U.S. patent application number 12/912079 was filed with the patent office on 2011-03-10 for biological navigation device.
Invention is credited to Mark Christopher SCHEEFF, Alexander Quillin TILSON.
Application Number | 20110060186 12/912079 |
Document ID | / |
Family ID | 41255363 |
Filed Date | 2011-03-10 |
United States Patent
Application |
20110060186 |
Kind Code |
A1 |
TILSON; Alexander Quillin ;
et al. |
March 10, 2011 |
BIOLOGICAL NAVIGATION DEVICE
Abstract
A biological navigation device that can be attached or
integrated with an elongated tool, such as an endoscope, is
disclosed. The device can be used for propulsive advance through a
biological lumen. The device can anchor to the biological lumen.
The device can subsequently or concurrently propel the endoscope
and anchor the device to the biological lumen. Methods for using
the same are also disclosed.
Inventors: |
TILSON; Alexander Quillin;
(Burlingame, CA) ; SCHEEFF; Mark Christopher; (San
Francisco, CA) |
Family ID: |
41255363 |
Appl. No.: |
12/912079 |
Filed: |
October 26, 2010 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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PCT/US2009/041637 |
Apr 24, 2009 |
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12912079 |
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61125720 |
Apr 27, 2008 |
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Current U.S.
Class: |
600/104 |
Current CPC
Class: |
A61M 25/04 20130101;
A61B 1/00135 20130101; A61B 1/00082 20130101; A61M 25/10 20130101;
A61B 1/01 20130101; A61B 1/0051 20130101; A61B 1/00156 20130101;
A61B 1/00151 20130101; A61B 1/0014 20130101; A61M 25/0116
20130101 |
Class at
Publication: |
600/104 |
International
Class: |
A61B 1/00 20060101
A61B001/00 |
Claims
1. A device for navigation through a biological lumen comprising: a
propulsion device comprising an extendable actuator and an anchor,
wherein the actuator is distal to the anchor, an endoluminal tool
attached to the actuator; and wherein the actuator has an actuator
outer wall and an actuator inner wall.
2. The device of claim 1, wherein the anchor is radially
expandable.
3. The device of claim 1, wherein the anchor is inflatable.
4. The device of claim 1, wherein the actuator comprises a
bellows.
5. The device of claim 1, wherein the actuator has an inner
diameter defining an actuator lumen, and wherein the endoluminal
tool is located inside the actuator lumen.
6. The device of claim 1, wherein the actuator comprises a
fiber-reinforced laminate.
7. A device for navigation through a biological lumen comprising:
an endoluminal tool having an articulatible section; and a bellows
attached to the endoluminal tool distal to the articulatible
section.
8. The device of claim 7, wherein the bellows has an annular
configuration.
9. The device of claim 7, wherein the bellows comprises an outer
wall comprising a fiber-reinforced laminate.
10. The device of claim 7, wherein the bellows comprises a
spring.
11. A device for navigating through a biological lumen comprising:
a propulsion device comprising an actuator and an overtube, the
actuator distal to the overtube; and an endoluminal tool attached
to the actuator.
12. The device of claim 11, wherein the endoluminal tool is
removably attached to the actuator.
Description
CROSS-REFERENCE TO REPLATED APPLICATIONS
[0001] The present application is a continuation of PCT Application
No. PCT/US2009/041637, filed 24 Apr. 2009, which claims priority to
U.S. Provisional Application No. 61/125,720, filed 27 Apr. 2008,
both of which are incorporated herein by reference in their
entireties.
BACKGROUND OF THE INVENTION
[0002] 1. Field of the Invention
[0003] Devices for propelling through and exploring luminal
cavities are disclosed. One such device example is an endoscope,
which can be used to explore body passages. Such passages typically
include, but are not limited to, the GI tract, the pulmonary and
gynecological systems, urological tracts, and the coronary
vasculature. Methods for use include exploration of the upper GI
tract, including the small intestine and exploration of the lower
part of the GI tract, for example the large intestine or colon.
[0004] 2. Description of the Related Art
[0005] Colonoscopy is a diagnostic and sometimes therapeutic
procedure used in the prevention, diagnosis and treatment of colon
cancer, among other pathologies. With colonoscopy, polyps can be
harvested before they metastasize and spread. With regular
colonoscopies, the incidence of colon cancer can be substantially
reduced.
[0006] The anus can provide entry into the colon for a colonoscopy.
The colon extends from the rectum to the cecum and has sigmoid,
descending, transverse, and ascending portions. The sigmoid colon
is the s-shaped portion of the colon between the descending colon
and the rectum.
[0007] Colonoscopy typically involves the anal insertion of a
semi-flexible shaft. To typically navigate the colon, the forward
few inches of tip are flexed or steered as the shaft is alternately
pushed, pulled, and twisted in a highly skill-based attempt to
advance to the end of the colon: the cecum. The medical
professional imparts these motions in close proximity to the anus,
where the device enters. Tip flexure has typically been
accomplished by rotating wheels--one that controls cables that move
the tip right-left, and one that controls cables that move the tip
up-down.
[0008] Colonoscopes typically utilize various conduits or channels.
The conduits or channels often contain elements that enable vision
(e.g., fiber optics, CCD cameras, CMOS camera chips) and lighting
(e.g., fiber optic light sources, high power LEDs (Light Emitting
Diodes)), such as energy delivery and/or receipt conduits. They
have conduits that provide suction or pressurization, fluid
irrigation, the delivery of instruments (e.g., for cutting,
coagulation, polyp removal, tissue sampling) and lens cleaning
elements (typically a right angle orifice that exits near the
camera, such that a fluid flush provides a cleansing wash).
[0009] Colonoscopes include articulating sections at their tip,
which allow the user to position the tip. These articulating
sections have rigid link bodies that rotate relative to each other
through the use of pins at their connecting joints. As tensile
cables pull from the periphery of the articulating sections, they
impart torques, which rotate the link sections on their pins,
articulating the tip section. The links are usually rotated by two
or four tensile cables.
[0010] Typical commercially available colonoscopes are currently
reusable. However, as disposable and other lower-cost colonoscopes
are developed, these articulatable sections are no longer
practical. Their high part count creates total costs that are
exorbitant for a lower cost, disposable device. The pivot pins can
also fall out, which can create a patient danger. Their design
geometries, while suited for long life, high cost, high strength
metals elements, do not readily suit themselves to the design goals
of lower-cost and more readily mass-produced parts.
[0011] Suction can be utilized to remove debris or fluid. The colon
can be pressurized to expand the diameter of the colon to enhance
visualization.
[0012] During advancement of the colonoscope through the colon,
landmarks are noted and an attempt is made to visualize a
significant portion of the colon's inside wall. Therapeutic actions
can occur at any time, but are typically performed during
withdrawal.
[0013] Navigating the long, small diameter colonoscope shaft in
compression through the colon--a circuitous route with highly
irregular anatomy--can be very difficult. Studies have shown a
learning curve for doctors performing colonoscopies of greater than
two-hundred cases. Even with the achievement of such a practice
milestone, the cecum is often not reached, thereby denying the
patient the potential for a full diagnosis.
[0014] During colonoscopy, significant patient pain can result.
This is typically not the result of colon wall contact or of anal
entry. The primary cause of pain is thought to be stretching and
gross distortion of the mesocolon (the mesentery that attaches the
colon to other internal organs). This is commonly referred to as
`looping` and is a result of trying to push a long, small diameter
shaft in compression as the clinician attempts to navigate a
torturous colon. While attempting to advance the tip by pushing on
the scope, often all that occurs is that intermediate locations are
significantly stretched and grossly distorted. Due to this pain,
various forms of anesthesia are typically given to the patient.
Anesthesia delivery results in the direct cost of the anesthesia,
the cost to professionally administer the anesthesia, the costs
associated with the capital equipment and its facility layouts, and
the costs associated with longer procedure time (e.g., preparation,
aesthesia administration, post-procedure monitoring, and the need
to have someone else drive the patient home). It has been estimated
that forty percent of the cost of a colonoscopy can be attributed
to the procedure's need for anesthesia.
[0015] Cleaning of colonoscopes is also an issue. Cleaning is time
consuming, and lack of proper cleaning can result in disease
transmission. Cleaning can utilize noxious chemicals and requires
back-up scopes (some in use while others being cleaned). Cleaning
also creates significant wear-and-tear of the device, which can
lead to the need for more servicing.
[0016] In recent years there have been advancements in the
navigation of the small intestine. One notable method is known as
Double Balloon Enteroscopy. Double-balloon enteroscopy, also known
as push-and-pull enteroscopy is an endoscopic technique for
visualization of the small bowel. It allows for the entire
gastrointestinal tract to be visualized in real time. The technique
involves the use of a balloon at the end of a special enteroscope
camera and an overtube, which is a tube that fits over the
endoscope, and which is also fitted with a balloon. The procedure
is usually done under general anesthesia, but may be done with the
use of conscious sedation. The enteroscope and overtube are
inserted through the mouth and passed in conventional fashion (that
is, as with gastroscopy) into the small bowel. Following this, the
endoscope is advanced a small distance in front of the overtube and
the balloon at the end is inflated. Using the assistance of
friction at the interface of the enteroscope and intestinal wall,
the small bowel is accordioned back to the overtube. The overtube
balloon is then deployed, and the enteroscope balloon is deflated.
The process is then continued until the entire small bowel is
visualized. The double-balloon enteroscope can also be passed in
retrograde fashion, through the colon and into the ileum to
visualize the end of the small bowel.
[0017] Though the procedure has played a vital role in the
diagnosis and treatment of disease in this part of the GI tract, it
remains problematic in several regards. Like colonoscopy, it
suffers from looping. A long and flexible shaft is pushed, but
instead of the tip moving forward, it often merely moves
inadvertently in intermediate locations. The procedure requires
significant skill, is laborious and time consuming--usually taking
more than an hour.
[0018] In both colonoscopy and in navigation of the small
intestine, it would be advantageous to have a device that enabled
local `pull` motion, i.e., if the device could pull itself forward
locally, rather than having to be pushed at a far proximal and less
effective location.
[0019] Methods have been suggested which create a force reaction
location outside of the body. Others have been suggested which
create a force reaction location--necessary to advance the
endoscope--within the body, including local to the endoscope tip.
Internal devices typically operate proximal to the tip's
articulating section, which can be kinematically disadvantageous
relative to being located distal to the articulating section.
[0020] Endoscopic devices have found it notably challenging to
create methods to appropriately navigate through torturous
geometries, particularly without undue colon wall stresses and
subsequent mesocolon stretch. Steering kinematics are critical and
have been an ongoing challenge--certainly for existing colonoscopes
(which result in `looping`), but also to more effective
next-generation devices.
[0021] The systems proposed to-date have geometries that create
suboptimal steering efficacies. When a propulsion element is
substantially distal to the tip articulating section, it can be
vectored in that direction when propelled. This can be highly
advantageous relative to systems in which the propulsive element is
located proximal to the articulating section. In this situation,
disadvantageous kinematics are created when the tip is retroflexed
and is pointing in one desired direction of advance and the system
advance is attempted. The system does not move in the direction of
the retroflexed tip, but rather in the direction of the system
proximal to that section. When the system is coaxial, these
directions are the same. However, should the tip be retroflexed
back 180 degrees, the desired advance direction (i.e., tip pointing
direction) and actual advance direction are 180 degrees apart. The
driven section presumes a vector--typically an axial manner--with
the steering tip only having efficacy as it relates to its
interaction with luminal walls. In endoscopy, this wall interaction
is undesirable--it creates unnecessary wall stress and trauma, and
can be a significant contributor to gross wall distortion, known as
looping. It would therefore be desirable to have system designs
that enable more lumen-centric steering that can point the
articulating section in a direction and move in that pointed
direction as the unit is advanced through the colon's straights and
curvatures.
[0022] Such kinematic enablement could be achieved through a novel,
dedicated system. Alternatively, it could be enabled through a
device that worked additive to existing endoscopes. This would be
advantageous, in that it would utilize a vast installed base of
advanced hardware, software, and training. Such `retrofit` devices
could potentially achieve scaled utilization in an accelerated
manner.
[0023] Devices to achieve these performance goals will often have
challenges with optimal material selection. The desired structure
can have a rare combination of requisite features: softness,
strength, radial stiffness, low thickness, freedom from leaks,
flex-crack resistance, puncture resistance, appropriate coefficient
of friction, the potential for modifiable geometry as a function of
length, and appropriate manufacturability and cost. Monolithic
materials often prove insufficient at providing the variety of
requisite specifications.
BRIEF SUMMARY OF THE INVENTION
[0024] A device for navigation through a biological lumen is
disclosed. The device can have a propulsion device and an
endoluminal tool. The actuator can have an actuator outer wall and
an actuator inner wall. The propulsion device can have an
extendable actuator and an anchor, wherein the actuator is distal
to the anchor. The endoluminal tool can be attached to the
actuator.
[0025] The actuator can have an actuator lumen extending through a
distal terminal end of the actuator. The actuator lumen can be
formed by the actuator inner wall. The actuator lumen can extend
through the proximal and/or distal terminal ends of the actuator.
The actuator lumen can extend through the entire actuator, opening
at both terminal ends of the actuator.
[0026] The anchor can be radially expandable. The anchor can be
inflatable. The anchor can be or have a balloon.
[0027] The endoluminal tool can have a longitudinal axis. The
actuator can be extendable along the longitudinal axis. The
actuator can have an expanded configuration and a retracted
configuration. The outer diameter of the actuator in the expanded
configuration can be substantially equal to the outer diameter of
the actuator in the contracted configuration.
[0028] The actuator can be inflatable. The actuator can have one or
more bellows. The bellows can have a hollow bellows lumen. The
endoluminal tool can be positioned in the hollow bellows lumen.
[0029] The endoluminal tool can have or be an endoscope. The
endoluminal tool can have an articulation section. The anchor can
be distal to the articulating section of the endoluminal tool.
[0030] The actuator, for example the bellows, can have a
fiber-reinforced laminate. The actuator can have a spring. The
spring can be a helical or a leaf spring. The spring can have a
circular or rectangular (e.g., a substantially flat spring)
cross-section of the coil of the spring.
[0031] A device for navigation through a biological lumen is also
disclosed that can have an endoluminal tool and a bladder defining
an inflatable extendable volume. The bladder can be annular and
define an inner lumen radially internal to, and not in fluid
communication with, the inflatable extendable volume. The
endoluminal tool can be located in the inner lumen. The distal end
of the endoluminal tool can be mechanically coupled to the distal
end of the distal end of the bladder, for example, via an
attachment clamp distal to the bladder.
[0032] Also disclosed is a device for navigation through a
biological lumen that can have an endoluminal tool having an
articulatible section, and a bellows attached to the endoluminal
tool distal to the articulatible section. The bellows can be
annular. The bellows can form a bellows lumen. A length of the
endoluminal tool can be located in the bellows lumen.
[0033] The bellows can longitudinally expand when inflated. The
bellows can have a substantially constant outer diameter in a
deflated configuration with respect to an inflated configuration. A
urethane adhesive can attach a spring to the outer wall of the
bellows.
[0034] Furthermore, a device for navigating through a biological
lumen having a propulsion device having an actuator and an
overtube, and an endoluminal tool is disclosed. The actuator can be
distal to the overtube. The endoluminal tool can be attached to the
actuator.
[0035] A method for navigating through a biological lumen is also
disclosed. The method can include attaching a distal end of a
propulsion device to a distal end of an endoluminal tool and
extending the actuator. The method can include pushing the
overtube. Extending the actuator can include inflating the
actuator. The method can include slidably translating the overtube
with respect to the endoluminal tool. The overtube can be directly
or not directly attached to the endoluminal tool. The method can
include clamping the propulsion device to the endoluminal tool.
[0036] A method is disclosed for navigating through a biological
lumen having an inner wall including inserting a device into the
biological lumen, anchoring the device to the inner wall of the
biological lumen, and extending the actuator. The device can have
an actuator and an anchor, and the actuator can be distal to the
anchor. The device can be attached to an endoluminal tool extending
proximal to the device.
[0037] Extending the actuator can include advancing the device
along the biological lumen. Extending the actuator can include
delivering pressurized fluid to the actuator and not exposing the
endoluminal tool to the pressurized fluid.
BRIEF DESCRIPTION OF THE FIGURES
[0038] FIG. 1 is a schematic view of a variation of the device.
[0039] FIG. 2 is a schematic view of a variation of the device.
[0040] FIG. 3 is a schematic view of a variation of the base and a
fluid system.
[0041] FIG. 4 illustrates a variation of the tip in a contracted or
retracted configuration and a distal portion of the endoscope.
[0042] FIG. 5 illustrates a variation of the tip in a partially
extended configuration and a distal portion of the endoscope.
[0043] FIG. 6 illustrates a variation of the tip in an extended
configuration and a distal portion of the endoscope.
[0044] FIG. 7 illustrates a variation of the tip in a contracted
configuration and a distal portion of the endoscope.
[0045] FIGS. 8a through 8d illustrate variations of cross-section
A-A of FIG. 7.
[0046] FIGS. 9 and 10 illustrate a variation of the springs of the
tip of FIG. 8b in contracted and expanded configurations,
respectively.
[0047] FIGS. 11a and 11b illustrate a variation of the spring of
the tip of FIG. 8b in contracted and expanded configurations,
respectively.
[0048] FIG. 12 illustrates a variation of the bellow.
[0049] FIG. 13 is a variation of a length of cross-section B-B of
FIG. 11b.
[0050] FIG. 14a and 14b are variations of cross-section A-A of the
support.
[0051] FIG. 15 illustrates a variation of the support.
[0052] FIG. 16 illustrates a variation of the anchoring
balloon.
[0053] FIGS. 17a through 17g illustrate a variation of a method for
using the device.
[0054] FIGS. 18a and 18c illustrate a variation of a method for
using the device.
DETAILED DESCRIPTION
[0055] A biological navigation device 10 for navigation of
passageways is disclosed. The device 10 can be utilized for
biological passageways. The device 10 can have an endoscope 12 for
navigating portions of the GI tract. The scope 12 can be attached
or integral with other elements to form an endoscopy system. The
endoscopy system can continuously examine and/or treat the GI
tract.
[0056] FIG. 1 illustrates that the device 10 can have a base 16, a
propulsion tip 18, and one or more control lines 140 connecting the
base 16 to the tip 18. The base 16 and tip 18 can be connected to
the lines 140. The tip 18 can have an anchor 20 and an actuator 22.
The anchor 20 can releasably attach to the wall of a biological
lumen. The actuator 22 can controllably extend and retract in a
longitudinal direction. The tip 18 may fit over an endoluminal tool
for navigating the body, such as an endoscope 12. The endoluminal
tool can be a device for performing therapeutic or diagnostic
functions. The endoluminal tool can have a tool or endoscope
longitudinal axis 14. The tip 18 can be removably or fixedly
attached to the endoluminal tool.
[0057] The control lines 140 can be fluid lines (i.e., for gas
and/or liquid) and/or electrical or mechanical leads, such as
conductive or mechanical control wires. The control lines 140 can
transmit or carry pressurized fluid (including negative pressure or
vacuum), electrical signals and power, and mechanical force to the
tip 18, such as to the anchor 20 and/or actuator 22.
[0058] The fluid pressure, electrical, or mechanical signals or
power from the base 16 can actuate the anchor 20 and/or the
actuator 22.
[0059] FIG. 2 illustrates that the device 10 can have an overtube
24. The overtube 24 may be positioned radially over the endoscope
12 or other device for navigating the body. The overtube 24 can
slidably translatable with respect to the endoluminal tool. The
overtube 24 can be not directly attached to the endoscope 12. The
overtube can be attached to the actuator 22. The endoscope can be
inside a lumen of the overtube 24. The overtube 24 may lead out of
the patient's body. The overtube 24 can be sufficiently axially
rigid to maintain the actuator 22 in a substantially controlled
position along the length of a biological lumen during navigation
of the lumen. The overtube 24 can be sufficiently flexible to
navigate a tortuous biological lumen, such as a colon. All or a
length of the lines 140 can embedded in or slidably or fixedly
attached to the overtube 24.
[0060] The overtube 24 can be made from a polymer such as
polyvinylchloride (PVC), Santoprene, Nylon, low density
polyethylene (LDPE). The overtube 24 can have a durometer from
about 70 shore A to about 80 shore A. The overtube 24 can have an
overtube outer diameter 26 from 10 mm to 15 mm. The overtube 24 can
have an overtube inner diameter 28 from about 9 mm to about 13 mm.
The overtube 24 can have an overtube thickness 30 from about 0.75
mm to about 3 mm, more narrowly from about 1 mm to about 1.5 mm,
for example about 1.2 mm. The overtube 24 can be a Fujinon
TS-13140, TS-12140, or TS-13101 (from Fujinon Inc., Japan)
[0061] The device 10 can have no anchoring balloon 32 or can have
one or more anchoring balloons 32.
[0062] FIG. 3 shows a possible configuration for the base 16. The
base 16 can have or be in fluid communication with a fluid control
system 124. The base 16, for example at the base pressure port 122,
can be connected to a pressure delivery line 140. The pressure
delivery line 140 can be connected to an outgoing second valve 136
and/or an incoming first valve 126.
[0063] The first valve 126 can be configured to open manually
and/or automatically. The first valve 126 can open when the tube
pressure exceeds a maximum desired tube pressure. The first valve
126 can be connected to a vacuum pump 128. The vacuum pump 128 can
be activated to deflate the tube 12 and withdraw the tube 12 or
reduce the tube pressure. The vacuum pump 128 can be attached to an
exhaust tank and/or directly to a bleed or drain line 132. The
exhaust tank 130 can be connected to the drain line 132, for
example to exhaust overflow from the exhaust tank 130.
[0064] Controls 134 can be in data communication with the first
valve 126 and the second valve 136. The controls 134 can be on the
base 16 (e.g., a button or switch on the base 16).
[0065] The second valve 136 can be attached to a pump 144, for
example a cylinder 146 with a displacement component 148, such as a
piston. A pressure regulator 138 can be in the flow path between
the pump 144 and the second valve 136. The pressure regulator 138
and/or the first valve 126 can open and release pressure from the
pump 144 when the tube pressure exceeds a maximum desired tube
pressure.
[0066] An intake tank 142 can be fed in line (as shown) or through
the pump 144 to the second valve 136, for example through the
pressure regulator 138. The fluid in the intake tank 142 can be fed
into the pressurized tube 12. The intake tank 142 can have a fill
line 150 for filling the intake tank 142 with fluid. The fill line
150 can be fed directly to the second valve 136, pressure regulator
138 or pump 144 without the intake tank 142.
[0067] The biological navigation device 10 can have capital
equipment which can provide utility to the remainder of the device
10. The capital equipment can include, for example, the elements in
the fluid control system 124. The fluid control system 124 can have
a fluid source (e.g., the intake tank 142 and/or fill line 150), a
pressurize source such as the pump 144, a conduit for delivery of
the pressurization media (e.g., the pressure delivery line 140),
controls 134, system monitoring elements (e.g., can be in the
controls 134). The capital equipment can reduce the profile of the
tube 12, for example, in which tools can be inserted. The
integrated tools can create elements that reduce waste, thereby
allowing for higher value capture and less refuse.
[0068] The delivery line 140 can be attached to a handle 46 that
attaches to the tip 18 or the delivery line 140 can attach directly
to the tip 18.
[0069] The fluid pressurization can be controlled by a variety of
user inputs, for example a button on the endoscope, handle, tip 18
or base 16, voice commands, foot pedals, or combinations
thereof.
[0070] FIGS. 4 through 6 illustrate that the tip 18 can have
increasingly extended configurations. The anchor 20 can have one or
more hooks, barbs, extendable fingers, or anchoring balloons 32.
The actuator 22 can have a controllably extendable element, such as
one or more springs 36. The springs 36 can be in fluid permeable or
fluid impermeable bellows 34. The terminal distal end of the tip 18
can have a traumatic or atraumatic cap 40.
[0071] FIG. 4 illustrates that the anchoring balloon 32 can be
partially or completely deflated and the actuator 22 retracted.
[0072] FIG. 5 illustrates that the anchoring balloon 32 can be
partially or completely expanded, for example by inflating the
balloon through fluid pressure delivered by a first line 140a. The
device 10 can have a second line 140b. The first line 140a can
transmit or carry signals, pressure, power, or combinations thereof
between the base 16 and the anchor 20. The second line 140b can
transmit or carry signals, pressure, power, or combinations thereof
between the base 16 and the actuator 22. The actuator 22 can be in
a retracted or extended configuration when the anchoring balloon 32
is expanding.
[0073] FIG. 6 illustrates that the anchoring balloon 32 can be in
an expanded configuration and the actuator 22 can be extended, as
shown by arrow. The actuator 22 can be activated by pressure,
signals and/or power from the second line 140b.
[0074] The actuator 22 can be expanded by the delivery of pressure
through second line 140b. The second line 140b can deliver a vacuum
to the actuator 22 to produce a negative pressure within the fluid
impermeable bellows 34 and retract the bellows 34 and the actuator
22. The bellows 34 and/or the anchoring balloon 32 can have annular
or toroidal configurations.
[0075] The first line 140a can deliver positive pressure to the
anchor 20 to activate or inflate the anchoring balloon 32, and
negative pressure or vacuum to contract the anchoring balloon
32.
[0076] The tip 18 and endoscope can be delivered into a biological
lumen, such as a colon, esophagus, or blood vessel. The anchoring
balloon 32, for example in an inflated configuration, can contact
the wall of the biological lumen. The balloon can exert a radial
force and engage against the lumen wall, creating axial forces
fixing or anchoring the anchor 20 to the lumen wall. The actuator
22 can then be expanded while the balloon remains substantially
fixed against the lumen wall. The endoscope can be slidably
attached to the anchor 20, but fixedly attached to the actuator 22.
Hence, expansion of the actuator 22 while the balloon remains fixed
against the lumen wall can advance the endoscope through the lumen,
the endoscope can slide though the anchor 20 and advance concurrent
with the advancement of the actuator 22.
[0077] The balloon can expand at a low pressure for example
minimizing forces to the lumen wall. This expansion pressure of the
balloon can be about 1 psi. The balloon can be made from a very low
durometer material, for example a material that can stretch and
contact the wall to a variety of anatomies at a low pressure. Latex
balloons can be utilized, along with other materials, including
urethanes or other elastomers.
[0078] The anchoring balloon 32 can be made from a non-elastomeric
or minimally-elastomeric material. The anchoring balloon 32 can
have a maximum expanded diameter larger than the diameter of the
lumen wall into which the anchoring balloon 32 is to be delivered.
The anchoring balloon 32 can be inflated to engage the wall without
significant pressure or stretching of the anchoring balloon 32.
[0079] The actuator 22 and anchor 20 can be activated by pressure
and/or vacuum from the base 16. The base 16 can be a pressure and a
vacuum source. The base 16 can deliver a first pressure of about 30
psi to the actuator 22 and/or anchor 20. The base 16 can deliver a
second pressure, for example less than about 5 psi, for example
about 1 psi or about 2 psi, to the actuator 22 and/or anchor 20
concurrent or subsequent to the delivery of the first pressure. The
base 16 can be a stand alone unit, or part of the facility (e.g.,
hospital or health care office) pressure and vacuum sources.
[0080] These pressures and vacuum sources can be activated by user
controls. User controls can be audible, foot-activated, or manually
activated. One user control can inflate the anchoring balloon 32. A
second user control can expand (e.g., inflate) the actuator 22 may
be inflated to drive the unit forward. The anchor 20 can be
retracted by application of a vacuum from the base 16. The anchor
20 can be retracted before the bellows pressure is reduced, or the
actuator 22 is otherwise retracted.
[0081] The anchoring inflation, actuator extension, anchoring
deflation, and actuator retraction sequence can be repeated in
sequence to advance the endoscope through a lumen. Sequential steps
of inflation and contraction can be automated. For instance,
pressing a single button may trigger repeated performance of the
inflation, extension, deflation, retraction sequence to advance the
endoscope.
[0082] FIG. 7 illustrates that the tip 18 can have an atraumatic
cap 40 and the distal terminal end of the tip 18. (The anchoring
balloon 32 and the outer wall of the actuator 22 are not shown for
illustrative purposes). The tip 18 can have a rigid anchor support
42. The anchor support 42 can support an anchor balloon 32. The
anchor support 42 may have a conical proximal entry, such as the
entry funnel 44. The entry funnel 44 may allow the proximal length
of the endoscope exiting the entry funnel 44 to articulate more
freely within and adjacent to the entry funnel 44. The actuator 22
can have one or more springs.
[0083] The anchor support 42 can have first and second line
connectors 46a and 46b. The first and second line connectors 46a
and 46b can connect to first and second lines 140a and 140b,
respectively. The first and second line connectors 46 and 46b can
deliver fluid pressure, signals and/or power between the lines 140
and the anchor 20 and actuator 22.
[0084] FIG. 8a illustrates that the anchoring balloon 32 can have
inflated and collapsed (shown in phantom lines) configurations. The
anchoring balloon 32 may be mounted on the anchor support 42. The
anchor support 42 may encircle the endoscope in a support lumen 60.
The anchor support 42 can block the anchor balloon 32 from clamping
to the endoscope or from exposure to the pressure in the inflated
anchor balloon 32. The anchor support 42 can have a balloon port 58
connecting flow to or from the line 140 from the line connector to
the anchoring balloon 32 or actuator 22.
[0085] The actuator 22 can have an actuating body 52. The actuating
body 52 can be expandable. The actuating body 52 can resilient or
deformable. The actuating body 52 can have one or more springs,
foam, sponge, elastomeric tube, fluid-filled and/or gel-filled
annular bladder, magnets, or combinations thereof. The device 10
can have no actuating body 52.
[0086] The actuator 22 can have an inner wall 50a and/or an outer
wall 50b. The inner and/or outer walls 50 can be fluid impermeable.
A fluid tight, or fluid-sealed, actuator chamber 48 or volume can
be between the outer wall 50b and the inner wall 50a. The outer
walls 50b of the actuator chamber 48 can form pleated bellows 34.
The bellows 34 can be an inflatable bladder. The bellows 34 can
form an annular shape. The bellows 34 can form a bellows lumen 54
through which the endoscope can be placed. The endoscope can be
isolated from exposure to the pressure in the bellows 34. The
bellows 34 can controllably expand along the direction of the
endoscopic longitudinal axis. The inner and/or outer diameter of
the bellows 34 in an expanded (e.g., inflated) configuration can be
substantially equal to the inner and/or outer diameter,
respectively, of the bellows 34 in a retracted (e.g., deflated)
configuration. The anchor support 42 can have an actuator port 70
connecting the second line connector 46b to the actuator chamber
48.
[0087] The inner wall 50a and/or outer wall 50b can be attached at
points or along the entire length of the actuating body 52. For
example, the inner wall 50a can be attached to the inner diameter
of the actuator body 52 and the outer wall 50b can be attached to
the outer diameter of the actuator body 52.
[0088] The anchor support 42 and/or the bellows 34 can have an
annular shape. The endoscope may pass thru the inner lumen of the
anchor support 42 and the bellows 34.
[0089] The tip 18 may be placed distal to an articulating section
on the endoscope. The tip 18 can be directionally oriented by the
endoscope. The tip 18 can be partially or completely overlapping in
length with the articulate section of the endoscope.
[0090] The tip 18 can have a releasable attachment clamp 38. The
attachment clamp 38 can be clamped onto the distal end of the
endoscope. The clamp can removably attach the actuator to the
endoscope. The attachment clamp 38 can interface with shear
geometry in the endoscope. As the clamp engages this shear groove
in the scope, the clamp can couple forward and reverse motion of
the bellows 34 to forward and reverse motion of the endoscope. The
clamp can be a collet and/or split clamp and/or a snap ring. The
clamp can be made to interface with the endoscope without any
endoscope modification required.
[0091] The distal end of the endoscope can have an endoscope face.
The endoscope face can have exposed therapeutic and diagnostic
instruments. The endoscope face can be exposed through a port in
the cap 40 at the distal end of the tip 18.
[0092] FIG. 8b illustrates that the actuator body 52 can be one or
more springs 36. The actuator body 52 can have an inner spring 36a
and an outer spring 36b. The outer diameter of the outer spring 36b
can be attached to the outer wall 50b of the bellows 34. The inner
diameter of the inner spring 36a can be attached to the inner wall
50a of the bellows 34.
[0093] The anchoring balloon 32 may be replaced or augmented by an
overtube 24. FIG. 8c illustrates that the anchoring balloon 32 has
been replaced by an overtube 24. The overtube 24 may be a tube that
encloses or partially encloses the endoscope 12. The overtube 24
may lead out of the body such that the physician can manipulate the
tube. The overtube 24 may be sufficiently rigid to provide a
reaction force to the actuator. The overtube 24 may be sufficiently
flexible to be navigated thru the body.
[0094] FIG. 8d illustrates that the device 10 can have a proximal
anchoring balloon 32a and a distal anchoring balloon 32b (shown in
an inflated configuration in solid lines and a deflated
configuration in phantom lines). The distal balloon 32b can be
attached to the cap 40. The distal balloon 32b can be in fluid
communication with a third line 140c through the cap 40.
[0095] The lines 140 can attach to the anchoring balloons 32 and
actuator chamber 48 through a connector and balloon port 58 as
shown elsewhere herein. The first line 140a can connect directly to
the proximal balloon 32a and/or to the proximal balloon 32a via a
direct connector into the proximal balloon 32a. The third line 140c
can connect the base 16 to the distal balloon 32b. The third line
140c can connect directly to the distal balloon 32b and/or to the
distal balloon 32b via a direct connector into the distal balloon
32b. The second line 140b can connect directly to the actuator 22
and/or to the actuator 22 via a direct connector into the actuator
chamber 48. The lines 140 can be on the radial outside or radial
inside of the support and the bellows 34.
[0096] The distal and proximal anchoring balloons 32a and 32b can
be activated sequentially, concurrently, overlapping in time, or
combinations thereof. For example, the device 10 can be used by
performing the following, in the sequential order listed or another
order: inflate the proximal anchoring balloon 32a anchoring the
proximal balloon to the biological lumen; extend the actuator
distally pulling the endoscope 12 distally with the distal end of
the actuator (e.g., inflate the bellows 34); inflate the distal
anchoring balloon 32b anchoring the distal anchoring balloon 32b to
the biological lumen; deflate the proximal anchoring balloon 32a,
retract the actuator pulling the proximal anchoring balloon 32a
distally with the proximal end of the actuator (e.g., deflate the
bellows 34); inflate the proximal anchoring balloon 32a prior to,
concurrent with or subsequent to deflating the distal balloon 32b.
When the anchoring balloons 32 are inflated, the anchoring balloons
32 can anchor to the wall of the biological lumen. When the
anchoring balloons 32 are deflated, the anchoring balloons 32 can
release the anchoring to the wall of the biological lumen.
[0097] FIG. 10 shows the inner spring 36a can nest within the outer
spring 36b. The springs 36 are shown retracted and extended. The
bellows wall is typically coupled to the springs 36. The springs 36
provide a retraction or expansion force, in addition to the force
provided by the vacuum or positive pressure. By coupling the
bellows wall to the springs 36, the bellows 34 expansion and
contraction can be more controlled. The springs 36 can be connected
to the bellows 34 through sewing, pocketing, adhesion bonding, or
combinations thereof.
[0098] FIGS. 9 and 10 illustrate that the outer and inner spring
36a of the actuator can be configured to resiliently expand (as
shown by arrow) or contract in a relaxed state. The pressure
applied to the bellows 34 to activate the actuator can oppose the
springs 36 to account for the desired action. For example, if the
springs 36 are contracted in a relaxed state, the bellows 34 can be
inflated to expand the actuator. The pressure in the bellows 34 can
be released and the springs 36 can retract the bellows 34 with or
without negative pressure. Also for example, if the springs 36 are
expanded in a relaxed state, the bellows 34 can be deflated to
contract the actuator. The pressure in the bellows 34 can be
released and the springs 36 can expand the bellows 34 with or
without positive pressure.
[0099] The bellows 34 may provide rapid, high-force actuation via
hydraulics and/or pneumatics. The bellows 34 can be annular to
allow the tool or endoscope 12 to pass through their interior. This
can be done with a single bellows 34, or with an array of smaller
(each individually non-annular) bellows 34. The bellows 34 can have
a low-profile exterior and an interior through which the endoscope
12 fits.
[0100] FIGS. 11a and 11b illustrate that the actuator body 52 can
be one or more flat springs 36. The spring can have an outer
diameter of about 0.92 in., an inner diameter of about 0.68 in.,
and a thickness of about 0.014 in. The spring can be made of a
spring metal, for example 17-4 stainless steel. The spring can be
made from a plastic. The cross section of the coil of the spring
can be rectangular.
[0101] FIG. 12 shows a bellows 34 separated from the tip 18. The
bellows 34 may have a large extension ratio (compressed to expanded
length), preferably 1:10. The bellows 34 may have an annular shape
with a clear passage through the device 10. The interior of the
bellows 34 may be placed at a pressure higher than the surrounding
pressure. This may cause the bellows 34 to expand in length. The
interior of the bellows 34 may be placed at a pressure lower than
the surrounding pressure. This may cause the bellows 34 to contract
in length.
[0102] The bellows wall material can be very thin. For example, the
thickness of the bellows wall material can be from about 0.001 in.
to about 0.002 in. The bellows 34 can have a
compression-to-extension ratio of about 10:1 (i.e., a 0.5 in.
contracted bellows 34 can expand to 5 in. at full expansion). The
bellow wall material can be high strength to withstand pressure.
The bellows wall material can have a low bending stiffness, high
tensile strength and stiffness. The bellows wall material can bond
well to adhesives.
[0103] The bellows wall material can be or include a
fiber-reinforced laminate, such as Cuben Fiber (from Cubic Tech
Corp., Mesa, Ariz.). The bellows wall material can be a composite
of a flexible, high shear strength adhesive, engineering films, and
high strength, small diameter fibers. The fibers can have a
unidirectional orientation. The bellows wall material can include
fibers and cloths including those made from Kevlar, spectra, nylon,
Dyneema, or combinations thereof. The fiber-based elements can be
deployed either as laminated unidirectional material, or woven or
knitted. The bellows wall material can have layers that can be sewn
together, bonded by wet adhesives or by heat activated elastomers
or film adhesives.
[0104] The bellows 34 can have a bellows first end 62a and a
bellows second end 62b. The bellows ends 62 can be configured to
fix to the adjacent elements when the device 10 is assembled. The
bellows ends 62 can be reinforced. The bellows ends 62 can be
attached to or integral with the inner wall 50a and the outer wall
50b to form a fluid-tight volume.
[0105] FIG. 13 illustrates that the inner or outer wall 50b of the
bellows 34 can be a laminate 66. The wall can be bonded to the edge
of the spring with adhesive 64. The spring can be a flat (as shown)
or round spring.
[0106] The inner and/or outer wall 50b of the bellows 34 can be
bonded to a thin urethane layer. The urethane layer can then be
bonded to the spring, or the urethane can be pre-bonded to the
spring. The urethane layer can be, for example, about 0.001 in. to
about 0.002 in. thick.
[0107] The adhesive 64 can have low stiffness and high strength.
The adhesive 64 can be heat deposited.
[0108] The adhesive 64 can be pre-deposited with the spring at a
predetermined pitch. Once the adhesive 64 is melted in place at
this pitch, excess adhesive 64 can be cut, leaving a predetermined
amount of adhesive 64 on each of the coils, with a predetermined
width and shear area. Subsequently, the inner laminate of the wall
can be bonded to this surface, now with sufficient area to resist
debonding from the spring, and from the laminate 66.
[0109] FIG. 14A illustrates that the first line 140a connector can
be in fluid communication with the balloon port 58. The balloon
port 58 can be in fluid communication with the anchoring balloon
32. FIG. 14B illustrates that the second line connector 46b can be
in fluid communication with the actuator port 70. The actuator port
70 can be in fluid communication with the actuator chamber 48 in
the bellows 34.
[0110] FIG. 15 illustrates that the support can be flexible. The
flexible support may extend over the articulating section of an
endoscope 12. The flexible support may prevent the anchoring
balloon 32 from clamping to the endoscope 12. The flexible support
may not hinder the ability of the navigation device to steer. The
flexible support may have an inflation pass-through line to connect
pressure to the bellows 34 distal of the flexible support.
[0111] FIG. 16 illustrates that the anchoring balloon 32 may be
toroidal in shape. The anchoring balloon 32 may or may not be
fluid-tight or leak-tight.
[0112] FIGS. 17a through 17f illustrate advancing the endoscope 12
through the colon using the device 10.
[0113] FIG. 17a illustrates that the biological navigation device
10 can be positioned before entry into the colon 156, for example
via the rectum 160 after passing the anus 154. The endoscope 12 can
be attached to the actuator 22 via the attachment clamp 38. For
example, the endoscope 12 can be delivered by a first manufacturer
and the tip 18 can be delivered by a second manufacturer, and the
tip 18 can be attached to the endoscope 12 in a health care
facility (e.g., hospital, doctor's office, clinic), for example by
a technician or physician. The physician can use the physician's
desired tip 18 with the physician's desired endoscope 12. The
endoscope 12 does not need to be pre-attached to the tip 18 by the
manufacturer. The physician can select the optimal tip 18 and
separately select the optimal endoscope 12 shortly before the
procedure based on the patient's anatomy, health issues and
procedure to be performed.
[0114] FIG. 17b illustrates that the device 10 can be delivered
into the rectum 160. The biological navigation device 10 can
translate into the rectum 160, attached to the elongated element
28. For example, initial delivery of the device 10 into the rectum
can be performed by inserting the device 10 through the anus by
hand.
[0115] The biological navigation device 10 is shown having an outer
diameter smaller than the inner diameter of the colon 156 for
exemplary purposes. The biological navigation device 10 can have an
outer diameter about equal to the inner diameter of the colon 156.
For example, the tip 18 and/or endoscope 12 can substantially fill
the cross-section of the length of the colon 156 occupied by the
tip 18 and/or endoscope 12.
[0116] Once positioned in the colon 156, the line 140 (or first
line) can deliver pressure from a base 16 to the anchoring balloon
32. The anchoring balloon 32 can expand, as shown by arrows. The
anchoring balloon 32 can press against the inner wall of the colon,
for example in the rectum.
[0117] The line 140 can be fixedly or slidably attached along all
or part of the length of the line 140 to the endoscope 12. For
example, the endoscope 12 can have collars or a channel that can
slidably or fixedly attach to the line 140 as the line 140 extends
distally away from the tip 18. The line 140 can be unattached to
the endoscope 12 along the entire length of the line 140.
[0118] The endoscopic face 56 can be unobstructed by the cap 40.
The one or more tools or other elements in the endoscopic face 56
can diagnose and treat during the delivery and advancement of the
device 10 through the colon.
[0119] FIG. 17c illustrates that the actuator 22 can extend, as
shown by arrow. For example, the line 140 (or second line) can
deliver pressurized fluid from the base 16 to the bellows 34. The
inflated anchoring balloon 32 can induce a resistive force against
the wall of the biological lumen to keep the anchoring balloon 32
substantially stationary while the actuator 22 advances. The
actuator 22 can be attached to the distal end of the endoscope 12.
When the actuator 22 advances, the endoscope 12 can advance. The
line 140 can remain substantially stationary. The line 140 can
slide against the side of, in a channel of, or within one or more
collars on the endoscope 12 when the endoscope 12 longitudinally
translates relative to the line 140.
[0120] FIG. 17d illustrates that the anchoring balloon 32 can
deflate or otherwise retract, as shown by arrows. The deflation of
the anchoring balloon 32 can release the tip 18 from being anchored
to the biological lumen wall.
[0121] FIG. 17e illustrates that the actuator 22 can retract, as
shown by arrow. For example, the bellows 34 can be deflated through
the line 140 (or second line). When the actuator 22 retracts, the
anchoring balloon 32 can move toward the terminal distal end of the
tip 18.
[0122] FIG. 17f illustrates that the endoscope 12 can have an
articulatable section 68. The distal end of the endoscope 12 can be
rotated, as shown by arrow, for example by the articulatable
section 68. For example, the direction the tip 18 is pointed can be
steered for the distal end of the tip 18 to follow the center of
the lumen of the colon or to point the endoscopic face 56 toward
the wall (e.g., to inspect or treat a polyp). At any length in the
colon 156, the biological navigation device 10, such as at the
endoscopic face 56, can gather diagnostic (e.g., sensing) data,
such as data for visualization, tissue inductance, RF absorption or
combinations thereof. At any length in the colon 156, such as at
the endoscopic face 56, the biological navigation device 10 can
also gather tissue samples (e.g., by performing a biopsy or
removing a polyp). At any length in the colon 156, such as at the
endoscopic face 56, the biological navigation device 10, can
perform treatment or therapy, such as delivery of a drug onto or
into tissue, tissue removal (e.g., polyp or tumor removal), or
combinations thereof.
[0123] The method shown in FIGS. 17b through 17f can be repeated to
steer and advance the endoscopic face 56 to a desired location.
[0124] FIG. 17g illustrates that the biological navigation device
10 can be advanced along the entire colon 156, passing through the
rectum 160, sigmoid colon 162, descending colon 164, transverse
colon 166, ascending colon 168, and having the tip 18 in the cecum
170. The biological navigation device 10 can be withdrawn, as shown
by arrows, from the colon 156, for example by applying a tensile
force against the endoscope 12, as shown by arrows 172 and/or by
performing the reverse of the method shown above (i.e., extend
actuator 22, then inflate anchoring balloon 32, then retract
actuator 22, then deflate anchoring balloon 32, then repeat as
desired). The biological navigation device 10 can be withdrawn, as
shown by arrows, from the colon 156, for example by applying a
tensile force to the line 140.
[0125] The device 10 can deliver agents or drugs to the target
site. The distal end of the device 10 can passively rotate, for
example if the biological navigation device 10 (e.g., the tip 18)
contacts a wall of the colon 156 (e.g., the superior wall of the
rectum 160), the biological navigation device 10 can then deflect
from or track to the wall of the colon 156.
[0126] FIG. 18a illustrates that a device 10 having an overtube 24
can be deployed in a colon. The tip 18 is shown in the descending
colon 164 for illustrative purposes. The line 140 (or lines) are
not shown for illustrative purposes.
[0127] FIG. 18b illustrates that the actuator 22 can extend, as
shown by arrow. The endoscope 12 can be attached to the actuator
22. The endoscope 12 can advance through the colon as the actuator
22 extends. The endoscope 12 can be slidably adjacent and within
the overtube 24. A lubricant can be applied between the endoscope
12 and the overtube 24.
[0128] FIG. 18c illustrates that the actuator 22 can be retracted.
The overtube 24 can slide to advance closer to the distal terminal
end of the device 10. The method can be repeated to advance the
endoscope 12 through the colon. The method can be reversed to
withdraw the device 10 from the colon.
[0129] The endoscope 12 can be isolated from exposure to the
pressure used to activate the actuator 22 and/or the anchor 20. The
endoscope 12 can extend through the bellows lumen 54 and the
support lumen 60.
[0130] The device 10 can be used to navigate other sections of the
colon (e.g., ascending, descending, transverse, sigmoid), small
intestine, esophagus, stomach, interstitial space, such as within
the pleural or peritoneal membrane, blood vessels, or combinations
thereof.
[0131] The biological navigation device 10 can be manually and/or
actuator controlled. Control inputs can be delivered through a
manually actuated controllable module, such as a joystick (e.g.,
for tip control) and/or a series of linear and rotary
potentiometers and switches. The biological navigation device 10
can be programmed to be controlled by voice commands. The
biological navigation device 10 can be controlled by a foot pedal
(e.g., for tube extension or translation), and/or a combinational
interface (e.g., hand controlled), for example for tip control. The
user interface can be attached as part of the biological navigation
device 10, and/or the user interface can be a control unit that is
attached by wires to the biological navigation device 10, and/or
the user interface can communicate wirelessly with the remainder of
the biological navigation device 10.
[0132] The entire tip 18 can load over the distal terminal end of
an endoscope 12. The tip 18 can attach to the endoscope 12, the
lines 140 can be attached to the line connectors and the device 10
can be delivered into the biological lumen.
[0133] As taught herein, the device 10 can anchor locally and pull
the endoscope 12 with a localized pull in the direction of the
distal terminal end of the device 10 or endoscope 12 distal
pointing end. The method can be repeated. Each iteration of the
method can advance the endoscope 12 and the distal terminal end of
the device 10, for example, from about 3 in. to about 7 in.
[0134] Any or all elements of the biological navigation device 10
and/or other devices or apparatuses described herein can be made
from, for example, a single or multiple stainless steel alloys,
nickel titanium alloys (e.g., Nitinol), cobalt-chrome alloys (e.g.,
ELGILOY.RTM. from Elgin Specialty Metals, Elgin, Ill.;
CONICHROME.RTM. from Carpenter Metals Corp., Wyomissing, Pa.),
nickel-cobalt alloys (e.g., MP35N.RTM. from Magellan Industrial
Trading Company, Inc., Westport, Conn.), molybdenum alloys (e.g.,
molybdenum TZM alloy, for example as disclosed in International
Pub. No. WO 03/082363 A2, published 9 Oct. 2003, which is herein
incorporated by reference in its entirety), tungsten-rhenium
alloys, for example, as disclosed in International Pub. No. WO
03/082363, polymers such as polyethylene teraphathalate (PET),
polyester (e.g., DACRON.RTM. from E. I. Du Pont de Nemours and
Company, Wilmington, Del.), polypropylene, aromatic polyesters,
such as liquid crystal polymers (e.g., Vectran, from Kuraray Co.,
Ltd., Tokyo, Japan), ultra high molecular weight polyethylene
(i.e., extended chain, high-modulus or high-performance
polyethylene) fiber and/or yarn (e.g., SPECTRA.RTM. Fiber and
SPECTRA.RTM. Guard, from Honeywell International, Inc., Morris
Township, N.J., or DYNEEMA.RTM. from Royal DSM N.V., Heerlen, the
Netherlands), polytetrafluoroethylene (PTFE), expanded PTFE
(ePTFE), polyether ketone (PEK), polyether ether ketone (PEEK),
poly ether ketone ketone (PEKK) (also poly aryl ether ketone
ketone), nylon, polyether-block co-polyamide polymers (e.g.,
PEBAX.RTM. from ATOFINA, Paris, France), aliphatic polyether
polyurethanes (e.g., TECOFLEX.RTM. from Thermedics Polymer
Products, Wilmington, Mass.), polyvinyl chloride (PVC),
polyurethane, thermoplastic, fluorinated ethylene propylene (FEP),
absorbable or resorbable polymers such as polyglycolic acid (PGA),
poly-L-glycolic acid (PLGA), polylactic acid (PLA), poly-L-lactic
acid (PLLA), polycaprolactone (PCL), polyethyl acrylate (PEA),
polydioxanone (PDS), and pseudo-polyamino tyrosine-based acids,
extruded collagen, silicone, zinc, echogenic, radioactive,
radiopaque materials, a biomaterial (e.g., cadaver tissue,
collagen, allograft, autograft, xenograft) any of the other
materials listed herein or combinations thereof. Examples of
radiopaque materials are barium sulfate, zinc oxide, titanium,
stainless steel, nickel-titanium alloys, tantalum and gold.
[0135] The systems, devices, elements and methods disclosed herein
can be used in conjunction or substituted with any of the systems,
devices, elements and methods disclosed in U.S. Pat. Nos. 5,470,632
and 5,333,568; U.S. patent application Ser. No. 12/023,986 filed 31
January 2008 (now U.S. Publication No. 2008/0183038); PCT
Application Nos. US 2008/052535 filed 30 Jan. 2008 (now PCT
Publication No. WO 2008/095046), and US2008/052542 filed 30 Jan.
2008 (now PCT Publication No. WO 2008/095052); and U.S. Provisional
Application No. 60/887,319, filed 30 Jan. 2007, 60/887,323, filed
30 Jan. 2007, and 60/949,219, filed 11 Jul. 2007, all of which are
incorporated herein by reference in their entireties.
[0136] The terms colonoscope and endoscope are used for exemplary
purposes and can be any deployable elongated element for use in a
body lumen. Any elements described herein as singular can be
pluralized (i.e., anything described as "one" can be more than
one). Any species element of a genus element can have the
characteristics or elements of any other species element of that
genus. The above-described configurations, elements or complete
assemblies and methods and their elements for carrying out the
invention, and variations of aspects of the invention can be
combined and modified with each other in any combination.
* * * * *