm.
[0135] Referring now to FIG. 5C, a perspective view of an
alternative opening of a support arm is illustrated, consistent
with the present inventive concepts. A segment of a support arm 133
is shown, such as a segment of proximal support arm 133a, 133b
and/or 133c of FIG. 5. Support arm 133 includes lumen 108 which is
configured to slidingly receive a fluid delivery tube and a fluid
delivery element such as a needle, fluid delivery tube and fluid
delivery element removed for illustrative clarity. Support arm 133
can comprise a diameter between 0.070'' and 0.100'', such as a
diameter approximating 0.090''. Support arm 133 may be constructed
of a rigid or flexible material, such as a metal material such as
stainless steel or Nitinol, or a plastic material such as a
Pebax.RTM. material. Lumen 108 can comprise a circular cross
section, as is shown in FIG. 5C, such as a circular cross section
with a diameter between 0.020'' and 0.040'', or approximately
0.035''. Support arm 133 further includes lumen 107, which is
configured to be fluidly attached to a supply of vacuum pressure
such as vacuum pressure supplied by an operator adjustable vacuum
source, such as vacuum source 340 of FIG. 1. Lumen 107 fluidly
applies the vacuum to a recess or opening in support arm 133, such
as opening 131', such as to cause tissue to be drawn into opening
131'. Lumen 107 may comprise a crescent shaped cross section, as is
shown in FIG. 5C. Opening 131' is further constructed and arranged
to receive a fluid delivery element such as a needle.
[0136] Opening 131' comprises projections 232 along the side walls
of opening 131' such as projections configured to limit the amount
of tissue drawn into opening 131' when a vacuum is applied to
opening 131' via lumen 107. In some embodiments, projections 232
are constructed and arranged to allow sufficient tissue to be drawn
into opening 131' such that one or more fluids delivered by a fluid
delivery element such as a needle into tissue, causes tissue
expansion to occur in a submucosal layer of gastrointestinal
tissue, while avoiding expansion of deeper layers such as the
muscularis or serosal layers. Additionally, opening 131' comprises
sloped walls 231 such as to cause tissue drawn into opening 131' to
have a preferred shape and/or a preferred array of tensional force
vectors imparted on the tissue.
[0137] Referring now to FIG. 6, a side sectional view of a fluid
delivery element comprising a penetrator and an atraumatic
surrounding tube is illustrated, consistent with the present
inventive concepts. Fluid delivery element 141 has been positioned
in a lumen of tissue, such as a lumen of the duodenum or other
gastrointestinal lumen. The tissue comprises multiple layers, such
as innermost layer L1, deeper layer L2 and yet deeper layer L3. In
some embodiments, L1 comprises a mucosal layer, L2 comprises a
submucosal layer, and L3 comprises a muscular layer with or without
an overlying serosal layer. Fluid delivery element 141 comprises a
hollow tube 144 that includes a rounded or otherwise atraumatic
distal end 145, which slidingly receives a sharpened tube,
penetrator 143, typically a hollow or solid tube, such as a
metallic hypotube with a sharpened distal end. Tube 144 includes a
hole in its wall, opening 142, positioned relatively proximate end
145. Tube 144 and penetrator 143 are sized such that fluid can be
delivered in the space between tube 144 and penetrator 143, such as
via one or more fluid delivery tubes, not shown but traveling
proximally and fluidly connected to a supply of injectable fluid,
such as is described in reference to FIG. 1 hereabove. Fluid can be
delivered to tissue out of the distal end of tube 144 and/or via
opening 142, such as when the distal end of tube 144 is occluded,
such as by a less expansive layer of deeper tissue.
[0138] Fluid delivery element 141 is configured to allow initial
penetration into tissue by penetrator 143, after which tube 144 can
be advanced into tissue, as is illustrated and described in
reference to FIGS. 6A and 6B herebelow. In FIG. 6, penetrator 143
has been advanced through tissue layer L1 and into tissue layer L2.
Injection of fluid during advancement of tube 144 while penetrator
143 is also advanced (as in FIG. 6) can be performed, with fluid
preferentially exiting through port 142, causing tissue expansion
of layer L2 during advancement.
[0139] Referring now to FIG. 6A, tube 144 has been advanced, over
penetrator 143, through tissue layer L1 and into tissue layer L2.
Penetrator 143 is positioned, via advancement of tube 144 and/or
retraction of penetrator 143, such that the distal end of
penetrator 143 is contained within tube 144, such as to prevent
further advancement of fluid delivery element 141 into deeper
layers of tissue such as into tissue layer L3.
[0140] Referring now to FIG. 6B, fluid has been injected in the
space between penetrator 143 and tube 144, such as to exit the
distal end 145 of tube 144 and/or through opening 142, causing
tissue layer L2 to expand.
[0141] Referring now to FIG. 7, a side sectional view of a fluid
delivery element comprising a needle with an internal lumen is
illustrated, consistent with the present inventive concepts. Fluid
delivery element 140' has been positioned in a lumen of tissue,
such as a lumen of the duodenum or other gastrointestinal lumen.
The tissue comprises multiple layers, such as innermost layer L1,
deeper layer L2, and yet deeper layer L3. Fluid delivery element
140' comprises a needle 141, including a lumen 147. Needle 141
comprises a sharpened distal tip 146, typically comprising a
beveled end, and may be configured to be operably advanceable from
shaft 101, such as via one or more controls on a proximal handle,
as is described in reference to FIG. 1 hereabove. Needle 141 can be
constructed and arranged to be rotated (e.g. when retracted), such
as to perform multiple fluid delivery events around a circumference
of tissue, such as to create a full or near full circumferential
tissue expansion. Lumen 147 is fluidly connected to one or more
fluid delivery tubes, not shown but traveling proximally and
fluidly connected to a supply of injectable fluid. Fluid can be
delivered to tissue out of distal end 146 of needle 141, such as
via one or more controls on a proximal handle or on a device
connected to a proximal handle, such as is described in reference
to FIG. 1 hereabove.
[0142] Referring now to FIG. 8, a side sectional view of a fluid
delivery element comprising a water jet including a nozzle and an
internal lumen is illustrated, consistent with the present
inventive concepts. Fluid delivery element 140'' has been
positioned in a lumen of tissue, such as a lumen of the duodenum or
other gastrointestinal lumen. The tissue comprises multiple layers,
such as innermost layer L1, deeper layer L2 and yet deeper layer
L3. Fluid delivery element 140'' comprises a nozzle 148, fluidly
connected to lumen 147. Nozzle 148 can be configured to allow a
high-pressure delivery of fluid, injectate 150, shown in a
collimated stream comprising sufficient pressure to penetrate one
or more tissue surfaces, such as to deliver tissue to a deeper
layer of tissue, such as a water nozzle as is used in the Erbejet 2
manufactured by Erbe Elektromedizin GmbH of Tubingen, Germany.
Nozzle 148 can be configured to be operably advanceable from shaft
101, such as via one or more controls on a proximal handle, as is
described in reference to FIG. 1 hereabove. Nozzle 148 can be
constructed and arranged to be rotated, such as to perform multiple
fluid delivery events around a circumference of tissue, such as to
create a full or near full circumferential tissue expansion. While
nozzle 148 is shown in an orientation along the axis of shaft 101,
nozzle 148 can be oriented off-axis, such as at an angle between 10
and 179.degree., typically between 10.degree. and 170.degree..
While nozzle 148 is shown as a single nozzle, multiple nozzles can
be employed. Lumen 147 is fluidly connected to one or more fluid
delivery tubes, not shown but traveling proximally and fluidly
connected to a supply of injectable fluid. Fluid can be delivered
to tissue from nozzle 148, such as via one or more controls on a
proximal handle or on a device connected to a proximal handle, such
as is described in reference to FIG. 1 hereabove.
[0143] Referring now to FIG. 9, a side sectional view of a fluid
delivery element comprising an iontophoretic fluid delivery
assembly is illustrated, consistent with the present inventive
concepts. Fluid delivery element 140''' has been positioned in a
lumen of tissue, such as a lumen of the duodenum or other
gastrointestinal lumen. The tissue comprises multiple layers, such
as innermost layer L1, deeper layer L2 and yet deeper layer L3.
Fluid delivery element 140''' comprises an iontophoretic delivery
element comprising reservoir 151 and electrode 152. Reservoir 151
is fluidly connected to lumen 147. Reservoir 151 and electrode 152
can be configured to be operably advanceable from shaft 101, such
as via one or more controls on a proximal handle, as is described
in reference to FIG. 1 hereabove. Reservoir 151 can be constructed
and arranged to be rotated, such as to perform multiple fluid
delivery events around a circumference of tissue, such as to create
a full or near full circumferential tissue expansion. Lumen 147 is
fluidly connected to one or more fluid delivery tubes, not shown
but traveling proximally and fluidly connected to a supply of
injectable fluid. Electrode 152 is connected to one or more wires,
not shown but traveling proximally to a control unit configured to
cause electrode 152 to apply an electric field in and/or around
reservoir 151. While electrode 152 is shown as a single electrode,
multiple electrodes may be employed. Injectate 150 comprises an
ionic fluid capable of being driven into at least tissue layers L1
and L2, by the electrical fields created by electrode 152, such as
via iontophoretic delivery well known to those of skill in the art.
Activation of electrode 152 can be accomplished via one or more
controls on a proximal handle or on a device connected to a
proximal handle, such as is described in reference to FIG. 1
hereabove.
[0144] Referring now to FIG. 10, a side sectional view of a distal
portion of a tissue expansion device comprising a side recess
portion and protected needle exit port is illustrated, consistent
with the present inventive concepts. Device 100 includes shaft 101
with integral side car 106, positioned at or near distal end 102 of
shaft 101. Side car 106 comprises a guidewire lumen 106', such that
shaft 101 can be advanced and/or exchanged over a guidewire via
rapid exchange delivery, as is known to those of skill in the art.
Shaft 101 further comprises two lumens, a first lumen 108 which can
slidingly receive a fluid delivery element, needle 141, and a
second lumen 107, configured to carry a vacuum. Shaft 101 comprises
a recess in its side wall, recess 155, relatively proximate distal
end 102 of shaft 101. Recess 155 can be positioned in a lumen of
tissue, such as a lumen of the duodenum or other gastrointestinal
lumen, such as to expand one or more layers of tissue, such as the
submucosal layer of the duodenum. An opening 158 is positioned
between lumen 107 and recess 155, such that an applied vacuum can
be introduced to recess 155 via lumen 107, such as to draw tissue
into recess 155 as shown as described in reference to FIGS. 10A and
10B herebelow.
[0145] Needle 141 includes lumen 147, which is fluidly connected to
one or more fluid delivery tubes, not shown but such as one or more
fluid delivery tubes in fluid communication with a supply of fluid,
such as is described in reference to device 100 of FIG. 1
hereabove. Needle 141 is configured to be operably advanceable
along the axis of shaft 101 and lumen 108, such as via one or more
controls on a proximal handle, also as is described in reference to
FIG. 1 hereabove, such as to have its distal end exit lumen 108 and
enter recess 155. A mechanical stop 157 is positioned within lumen
of 108. A collar 156 is attached to needle 141, such that
advancement of needle 141 is limited when collar 156 makes contact
with mechanical stop 157. In some embodiments, the position of
collar 156 and/or stop 157 can be adjusted, such as via one or more
controls positioned on a proximal handle, such as to adjust the
permitted travel of needle 141. In some embodiments, the length of
needle 141 is chosen such that it is longer than the axial length
of recess 155, such as to prevent needle 141 from exiting device
100 if needle 141 were to become detached.
[0146] In some embodiments, device 100 includes an imaging
component, visualization element 165 which is connected to cables
166. Imaging component 165 is configured to provide an image to the
operator, such as via one or more visual displays, not shown but
connected to cables 166 and positioned in view of one or more
operators of device 100. Imaging component 165 may comprise an
imaging element selected from the group consisting of: an
ultrasound imager; an optical coherence domain reflectometry (OCDR)
imager; an optical coherence tomography (OCT) imager; confocal
endomicroscopy via either scanning or structured illumination; and
combinations of these. Cables 166 may comprise electrical wires,
optical fibers and/or one or more rotating shafts, such as to
provide power or otherwise enable imaging component 165 to provide
an image. Images provided by imaging component 165 can be used to
determine sufficiency or otherwise assess the tissue expansion
caused by delivering fluid to one or more tissue layers via needle
141.
[0147] Referring now to FIG. 10A, the distal portion of shaft 101
and recess 155 have been positioned proximate tissue, such as
gastrointestinal tissue, and a vacuum has been applied to recess
155 via port 158 and lumen 107, such as via a vacuum source within
and/or attached to a proximal handle. As the vacuum is applied,
tissue proximate recess 155 is drawn into recess 155 as illustrated
in FIG. 10A. In some embodiments, recess 155 comprises a geometry
and size to precisely cause tissue expansion of specific layers of
the intestinal anatomy. For example, recess 155 may comprise a
geometry and size to cause the mucosal layer (<1 mm thick) to
enter recess 155 without including the muscularis layer. In these
embodiments, the spongy submucosal layer stretches and enlarges as
tissue is drawn into recess 155, creating a larger target for
needle 141 insertion. Minimizing the recess 155 width can be used
to prevent drawing the full thickness of tissue into recess 155 by
vacuum applied through lumen 107. In some embodiments, recess 155
comprises a width less than 2.0 mm, such as a width less than 1.5
mm or less than 1.0 mm. Minimizing recess 155 axial length can be
used to improve needle 141 penetration into tissue drawn into
recess 155, such as when the distal end of recess 155 provides a
normal force in reaction to needle 141 tissue penetration. In some
embodiments, recess 155 length is less than 5.0 mm, such as a
length less than 4.0 mm or less than 3.0 mm. In some embodiments,
recess 155 comprises a width approximating 1.5 mm and a length
approximating 4.0 mm. In some embodiments, lumen 107 and needle 141
are each contained in a single tube, such as the dual lumen tube
described in reference to FIG. 5C hereabove.
[0148] Referring now to FIG. 10B, while maintaining a vacuum in
lumen 107, needle 141 has been axially advanced into the tissue, as
illustrated. Advancement of needle 141 can be accomplished by one
or more controls on the proximal end of shaft 101, such as controls
integral to a handle such as are described in reference to handle
110 of FIG. 1. After insertion of needle 141 into the tissue
contained within recess 155, such as via fluid delivery tubes which
travel proximally to one or more sources of fluid on the proximal
end of shaft 101. In some embodiments, recess 155 is sized and
configured to limit the excursion distance between the location
where the tip of needle 141 enters recess 155 and the location
where needle 141 first penetrates tissue. Minimizing this distance
can prevent bunching or stretching of tissue or otherwise improve
needle 141 penetration into tissue captured within recess 155.
[0149] Shaft 101 and recess 155 of FIGS. 10, 10A and 10B can be
constructed and arranged to be rotated. In these embodiments,
multiple fluid delivery events can be performed around a
circumference of tissue, such as to draw a series of tissue
sections via vacuum into recess 155, followed by multiple
advancements of needle 141 and delivery of fluid, such as to create
a full or near full circumferential tissue expansion.
[0150] Referring now to FIG. 11, a side sectional view of a distal
portion of a tissue expansion device comprising an end recess
portion and protected needle exit port is illustrated, consistent
with the present inventive concepts. Shaft 101' and recess portion
155' are similar to shaft 101 and recess 155 of FIG. 10 except
recess portion 155' is positioned at the distal end 102 of shaft
101'.
[0151] Shaft 101' further comprises a first lumen 108 which
slidingly receives fluid delivery tube 121 and a fluid delivery
element, needle 141. Shaft 101' further comprises a second lumen
107, configured to carry a vacuum. Recess 155' and lumen 107 are
constructed and arranged to withdraw tissue into recess 155' and
apply tension to this tissue to resist forces encountered during
penetration of the tissue by needle 141.
[0152] Recess 155' can be positioned in a lumen of tissue, such as
a lumen of the duodenum or other gastrointestinal lumen, such as to
expand one or more layers of tissue, such as the submucosal layer
of the duodenum. An opening 158' is positioned between lumen 107
and recess 155', such that an applied vacuum can be introduced to
recess 155' via lumen 107, such as to draw tissue into recess 155'
as shown as described in reference to FIGS. 10A and 10B
hereabove.
[0153] Needle 141 includes lumen 147, which is fluidly connected to
fluid delivery tube 121 which attaches at its proximal end to one
or more supplies of fluid, such as is described in reference to
device 100 of FIG. 1 hereabove. Needle 141 is configured to be
operably advanceable along the axis of shaft 101' and lumen 108,
such as via one or more controls on a proximal handle, also as is
described in reference to FIG. 1 hereabove, such as to exit lumen
108 and enter recess 155'. In typically use, distal end 102 of
shaft 101 is positioned proximate tissue, vacuum is applied via
opening 158', after which needle 141 is advanced into the capture
tissue and one or more fluids are injected into the tissue via
lumen 108 and fluid delivery tube 121, causing one or more tissue
layers to expand.
[0154] Referring now to FIG. 12, a side sectional view of the
distal portion of a tissue expansion device comprising an endoscope
and an advanceable needle is illustrated, consistent with the
present inventive concepts. Endoscope 170 has been advanced through
luminal tissue, such as through the gastrointestinal tract such as
to a location in the duodenum. The tissue comprises multiple
layers, such as innermost layer L1, deeper layer L2 and yet deeper
layer L3. Endoscope 170 has had its distal end deflected, via one
or more steering controls common to endoscope devices, such that
needle 141 can be axially advanced to penetrate layer L1 and L2 of
tissue, while avoiding penetration of layer L3, such as to
penetrate a mucosal and submucosal layer of the gastrointestinal
tract, while avoid penetrating deeper layers such as the
serosa.
[0155] Needle 141, including a lumen 147, may be configured to be
operably advanceable from working channel 172 of endoscope 170,
such as via one or more controls. Endoscope 170 can be constructed
and arranged to be rotated (e.g. when needle 141 is retracted),
such as to perform multiple fluid delivery events around a
circumference of tissue, such as to create a full or near full
circumferential tissue expansion. Needle 141 and lumen 147 are
fluidly connected to fluid delivery tube 121 (e.g. a hypotube) via
bond joint 122. Lumen 147 is fluidly attached to lumen 147' of
fluid delivery tube 121. In some embodiments, lumen 147' is a
larger diameter than lumen 147 as shown in FIG. 12, such as to
reduce the pressure required to deliver fluid through fluid
delivery tube 121. Fluid delivery tube 121 travels proximally and
fluidly connected to a supply of injectable fluid, such as a
syringe or pumping assembly. Fluid can be delivered to tissue out
of distal end of needle 141, such as via one or more controls on a
proximal handle or on a device connected to a proximal handle, such
as is described in reference to FIG. 1 hereabove.
[0156] In some embodiments, needle 141 and/or fluid delivery tube
121 comprise a flexibility and radial support that allow flexing
without luminal collapse, such that needle 141 can translate toward
the center of the lumen as tissue layer L2 expands.
[0157] Endoscope 170 includes a camera 171, positioned to allow an
operator to visualize penetration of needle 141 into tissue, as
well as the expansion of one or more tissue layers such as layer L2
shown. In some embodiments, the injected fluid comprises a dye or
other visualizable colorant that can be used to quantify or
otherwise assess the amount of tissue expansion (e.g. the deeper
the color visualized at a location, the thicker the expansion at
that location). Alternatively or additionally, endoscope 170 may
comprise another visualization device, such as a device selected
from the group consisting of: an ultrasound imager; an optical
coherence domain reflectometry (OCDR) imager; an optical coherence
tomography (OCT) imager; and combinations of these. Endoscope 170
can further comprise a source of light, such as LED 173, such as to
deliver visible light and/or infrared light. Endoscope 170 can
further comprise a second working channel 174, such as a working
channel sized to slidingly receive a tissue manipulating device,
such as a tissue manipulating device described in reference to FIG.
18 herebelow.
[0158] Referring now to FIG. 13, a side view of the distal portion
of a tissue expansion device comprising multiple needles and a
fluid dispersion manifold is illustrated, consistent with the
present inventive concepts. Expandable assembly 130 is shown distal
to distal end 102 of shaft 101. Expandable assembly 130 comprises
at least three support arms, such as support arms 132a, 132b and
132c shown. Support arms 132a, 132b and 132c can be resiliently
biased in the radially expanded condition shown in FIG. 13. In some
embodiments, expandable assembly 130 is slidingly received by shaft
101, such that retraction of expandable assembly 130 into shaft 101
causes expandable assembly 130 to radially compress. In other
embodiments, expandable assembly 130 may be fixed relative to shaft
101, such as when expandable assembly 130 is inserted through an
endoscope whose working channel radially compresses expandable
assembly. Tip 139 can connect and/or surround the distal ends of
support arms 132a, 132b and 132c, and tip 139 may include an
atraumatic covering such as an elastomer or other relatively soft
material. In an alternative embodiment, expandable assembly 130
comprises two support arms, such as two support arms 132a and 132b
positioned 180.degree. from each other.
[0159] Support arms 132a, 132b and 132c each comprise a radially
outward facing opening, openings 131a, 131b and 132c respectively.
A fluid delivery element, such as needles 141a, 141b and 141c, are
slidingly received by arms 132a, 132b and 132c, respectively.
Needles 141a, 141b and 141c are constructed and arranged to be
operably advanced out of openings 131a, 131b and 131c,
respectively, such as has been described in detail hereabove.
[0160] Needles 141a, 141b and 141c are each attached to a fluid
delivery tube, fluid delivery tubes 121a, 121b and 121c
respectively. Fluid delivery tubes 121a, 121b and 121c are fluidly
attached to a fluid dispersion manifold, valve assembly 160, which
in turn is fluidly attached to a single fluid delivery tube, lumen
108. Lumen 108 travels proximally and is fluidly connected to one
or more sources of injectable fluid, such as has been described in
detail hereabove.
[0161] Referring now to FIG. 13A, a magnified sectional view of the
valve assembly 160 of FIG. 13 is illustrated, consistent with the
present inventive concepts. Valve assembly 160 is connected at its
proximal end to lumen 108. Valve assembly 160 comprises three sets
of solenoids and pistons, including solenoids 161a, 161b and 161c,
which advance and retract pistons 162a, 162b and 162c,
respectively. Pistons 162a, 162b and 162c are positioned in fluid
delivery tubes 121a, 121b and 121c, such as to cause a flow path
between each tube and lumen 108 to be open or closed. A cable of
wires 163 is attached on its distal end to solenoids 161a, 161b and
161c. Wires 163 travel proximally, such as to a control circuit
included in a handle and configured to allow an operator to
independently cause fluid to flow to any or all of fluid delivery
tubes 121a, 121b and 121c.
[0162] Referring now to FIG. 13B, a magnified sectional view of a
support arm of FIG. 13 is illustrated, consistent with the present
inventive concepts. Support arm 132a comprises proximal segment
133a, configured to slidingly receive a fluid delivery element,
needle 141a, and includes opening 131a, Needle 141a and attached
fluid delivery tube 121a have been advanced, such as via one or
more controls on a proximal handle, such as handle 110 of FIG. 1,
configured to allow an operator to advance needle 141a, In some
embodiments, as needle 141a is advanced, it makes contact with ramp
136a, positioned proximate opening 131a and typically a hard
surface configured to direct needle 141a at a pre-determined
trajectory, such as to penetrate one or more layers of tissue, such
as one or more layers of gastrointestinal tissue.
[0163] Referring now to FIG. 14, a side sectional view of a distal
portion of a tissue expansion device comprising a spring-loaded
needle injector is illustrated, consistent with the present
inventive concepts. Shaft 101 includes distal end 102 and surrounds
a fluid delivery element, such as needle 141. An injection assembly
190 is included and configured to allow an operator to cause a
spring-force driven advancement of needle 141, such as an automated
advancement of a predetermined distance and/or pre-determined force
into tissue. An optional mechanical stop may be included,
projection 197, attached to an inner wall of shaft 101.
[0164] Injection assembly 190 includes a spring 191, which is
attached on one end to needle 141 and on its other end to an inner
wall of shaft 101. Spring 191 is positioned to exert an advancing
force (i.e. to the left of the page as shown) on needle 141 when
needle 141 is in the retracted state shown in FIG. 14. Injection
assembly 190 further includes a latching assembly 193 comprising
control rod 194 which is attached to one end of biasing spring 192.
The other end of biasing spring 192 is attached to an inner wall of
shaft 101, such as to create a biasing force on rod 194 toward the
left of the page as shown. Control rod 194 travels proximally and
is typically attached to an advancement and retraction control on a
handle on the proximal end of shaft 101, such as has been described
in detail in reference to FIG. 1 hereabove. Control rod 194
operably engages a pivoting latch 195, which releasably engages a
radial extending portion of needle 141, projection 196. When
positioned as shown in FIG. 14, pivoting latch 195 applies a force
to needle 141 via projection 196 that prevents spring 191 from
advancing needle 141 out of the distal end 102 of shaft 101.
[0165] Referring now to FIG. 14A, control rod 194 has been
retracted, causing pivoting latch 194 to pivot and release
engagement with projection 196. The force applied by spring 191
causes needle 141 to advance to the left of the page as shown. In
some embodiments, a mechanical stop is included, projection 197,
causing needle 141 to advance a maximum distance, such as to a
target tissue layer and/or target tissue depth. After advancement,
one or more fluids can be delivered to one or more tissue layers as
has been described in detail hereabove.
[0166] In some embodiments, projection 197 can be moved along the
axis of shaft 101, such as when slidingly received by a slot and
securement mechanism, each not shown but configured to allow
operator adjustment of the position of projection 197. Subsequent
retraction of needle 141, such as by one or more controls on a
proximal handle as has been described in detail hereabove, will
cause injection assembly 190 and latching assembly 193 to reset to
the condition shown in FIG. 14, ready for repositioning of the
device, and additional spring-loaded advancement of needle 141 into
tissue to support tissue expansion via fluid delivery. Injection
assembly 190 may be included in one or more of the tissue expansion
devices described herein, such as to allow automated fluid delivery
advancement, e.g. advancement of needle 141 and/or to allow
controlled force of tissue penetration and/or controllable
advancement distance.
[0167] Referring now to FIG. 15, a side sectional view of a distal
portion of a tissue expansion device comprising a needle biased in
a retracted state is illustrated, consistent with the present
inventive concepts. Shaft 101 includes distal end 102 and surrounds
a fluid delivery element, such as needle 141. A biasing assembly
198 includes a spring 199 connected on one end to needle 141 and on
its other end to an inner wall of shaft 101. Spring 199 is attached
and oriented to provide a biasing force tending needle 141 to be in
a retracted state, such as the retracted state shown in FIG.
15.
[0168] Referring now to FIG. 15A, needle 141 has been advanced (to
the left of the page as shown), such as via one or more controls
included in a proximal handle as has been described in detail
hereabove. Spring 199 is extended, placing a biasing force tending
to cause needle 141 to retract. Biasing assembly 198 may be
included in one or more of the tissue expansion devices described
herein, such as to prevent an operator from inadvertently leaving a
fluid delivery element, such as needle 141, in an advanced
position.
[0169] Referring now to FIG. 16, a side sectional view of a luminal
occlusion assembly and fluid delivery element comprising a needle
is illustrated, consistent with the present inventive concepts. A
fluid delivery element, needle 141 has been positioned in a lumen
of tissue, such as a lumen of the duodenum or other
gastrointestinal lumen. The tissue comprises multiple layers, such
as innermost layer L1, deeper layer L2 and yet deeper layer L3.
Needle 141, including a side exit port, opening 142 which is
fluidly attached to lumen 147, can be configured to be operably
advanceable from shaft 101, such as via one or more controls on a
proximal handle, as is described in reference to FIG. 1 hereabove.
Shaft 101 can be constructed and arranged to be rotated (e.g. when
needle 141 retracted), such as to perform multiple fluid delivery
events around a circumference of tissue, such as to create a full
or near full circumferential tissue expansion. Lumen 147 is fluidly
connected to one or more fluid delivery tubes, not shown but
traveling proximally and fluidly connected to a supply of
injectable fluid. Fluid can be delivered to tissue out of the
distal end of needle 141, such as via one or more controls on a
proximal handle or on a device connected to a proximal handle, such
as is described in reference to FIG. 1 hereabove.
[0170] An assembly for fully or partially occluding a lumen,
occlusion assembly 180 is positioned relatively proximate needle
141, such as to occlude flow of one or more fluids in the lumen
surrounded by layer L1 (e.g. insufflation fluids), and/or to
occlude flow of fluid within one or more of tissue layers L1, L2
and/or L3 (e.g. the fluid injected by needle 141, blood and/or
other fluids within layers L1, L2 and/or L3). Occlusion assembly
180 includes an expandable device, such as balloon 182 which can be
operably expanded, such as via the delivery of one or more fluids
such as air, CO.sub.2 and/or saline into balloon 182 via inflation
tube 181. Inflation tube 181 travels proximally and connects to an
inflation port or other supply of fluids, such as on a handle as
has been described hereabove. In FIG. 16, balloon 182 has yet to be
expanded, and needle 141 has not yet penetrated tissue layer L. In
alternative embodiments, occlusion assembly 180 may comprise
another expandable element, such as an expandable cage or basket
configured to apply force to one or more layers of tissue.
[0171] Referring now to FIG. 16A, balloon 182 is inflated to
contact tissue layer L1, such as with a full or partial
circumferential contact. The level of expansion may be chosen to
compress one or more tissue layers such as L1, L2 and/or L3, as
shown.
[0172] Referring now to FIG. 16B, needle 141 has been advanced
through tissue layer L1 and into tissue layer L2, positioning
opening 142 in tissue layer L2. Balloon 182 has been maintained in
its inflated state.
[0173] Referring now to FIG. 16C, fluid has been advanced through
opening 142 into tissue layer L2, causing tissue layer L2 to expand
as shown. Maintenance of balloon 182 in the inflated state reduces
and/or prevents migration of fluid beyond the position of balloon
182, such as to direct the expansion of tissue circumferentially
and/or in a direction to the right of balloon 182 as shown on the
page.
[0174] While balloon 182 is shown positioned distal to the
penetration site of needle 141 into tissue, in alternative methods
balloon 182 can be placed proximally to needle 141. While occlusion
assembly 180 is illustrated have a single balloon 182, in
alternative embodiments, multiple balloons or other inflatable
elements may be included, such as to be positioned distal and/or
proximal to the penetration site of needle 141. In these multiple
balloon embodiments, a fluid delivery element such as needle 141
may be configured to be deployed between a first balloon and a
second balloon.
[0175] Referring now to FIG. 17, the distal portion of a tissue
expansion device including a fluid delivery element with an
operator adjustable needle trajectory guide is illustrated,
consistent with the present inventive concepts. Shaft 101 includes
distal end 102 and an opening 131 proximate distal end 102. Shaft
101 surrounds a fluid delivery element, needle 141, configured to
be advanced into one or more tissue layers to support fluid
delivery to expand the one or more tissue layers. Needle 141 passes
through a needle guide assembly 115. Needle guide assembly 115
comprises needle guide 117, typically a metal or other rigid
material configured to slidingly receive needle 141 and direct a
distal portion of needle 141 into tissue. Needle guide assembly 115
further comprises a pivot point, pin 116, which is slidingly
received by guide 117 and about which needle guide 117 can pivot.
Needle guide 117 is attached to cable 104, which travels proximally
to a control, not shown but typically an operator control on a
handle configured to advance and/or retract cable 104. Cable 104
can be advanced and/or retracted to cause needle guide 117 to
pivot, such as to change the trajectory that needle 141 exits
opening 131 of shaft 101. In FIG. 17, cable 104 and needle guide
117 are positioned such that needle 141 exits shaft 101 at
approximately 90.degree..
[0176] Referring now to FIG. 17A, cable 104 has been retracted,
causing the trajectory taken by needle 141 to tend toward distal
end 102 of shaft 101.
[0177] Referring now to FIG. 17B, cable 104 has been advanced,
causing the trajectory taken by needle 141 to tend away from distal
end 102 of shaft 101 (e.g. toward the proximal end of shaft
101.
[0178] Referring now to FIG. 18, a side sectional view of a fluid
delivery element comprising a needle with a side hole is
illustrated, consistent with the present inventive concepts. The
needle has been advanced to penetrate into a second layer of a body
lumen. A fluid delivery element comprises needle 141, which
includes a solid tip, a lumen 147, and a side hole, opening 142 as
shown. Lumen 147 is fluidly connected to one or more fluid delivery
tubes, not shown but traveling proximally to connect to a fluid
delivery assembly, such as fluid delivery assembly 330 described
herein. The fluid delivery assembly 330 is configured to deliver
one or more fluids, as has been described hereabove. Shaft 101
includes lumen 108, through which needle 141 is slidingly advanced.
In some embodiments, lumen 108 and/or another lumen of shaft 101 is
fluidly attached to a source of vacuum, such as vacuum source 340
described herein. The vacuum source 340 may be set to a
pre-determined vacuum pressure and/or it may be operator
adjustable. In FIG. 18, needle 141 and shaft 101 have been inserted
into a body lumen comprising layers L1, L2 and L3, such as through
the working channel of an endoscope or other body access device, or
over a guidewire, neither shown but described in reference to other
embodiments herein. Needle 141 has been advanced into tissue layer
L2. A vacuum may have been applied to lumen 108 by vacuum source
340 as needle 141 was advanced into tissue.
[0179] Referring now to FIG. 18A, fluid has been injected from a
fluid delivery assembly, through lumen 147 and opening 142 to cause
expansion of tissue layer L2. During injection, a vacuum may have
been applied to lumen 108 via vacuum source 340.
[0180] Referring now to FIG. 18B, a tissue manipulating assembly
175 has been introduced to a site proximate the tissue penetration
site of needle 141. Tissue manipulating assembly 175 comprises an
elongate tube, shaft 176 through which probe 177 has been advanced
such that its distal end, including opening 178, is in contact with
tissue. A vacuum is applied by vacuum source 340 through lumen 179
to opening 178. A vacuum may have simultaneously been applied to
lumen 108 of shaft 101.
[0181] Referring now to FIG. 18C, tissue manipulating assembly 175
has been repositioned, while a vacuum remains applied via lumen 179
and opening 178, causing a force to be applied to the contacted
tissue. The applied force causes the geometry of the expanded
tissue and/or the fluid contained within the expanded tissue, to be
operator adjusted. In some embodiments, tissue manipulation is
performed during injection of fluid into tissue via needle 141,
such as to direct the flow of fluid within the tissue. The applied
force can be used to cause the tissue to "tent", such as to adjust
the expanded tissue area and/or to create a greater target for
penetration by needle 141.
[0182] In some embodiments, a visualization device, such as a
camera integral to or inserted through an endoscope, such as the
visualization element described in reference to FIG. 10 hereabove,
is used to adjust the expanded tissue geometry. In some
embodiments, fluid is continuously or intermittently injected as
various forces are applied to tissue by tissue manipulating
assembly 175. In some embodiments, a vacuum is applied to lumen 108
of shaft 101 to provide a second tissue manipulating probe.
[0183] While the tissue manipulating assembly 175 of FIGS. 18B and
18C comprises a vacuum assisted device, numerous forms and
configurations of devices that can apply a force to tissue are to
be considered within the spirit and scope of the present inventive
concepts. In some embodiments, the tissue manipulator comprises one
or more of: a balloon; an expandable ring; a vacuum port; a grasper
such as a pair of articulating jaws; a radially expandable cage; a
radially deployable arm; and combinations of these.
[0184] Referring now to FIG. 19, a system for expanding tissue as
well as for ablating or otherwise treating target tissue is
illustrated, consistent with the present inventive concepts. System
300 is constructed and arranged to treat target tissue 10,
including one or more tissue portions. System 300 may include one
or more ablation devices or ablation elements, such as those
described in International PCT Application Serial Number
PCT/US2012/01739, entitled "Devices and Methods for the Treatment
of Tissue", filed Jan. 18, 2012; and International PCT Application
Serial Number PCT/US2013/28082, entitled "Heat Ablation Systems,
Devices and Methods for the Treatment of Tissue", filed Feb. 27,
2013; the contents of which are each incorporated herein by
reference in their entirety. In the embodiment of FIG. 19, system
300 includes a multiple filament elongate device 301 comprising
shafts 311a and 311b. In some embodiments, device 301 comprises a
flexible portion with a diameter less than 6 mm and a length of 100
cm or longer, such as a length of up to 300 cm or other length
configured to allow treatment of gastrointestinal tissue including
the duodenum, the jejunum and/or the ileum. Shaft 311a has a distal
end 312. Shafts 311a and 311b are sized and configured such that
shaft 311a is slidingly received by shaft 311b. Shafts 311a and
311b have been inserted through a working channel (e.g. a 6 mm
working channel), lumen 351, of endoscope 350. Shafts 311a and 311b
may be inserted over a guidewire, such as guidewire 371 shown
exiting distal end 312.
[0185] Device 301 includes fluid delivery assembly 130, which may
comprise an expandable or other fluid delivery assembly comprising
one or more fluid delivery elements such as has been described
hereabove. Fluid delivery assembly 130 includes at least one fluid
delivery element, needle 141, constructed and arranged to deliver
fluid to expand one or more layers of tissue. Alternatively or
additionally, fluid delivery assembly 130 can comprise additional
or alternative fluid delivery elements, such as water jets or other
fluid delivery elements described hereabove. In some embodiments,
needle 141 is constructed and arranged to deliver fluid to tissue
by exiting opening 131 and penetrating tissue, such as has been
described in reference to FIG. 4B hereabove. In other embodiments,
a vacuum can be applied to opening 131, such as to draw tissue into
opening 131 allowing needle 141 to penetrate tissue without exiting
opening 131, such as is described in reference to FIGS. 5 and 10
hereabove. System 300 can include source of vacuum, such as vacuum
source 340 which can be fluidly attached to an opening or recess of
fluid delivery assembly 130, such as a vacuum applied by vacuum
source 340 to opening 131.
[0186] Fluid delivery assembly 130 can include one or more support
arms, such as the various support arms included in the tissue
expansion devices of FIGS. 4, 5 and 13 described hereabove. Fluid
delivery assembly 130 can comprises a resiliently biased cage or
other assembly biased in a radially expanded condition by radially
compactable, such as to be inserted through a lumen of an
endoscope. Alternatively, fluid delivery assembly 130 may be
expandable from a radially compact state to a radially expanded
state. Fluid delivery assembly 130 can include an expandable
balloon such as a balloon used to position one or more fluid
delivery elements proximate tissue to be expanded.
[0187] Device 301 further includes an expandable tissue treatment
element, expandable treatment element 322b, mounted to shaft 311b.
Treatment element 322b may be configured in various forms to treat
the target tissue, such as in one or more of the treatment element
forms, such as a balloon configured to contain a hot or cold fluid,
an array of electrodes configured to deliver RF energy, or other
treatment forms. In one embodiment, element 322b comprises an
expandable balloon, such as one or more of: a compliant balloon; a
non-compliant balloon; a balloon with a pressure threshold; a
balloon with compliant and non-compliant portions; a balloon with a
fluid entry port; a balloon with a fluid exit port; and
combinations of these. In another embodiment, treatment element
322b comprises one or more of an abrasive element configured for
abrading tissue; and an energy delivery element such as an energy
delivery element configured to deliver RF energy. Shafts 311a and
311b may include one or more lumens passing therethrough, and may
comprise wires or optical fibers for transfer of data and/or
energy. Shaft 311b may comprise one or more shafts, such as one or
more concentric shafts configured to deliver and/or recirculate hot
fluid through treatment delivery element 322b, such as to deliver a
bolus of hot fluid energy or other thermal dose. Device 301 may
comprise multiple treatment elements, such as two or more treatment
elements configured to deliver similar and/or dissimilar forms of
energy or other treatment. In an alternative embodiment, fluid
delivery assembly 130 is not expandable, simply comprising a fluid
delivery element capable of delivering fluid to expand one or more
layer of tissue.
[0188] Endoscope 350 may be a standard endoscope, such as a
standard gastrointestinal endoscope, or a customized endoscope,
such as an endoscope including sensor 353 configured to provide
information related to the tissue treatment of the present
inventive concepts. Sensor 353 and the other sensors of system 300
may be a sensor selected from the group consisting of: heat sensors
such as thermocouples; impedance sensors such as tissue impedance
sensors; pressure sensors; blood sensors; optical sensors such as
light sensors; sound sensors such as ultrasound sensors;
electromagnetic sensors such as electromagnetic field sensors; and
combinations of these. Sensor 353 may be configured to provide
information to one or more components of system 300, such as to
monitor the treatment of target tissue 10 and/or to treat target
tissue 10 in a closed loop fashion. Energy delivery may be modified
by one or more sensor readings. In one embodiment, an algorithm
processes one or more sensor signals to modify amount of energy
delivered, power of energy delivered and/or temperature of energy
delivery.
[0189] A sensor such as a chemical detection sensor may be
included, such as to confirm proper apposition of treatment element
322b, fluid delivery assembly 130 and/or needle 141. In this
configuration, a chemical sensor such as a carbon dioxide sensor
can be placed distal to treatment element 322b and/or fluid
delivery assembly 130, and a fluid such as carbon dioxide gas is
introduced proximal to the treatment element 322b and/or fluid
delivery assembly 130. Detection of the introduced fluid may
indicate inadequate apposition of treatment element 322b, fluid
delivery assembly 130 and/or needle 141, such as to prevent
inadequate transfer of energy to the target tissue and/or to
prevent inadequate tissue expansion.
[0190] Endoscope 350 may include camera 352, such as a visible
light, ultrasound and/or other visualization device used by the
operator of system 300 prior to, during or after the treatment of
target tissue 10, such as during insertion or removal of endoscope
350 and/or shafts 311a and 311b. Camera 352 may provide direct
visualization of internal body spaces and tissue, such as the
internal organs of the gastrointestinal tract. Endoscope 350 may be
coupled with or otherwise include a guidewire, such as to allow
insertion of endoscope 350 into the jejunum.
[0191] System 300 may be configured to perform insufflation of the
body lumen. The body lumen may be pressurized, such as by using one
or more standard insufflation techniques. Insufflation fluid can be
introduced through lumen 354 of endoscope 350. Lumen 354 travels
proximally and connects to a source of insufflation liquid or gas,
not shown, but typically a source of air, CO.sub.2 and/or water.
Alternatively or additionally, insufflation fluid may be delivered
by device 301, such as through shaft 311a and/or 311b, or through a
port in treatment element 322a and/or 322b, ports not shown but
fluidly attached to a source of insufflation liquid or gas, also
not shown. Alternatively or additionally, a separate device,
configured to be inserted through endoscope 350 or to be positioned
alongside endoscope 350, may have one or more lumens configured to
deliver the insufflation fluid. System 300 may include one or more
occlusive elements or devices, such as expandable treatment element
322b, fluid delivery assembly 130, or another expandable device,
not shown but configured to radially expand such as to fully or
partially occlude the body lumen, such that insufflation pressure
can be achieved and/or maintained over time (e.g. reduce or prevent
undesired migration of insufflation fluid). The one or more
occlusive elements or devices may be positioned proximal to and/or
distal to the luminal segment to be insufflated.
[0192] The treatment elements and fluid delivery assemblies of the
present inventive concepts, such as treatment element 322b and
fluid delivery assembly 130, respectively, of FIG. 19, may have a
fixed diameter or they may be expandable. Expandable elements may
comprise inflatable balloons, expandable cages, radially deployable
arms, and the like. Treatment elements may include an energy
delivery element or arrays of elements, such as an array of balloon
lobes for delivery of thermal energy from a hot fluid. Energy
delivery elements may be configured to deliver one or more
different forms of energy. Energy may be delivered in constant or
varied magnitudes or other energy levels. Energy may be continuous
or pulsed, and may be delivered in a closed-loop fashion. Energy
delivery may be varied from a first tissue location to a second
location, such as a decrease in energy from a first treated
location to a second treated location when the second treated
location is thinner than the first treated location. Alternatively
or additionally, energy delivery may be varied during a single
application to a single tissue location, such as by adjusting the
amount of energy delivered, or by moving a portion of the energy
delivery element, such as by deflating an energy delivery element
as has been described in detail hereabove.
[0193] Treatment element 322b may be configured to cause the
complete or partial destruction of the target tissue, such as the
complete or partial destruction of the duodenal mucosa. Treatment
element 322b may be configured to remove previously treated and/or
untreated tissue. Pressure maintained within treatment element 322b
can be set and/or varied to adjust the treatment being performed
such as to: adjust the depth of treatment; adjust the force applied
by a mechanical abrasion device; adjust the amount of energy
applied during thermal energy delivery (e.g. by changing tissue
contact); and combinations of these.
[0194] Treatment element 322b may include one or more sensors 316b.
Sensor 316b may be one or more sensors as described hereabove.
Sensor 316b may be a sensor configured to provide information
related to the tissue treatment performed by treatment element
322b, such as a visualization sensor mounted to treatment element
322b that is configured to differentiate tissue types that are
proximate treatment element 322b, such as to differentiate mucosal
and submucosal tissue. Alternatively or additionally, sensor 316b
may be a sensor configured to provide information related to the
tissue treatment performed by treatment element 322b, such as a
temperature sensor mounted to treatment element 322b and configured
to monitor the temperature of treatment element 322b and/or tissue
proximate treatment element 322b.
[0195] Energy Delivery and Fluid Transport Unit (EDU) 330 may be
configured to deliver and extract one or more fluids from treatment
element 322b, as well as deliver one or more forms of energy to
target tissue. In one embodiment, EDU 330 is configured to deliver
one or more supplies of hot fluid, such as hot water or saline to a
balloon treatment element. In these embodiments, EDU 330 typically
includes one or more fluid pumps, such as one or more peristaltic,
displacement or other fluid pumps; as well as one or more heat
exchangers or other fluid heating elements internal or external to
device 301. EDU 330 may be constructed and arranged to rapidly
deliver and/or withdraw fluid to and/or from treatment element 322b
with one or more fluid transport means. Fluid transport means may
include a pump configured to deliver fluid at a flow rate of at
least 50 ml/min and/or a pump or vacuum source configured to remove
fluid at a flow rate of at least 50 ml/min. A pump or vacuum source
may be configured to continuously exchange hot fluid and/or to
perform a negative pressure priming event to remove fluid from one
or more fluid pathways of device 301. EDU 330 and/or device 301 may
include one or more valves in the fluid delivery and/or fluid
withdrawal pathways in fluid communication with treatment element
322b. Valves may be configured to control entry of fluid into an
area and/or to maintain pressure of fluid within an area. Valves
may be used to transition from a heating fluid, such as a fluid of
90.degree. C. maintained in a treatment element for approximately
12 seconds, to a cooling fluid, such as a fluid between 4.degree.
C. and 10.degree. C. maintained in the treatment element for
approximately 30 to 60 seconds. Typical valves include but are not
limited to: duck-bill valves; slit valves; electronically activated
valves; pressure relief valves; and combinations of these. EDU 330
may be configured to rapidly inflate and/or deflate treatment
element 322b. EDU 330 may be configured to purge the fluid pathways
of device 301 with a gas such as air, such as to remove cold or
hold fluid from device 301 and/or to remove gas bubbles from device
301.
[0196] In another embodiment, EDU 330 is configured to deliver at
least radiofrequency (RF) energy, and system 300 includes ground
pad 332 configured to be attached to the patient (e.g. on the back
of the patient), such that RF energy can be delivered in monopolar
delivery mode. Alternatively or additionally, EDU 330 may be
configured to deliver energy in a bipolar RF mode, such as when
treatment element 322b is configured to deliver RF energy and/or
system 300 includes a second energy delivery element, not shown but
typically including one or more electrodes or electrically
conductive surfaces.
[0197] Alternatively or additionally, EDU 330 may be constructed
and arranged to deliver fluid to tissue, such as fluid delivered to
one or more fluid delivery elements such as needle 141, to cause
expansion of one or more tissue layers, such as one or more layers
of submucosal layers of the gastrointestinal tract. Fluid can be
delivered simultaneously and/or sequentially to multiple fluid
delivery elements. EDU may provide fluid in a controlled matter,
such as at a controlled pressure or flow rate, or at a
pre-determined volume, such as at a pre-determined volume per
injection.
[0198] System 300 may include controller 360, which typically
includes a graphical user interface, not shown but configured to
allow one or more operators of system 300 to perform one or more
functions such as entering of one or more system input parameters
and visualizing and/or recording of one or more system output
parameters. Typical system input parameters include but are not
limited to: temperature of a fluid to be delivered to a treatment
element such as a balloon; temperature of a cooling fluid to be
delivered; flow rate of a hot fluid to be delivered; volume of a
hot fluid to be delivered; type of energy to be delivered such as
RF energy, thermal energy and/or mechanical energy; quantity of
energy to be delivered such as a cumulative number of joules of
energy to be delivered or peak amount of energy to be delivered;
types and levels of combinations of energies to be delivered;
energy delivery duration; pulse width modulation percentage of
energy delivered; number of reciprocating motions for an abrasive
device to transverse; temperature for a treatment element such as
target temperature or maximum temperature; insufflation pressure;
insufflation duration; fluid flow rate for tissue expansion; flow
volume for tissue expansion; vacuum duration for capture into a
recess such as recess 155 of FIG. 10; vacuum pressure level such as
vacuum level applied to a recess such as recess 155 of FIG. 10; and
combinations of these. System input parameters may include
information based on patient anatomy or conditions such as
pre-procedural or peri-procedural parameters selected from the
group consisting of: mucosal density and/or thickness; mucosal
"lift" off of submucosa after a submucosal injection; longitudinal
location of target tissue within the GI tract; tissue layer
thickness such as thickness of a layer pre-expansion, during
expansion and/or after expansion by a fluid delivery element such
as needle 141; and combinations of these. Typical system output
parameters include but are not limited to: temperature information
such as tissue and/or treatment element temperature information;
pressure information such as balloon pressure information or
insufflation pressure information; force information such as level
of force applied to tissue information; patient information such as
patient physiologic information recorded by one or more sensors;
and combinations of these.
[0199] Controller 360 and/or one or more other components of system
300 may include an electronics module, such as an electronics
module including a processor, memory, software, and the like.
Controller 360 is typically configured to allow an operator to
initiate, modify and cease treatment of tissue by the various
components of system 300, such as by energy delivery unit 330
and/or vacuum source 340. Controller 360 may be configured to
adjust the temperature, flow rate and/or pressure of fluid
delivered to expandable treatment element 322b and/or one or more
fluid delivery elements, such as needle 141. Controller 360 may be
configured to initiate insufflation and/or to adjust insufflation
pressure. Controller 360 may be configured to deliver energy (e.g.
from EDU 330) or other tissue treatment in a closed-loop fashion,
such as by modifying one or more tissue treatment parameters based
on signals from one or more sensors of system 300. Controller 360
may be programmable such as to allow an operator to store
predetermined system settings for future use. System 300, EDU 330
and/or controller 360 may be constructed and arranged to modify the
temperature, flow rate and/or pressure of a fluid delivered to one
or more treatment elements and/or to one or more fluid delivery
elements based a parameter selected from the group consisting of:
one or more measured properties of delivered fluid; one or more
measured properties of the treatment element; one or more
properties of the fluid delivery element; one or more measured
properties of tissue to be treated; one or more measured properties
of tissue to be expanded; and combinations of these.
[0200] Controller 360 and EDU 330 may be configured to deliver
energy in constant, varied, continuous and discontinuous energy
delivery profiles. Pulse width modulation and/or time division
multiplexing (TDM) may be incorporated to achieve precision of
energy delivery, such as to ensure ablation of target tissue while
leaving non-target tissue intact.
[0201] System 300 may include a mechanism configured to apply
motion to treatment element 322b and/or fluid delivery assembly
130, such as motion transfer element 335. Motion transfer element
335 may be configured to rotate and/or axially translate shafts
311a and/or 311b such that treatment element 322b and/or fluid
delivery assembly 130, respectively, are rotated and/or translated.
Motion transfer element 335 may be configured to rotate treatment
element 322b and fluid delivery assembly 130 independently or in
unison. Motion transfer element 335 may include one or more
rotational or linear drive assemblies, such as those including
rotational motors, magnetic and other linear actuators, and the
like which are operably connected to shaft 311a and/or 311b. Shafts
311a and/or 311b are constructed with sufficient column strength
and/or torque transfer properties to sufficiently rotate and/or
translate treatment element 322b and/or fluid delivery assembly
130, respectively, during associated tissue treatment and/or tissue
expansion. Motion transfer element 335 may be in communication with
controller 360, such as to activate, adjust and/or otherwise
control motion transfer element 335 and thus the motion of
treatment element 322b and/or fluid delivery assembly 130. Motion
transfer element 335 may be manually driven and/or automatically
(e.g. motor) driven. Alternatively or additionally, motion transfer
element 335 may be used to advance or retract treatment element
322b and/or fluid delivery assembly 130 from a first position to
treat or expand a first portion of target tissue, to a second
position to treat or expand a second portion of target tissue. In
this embodiment, repositioning of treatment element 322b and/or
fluid delivery assembly 130 may be configured to provide
overlapping treatments and/or tissue expansions.
[0202] Controller 360 may be configured to control energy delivery,
such as controlling energy delivery to treatment element 322b. For
example, if treatment element 322b is an RF electrode array, and
EDU 330 comprises an RF generator, controller 360 may be programmed
to provide a specific amount of RF energy for a defined period of
time. In another example, if treatment element 322b is a heated
saline balloon, then controller 360 can be configured to provide
and withdraw heated saline to treatment element 322b, such as
through an energy transfer tube not shown, at a desired temperature
and for a desired time period. Controller 360 may be configured for
manual control, so that the operator first initiates the energy
delivery, then allows the treatment element 322b to ablate the
tissue for some time period, after which the operator terminates
the energy delivery.
[0203] System 300 may further include one or more imaging devices,
such as imaging device 370. Imaging device 370 may be configured to
be inserted into the patient and may comprise a visual light
camera; an ultrasound imager; an optical coherence domain
reflectometry (OCDR) imager; and/or an optical coherence tomography
(OCT) imager, such as when integral to, attached to, contained
within and/or proximate to shaft 311a and/or 311b. Imaging device
370 may be inserted through a separate working channel of endoscope
350, lumen not shown. In one embodiment, imaging device 370 is an
ultrasound transducer connected to a shaft, not shown but
surrounded by shaft 311a and typically rotated and/or translated to
create a multi-dimensional image of the area surrounding imaging
device 370. Alternatively or additionally, imaging device 370 may
be external to the patient, such as an imaging device selected from
the group consisting of: an X-ray; a fluoroscope; an ultrasound
image; an MRI; a PET Scanner; and combinations of these.
[0204] System 300 may further include protective cap 380,
configured to be positioned proximate tissue to prevent damage to
certain tissue during energy delivery or other tissue treatment
event. Protective cap 380 may be delivered with endoscope 350 or
another elongate device such that cap 380 can be placed over and
then positioned to protect the Ampulla of Vater. In a typical
embodiment, protective cap 380 is removed within 24 hours of
placement, such as by being removed during the procedure after
treatment of the target tissue.
[0205] In addition to or as an alternative to fluid delivery
assembly 130, system 300 may further include tissue expansion
device 390, configured to expand the target tissue area, such as
sub-mucosal tissue expanding device, such one or more tissue
expansion devices 100 of FIG. 1 or another tissue expansion device
described herein in reference to FIGS. 2 through 18. Tissue
expansion device 390 may be inserted through endoscope 350 and/or
alongside endoscope 350. Tissue expansion can greatly alleviate the
need for precision of treatment, such as precision of energy
delivery, due to the increased size (e.g. increased depth) of the
target tissue and an associated safety zone of tissue to which
treatment causes no significant adverse event (e.g. an expanded
submucosal layer prior to a mucosal layer ablation).
[0206] System 300 may further include one or more pharmaceutical or
other agents 500, such as an agent configured for systemic and/or
local delivery to a patient. These agents may be delivered,
pre-procedurally, peri-procedurally and/or post-procedurally. The
agents may be configured to improve healing, such as agents
selected from the group consisting of: antibiotics, steroids,
mucosal cytoprotective agents such as sucralfate, proton pump
inhibitors or other acid blocking drugs; and combinations of these.
Alternative or in addition to these agents, pre-procedural and/or
post-procedural diets may be employed. Pre-procedural diets may
include food intake that is low in carbohydrates and/or low in
calories. Post-procedural diets may include food intake that
comprise a total liquid diet or a diet that is low in calories
and/or low in carbohydrates. In some embodiments, a diuretic or
other fluid reducing agent may be delivered to the patient, such as
a diuretic delivered after completion of a tissue expansion
procedure.
[0207] In a typical embodiment, system 300 does not include a
chronically implanted component or device, only body inserted
devices that are removed at the end of the clinical procedure or
shortly thereafter, such as devices removed within 8 hours of
insertion, within 24 hours of insertion and/or within one week of
insertion. In an alternative embodiment, implant 510 may be
included. Implant 510 may comprise one or more of: a stent; a
sleeve; and a drug delivery device such as a coated stent, a coated
sleeve and/or an implanted pump. In embodiments including an
implant, such as implant 510, tissue expansion such as submucosal
tissue expansion can be performed to enhance the anchoring of the
implant such as to the luminal wall of the gastrointestinal
tract.
[0208] Each of the components of system 300 may be removably
attached to another component, particularly controller 360, energy
delivery unit 330, vacuum source 340, motion transfer element 335,
ground pad 332 and endoscope 350 and device 301.
[0209] While the preferred embodiments of the devices and methods
have been described in reference to the environment in which they
were developed, they are merely illustrative of the principles of
the inventions. Modification or combinations of the above-described
assemblies, other embodiments, configurations, and methods for
carrying out the invention, and variations of aspects of the
invention that are obvious to those of skill in the art are
intended to be within the scope of the claims. In addition, where
this application has listed the steps of a method or procedure in a
specific order, it may be possible, or even expedient in certain
circumstances, to change the order in which some steps are
performed, and it is intended that the particular steps of the
method or procedure claim set forth herebelow not be construed as
being order-specific unless such order specificity is expressly
stated in the claim.
* * * * *