U.S. patent application number 13/793465 was filed with the patent office on 2013-07-25 for systems and methods for performing minimally invasive procedures.
This patent application is currently assigned to HANSEN MEDICAL, INC.. The applicant listed for this patent is Hansen Medical, Inc.. Invention is credited to Federico Barbagli, Christopher R. Carlson, Frederic H. Moll, Gregory J. Stahler, Daniel T. Wallace.
Application Number | 20130190741 13/793465 |
Document ID | / |
Family ID | 38997906 |
Filed Date | 2013-07-25 |
United States Patent
Application |
20130190741 |
Kind Code |
A1 |
Moll; Frederic H. ; et
al. |
July 25, 2013 |
SYSTEMS AND METHODS FOR PERFORMING MINIMALLY INVASIVE
PROCEDURES
Abstract
A robotic medical surgical system configured for performing
prostate procedures includes a controller including a master input
device, an instrument driver in communication with the controller,
an instrument assembly operatively coupled to the instrument
driver, and a surgical tool operatively coupled to the controller
and carried on the distal end portion of the instrument assembly,
wherein the controller and master input device are configured to
allow a system operator to position the surgical tool proximate a
prostate abnormality without entering a restricted zone, at least
partially automatically controlled based on an images obtained of
the surgical zone.
Inventors: |
Moll; Frederic H.; (San
Francisco, CA) ; Wallace; Daniel T.; (Santa Cruz,
CA) ; Stahler; Gregory J.; (San Jose, CA) ;
Carlson; Christopher R.; (Menlo Park, CA) ; Barbagli;
Federico; (San Francisco, CA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Hansen Medical, Inc.; |
Mountain View |
CA |
US |
|
|
Assignee: |
HANSEN MEDICAL, INC.
Mountain View
CA
|
Family ID: |
38997906 |
Appl. No.: |
13/793465 |
Filed: |
March 11, 2013 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
11833969 |
Aug 3, 2007 |
8409172 |
|
|
13793465 |
|
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|
|
60835592 |
Aug 3, 2006 |
|
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60838075 |
Aug 15, 2006 |
|
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60840331 |
Aug 24, 2006 |
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Current U.S.
Class: |
606/13 ; 606/130;
606/41 |
Current CPC
Class: |
A61B 17/0057 20130101;
A61B 17/12172 20130101; A61B 2017/00632 20130101; A61B 2017/22069
20130101; A61B 2017/2212 20130101; A61B 17/221 20130101; A61B 1/307
20130101; A61B 2017/003 20130101; A61B 2017/22034 20130101; A61B
1/00082 20130101; A61B 18/1492 20130101; A61B 2034/741 20160201;
A61B 2090/3614 20160201; A61B 2017/00274 20130101; A61B 2017/2215
20130101; A61B 2034/301 20160201; A61M 2025/1072 20130101; A61B
18/26 20130101; A61B 17/32056 20130101; A61M 25/0127 20130101; A61B
34/37 20160201; A61B 17/29 20130101; A61B 34/32 20160201; A61B
34/30 20160201; A61B 2017/22072 20130101; A61M 2025/1086 20130101;
A61B 2018/00392 20130101; A61B 2090/3782 20160201; A61B 2017/00247
20130101; A61B 2017/22059 20130101; A61M 25/1002 20130101; A61B
2018/00547 20130101; A61B 2017/00243 20130101; A61B 1/018 20130101;
A61B 18/20 20130101; A61B 17/12122 20130101; A61B 2017/00575
20130101 |
Class at
Publication: |
606/13 ; 606/130;
606/41 |
International
Class: |
A61B 19/00 20060101
A61B019/00 |
Claims
1. A robotic medical system configured for performing a medical
procedure on an abnormality of a prostate of a patient, the system
comprising: a controller including a master input device; an
instrument driver in communication with the controller; an elongate
flexible instrument operatively coupled to the instrument driver,
whereby a distal end portion of the catheter instrument may be
robotically manipulated by a remotely located system operator by
corresponding manipulation of the master input device; a surgical
tool operatively coupled to the controller and carried on the
distal end portion of the flexible instrument, and an imaging
system operatively coupled to the controller and configured to
acquire and display an area of a patient's prostate containing the
abnormality, wherein the controller and master input device are
configured to allow a system operator to advance the distal portion
of the flexible instrument along the patient's urethra and operate
the surgical tool by manipulation of the master input device in
order to perform a medical procedure an abnormality of the
patient's prostate, wherein the operation of the surgical tool is
at least partially automatically controlled based on the image
obtained by the imaging system.
2. The system of claim 1, wherein the surgical tool is a laser, and
the abnormality is treated by conveying laser energy from the laser
to destroy tissue of the prostate.
3. The system of claim 1, wherein the surgical tool is a
resectoscope, and the abnormality is treated by scraping tissue
away from the prostate with the resectoscope.
4. The system of claim 1, wherein the surgical tool is a wire loop
tool, and the abnormality is treated by conveying electrical energy
from the wire loop tool.
5. The system of claim 1, wherein the surgical instrument is a
tissue grasper that is operated to remove tissue from the
prostate.
6. The system of claim 1, wherein the imaging system comprises an
imaging device carried on the distal end portion of the flexible
instrument.
7. The system of claim 6, wherein the imaging device is an optical
imaging fiber.
8. The system of claim 1, further comprising a flush port disposed
on the distal end portion of the flexible instrument.
9. A robotic medical system configured for performing a medical
procedure on an abnormality of a prostate of a patient, the system
comprising: a controller including a master input device; an
instrument driver in communication with the controller; an elongate
flexible instrument operatively coupled to the instrument driver,
whereby a distal end portion of the catheter instrument may be
robotically manipulated by a remotely located system operator by
corresponding manipulation of the master input device; a surgical
tool operatively coupled to the controller and carried on the
distal end portion of the flexible instrument, and an imaging
system operatively coupled to the controller and configured to
acquire and display an area of a patient's prostate containing the
abnormality, wherein the controller and master input device are
configured to allow a system operator to (i) create a restricted
zone, based on the displayed image of the area of the prostate,
into which the surgical tool is restricted from entering by a
navigation logic of the robotically controlled system, and (ii)
cause the instrument driver to manipulate the distal end portion of
the flexible instrument so that the surgical tool is positioned
proximate the prostate abnormality without entering the restricted
zone, and wherein the operation of the surgical tool is at least
partially automatically controlled based on the image obtained by
the imaging system.
10. The system of claim 9, wherein the controller and master input
device are further configured to allow a system operator to locate
an anatomical landmark using the displayed image of the area of the
patient's prostate, and store a desired position and orientation of
the distal end portion of the guide instrument proximate the
anatomical landmark.
11. The system of claim 9, wherein the controller and master input
device are further configured to allow a system operator to advance
the distal portion of the flexible instrument along the patient's
urethra, and to operate the surgical tool by manipulation of the
master input device.
12. The system of claim 9, wherein the surgical tool is a laser,
and the abnormality is treated by conveying laser energy from the
laser to destroy tissue of the prostate.
13. The system of claim 9, wherein the surgical tool is a
resectoscope, and the abnormality is treated by scraping tissue
away from the prostate with the resectoscope.
14. The system of claim 9, wherein the surgical tool is a wire loop
tool, and the abnormality is treated by conveying electrical energy
from the wire loop tool.
15. The system of claim 9, wherein the surgical instrument is a
tissue grasper that is operated to remove tissue from the
prostate.
16. The system of claim 9, wherein the imaging system comprises an
imaging device carried on the distal end portion of the flexible
instrument.
17. The system of claim 16, wherein the imaging device is an
optical imaging fiber.
18. The system of claim 1, further comprising a flush port disposed
on the distal end portion of the flexible instrument.
Description
RELATED APPLICATION DATA
[0001] The present application is a continuation of U.S.
application Ser. No. 11/833,969, filed on Aug. 3, 2007, which
claims the benefit under 35 U.S.C. .sctn.119 to U.S. Provisional
Patent Application Ser. Nos. 60/835,592, filed on Aug. 3, 2006;
60/838,075, filed on Aug. 15, 2006; and 60/840,331, filed on Aug.
24, 2006. The foregoing applications, along with U.S. patent
application Ser. No. 11/829,076, filed Jul. 26, 2007, are all
incorporated by reference into the present application in their
entirety for all purposes.
FIELD OF INVENTION
[0002] The invention relates generally to robotically controlled
systems, such as telerobotic surgical systems, and more
particularly to robotic catheter systems for performing minimally
invasive diagnostic and therapeutic procedures.
BACKGROUND
[0003] Robotic diagnostic and interventional systems and devices
are well suited for use in performing minimally invasive medical
procedures, as opposed to conventional techniques wherein a
patient's body cavity is open to permit the surgeon's hands access
to the internal organs. There is a need for highly controllable yet
minimally sized systems to facilitate imaging, diagnosis, and
treatment of tissues which may lie deeply and/or concealed within
the body cavity of a patient, and which may be accessed through
natural body orifices or percutaneous incisions and by way of
naturally-occurring pathways such as blood vessels or other bodily
lumens.
SUMMARY OF THE INVENTION
[0004] In accordance with one aspect of the disclosed inventions, a
robotic surgical system includes an instrument driver, an
instrument assembly operatively coupled to the instrument driver
such that mechanisms of the instrument driver operate or control
movement, operation, or both, of components of the instrument
assembly, and an operator control station operatively coupled to
the instrument driver via a remote communication link. The
instrument assembly components include an elongate flexible guide
instrument, an optical light source, a camera and a working tool,
wherein the light source, camera, and working tool are carried in
one or more lumens of the guide instrument. The instrument assembly
further includes an inflatable visualization balloon carried on a
distal end portion of the guide instrument, the light source and
camera having distal ends located within an interior of the
balloon, the balloon comprising a lumen extending from the guide
instrument to a distal facing wall of the balloon, wherein the
working instrument may extend from a respective lumen of the guide
instrument through the balloon lumen to contact body tissue when
the distal end of the guide instrument is positioned in an interior
body region. In one embodiment, the working instrument is a laser
fiber, e.g., a lithotripsy laser fiber such as a Holmium YAG laser,
which may be movable relative to the guide instrument. In other
embodiments, the working instrument may be a tissue grasper or
manipulator, or a basket apparatus, which may be movable relative
to the guide instrument. In some embodiments, the instrument
assembly components further include a sheath instrument, wherein
the guide instrument is carried in a lumen of, and is movable
relative to, the sheath instrument.
[0005] In accordance with another aspect of the disclosed
inventions, a robotic surgical system includes an instrument
driver, an instrument assembly operatively coupled to the
instrument driver such that mechanisms of the instrument driver
operate or control movement, operation, or both, of components of
the instrument assembly, and an operator control station
operatively coupled to the instrument driver via a remote
communication link. The instrument assembly components include an
elongate guide instrument sized for being positioned in a urethra,
an image capture device and a working tool, wherein the image
capture device and working tool are carried in one or more lumens
of the guide instrument, wherein movement, operation, or both, of
components of the instrument assembly are at least partially
automatically controlled based on images obtained by the image
capture device. In one embodiment, the working instrument is a
laser fiber, e.g., a lithotripsy laser fiber such as a Holmium YAG
laser, which may be movable relative to the guide instrument. In
some embodiments, the image capture device is an imaging fiber. In
some embodiments, a flush port is provided in fluid communication
with a fluid flush lumen extending through the guide instrument. By
way of non-limiting example, the fluid flush lumen may be provided
in a tubular body that extends out of a distal end of the guide
instrument. In some such embodiments, the tubular body has a distal
end section that bends or curves back in a proximal facing
direction, such that fluid discharged out of the flush port is
directed at the distal end of the guide instrument. In some
embodiments, the imaging device is carried in the tubular body. In
some embodiments, the instrument assembly components further
include a sheath instrument, wherein the guide instrument is
carried in a lumen of, and is movable relative to, the sheath
instrument. In some embodiments, a second working instrument (e.g.,
a wire loop apparatus or tissue grasper) may be carried in a lumen
of the guide instrument.
[0006] In accordance with yet another aspect of the disclosed
inventions, a robotic surgical system includes an instrument
driver, an instrument assembly operatively coupled to the
instrument driver such that mechanisms of the instrument driver
operate or control movement, operation, or both, of components of
the instrument assembly. The instrument assembly components include
an elongate sheath instrument sized for positioning in a urethra,
an elongate guide instrument carried in a lumen of and movable
relative to the sheath instrument, and a resectoscope carried in a
lumen of the guide instrument.
[0007] Other aspects and advantages of the present invention will
become apparent from the following description, taken in
conjunction with the accompanying drawings, illustrating by way of
examples the principles of the invention.
BRIEF DESCRIPTION OF THE DRAWINGS
[0008] The present invention will be readily understood by the
following detailed description, taken in conjunction with
accompanying drawings, illustrating by way of examples the
principles of the invention. The drawings illustrate the design and
utility of preferred embodiments of the present invention, in which
like elements are referred to by like reference symbols or
numerals. The objects and elements in the drawings are not
necessarily drawn to scale, proportion, or precise positional
relationships; instead emphasis is focused on illustrating the
principles of the invention.
[0009] FIG. 1 illustrates one embodiment of a robotic surgical
system.
[0010] FIG. 2 illustrates another embodiment of a robotic surgical
system.
[0011] FIG. 3 illustrates one embodiment of a robotic surgical
system being used to perform diagnostic and/or interventional
operations on a patient.
[0012] FIG. 4A illustrates a cross sectional view of a heart.
[0013] FIG. 4B illustrates an instrument assembly advanced into a
chamber of the heart.
[0014] FIG. 4C illustrates an ablation tool advanced through the
lumen of the instrument assembly into a chamber of the heart.
[0015] FIG. 5A illustrates a target of an operation site in a
chamber of the heart.
[0016] FIG. 5B illustrates an instrument assembly advanced toward a
target site in a chamber of the heart.
[0017] FIG. 5C illustrates an ablation tool advanced through a
lumen of an instrument assembly toward a target site in a chamber
of the heart.
[0018] FIG. 6A through 6C respectively illustrate an instrument
assembly and an ablation tool being used to address a target site
related to atrioventricular nodal reentrant tachycardia.
[0019] FIG. 7A through FIG. 7C respectively illustrates an
instrument assembly and an ablation tool being used to address a
target site related to ventricular tachycardia.
[0020] FIG. 7D through FIG. 7F respectively illustrates an
instrument assembly being used to address a target site related to
a left-sided ventricular tachycardia.
[0021] FIG. 7G through FIG. 7I respectively illustrates a
retrograde approach to address a ventricular tachycardia
condition.
[0022] FIG. 8A illustrates an instrument assembly being used to
treat a patent foramen ovale condition.
[0023] FIG. 8B illustrates an instrument assembly with an ablation
tool being used to treat a patent foramen ovale condition.
[0024] FIG. 8C and FIG. 8D respectively illustrates an instrument
assembly with a suturing tool being used to treat a patent foramen
ovale condition.
[0025] FIG. 8E and FIG. 8F respectively illustrates an instrument
assembly with a clip application tool being used to treat a patent
foramen ovale condition.
[0026] FIG. 8G and FIG. 8H respectively illustrates an instrument
assembly with a needle instrument being used to treat a patent
foramen ovale condition.
[0027] FIG. 8I and FIG. 8J respectively illustrates an instrument
assembly with an irritation tool being used to treat a patent
foramen ovale condition.
[0028] FIG. 9A and FIG. 9B respectively illustrates an instrument
assembly with a suturing tool being used to treat a left atrial
appendage occlusion condition.
[0029] FIG. 9C through FIG. 9H respectively illustrates an
instrument assembly coupled with various tools being used to treat
a left atrial appendage occlusion condition.
[0030] FIG. 10A and FIG. 10B respectively illustrates an instrument
assembly with lead deploying tool.
[0031] FIG. 10C and FIG. 10D respectively illustrates an instrument
assembly deploying leads in the right and left atrium of the
heart.
[0032] FIG. 11A through FIG. 11F respectively illustrates an
instrument assembly with various tools being used to treat a
chronic total occlusion condition.
[0033] FIG. 12A and FIG. 12B respectively illustrates an instrument
assembly with an injection tool being used to treat congestive
heart failure condition.
[0034] FIG. 12C illustrates one embodiment of an injection pattern
for treating infarcted tissue.
[0035] FIG. 13A through FIG. 13G respectively illustrates an
instrument assembly with various tools being used to perform valve
repair procedures.
[0036] FIG. 13H and FIG. 13I illustrate the chords, chordae
tendineae, or papillary muscle of the mitral valve leaflet being
adjusted.
[0037] FIG. 14 illustrates an instrument assembly with an ablation
tool being used to perform valve repair.
[0038] FIG. 15A through FIG. 15D illustrate a retrograde method to
deploy an expandable aortic valve prosthetic to repair an aortic
valve.
[0039] FIG. 15E through FIG. 15J illustrate a method of deploying
an expandable valve prosthetic by way of the inferior vena cava
through the septum and the mitral valve to the aortic valve.
[0040] FIG. 15K illustrates a two-handed approach to deploy an
expandable valve prosthetic.
[0041] FIG. 16 illustrates an instrument assembly with a
lithotripsy laser fiber for performing lithotripsy procedures.
[0042] FIG. 17 illustrates an instrument assembly with a grasper
including an energy source configured for performing lithotripsy
procedures.
[0043] FIG. 18 illustrates an instrument assembly with a basket
tool including an energy source configured for performing
lithotripsy procedures.
[0044] FIG. 19 illustrates an expandable grasping tool assembly
including an energy source.
[0045] FIG. 20 illustrates a bipolar electrode grasper
assembly.
[0046] FIG. 21 illustrates an instrument assembly configured with
basket arms.
[0047] FIG. 22 illustrates an instrument assembly including a
lithotripsy fiber and image capture device.
[0048] FIG. 23 illustrates an instrument assembly including a
grasping tool.
[0049] FIG. 24 illustrates an instrument assembly including a
basket tool apparatus.
[0050] FIG. 25 and FIG. 26 respectively illustrates an operation of
an instrument assembly with a basket tool apparatus.
[0051] FIG. 27 illustrates an instrument assembly including a
basket arm capture device and image capture device.
[0052] FIG. 28 illustrates an instrument assembly including a
balloon apparatus.
[0053] FIG. 29 illustrates an instrument assembly including another
balloon apparatus.
[0054] FIG. 30 illustrates an instrument assembly including yet
another balloon apparatus.
[0055] FIG. 31 through FIG. 33 respectively illustrates an
instrument assembly including an inflatable balloon cuff
apparatus.
[0056] FIG. 34 through FIG. 36 respectively illustrate an
instrument assembly including a flexible balloon cuff
apparatus.
[0057] FIG. 37 and FIG. 38 respectively illustrates an instrument
assembly including image capture apparatuses.
[0058] FIG. 39 through FIG. 40 respectively illustrates detailed
views of the image capture assembly.
[0059] FIG. 41 illustrates a cross sectional view of a tubular
structure for housing the image capture device assembly.
[0060] FIG. 42 through FIG. 45 respectively illustrates variations
of embodiments of image capture assembly.
[0061] FIG. 46A illustrates a steerable instrument assembly being
used in the bladder.
[0062] FIG. 46B illustrates a steerable instrument assembly being
used in the prostate.
[0063] FIG. 47 illustrates another steerable instrument
assembly.
[0064] FIG. 48 and FIG. 49 respectively illustrates yet another
steerable instrument assembly.
[0065] FIG. 50A illustrates one embodiment of a sheath and catheter
assembly together with a retracted conical balloon apparatus.
[0066] FIG. 50B illustrates the embodiment of FIG. 50A wherein the
retracted conical balloon apparatus is deployed.
[0067] FIG. 51 illustrates one embodiment of a sheath and catheter
assembly with a deflated balloon apparatus.
[0068] FIG. 52 illustrates a sheath and catheter assembly with one
embodiment of an inflated balloon apparatus.
[0069] FIG. 53 illustrates a sheath and catheter assembly with one
embodiment of a toroid shaped balloon.
[0070] FIG. 54 illustrates a sheath and catheter assembly with
distal tip portion of the catheter where a balloon apparatus may be
deployed is highlighted.
[0071] FIG. 55 illustrates one embodiment of a conical shaped
balloon apparatus manufactured with a heat bonding process.
[0072] FIG. 56 illustrates another embodiment of a conical shaped
balloon apparatus.
[0073] FIG. 57 illustrates one embodiment of a cylindrical shaped
balloon apparatus manufactured with a heat bonding process.
[0074] FIG. 58 illustrates one embodiment of a conical shaped
balloon apparatus having two chambers that can be inflated to
different pressures.
[0075] FIG. 59 illustrates one embodiment of a conical shaped
balloon apparatus having one inflatable chamber and a soft distal
tip.
[0076] FIG. 60 illustrates one embodiment of a conical shaped
balloon apparatus having structural reinforcement wires.
[0077] FIG. 61 illustrates one embodiment of a cup shaped balloon
apparatus having a stent type or mesh type of reinforcement.
[0078] FIG. 62 illustrates one embodiment of a cylindrical shaped
balloon apparatus having a stent type or mesh type of
reinforcement.
[0079] FIG. 63 illustrates one embodiment of a cup shaped balloon
apparatus having lateral ring supports.
[0080] FIG. 64 illustrates one embodiment of a cup-shaped balloon
apparatus having a first chamber with a stent or type of
reinforcement structure and a distal second chamber without the
stent or mesh type reinforcement.
[0081] FIG. 65 illustrates one embodiment of a cup shaped balloon
apparatus having a first chamber with a stent or mesh type of
reinforcement structure and a distal edge portion constructed of a
soft material.
[0082] FIG. 66 illustrates one embodiment of a cup-shaped balloon
apparatus with an image capture device and flush port at the distal
portion of a catheter.
[0083] FIG. 67 illustrates one embodiment of a catheter having a
cup-shaped balloon apparatus with an image capture device, a flush
port, and a working lumen at the distal portion of a catheter.
[0084] FIG. 68 illustrates one embodiment of a toroid-shaped
balloon apparatus with a suction port at the distal portion of a
catheter.
[0085] FIG. 69 illustrates one embodiment of a balloon apparatus
with support ribs.
[0086] FIG. 70 illustrates one embodiment of two-layered balloon
apparatus with an image capture device at the distal portion of a
catheter.
[0087] FIG. 71 illustrates one embodiment of a side-firing
ultrasound transducer enclosed within an inflated balloon apparatus
at the distal portion of a catheter.
[0088] FIG. 72 illustrates one embodiment of a balloon apparatus
with spikes at the distal portion of a catheter.
[0089] FIG. 73 illustrates one embodiment of a balloon apparatus
with spines at the distal portion of a catheter.
[0090] FIG. 74 illustrates one embodiment of an image capture
device with a reticle and illumination fibers enclosed within a
balloon apparatus at the distal portion of a catheter.
[0091] FIG. 75 illustrates one embodiment of an articulating
endoscope enclosed within a balloon apparatus at the distal portion
of a catheter.
[0092] FIG. 76 illustrates one embodiment of a laser fiber and an
image capture device enclosed within a balloon apparatus at the
distal portion of a catheter.
[0093] FIG. 77 illustrates one embodiment of an image capture
device and illumination fibers enclosed within a balloon apparatus
having magnifying lenses at the distal portion of a catheter.
[0094] FIG. 78 illustrates one embodiment of a balloon apparatus
having a radio frequency (RF) electrode deployed on its
surface.
[0095] FIG. 79 illustrates one embodiment of a balloon apparatus
having a magnet on its outer surface.
[0096] FIG. 80 illustrates one embodiment of balloon apparatus
having a pair of mapping electrodes mounted on its outer
surface.
[0097] FIG. 81 illustrates one embodiment of a balloon apparatus
having a through lumen.
[0098] FIG. 82 illustrates one embodiment of a balloon apparatus
having an ablation tool deployed in its through lumen.
[0099] FIG. 83 illustrates one embodiment of a balloon apparatus
having a grasper deployed in its through lumen.
[0100] FIG. 84 illustrates one embodiment of a balloon apparatus
having a basket tool deployed in its through lumen.
[0101] FIG. 85 illustrates a balloon apparatus and an ablation
catheter deployed in a working lumen located outside of the balloon
apparatus at a distal portion of a catheter.
[0102] FIG. 86 illustrates a balloon apparatus and a grasper
deployed in a working lumen located outside of the balloon
apparatus at the distal portion of a catheter.
[0103] FIG. 87 illustrates a balloon apparatus and a basket tool
apparatus deployed in a working lumen located outside of the
balloon at the distal portion of a catheter.
[0104] FIG. 88 through FIG. 90 respectively illustrates various
views of one embodiment of a mold for manufacturing a balloon
apparatus.
[0105] FIG. 91 through FIG. 95 respectively illustrates one
embodiment of a method for deploying an angioplasty ring with a
balloon apparatus.
[0106] FIG. 96 illustrates one method for performing ablation using
a balloon apparatus.
[0107] FIG. 97 illustrates one embodiment of a toroid-shaped
balloon apparatus that is deployed and an ablation tool.
[0108] FIG. 98 illustrates one embodiment of a circular-shaped
balloon apparatus with an electrode strip mounted on its outer
surface.
[0109] FIG. 99 illustrates one a method of performing
electro-anatomic mapping and RF ablation with a balloon apparatus
using electrodes.
[0110] FIG. 100 illustrates the top surface of a balloon apparatus
of FIG. 99.
[0111] FIG. 101 through 104 respectively illustrates one method for
performing patent foramen ovale procedure using a balloon
apparatus.
[0112] FIG. 105 illustrates one embodiment of a method for aortic
valve destenosis/decalcification using a balloon apparatus.
[0113] FIG. 106 illustrates a prostate with benign prostatic
hyperplasia.
[0114] FIG. 107 illustrates a steerable sheath and guide catheter
traveling up a urethra.
[0115] FIG. 108 illustrates a close-up view of the prostate with
one embodiment of a catheter that includes a laser and imaging
fiber.
[0116] FIG. 109 illustrates another close-up view of the prostate
with one embodiment of a catheter that includes a laser, imaging
fiber, and flush port.
[0117] FIG. 110 illustrates yet another close-up view of the
prostate with another embodiment of a catheter that includes a
laser, imaging fiber, and flush port.
[0118] FIG. 111 illustrates additional close-up view of the
prostate with yet another embodiment of a catheter that includes a
laser, imaging fiber, and flush port.
[0119] FIG. 112 illustrates a further close-up view of the prostate
with still another embodiment of a catheter that includes a laser,
imaging fiber, and flush port.
[0120] FIG. 113 illustrates a yet further close-up view of the
prostate with one embodiment of a catheter that includes a laser
and grasper.
[0121] FIG. 114 illustrates another close-up view of the prostate
with one embodiment of a resectoscope deployed within the working
lumen of a steerable guide catheter.
[0122] FIG. 115 illustrates yet another close-up view of the
prostate with one embodiment of a catheter that includes a wire
loop, imaging fiber, and flush port.
[0123] FIG. 116 illustrates one embodiment of a robotic catheter
system that includes both a master input device and a pair of data
gloves.
[0124] FIG. 117 illustrates the operator control station of FIG.
116.
[0125] FIG. 118 illustrates another embodiment of an operator
control station that includes a master input device and a pair of
data gloves.
[0126] FIG. 119 illustrate the input devices of the control station
in FIG. 118.
[0127] FIG. 120 illustrates one embodiment of a robotic catheter
system that includes data gloves.
[0128] FIG. 121 illustrates the operator control station of FIG.
120.
[0129] FIG. 122 illustrates another embodiment of an operator
control station including a pair of data gloves.
[0130] FIG. 123 illustrate the various input devices of a control
station.
[0131] FIG. 124 illustrates one embodiment of a data glove.
[0132] FIG. 125 illustrates one embodiment of a wired data
glove
[0133] FIG. 126 illustrates one embodiment of a wireless data glove
system.
[0134] FIG. 127 illustrates a display screen showing sensor data
signals received by the system from the data gloves in accordance
to one embodiment.
[0135] FIG. 128 illustrates a block diagram of the controls system
flow for one embodiment.
DETAILED DESCRIPTION OF THE ILLUSTRATED EMBODIMENTS
[0136] Reference will now be made in detail to the preferred
embodiments of the present invention, examples of which are
illustrated in the accompanying drawings. While the invention will
be described in conjunction with the preferred embodiments, it will
be understood that they are not intended to limit the invention to
these embodiments. On the contrary, the invention is intended to
cover modifications, alternatives, and equivalents that may be
included within the spirit and scope of the invention as defined by
the appended claims. Furthermore, in the following detailed
description of the embodiments, numerous specific details are set
forth in order to provide a thorough understanding of the present
invention. However, it will be readily apparent to one skilled in
the art that the present invention may be practiced without these
specific details. In other instances, well-known methods,
procedures, and components have not been described in detail so as
not to unnecessarily obscure aspects of the present invention.
[0137] Standard surgical procedures typically involve using a
scalpel to create an opening of sufficient size to enable a
surgical team to gain access to an area in the body of a patient
for the surgical team to diagnose and treat one or more target
sites. When possible, minimally invasive surgical procedures may be
used instead of standard surgical procedures to minimize physical
trauma to the patient and reduce recovery time for the patient to
recuperate from the surgical procedures. Minimally invasive
surgical procedures typically require using extension tools (e.g.,
catheters, etc.) to approach and address the target site through
natural pathways (e.g., blood vessels, gastrointestinal tract,
etc.) from a remote location either through a natural body orifice
or a percutaneous incision. As can be appreciated, the surgeon may
have limited information or feedback (e.g., visual, tactile, etc.)
to accurately navigate the extension tools, such as one or more
catheters, and place the working portions of the extension tools at
precise locations to perform the necessary diagnostic and/or
interventional procedures. Even with such potential limitations,
minimally invasive surgical procedures may be more effective and
beneficial for treating the patient, instead of standard open
surgery.
[0138] Minimally invasive diagnostic and interventional operations
may require the surgeon to remotely approach and address the
operation or target site by using extension tools. The surgeon
usually approaches the target site through either a natural body
orifice or a small percutaneous incision in the body of the
patient. In some situations, the surgeon may use multiple extension
tools and approach the target site through one or more natural body
orifices as well as small percutaneous incisions in the body of the
patient. Typically, the natural body orifices or small incisions
are located at some distance away from the target site. Extension
tools (e.g., various types of catheters and surgical instruments)
enter the body through one or more natural body orifices or small
percutaneous incisions, and the extension tools are guided,
navigated, manipulated, maneuvered, and advanced toward the target
site typically by way of natural body pathways (e.g., blood
vessels, esophagus, trachea, small intestine, large intestine,
urethra, etc.). The extension tools might include one or more
catheters as well as other surgical tools or instruments. The
catheters may be manually controlled catheters or robotically
operated catheters. In most situations, the surgeon has limited
visual and tactile information to discern the location of the
catheters and surgical instruments relative to the target site
and/or other organs in the patient.
[0139] For example, in the treatment of cardiac arrhythmias such as
atrial fibrillation (AF), cardiac ablation therapy is applied to
the left atrium of the heart to restore normal heart function. For
this operation, one or more catheters (e.g., sheath catheter, guide
catheter, ablation catheter, endoscopic catheter, intracardiac
echocardiography catheter, etc.) may be inserted through one or
more natural orifices or one or more percutaneous incisions at the
femoral vein near the thigh or pelvic region of the patient, which
is located at some distance away from the operation or target site.
In this example, the operation or target site for performing
cardiac ablation is in the left atrium of the heart. Catheters may
be guided (e.g., by a guide wire, a sheath, etc.), manipulated,
maneuvered, and advanced toward the target site by way of the
femoral vein to the inferior vena cava into the right atrium of the
heart and through the interatrial septum to the left atrium of the
heart. The catheters may be used separately or in combination of
multiple catheters. Currently, the surgeon has limited visual and
tactile information to assist him or her with maneuvering and
controlling the catheters (separately or in combination). In
particular, because of limited information and/or feedback, it is
especially difficult for the surgeon to maneuver and control one or
more distal portions of the catheters to perform cardiac ablation
at precise locations or spots on the surface or wall of the left
atrium of the heart. As will be explained below, embodiments of the
present invention provide improved systems and methods that would
facilitate imaging, diagnosis, address, and treatment of tissues
which may lie deeply and/or concealed under other tissues or organs
within the body cavity of a patient. With embodiments of the
present invention, the surgeon may be able to position the catheter
more precisely and accurately to address the operation or target
sites. For example, with the improved imaging capability, the
surgeon may be able to apply cardiac ablation at the desired
locations or spots on the surface or wall of the left atrium of the
heart in a more precise and accurate manner to address cardiac
arrhythmias such as atrial fibrillation. In addition, U.S. patent
application Ser. Nos. 11/185,432, filed on Jul. 19, 2005;
11/202,925, filed on Aug. 12, 2005; and 11/481,433, filed Jul. 3,
2006 are incorporated herein by reference in their entirety.
[0140] FIG. 1 illustrates one embodiment of a robotic surgical
system (100), e.g., the Sensei.TM. Robotic Catheter System from
Hansen Medical, Inc. in Mountain View, Calif., U.S.A., an operator
control station (102) located remotely from an operating table
(104) to which an instrument driver (106) and instrument assembly
(108), e.g., the Artisan.TM. Control Catheter also from Hansen
Medical, Inc. in Mountain View, Calif., U.S.A., are supported by an
instrument driver mounting brace (110) that is mounted on the
operating table (104). A wired connection (112) transfers signals
between an electronics rack (114) at the operator control station
(102) and instrument driver (106). The electronics rack (114)
includes system hardware, software, firmware, and combinations
thereof that substantially operate and perform the many functions
of the robotic surgical system (100). The instrument driver
mounting brace (110) is a substantially arcuate-shaped structural
member configured to position the instrument driver (106) above a
patient (not shown) who is lying on the operating table (104). The
wired connection (112) may transmit manipulation and control
commands from an operator or surgeon (116) who is working at the
operator control station (102) to the instrument driver (106) to
operate the instrument assembly (108) to perform minimally invasive
operations on the patient who is lying on the operating table
(104). The surgeon (116) may provide manipulation and control
commands using a master input device (MID) (118). In addition, the
surgeon may provide inputs, commands, etc. by using one or more
keyboards (120), trackball, mouse, etc. The wired connection (112)
may also transmit information (e.g., visual views, tactile or force
information, position, orientation, shape, localization,
electrocardiogram, map, model, etc.) from the instrument assembly
(108), the patient, and monitors (not shown in this figure) to the
electronics rack (114) for providing the necessary information or
feedback to the operator or surgeon (116) to facilitate monitoring
of the instrument assembly (108), the patient, and one or more
target sites for performing precise manipulation and control of the
instrument (108) during the minimally invasive surgical procedure.
The wired connection (112) may be a hard wire connection, such as
an electrical wire configured to transmit electrical signals (e.g.,
digital signals, analog signals, etc.), an optical fiber configured
to transmit optical signals, a wireless link configured to transmit
various types of signals (e.g., RF signals, microwave signals,
etc.), or any combinations of electrical wire, optical fiber,
wireless link, etc. The information or feedback may be displayed on
one or more monitors (122) at the operator control station
(102).
[0141] FIG. 2 illustrates another embodiment of a robotic surgical
system (100). For more detailed discussions of robotic surgical
systems, please refer to U.S. Provisional Patent Application No.
60/644,505, filed on Jan. 13, 2005; U.S Patent Application
Publication No. 2007-0043338, filed on Jul. 3, 2006; and U.S.
patent application Ser. No. 11/637,951, filed on Dec. 11, 2006; and
they are incorporated herein by reference in their entirety.
[0142] FIG. 3 illustrates one embodiment of a robotic surgical
system (100) configured to perform minimally invasive surgery using
one or more instrument assemblies (108). For example, the
instrument assembly (108) may include a sheath catheter, guide
catheter, ablation catheter, endoscopic catheter, intracardiac
echocardiography catheter, etc., or any combination thereof. In
addition, surgical instruments or tools (e.g., lasers, optics,
cutters, needles, graspers, scissors, baskets, balloons, etc.) may
be attached or coupled to any one or combination of the catheters.
In one embodiment, the instrument assembly (108) may be a catheter
system that includes a sheath catheter, guide catheter, a surgical
catheter, and/or surgical instrument, such as the Artisan.TM.
Control Catheter available from Hansen Medical, Inc. at Mountain
View, Calif., U.S.A. The instrument assembly (108) also includes
all the control mechanisms to operate its various components, e.g.,
sheath catheter, guide catheter, a surgical catheter, and/or
surgical instrument. The robotic surgical system (100) including
the control station (102), instrument driver (106), instrument
(108), and the wired connection (112) may be used to treat or
perform cardiac related diseases, maladies, conditions, or
procedures (e.g., atrial flutter, Wolf-Parkinson-White ("WPW"),
atrioventricular nodal reentrant tachycardia ("AVNRT"), Ventricular
tachycardia ("V-tach"), patent foramen ovale ("PFO"), left atrial
appendage occlusion, pacing lead placement, chronic total occlusion
("CTO"), ventricular injection therapy, valve repair).
[0143] For example, atrial flutter is characterized by a rapid but
organized and predictable pattern of beating of the atria. Similar
to atrial fibrillation, the ventricles cannot respond to all of the
atrial beats, which may cause blood to accumulate and collect or
pool in the atria increasing the risk of stroke. FIG. 4A
illustrates a cross sectional view of a heart (400). The cross
sectional view illustrates the inferior vena cava (402), the right
atrium (408), the left atrium (410), the right ventricle (412), and
left ventricle (414). In addition, FIG. 4A illustrates a targeted
location (416) (e.g., an area for linear lesion) for performing
atrial flutter ablation lesion. FIG. 4B illustrates instrument
(108) that may include a robotic sheath instrument or catheter
(422) and a guide instrument or guide catheter (424) that have been
navigated and positioned through the inferior vena cava (402) into
the right atrium (408). Referring to FIG. 4C, an ablation tool
(426) is depicted as having been navigated and placed through the
working lumen of the guide instrument or guide catheter (424) and
the ablation tool (426) is depicted as protruding slightly from the
distal end of the guide instrument (424) to enable the guide
instrument (424) to navigate the ablation tool (426) or the tip of
the ablation tool (426) into position against portions of right
atrium (408) to create the desired lesion (e.g., linear lesion),
and preferably substantially treat or eliminate atrial flutter.
[0144] Wolf-Parkinson-White ("WPW") is another type of arrhythmia
that may be caused by an abnormal bridge of tissue, such as the
eustachian ridge, which connects the atria and ventricles of the
heart. This accessory pathway allows electrical signals to go back
and forth between the atria and the ventricles without going
through the heart's natural pacemaker, or atrioventricular node or
AV node. If the signal ricochets back and forth, very fast heart
rates and life-threatening arrhythmias can develop. Referring to
FIG. 5A, an example of a targeted location (516) for an ablation
lesion near or around the eustachian ridge is depicted. Referring
to FIG. 5B, an instrument assembly (108) including a sheath
instrument or sheath catheter (422) and a guide instrument or guide
catheter (424) is depicted with the distal portions of the
instruments (422 and 424) positioned in the right atrium (408).
Referring to FIG. 5C, an ablation tool (526) is advanced through
the working lumen or inner channel of the guide instrument (424) to
a position wherein it may be utilized to contact and ablate desired
portions of the targeted tissue.
[0145] Atrioventricular Nodal Reentrant Tachycardia ("AVNRT") is a
common form of arrhythmia that arises from the atria. There are two
distinct pathways between the atria and ventricle, one fast and one
slow. In AVNRT, the abnormal signal begins in the atria and
transfers to the AV node. Instead of conducting down to the
ventricle, the signal is returned to the atria. Referring to FIGS.
6A-6C, a sheath (422) and guide (424) instrument assembly (108) may
be utilized, along with an ablation catheter (626) or ablation
electrode (626), to create an ablation lesion (616) in the right
atrium (408) to address aberrant conduction pathways causing
AVNRT.
[0146] Ventricular tachycardia ("V-tach") is a condition arises
from the lower chambers of the heart as the name implies. It is
characterized by heart rates over 100 beats per minute, but heart
rates often approach 200 beats per minute. At this rate, very
little blood is actually pumped out of the heart to the brain and
other organs. As such, extremely fast V-tach can be fatal.
Referring to FIGS. 7A-7C, a sheath (422) and guide (424) instrument
assembly (108) may be utilized, along with an ablation catheter
(726) or ablation electrode (726), to create an ablation lesion
(716) in, for example, the right ventricle (412), to address
aberrant conduction pathways causing right-sided V-tach. To reach
the targeted lesion location, the sheath (422) may be positioned
adjacent the tricuspid valve (702), and the guide (424) may be
navigated across the tricuspid valve (702) to deliver the ablation
electrode (726) against the targeted tissue, as depicted in FIG.
7C. FIGS. 7D-7F depict a similar instrument configuration (108) is
utilized to address a left-sided V-tach scenario by navigating
across the septum (704), by way of a transseptal puncture, into the
left atrium (410), and down through the mitral valve (706) into the
left ventricle (414) and to the targeted left ventricular tissue
lesion (736) where an ablation lesion may be created to prevent
aberrant conduction related to V-tach. FIGS. 7G-7I depict a
retrograde approach, through the aorta (404), across the aortic
valve (406), and into the left ventricle (414), subsequent to which
the sheath instrument (422) may be utilized to direct the guide
instrument (424) and ablation tool (766) up toward the inferior
mitral annulus region (756) where ablation lesions may be created
to address a V-tach scenario.
[0147] A patent foramen ovale ("PFO") is an abnormal opening in the
arterial septum which results in shunting of blood between the
atrial chambers. PFOs are believed to be present in as many as 20%
of the adult population and there is strong evidence that PFOs are
responsible for the occurrence of a type of stroke, known as
cryptogenic stroke, which occurs as a result of a blood clot in an
otherwise healthy individual. Additionally, there is increasing
evidence that the presence of a PFO is in some way related to the
occurrence of migraine headache with aura in certain patients.
Historically, PFOs have been treated with surgery, where the defect
is sewn shut with direct suturing. Although this works well to
close the defect, it requires open heart surgery and is very
traumatic, which requires significant post-operative recovery. More
recently, PFOs have been closed successfully with prosthetic
patches that are delivered via a catheter based procedure. These
procedures offer a minimally invasive approach, but require that
the clinician leave prosthesis inside the heart to cover and
occlude the PFO defect. The presence of foreign material inside the
heart can lead to significant complications including infection,
thrombus formation leading to stroke, development of cardiac
arrhythmias, and dislodgment or migration of prosthesis that might
necessitate surgical removal of the devices.
[0148] Referring to FIG. 8A, a sheath (422) and guide (424)
instrument assembly (108) may be utilized to direct a laser fiber
(826) to the location of a PFO (802) and use laser energy to ablate
or "weld" the PFO (802) shut with a concomitant inflammation
reaction. Referring to FIG. 8B, an ablation tool (836) is threaded
through the working lumen of an instrument assembly (422, 424, 108)
may be similarly used to tack a PFO (802) shut and induce a
localized healing response. Referring to FIGS. 8C and 8D, a
suturing tool (846) may be utilized to suture a PFO (802) shut.
Referring to FIGS. 8E and 8F, a clip applying tool (856) may be
utilized to clip a PFO (802) into a shut position. Referring to
FIGS. 8G and 8H, a needle tool (866) advanced through the working
lumen of a sheath (422) and guide (424) which are subsystems of the
instrument assembly (108) may be utilized to irritate the tissue
surrounding and/or forming the PFO (802), via full or partial
thickness insertions of the needle (866) into the subject tissue,
to induce a healing response sufficient to "scar" the PFO (802)
shut. Referring to FIGS. 8I and 8J, an irritation tool (876) may be
utilized to contact-irritate the subject tissue and induce a
subsequent scarring shut of the PFO (802).
[0149] Left atrial appendage occlusion is anther cardiac
abnormality. One of the significant clinical risks associated with
atrial rhythm abnormalities is the development of blood clots in
the atrial chamber which can result in stroke. An anatomic portion
of the left atrium, referred to as the left atrial appendage
("LAA") is particularly susceptible to clot formation. One approach
to eliminate the risk of clot formation in the LAA is the use of
catheter-based devices that are capable of blocking blood flow and
pooling of blood in the LAA, thereby reducing the risk of forming
blood clots in the atrium. These devices may work well if they
could be properly positioned and oriented at the opening of the
LAA. Such precise placement can be exceedingly challenging with
conventional catheter techniques. Embodiments of the present
invention facilitate the process of performing the aforementioned
procedure and accurately navigating the devices necessary to
address the LAA. Referring to FIGS. 9A and 9B, a suturing tool
(926) may be utilized to close the entrance of an LAA, as
facilitated by a robotic instrument assembly such as that depicted
(108, 422, 424). Similarly, a clip application tool (936) applying
a clip (938), expandable prosthetic tool (946) applying expandable
prosthetic (948) (such as that available from Atri-Tech corporation
under the trade name "Watchman", and ablation tool (956) (i.e., to
induce tissue welding to shut the entrance of the LAA) may be
utilized to address the dangers of an open LAA, as depicted in
FIGS. 9C-9H.
[0150] Pacing Lead Placement is another procedure performed to
address cardiac abnormalities. Pacemakers have been used in
cardiology for many years to treat rhythm abnormalities and improve
cardiac function. More recently, many physicians have concluded
that synchronistical pacing both ventricles of the heart is, in
many patients, more effective than provide pacing at one
ventricular location of the heart. This technique requires that one
of the pacing leads be positioned at an optimal location in the
wall of the left ventricle. In order to deliver the left
ventricular lead, cardiologists often use a catheter based approach
that delivers the pacing lead by introducing a cannula or tube into
the coronary sinus. The coronary sinus is a vein that runs along
the outside surface of the heart. Navigating this coronary sinus
vein requires significant catheter manipulation and control. In
addition, it also requires stability of the catheter tip when the
proper anatomic location has been reached. Embodiments of the
present invention facilitate placement of biventricular leads to
their optimal locations to achieve the desired results.
[0151] Referring to FIGS. 10A-10B, a sheath (422) and guide (424)
instrument assembly (108) carrying a lead deploying tool (1026) may
be advanced across the tricuspid valve (702) to press a lead (1028)
into place at a targeted location (1002), such as a location
adjacent the right ventricular apex. Referring to FIGS. 10C-10D,
another pacing lead (1030) may be deployed at another targeted
position by advancing a guide instrument (424) with a lead
deploying tool (1026) through the coronary sinus (1004) to a
desired location, such as a location adjacent or within one of the
branches off of the coronary sinus in the left ventricular
myocardium.
[0152] Chronic Total Occlusion ("CTO") is another cardiac malady or
condition that may be addressed by using the robotic surgical
system (100). Chronic total occlusions generally are blockages of
the coronary vasculature system which prevent blood from passing.
These occlusions create inadequate blood flow to the region of the
heart that derives its blood from the occluded artery, and forces
the affected region to survive based on collateral circulation from
other vessels. Unlike partial occlusions, CTOs are difficult to
pass a catheter or guide wire through because of the lack of any
central lumen in the artery. As a result, conventional therapy of
balloon dilation and stent placement is often impossible to
perform, and the atrial lesion may be left untreated. Many
specialized devices have been developed to try to pass through the
center of a CTO lesion. However, procedures using these devices are
often lengthy and are associated with significant complications and
unsuccessful outcomes due to calcification of the lesion or
inability to navigate the catheter tip through the center of the
artery. The subject robotic catheter system (100), because of its
ability to precisely control and stabilize the tip of the catheter
as it is advanced, facilitates the crossing and removal of CTOs.
For example, referring to FIG. 11A, a sheath (422) and guide (424)
instrument assembly (108) may be utilized to advance an RF ablation
tool (11026) into position where a CTO (1104) may be ablated with
precision and destroyed and/or removed in a coronary artery (1102).
FIG. 11B depicts another embodiment wherein an RF guidewire (11036)
is advanced to destroy and/or remove a CTO (1104) in a coronary
artery (1102). FIG. 11C depicts another embodiment wherein a laser
fiber (11046) is utilized to destroy and/or remove a CTO (1104).
FIG. 11D depicts another embodiment wherein a very small grasping
tool (11056) is utilized to destroy and/or remove a CTO (1104).
FIGS. 11E-11F depict another embodiment wherein a cutting/removing
tool (11066), such as those available from Fox Hollow Corporation
is utilized to destroy and/or remove a CTO (1104)
[0153] Robotic surgical system (100) may also be used to perform
ventricular injection therapy. Many chronic heart maladies cause
progressive deterioration of heart functions that often resulting
in debilitating and fatal conditions commonly referred as
congestive heart failure ("CHF"). In CHF, the heart muscle becomes
less efficient, the chambers of the heart begin to dilate and
cardiac function tends to deteriorate. As the heart muscle becomes
weaker, the heart has to work harder to pump adequate amount of
blood through the circulatory system. The harder the heart has to
work, the more damage may be done to its structure and function.
Typically, clinicians treat CHF with a variety of drugs that
substantially decrease blood volume and increase contractility of
the heart muscle. Recently, there have been investigations of
techniques that could repair damaged muscle cells by directly
injecting growth factors or healthy cells into injured or damaged
muscles. These techniques have shown some promising results of
healing the damaged muscle; however, these techniques require the
drugs to be applied directly to the damaged muscle. Accordingly,
the needle injector for delivering the drug to the damaged muscle
in the heart must be precisely and accurate controlled in order to
ensure direct delivery of the drugs to the damaged muscle. The
subject robotic surgical system (100) is an effective means for
delivering ventricular injections at the precise locations where
clinicians desire to deliver drugs and cell therapies. Referring to
FIGS. 12A-912B, an injection tool (12026) may be operatively
coupled to the sheath (422) and guide (424) instrument assembly
(108). The assembly (108, 422, 424, and 12026) is advanced
trans-septally into the left atrium, across the mitral valve, and
into the left ventricle (414), as illustrated in the figures. With
the guide instrument (424) advanced into the left ventricle (414)
along with the injection tool (12026), a precision pattern (1204)
of injections may be made, for example, around an infarcted tissue
portion (1202), to start revascularization and/or rebuilding of
such portion. In one embodiment, the pattern (1204) may be in a
pattern of a matrix as illustrated in FIG. 12C. Several subsequent
treatments may be applied to increase the rebuilding of such
portion of tissue.
[0154] The robotic surgical system (100) may be used to perform a
valve repair procedure. Heart valve disease is a common disorder
which affects millions of patients and is characterized by a
progressive deterioration of one or more of the heart's valvular
mechanisms. Repair of heart valves has historically been
accomplished by open heart surgery. Although such open heart
surgery is often successful in improving valve function, however,
there is also a high risk of death associated with open heart or
heart valve surgeries. Even if such surgery is successful, there is
a long period of post-operative recovery associated with open heart
surgery. As a result, cardiologists tend to wait as long as
possible before resorting to surgery in patients with deteriorating
valve function.
[0155] There is increasing interest in treating valve disease with
less invasive procedures in order to encourage treatment in the
earlier stages of the disease and potentially slow or stop the
progression of heart failure. In recent years, catheter-based
procedures have been developed for repairing valves in a surgical
manner. As these procedures develop, physicians require a new
generation of catheters that can be used like surgical tools and
which can be precisely controlled, as may be provide by the subject
robotic catheter system (100). Referring to FIG. 13A, a clip
deployer (13026) may be utilized to deploy clips (13028) around the
mitral annulus and adjust the geometry of the annulus. FIG. 13B
depicts an ablation tool (13036) utilized to induce localized
ablations to adjust or shrink the geometry of the mitral annulus.
Similarly, an ablation tool (13036) may be used to adjust or shrink
the geometry of the mitral valve leaflets. FIG. 13C depicts a clip
or suture deploying tool (13046), such as those available from
E-Valve Corporation, to position a clip or suture (13048) across
the mitral leaflets in an Alfieri technique procedure, utilizing
the precision and stability of the sheath (422) and guide (424) of
the instrument assembly (108). FIG. 13D depicts a sheath (422) and
guide (424) of instrument assembly (108) delivering a resecting
tool (13056) which may be utilized to resect the mitral leaflets
and improve coaptation. FIG. 13E depicts an antegrade approach
using a suture tool (13066) to deploy sutures into the mitral
annulus to modify the geometry of the mitral valve. FIG. 13F
depicts both antegrade and retrograde instrument assemblies (e.g.,
13066, etc.) to deploy sutures into the mitral annulus. FIG. 13G
depicts both antegrade and retrograde ablation of the mitral
annulus, for example by a bipolar electrode configuration formed by
the electrodes carried by the opposing instrument assemblies (e.g.,
13066). FIGS. 13H and 13I illustrate the positions of the mitral
valve leaflets may be adjusted by adjusting (e.g., shortening,
etc.) the length of the leaflet chords (13070), chordae tendineae
(13070), or papillary muscle (13072) to ensure proper closure
and/or alignment of the leaflets to prevent leakage by using a clip
tool (13026) to deploy a clip (13028), an ablation tool (13036), a
suturing tool (13046), etc.
[0156] FIG. 14 depicts an ablation tool (14026), similar to the
description and procedure as described above, modifying the
geometry of the tricuspid valve (702). The configurations of tools
similar to those as illustrated in FIGS. 13A-13G may be utilized on
the tricuspid valve (702).
[0157] FIG. 15A through FIG. 5D depict a robotic instrument
assembly (108) using a retrograde approach to deploy an expandable
aortic valve prosthetic (15028). Alternatively, FIG. 15E through
FIG. 15J illustrate a robotic instrument assembly (108) being used
by way of the inferior vena cava through the septum and the mitral
valve, and then going up the aorta to deploy an expandable aortic
valve prosthetic (15028) in the aorta. The methods as described may
be referred a "single-handed" approach. That is, the expandable
aortic valve prosthetic (15028) may be deployed by the method as
illustrated in FIGS. 15A through 15D or the method as illustrated
in FIG. 15E through FIG. 15J using one instrument assembly (108).
Alternatively, the expandable aortic valve prosthetic (15028) may
be deployed using a "two-handed" approach. That is, the expandable
aortic valve prosthetic may be deployed using two robotic
instrument assemblies (108). For example, a first instrument
assembly (108) may be used to position or adjust the placement of
the aortic valve prosthetic (15028) while a second instrument
assembly (108) may be used to place the aortic valve prosthetic.
FIG. 15K, illustrates one embodiment of a two-handed approach. As
illustrated in FIG. 15K, an expandable valve prosthetic (15028) is
being deployed by a first instrument assembly (108-422, 424) using
a retrograde approach as illustrated in FIG. 15A through FIG. 15D.
At the same time, a second instrument assembly (108-422, 424) with
a positioning apparatus (e.g., a balloon with a scope, etc.)
approaches the aortic valve (406) from different direction of
deployment for the valve prosthetic (15028), such that the
positioning apparatus assists with the placement or positioning of
the prosthetic (15028) as it is being deployed.
[0158] In addition, the robotic surgical system (100) including the
control station (102), instrument driver (106), instrument (108),
and the wired connection (112) may be used to treat other diseases,
maladies, or conditions in the tissues or organs of the digestive
system, colon, urinary system, reproductive system, etc. For
example, the robotic surgical system (100) may be used to perform
Extracorporeal Shock Wave Lithotripsy (ESWL). FIG. 16 illustrates
one embodiment of instrument (108) configured to perform ESWL. As
illustrated in FIG. 16, instrument (108) may include a sheath
catheter (422), a guide catheter (424), and a lithotripsy laser
fiber (16026). Analogous to the discussion above, components or
subsystems of the instrument (108) may be guided, manipulated, or
navigated to the kidney to perform various operations. For example,
subsystems of the instrument (108) may be guided, manipulated, or
navigated to the kidney to remove kidney stones as oppose to
similar components or subsystems of embodiments of the instrument
(108), e.g., an ablation catheter, being guided, manipulated, or
navigated to the left atrium of the heart to performing cardiac
ablation to address cardiac arrhythmias. The lithotripsy laser
fiber (16026) may include a quartz fiber coupled, connected to, or
associated with a laser, such as a Holmium YAG laser, to apply
energy to objects such as kidney stones, etc. In one configuration,
the laser source may be positioned and interfaced with the fiber
(16026) proximally, as in a typical lithotripsy configuration, with
the exception that in the subject embodiment, the fiber (1602) is
positioned down the working lumen of one or more robotic catheters
(e.g., sheath catheter (422) and guide catheter (424)). All the
necessary power source and control mechanisms including hardware
and software to operate the laser may be located in the electronics
rack (114) near the operator control station (102) of the robotic
surgical system (100)
[0159] Since the distal tip of the lithotripsy fiber (16026) is
configured to deliver energy to a target object, such as a kidney
stone, the distal tip may be more generically described as an
energy source. Indeed, in other embodiments, other energy sources,
besides a laser, may be used to affect tissue. For example, in
other embodiments, the energy source may be comprised of an RF
electrode, an ultrasonic transducer, such as a high-frequency
ultrasonic transducer, or other radiative, conductive, ablative, or
convective energy source.
[0160] As may appreciated, the components or subsystems of
instrument (108) may be configured with numerous different
instruments or tool for performing various minimally invasive
operations. For example, FIG. 17 depicts a guide instrument (424)
operatively coupled to a grasper (17026) fitted with an energy
source (17036), such as a lithotripsy laser fiber (16026) in a
configuration wherein an object, such as a kidney stone, grasped
within the clutches of the grasper (17026), may also be ablated,
destroyed, fragmented, etc, by applied energy from the source
(17036), which is positioned to terminate approximately at the apex
of the grasper (17026) which it is likely to be adjacent to
captured objects.
[0161] FIG. 18 depicts a similar configuration as the instrument
assembly (108) including the sheath (422) and guide (424) that is
illustrated in FIG. 17. FIG. 18 illustrates a basket tool (18026)
and energy source (17036), such as a lithotripsy fiber (16026),
positioned through the working lumen of the guide instrument (424).
In each of the configurations depicted in FIG. 17 and FIG. 18, the
energy source (17036) may be coupled to the pertinent capture
device, or may be independently positioned through the working
lumen of the guide instrument (424) to the desired location
adjacent the capture device (17026, 18026). Each of the tools
described herein, such as graspers, baskets, and energy sources,
may be controlled proximally as they exit the proximal end of the
working lumen defined by the guide instrument (424), or they may be
actuated manually, automatically or electromechanically, for
example through the use of electric motors and/or mechanical
advantage devices. For example, in one embodiment, a configuration
such as that depicted in FIG. 18, the sheath (422) and guide (424)
instruments are preferably electromechanically operated utilizing
an instrument driver (106) (not shown in these two figures) such as
that described in the U.S. patent application Ser. No. 11/481,433,
which is incorporated herein by reference in their entirety. The
grasping mechanisms (17026, 18026) may be manually actuated, for
example utilizing a positioning rod and tension wire, or
electromechanically operated using a servomechanism or other
proximal actuation devices. The energy source (17036) may be
operated proximally utilizing a switch, such as a foot pedal or
console switch, which is associated with the proximal energy
control device (not shown in FIGS. 17 and 18).
[0162] FIG. 19 depicts an expandable grasping tool assembly (19026)
with an energy source (17036, 16026) mounted at the apex of the
grasper mechanism. The energy source (17036, 16026) is proximally
associated, by one or more transmission leads (1904), such as a
fiber or wire, with a device (1902) such as an RF generator or
laser energy source. The opposing jaws (19024) of the depicted
grasping tool assembly (19026) are biased to spring outward, thus
opening the grasper when unbiased. When pulled proximally into a
confining structure, such as a lumen of a guide instrument (424),
the hoop stress applied by the confining structure urges the jaws
(19024) together, creating a powerful grasping action.
[0163] FIG. 20 depicts a bipolar electrode grasper with a
proximally associated RF generator or other energy source (2002).
In this embodiment, each of the jaws (19024) is biased to swing
outward, as in the embodiment depicted in FIG. 19, and each of the
jaws (19024) also serves as an electrode for the bipolar pairing,
to be able to apply energy to items or objects which may be
grasped. Leads (2004) are depicted to couple the jaws (19024) with
a proximally positioned energy source (2002), such as an RF
generator
[0164] FIG. 21 depicts a sheath instrument (422) coupled to a group
of basket arms (2102) that are biased to bend inward (i.e., toward
the longitudinal axis of the sheath/guide as depicted), and
configured to grasp a stone or other object as the guide instrument
(424) is withdrawn proximally into the sheath instrument (422). The
depicted embodiment features an image capture device (2104) which
may or may not have a lens (2106), illumination fibers (2108) to
radiate light, infrared radiation, or other radiation, and a
working lumen (2110) for positioning tools distally. The image
capture device (2104), which may comprise a fiberscope, CCD chip,
infrared imaging device, such as those available from CardioOptics
Incorporated, ultrasound device, or other image capture device, may
be used, for example, to search for objects such as stones, and
when located, the guide instrument (424) may be withdrawn into the
sheath instrument (422) to capture the object, which the entire
assembly is gently advanced to ensure that the object remains close
to the distal tip of the assembly for easy capture by the basket
device (2102)
[0165] FIG. 22 depicts an assembly comprising a lithotripsy fiber
(2202) and image capture device (2204) configured to enable the
operator to see and direct the laser fiber (2202) to targeted
structures, utilizing, for example, the high-precision navigability
of the subject sheath (422) and guide (424) instrument assembly
(108), and apply energy such as laser energy to destroy or break up
such structures. Preferably the image capture device (2204) is
positioned to include the position at which the energy source (such
as a lithotripsy fiber 2202) as part of the field of view of the
image capture device (2204)--i.e., to ensure that the operator can
utilized the field of view to attempt to bring the energy source
into contact with the desired structures.
[0166] FIG. 23 depicts a similar embodiment as the one shown in
FIG. 22, which includes a grasping tool (2302) to grasp a stone or
other object and bring it proximally toward the image capture
device (2204), such that it may be examined, removed proximally
through the working lumen of the guide instrument (424), etc.
[0167] FIG. 24 illustrates another similar embodiment, which
includes a basket tool (2402). FIG. 25 and FIG. 26, illustrate how
an embodiment such as one depicted in FIG. 24 may be used to grasp
and retrieve stones or other objects toward the distal portion of
the guide (424). As the retrieved object approaches the guide
(424), energy source (17036, 16026) breaks up the object in the
basket tool (2402); this operation is similar to the operation in
the embodiment illustrated in FIG. 18.
[0168] FIG. 27 depicts an embodiment with a proximal basket arm
capture (2102) and an image capture device (2108). As described
above in the portion of the description describing FIG. 21, when an
object is observed with the image capture device (2108), the entire
assembly may be advanced while the guide instrument (424) is
withdrawn proximally into the sheath instrument (422) until the
depicted basket capture arms (2102) are able to rotate toward the
central axis of the guide instrument (424) working lumen and
capture objects positioned adjacent the distal tip of the guide
instrument (424)
[0169] FIG. 28 depicts a configuration with an inflatable balloon
(2802) configured to be controllably filled with or evacuated of
saline (2804), through which an image capture device (2204) and
illumination source (2806) may be utilized to observe objects
forward of the balloon that preferably fall within the field of
broadcast (2808) of the illumination source (2806) and field of
view (2810) of the image capture device (2204). The balloon (2802)
also defines a working lumen (2812) through which various tools may
be passed--such as a laser fiber (2202), as depicted. FIG. 29
depicts a similar embodiment also comprising a grasping tool
(2302). FIG. 30 depicts a similar embodiment with a basket tool
(2402).
[0170] FIG. 31 through FIG. 33 depict similar embodiments which
comprise an inflatable balloon cuff (3102) configured to provide a
distal working volume (3104) which may be flushed with a saline
flush port (2806). The inflatable balloon cuff (3102) preferably
works not only as an atraumatic tip, but also as a means for
keeping the image capture device (2810) positioned slightly
proximally of structures that the inflatable balloon cuff (3102)
may find itself against--thus providing a small amount of volume to
image such structures without being immediately adjacent to them.
With an optical fiberscope as an image capture device (2810), it
may be highly valuable to maintain a translucent saline-flushed
working volume (3104) through which the image capture device (2810)
may be utilized to image the activity of objects, such as tissues
and/or kidney stones, as well as the relative positioning of tools,
such as fibers, graspers, baskets, etc., from proximal positions
into the working volume (3104)--which may be used, for example, to
grasp and/or modify or destroy stones or other structures. The
inflatable balloon cuff (3102) may be advanced to the desired
operational theater, such as the calices of a kidney, in an
uninflated configuration, and then inflated in situ to provide the
above functionality. Alternatively, the cuff (3102) may be inflated
before completing the navigation to the operational theater, to
provide atraumatic tip functionality as well as image capture
guidance and deflection from adjacent objects, during navigation to
the desired operational theater.
[0171] FIG. 34 through FIG. 36 depict similar embodiments, but with
a flexible cuff (3402), preferably comprising a soft polymer
material, rather than an inflatable cuff (3102) as in the previous
set of figures. The flexible cuff (3402) is configured to have
similar functionalities as those described in reference to the
inflatable cuff (3102) above.
[0172] FIG. 37 through FIG. 41 depict an embodiment wherein an
assembly of an image capture device (2104), which may optionally
comprise a lens (2106), transmission fibers (2108) for imaging, and
a working lumen (2110), through which various tools or combinations
of tools may be positioned. The components of this embodiment are
all packaged within one tubular structure as illustrated in the
cross sectional view of FIG. 41, which may comprise a co-extruded
polymeric construct. FIG. 38 through FIG. 40 depict the
interconnectivity of an image capture device (2104), such as a
fiberscope comprising a proximal optics fitting (3802), an optics
body member (3804), a proximal surface (3806) for interfacing with
a camera device with the illumination fibers and working lumen,
comprising a female luer fitting (3808) for accessing the working
lumen (2110), a working lumen proximal member (3810), an
illumination input tower (3812), an insertion portion (3814), a
central body structure (3816). Variations of this embodiment are
depicted in FIG. 42 through FIG. 45, with different distal
configurations similar to those depicted in reference to the
figures described above. FIG. 42 depicts a variation having a
distally-disposed flexible cuff (3402) defining a working volume
(3104) flushable with a saline port (2806) and imaged with an image
capture device (2810) as described above. FIG. 43 depicts a similar
variation having an inflatable cuff (3102). Tools such as graspers,
energy sources, fibers, baskets, etc may be utilized through the
working lumens (2110) of the embodiments depicted in FIG. 42, FIG.
43, FIG. 44, FIG. 45, etc. The embodiment of FIG. 44 comprises a
grasping tool (2302) positioned through the working lumen of the
assembly (2104--the assembly depicted in FIG. 37 through FIG. 41),
which the embodiment of FIG. 45 comprises a basket tool (2402).
[0173] Each of the above discussed tools, configurations, and/or
assemblies may be utilized for, among other things, endolumenal
urinary intervention, such as the examination, removal,
fragmentation, and/or destruction of stones such as kidney or
bladder stones.
[0174] Referring to FIG. 46A, a steerable instrument assembly
according to one embodiment may be steered through the urethra
(4602) and into the bladder (4604), where an image capture device
(2810) may be utilized, as facilitated by injected saline, to
conduct a cystoscopy and potentially observe lesions (4606) of
interest. The omni-directional steerability and precision of the
robotic guide and/or sheath to which the image capture device is
coupled facilitates collection of images of inside of the bladder
(4606) which may be patched together to form a 3-dimensional image.
The instrument assembly (108-422, 424, 2810) may also be utilized
to advance toward and zoom the image capture device upon any
defects, such as obvious bleeds or tissue irregularities. Indeed,
aspects of the images captured utilizing the image capture device
(2810) may be utilized in the controls analysis of the subject
robotic catheter system to automate, or partially automate aspects
of the system/tissue interaction. For example, as described above,
more than one two-dimensional image may be oriented relative to
each other in space to provide a three-dimensional mosaic type
composite image of a subject tissue mass, instrument, or the like.
Localization techniques may be utilized to assist with the "glueing
together" of more than one image; for example, spatial coordinates
and orientation may be associated with each image captured by the
image capture device, to enable re-assembly of the images relative
to each other in space. Such a three-dimensional composite image
may be registered in three dimensions to the workspace or
coordinate system of the subject elongate instrument or instrument
assembly, to provide automated display, zooming, and reorientation
of the images displayed relative to the distal portion of the
elongate instruments as the instruments are moved around in the
workspace. Further, the system may be configured to update the
composite image with more recently-captured images as the
instruments are navigated about in the workspace. Image recognition
algorithms may be utilized to bolster the information gleaned from
image capture; for example, a substantially round and dark shape in
a particular location known to be at least relatively close to a
lumen entry into or exit from a particular anatomic space may be
analyzed and determined via application of the pertinent algorithms
to be a given lumen entry or exit anatomical landmark, and the
location of such landmark may be stored on a database along with
the position and orientation variables of the elongate instruments
utilized in the particular instance to arrive at such location--to
enable easy return to such location using such variables. The
system may thus be configured to allow for automated return of the
instruments to a given landmark or other marker created manually or
automatically upon the composite image and associated database.
Further, given the composite image of the actual tissue in-situ,
the system may be configured to not only to allow for the storage
of and return to certain points, but also for the creation and
execution of configurable "keepout zones", into which the
instruments may be disallowed under navigation logic which may be
configured to prevent touching of the instruments to certain tissue
locations, navigation of the instruments into particular regions,
etc. Similar procedures may be performed in the prostate (4608) as
illustrated in FIG. 46B.
[0175] Referring to FIG. 47, the instrument assembly (108-422, 424,
4702) may alternatively or additional comprise an interventional
tool such as an ablation tool (4702) for ablating tumors or other
lesions (4606) within the bladder (4604) or prostate (4608). Any of
the above-discussed assemblies may be utilized for such a
cystoscopy procedure.
[0176] Each of the above-discussed constructs may also be utilized
adjacent to or within the kidneys. Referring to FIG. 48 and FIG.
49, for illustrative purposes, a portion of a relatively simple
instrument assembly embodiment (for example, a sheath distal tip
may be positioned in the bladder at the entrance to the urethra
while the more slender guide, 424, is driven toward and into the
kidney, 4802) is depicted. Such assembly may be advanced toward
and/or steerably driven into the kidney (4802), where stones (4804)
may be captured with graspers or other tools, or where stones may
be destroyed using chemistry, cryo, RF, laser lithotripsy, or laser
ablation tools (4806), or other radiative techniques, such as
ultrasound, as depicted in FIG. 48 and FIG. 49. Each of the tools,
configurations, and/or assemblies discussed above in reference to
FIG. 16 through FIG. 45 may be utilized for the examination,
removal, fragmentation, and/or destruction of stones such as kidney
or bladder stones. Preferably, an image capture device (2810) is
positioned in or adjacent to the calices of the kidney to enable
interactive viewing of objects such as stones, while various tool
configurations may be utilized to examine, capture, grasp, crush,
remove, destroy, etc, such stones, before withdrawing the
instrument assembly.
[0177] Additional instruments and tools may be operatively coupled
to the instrument (108) to perform various minimally invasive
surgical procedures. As may be appreciated, the instruments and
tools may be operatively coupled to manually or robotically
operated instruments (108). FIG. 50A illustrates one embodiment of
a sheath (422) and guide (424) instrument (108) assembly that is
operatively coupled to conical balloon instrument (5002), wherein
the conical balloon is in a retracted configuration. In this
embodiment, the balloon (5002) may be deployed by extruding the
balloon structure (5002) from the distal tip of the guide catheter
(424) and extricated by pulling the balloon structure (5002) back
into the guide catheter (5002). FIG. 50B illustrates the embodiment
shown in FIG. 50A wherein the retracted conical balloon (5002) is
in a deployed configuration.
[0178] FIG. 51 illustrates one embodiment of a sheath (422) and
catheter (424) of the instrument assembly (108) with a deflated
balloon (5102). In one embodiment, the balloon is deployed by
inflating the balloon (5102) with a gas or liquid. For example, the
balloon may be inflated by air, carbon dioxide, saline, contrast
agent, etc., but is not limited as such. FIG. 52 illustrates a
sheath (422) and catheter (424) with one embodiment of an inflated
balloon (5202). In this example, an image capture device (5204) is
located in the working lumen of the catheter (424). A user can
manipulate the proximal end of the image capture device (5204). The
device (5204) may be maneuvered about the interior of the balloon
(5202) to view various areas. For one embodiment, the balloon
(5202) is inflated with a gas or liquid that allows for visibility
through it. In other words, the balloon (5202) is inflated with an
appropriate material wherein the image capture device (5204) can
operate properly and capture images with sufficient detail. For
example, the balloon may be placed near or against tissues in the
body of a patient to facilitate diagnostic or interventional
operations. FIG. 53 illustrates a sheath (422) and catheter (424)
with one embodiment of a toroid shaped balloon (5302). The balloon
(5302) of this embodiment includes a lumen (5304) through its
center and allows for the deployment of items such as tools,
catheters, contrast agent, solutions, etc. from the proximal end of
the catheter (424).
[0179] FIG. 54 illustrates a sheath (422) and catheter (424) with
distal tip portion (5402) of the catheter (424) where a balloon may
be deployed is highlighted. The discussion that follows below for
FIG. 55 through FIG. 87 is described in the context of the distal
tip portion (5402) of the catheter (424). Although various types of
material may be used to construct the balloon, it may be preferably
in some embodiments to use a polyamide material that allows for the
transmission of light through the material or a material that is
optically transparent. For instance, it may be desirable to view
tissues of an organ in a patient through the surface of an inflated
balloon with an image capture device.
[0180] FIG. 55 illustrates one embodiment of an inflated conical
shaped balloon (5502) manufactured by a heat bonding process. For
example, the inflatable chambers are joined by a heat bonding by
process. In this embodiment of a balloon (5502) implementation, the
balloon (5502) is constructed with three inflatable chambers
(5504A, 5504B, 5504C) through a heat bonding process. The chambers
(5504A, 5504B, 5504C) are oriented around the axis of the catheter
(424). In one embodiment, the pressure for each one of the three
chambers may be independently controlled, thus allowing each
chamber to be inflated to a different or the same pressure as the
other chambers. In another embodiment, the three chambers may be
all inflated to the same pressure. Depending on the balloon design,
the chambers may function independent of the others wherein
puncturing one of the chambers will not affect the other
chambers.
[0181] FIG. 56 illustrates another embodiment of a conical shaped
balloon (5602). Similar to the balloon (5502) illustrated in FIG.
55, this balloon (5602) is also constructed with a plurality of
inflatable chambers (5604) by a heat bonding process. The chambers
(5604) of this embodiment extend laterally along the axis of the
catheter (424). FIG. 57 illustrates one embodiment of a cylindrical
shaped balloon (5702) manufactured by a heat bonding process. The
chambers (5704) of this embodiment also extend laterally along the
axis of the catheter (424). Due to the cylindrical shape of the
balloon (5702) of this embodiment, each of the chambers (5704) may
be similar to the others in dimensions and capacity, whereas the
chambers of the balloons illustrated in FIG. 55 and FIG. 56 may
have different dimensions and capacities.
[0182] FIG. 58 illustrates one embodiment of a conical shaped
balloon (5802) having two or more chambers (5804-1, 5804-2 . . . ,
5804-n) that may be inflated to the same or different pressures. In
one embodiment, the proximal chamber (5804-1) may be inflated to a
higher pressure than the second chamber (5804-2). It may be
desirable to inflate the second chamber (5804-2) to a lower
pressure because the second chamber may come into contact with
tissue and rest against the tissue, such that the lower pressure of
the chamber (5804-2) could make a substantially softer contact with
a tissue surface. As may be appreciated, it may be desirable in
some applications or procedures to have a softer contact with the
surface of tissues. FIG. 59 illustrates one embodiment of a conical
shaped balloon (5902) having one inflatable chamber (5904-1) and a
soft distal section (5904-2). The soft distal section (5904-2) may
be slightly softer than the inflatable chamber (5904-1). In one
embodiment, the soft distal section (5904-2) may be a curtain or
skirt constructed with a soft polyamide material or plastic having
a relatively low Durometer hardness value.
[0183] Depending on the construction of a balloon, some
reinforcement may be desirable in certain instances. For example, a
user may not want a balloon to collapse during a procedure or a
particular procedure may require the balloon to provide a minimal
level of rigidity. FIG. 60 illustrates one embodiment of a conical
shaped balloon (6002) having a structural reinforcement wire (6004)
deployed within balloon (6002). In one instance, the wire (6004) is
woven into the surface of the balloon (6002). In this example, the
wire (6004) may be a coil that extends from the distal tip of the
catheter (424) through the balloon (6002) to the distal edge of the
balloon (6002). FIG. 61 illustrates one embodiment of a cup shaped
balloon (6102) having a stent type of reinforcement (6104). In this
embodiment, the stent structure is built into the balloon body and
is collapsible. By pulling the balloon (6102) back into the distal
tip of the catheter (424), the stent structure collapses. To deploy
the balloon (6102), the balloon (6102) is pushed out from a working
lumen or channel of the catheter (424) and the stent structure
expands automatically. FIG. 62 illustrates one embodiment of a
cylindrical shaped balloon (6202) having a stent type of
reinforcement (6204).
[0184] FIG. 63 illustrates one embodiment of a cup shaped balloon
(6302) having lateral support rings (6304). In this example, the
ring supports are constructed of a polyamide material and located
within the sidewalls of the balloon (6302). For one embodiment, the
support rings (6304) are approximately the same size. In other
embodiments, the support rings (6304) may vary in size depending on
its designated location within the balloon (6302). FIG. 64
illustrates one embodiment of a cup shaped balloon (6402) having a
first chamber (6404) with a stent type reinforcement structure and
a distal second chamber (6406) without the stent type
reinforcement. In this example, both chambers (6404, 6406) may be
inflated to the same or different pressures. For one
implementation, the distal second chamber (6406) is inflated to a
pressure sufficiently low such that the surface of the second
chamber (6406) may be pliable or relatively soft when in contact
with tissue. FIG. 65 illustrates one embodiment of a cup shaped
balloon (6502) having a first chamber (6504) with a stent type
reinforcement structure and a distal edge (6506) constructed of a
soft material. In this embodiment, the distal edge is constructed
with a soft pliable polyamide material.
[0185] FIG. 66 illustrates one embodiment of a cup shaped balloon
(6602) together with an image capture device (6604) and flush port
(6606) at the distal tip of a catheter (424). The cup shape of this
embodiment allows for the creation of a working volume (6608). By
placing the distal edge of the balloon (6610) up against tissue, a
working volume (6608) is formed by the surface of the tissue and
the inner surface of the balloon (6612). Although the working
volume (6608) may contain blood during some procedures, the blood
may be evacuated by flushing the working volume (6608) by injecting
saline or carbon dioxide through the flush port (6606). With the
working volume (6608) cleared, the image capture device (6604) may
be used to examine the surrounding tissue. FIG. 67 illustrates one
embodiment of a catheter (424) having a cup shaped balloon (6602)
together with an image capture device (6604), a flush port (6606),
and a working lumen (6702) at the distal tip of a catheter (424).
The working lumen (6702) is a hollow channel in which tools or
surgical instruments may be passed from the proximal end of the
catheter (424) to the distal end of the catheter (424) to perform
operations in the working volume (6608) of the balloon (6602).
[0186] FIG. 68 illustrates one embodiment of a toroid shaped
balloon (6802) with a suction port (6804) at the distal tip of a
catheter (424). The balloon (6802) of this embodiment includes a
working volume (6806) that can be evacuated by suctioning out the
contents therein when the distal surface of the balloon (6802) is
up against a surface. Furthermore, the suction provided by the
suction port (6804) may allow the balloon to be anchored to a
surface if a sufficient vacuum force is created in the working
volume (6806).
[0187] FIG. 69 illustrates one embodiment of a balloon (6902) that
includes collapsible support ribs (6904).
[0188] FIG. 70 illustrates one embodiment of a two layered balloon
(7002) together with an image capture device (6604) at the distal
tip of a catheter (424). In this embodiment, the balloon (7002) has
an outer layer (7004) and an inner layer (7006). Encapsulated
between the two layers (7004, 7006) is a space (7008) which may be
filled with a saline solution or a gas medium, e.g., carbon
dioxide, etc. Preferably, the solution/gas medium encapsulated
between the layers (7004, 7006) as well as the material of the
balloon and the combination thereof, are transparent to the image
capture device (6604), such that image capture device (734) would
be able to "view" tissue outside of the balloon (7002). The image
capture device (6604) may be any suitable image capturing device,
e.g., optical, ultrasound, laser, CCD, etc.
[0189] FIG. 71 illustrates one embodiment of a side firing
ultrasound transducer catheter (7102) enclosed within an inflated
balloon (7104) at the distal tip of a catheter (424). In this
embodiment, ultrasound transducer elements (7106) are mounted on
the circumferential surface of the transducer catheter.
[0190] FIG. 72 illustrates one embodiment of a balloon (7202) with
a plurality of spikes (7204) at the distal tip of a catheter (424).
In one embodiment, the spikes (7204) may be employed to temporarily
anchor an inflated balloon (7202) to a tissue structure. The
catheter (424) of this embodiment includes a first lumen (6702) and
a second lumen (7206). As with other lumens, each can be used to
transfer tools, imaging devices, catheters, illumination fibers,
etc. from the proximal end of the catheter (424) to the distal tip.
FIG. 73 illustrates one embodiment of a balloon (7302) with spines
(7304) at the distal tip of a catheter (424). The spines (7304) may
be employed for anchoring the balloon (7302) like the spikes (7204)
discussed directly above.
[0191] FIG. 74 illustrates one embodiment of an image capture
device (7404) with a reticle (7406) and illumination fibers (7408)
enclosed within a balloon (7402) at the distal tip of a catheter
(424). The depicted embodiment features an image capture device
(7404) which may or may not have a lens. The illumination fibers
(7408) may radiate light, infrared radiation, or other radiation to
illuminate an area of interest. The image capture device (7404),
which may comprise a fiberscope, CCD chip, infrared imaging device,
such as those available from CardioOptics Incorporated, ultrasound
device, or other image capture device, may be used, for example, to
search for objects such as stones. In one embodiment, the reticle
(7406) allows for the measurement of interesting tissue structures.
FIG. 75 illustrates one embodiment of an articulating endoscope
(7502) enclosed within a balloon (7402) at the distal tip of a
catheter (424). The articulating endoscope (7502) of one embodiment
may, in addition to moving in and out relative to the distal tip of
the catheter (424); it is capable of additional manipulations,
e.g., bend, roll, and pitch, within the volume defined by the
balloon in order to access any desired position or area on the
balloon surface.
[0192] FIG. 76 illustrates one embodiment of a laser fiber (7602)
and an image capture device (6604) enclosed within a balloon (7402)
at the distal tip of a catheter (424). In one embodiment, the laser
fiber may be a lithotripsy laser fiber. Such a fiber may comprise a
quartz fiber and be associated with a laser, such as a Holmium YAG
laser, to apply energy to objects such as kidney stones. In one
configuration, the laser source is positioned and interfaced with
the fiber (16026) proximally, as in a typical lithotripsy
configuration, with the exception that in the subject embodiment,
the fiber is positioned down the working lumen of one or more
robotic catheters. Since the distal tip of the lithotripsy fiber is
configured to deliver energy to a target object, such as a kidney
stone, the distal tip may be more generically described as an
energy source. Indeed, in other embodiments, other energy sources,
besides laser, may be utilized to effect tissue. For example, in
other embodiments, the energy source may comprise an RF electrode,
an ultrasound transducer, such as a high-frequency ultrasound
transducer, or other radiative, conductive, ablative, or convective
energy source.
[0193] FIG. 77 illustrates one embodiment of an image capture
device (6604) and illumination fibers (7408) enclosed within a
balloon (7702) having a plurality of magnifying lenses (7704)
positioned at various locations on the balloon surface. When using
the image capture device to view structures outside of the balloon
during a procedure, one of the magnifying lenses may be maneuvered
in the direction of the desired item. By positioning the image
capture device to look at the item through the appropriate
magnifying lens, the object may be magnified without the use of an
additional magnifying apparatus on the catheter or system.
[0194] FIG. 78 illustrates one embodiment of a balloon (7802)
having a radio frequency (RF) electrode (7804) deployed on its
surface. In one procedure, the balloon may be positioned up against
the target tissue. By maneuvering the electrode (7804) to the
appropriate orientation and position, the target tissue may be
ablated.
[0195] FIG. 79 illustrates one embodiment of a balloon (7902)
having a magnet (7904) on its outer surface. Magnetic energy may be
used to treat tissues in a patient.
[0196] FIG. 80 illustrates one embodiment of balloon (8002) having
a pair of mapping electrodes (8004, 8006) mounted on the outer
surface of the balloon. The mapping electrodes (8004, 8006) may be
used to map the surface tissues or organs in a patient.
[0197] FIG. 81 illustrates one embodiment of a balloon (8102)
having a through lumen (8104). Also located within the balloon
(8102) are illumination fibers (7408) and an image capture device
(6604). FIG. 82 illustrates one embodiment of a balloon (8102)
having an ablation tool (8106) deployed in its through lumen
(8104). FIG. 83 illustrates one embodiment of a balloon (8102)
having a grasper (8108) deployed in its through lumen (8104). The
grasper (8108) of one embodiment may be fitted with an energy
source, such as a lithotripsy laser fiber in a configuration
wherein an object, such as a kidney stone, grasped within the
clutches of the grasper (8108) may be ablated, destroyed,
fragmented, etc., by applied energy from the source, which is
positioned to terminate approximately at the apex of the grasper
(8108) which it is likely to be adjacent to captured objects. FIG.
84 illustrates one embodiment of a balloon (8102) having a basket
tool (8110) deployed in its through lumen (8104). The energy source
may be coupled to the pertinent capture device, or may be
independently positioned through the working lumen of the guide
instrument (424) to the desired location adjacent the capture
device. Each of the tools described herein, such as graspers,
baskets, and energy sources, may be controlled proximally as they
exit the proximal end of the working lumen defined by the guide
instrument (424), or they may be actuated automatically or
electromechanically, for example through the use of electric motors
and/or mechanical advantage devices.
[0198] FIG. 85 illustrates the distal tip of one embodiment of a
catheter (424) having a balloon (8502) and an ablation catheter
(8106) deployed in a working lumen located outside of the balloon
(8502). In this embodiment, illumination fibers (7408) and an image
capture device (6604) is located within the confines of the balloon
(8502). FIG. 86 illustrates the distal tip of one embodiment of a
catheter (424) having a balloon (8502) and a grasper (8108)
deployed in a working lumen located outside of the balloon (8502).
FIG. 87 illustrates the distal tip of one embodiment of a catheter
having a balloon (8502) and a basket tool (8110) deployed in a
working lumen located outside of the balloon (8502).
[0199] All of the aforementioned tools and instruments, e.g.,
balloons, ablation tools, baskets, graspers, scopes, etc.
apparatuses are configured to be operatively coupled to the
instrument assembly (108) in combination with the sheath catheter
(422) and guide catheter (424). In some embodiments, the tools and
instruments may be used with the guide catheter (424) without the
sheath catheter (422). In other embodiments, additional catheters
may be used with the tools and instruments. As apparent to one
skilled in the art, the tools and instruments are configured to be
either manually operated or robotically operated by the instrument
driver (106) in connection with the instrument (108). Some of the
circuitry, e.g., electrical, mechanical, hardware, software,
firmware, etc. systems for controlling and operating all of the
aforementioned tools and instruments may be configured at the
instrument driver (106) and the system electronics rack (114).
[0200] FIG. 88 through 90 illustrate various views of one
embodiment of a mold (8802) for manufacturing a balloon. FIG. 88
illustrates a side view of the mold (8802) for manufacturing the
balloon. In one embodiment, the balloon is formed over the ball
structure towards the bottom of the mold. FIG. 89 illustrates a top
view of the mold (8802). FIG. 90 illustrates an isometric view of
the mold (8802).
[0201] FIG. 91 through FIG. 95 illustrate one embodiment of a
method for deploying an angioplasty ring (9116) using a balloon
apparatus (9110, 9112), within the balloon apparatus may be similar
to the embodiment described in FIG. 74. That is, the balloon
apparatus includes an image capture device 7404 to enable visual
access through the balloon. In this embodiment, the balloon portion
(9110) of the balloon apparatus (9110, 9112) is used to hold the
ring (9116) in place while the ring is being deployed by a second
catheter (9106). For example, an angioplasty ring (9116) may be
applied to the mitral annulus (9104) near the mitral valve of the
heart (9102). As illustrated in FIG. 91, a catheter (9106) may be
maneuvered toward the mitral valve by the guide catheter (424). A
ring applicator (9108) at the distal portion of the catheter (9106)
is position near the mitral annulus (9104) by the mitral valve. The
balloon apparatus (9110) deployed by the catheter (9112) moves the
ring applicator (9108) into position over the mitral annulus
(9104). Once the ring applicator (9108) is in position, the ring
(9116) is secured in place by one or more clips (9114). The ring
(9116) or the clip (9114) may be adjusted, e.g., by tension wires
(not shown), to clinch the ring more tightly on the mitral annulus
(9104) around the mitral valve.
[0202] FIG. 96 illustrates one embodiment of a method for ablation
using a balloon apparatus. In this embodiment, the ablation
catheter (9604) travels around the outer edge of the first balloon
(9606) to ablate the desired tissue at an operation site
(9602).e.g., pulmonary vein. A second catheter or balloon (9608)
may be used to anchor the first balloon (9606)) to the pulmonary
vein. In this example, the first balloon (9606) serves as a guide
for the ablation catheter (9604).
[0203] FIG. 97 illustrates one embodiment of a catheter (9702) with
a toroid shaped balloon (9704) deployed at its distal tip and an
ablation catheter (9706) for performing various ablation
procedures. The catheter (9702) may be advanced to the operation
site with the balloon (9704) initially in a deflated or undeployed
configuration. Once the catheter (9702) is advanced to the
operation site, the balloon (9704) may be inflated or deployed
using a suitable medium, e.g., saline solution, air, etc., to
position or secure the catheter (9792). An ablation operation may
be performed using the ablation catheter (9706).
[0204] FIG. 98 illustrates one embodiment of a catheter (9702) with
a circular shaped balloon (9802) with an electrode strip (9804)
mounted on its outer surface. In one embodiment, the electrode
strip is employed for performing ablation procedures.
[0205] FIG. 99 illustrates one embodiment of a method for RF
mapping with a balloon (9902) mounted with electrodes (9904-1,
9904-2 . . . , 9904-n). Depending on the specific circuitry coupled
to each of the electrodes and the signal commands to operate the
electrodes, different procedures may be accomplished using the
electrodes (9904-1, 9904-2 . . . , 9904-n). In one embodiment, the
electrodes (9904-1, 9904-2 . . . , 9904-n) may be used for mapping
a cavity or the interior volume of an organ of a patient to
generate a three-dimensional map of the cavity or interior volume.
In a second embodiment, the electrodes may be used for performing
ablation procedures on tissues of an organ in a patient. FIG. 100
illustrates a portion of the top surface of the balloon (9902) that
was illustrated in FIG. 99
[0206] FIG. 101 through FIG. 104 illustrate one embodiment of a
method for performing a patent foramen ovale (PFO) procedure using
a balloon apparatus. As illustrated in FIG. 101, a first catheter
with (10102) the balloon structure (10104) travels up the inferior
vena cava to the right atrium. This balloon (10102) includes a
magnet (10106) mounted on its surface. A second catheter (10108)
travels to the left atrium of the heart through a retro grade path.
The two catheters meet at the wall separating the atriums as
illustrated in FIG. 101 and FIG. 104. The second catheter (10108)
may include a metallic material at its distal portion, such that
the magnet (10106) on the balloon (10102) may be attracted to the
distal portion of the catheter (10108) against the tissue (1114)
and substantially holding and positioning the balloon (10102) at a
desired location against the tissue (1114). FIG. 102 and FIG. 103
illustrate the balloon apparatus (10102) includes a scope (10110)
and a needle or an ablation instrument (1112). As the balloon
(10102) is held at a substantially desired location, the needle or
ablation instrument (1112) may be used to perform the procedure for
closing the PFO as the scope (10110) is used to view or monitor the
procedure.
[0207] FIG. 105 illustrates one embodiment of a method for
performing aortic valve destenosis and/or decalcification using one
or more balloons. In one embodiment, two balloon structures may be
deployed. A first balloon (10502) anchors the catheter structure
(10510) in the aorta to the heart (10500). A lumen through the
balloons is configured to allow for the passage and flow of blood
(10506). However, the flow is controlled by a valve (10508) within
the second balloon structure (10504). When the structures are
anchored, blood flow (10506) through the first balloon is
restricted and controlled by the valve (10508) in the second
balloon structure (10504). A second catheter (not shown) may be
advanced and navigated to the first balloon (10502) and through an
opening or port (10512) at the first balloon (10502) to dispense a
bio-decalcifying solution or a mechanical instrument, e.g., scraper
and vacuum tube, etc., for perform destenosis and/or
decalcification procedures.
[0208] In addition to the operations and procedures as discussed,
each of the above discussed tools, systems, and/or assemblies may
be utilized for, among other things, endolumenal urinary
intervention, such as the examination, removal, fragmentation,
and/or destruction of stones such as kidney or bladder stones
[0209] The prostate has a tendency to grow in aging males. In some
cases, the prostate may grow to a sufficient size that would put
pressure on the urethra and cause problems with urination, such as
incomplete emptying of the bladder or dribbling of urine. This
condition is known as benign prostatic hyperplasia (BPH). There are
a number of treatments for BPH. A transurethral resection of the
prostate (TURP) is one treatment that is usually performed to
address BPH. TURP is a urological operation to remove some or all
of an enlarged prostate gland so that urine can flow more freely.
This procedure is performed by observing the prostate through the
urethra and removing tissue by electrocautery or sharp dissection.
While the patient is under anesthesia, the surgeon inserts a
resectoscope into the penis through the urethra. Some resectoscopes
may include a camera, light, valves for controlling irrigating
fluid, and/or specially adapted surgical instruments. These
instruments allow the surgeon to see the prostate clearly. A wire
loop attachment that carries an electric current is typically used
to "chip away" at the prostate by removing obstructing tissue and
to seal blood vessels. During the operation, the bladder is flushed
with sterile solution to remove the chippings of prostate tissue.
The debris is removed by irrigation and any remaining debris is
eliminated in the urine over time. A catheter with a large lumen
may be inserted through the urethra to irrigate and drain the
bladder after the surgical procedure is completed.
[0210] Another procedure to treat the prostate may involve the use
of a laser. Laser surgery uses a high-energy laser to destroy
overgrown prostate tissue. The laser does not penetrate tissue
deeply, so surrounding tissue is not harmed. There are a various
types of laser surgery available. Transurethral evaporation of the
prostate (TUEP) is one type. This procedure is similar to TUVP. The
difference is that prostate tissue is destroyed with laser energy
instead of electrical current. The procedure is generally safe and
causes limited bleeding. It is often effective, with noticeable
improvement in urine flow soon after the procedure. Due to the
evolution of laser technology, this procedure has largely been
replaced by new laser treatments such as PVP and HoLEP. Visual
laser ablation of the prostate (VLAP) is another type of laser
surgery. This treatment involves applying sufficient laser energy
to dry up and destroy excess prostate cells. Another type of
surgery is photosensitive vaporization of the prostate (PVP). PVP
is newer form of laser treatment for prostate gland enlargement.
This procedure and its results are similar to transurethral
resection of the prostate (TURP), which is the most common surgical
treatment for enlarged prostate. However, PVP uses laser energy
instead of the electrical current used by TURP to destroy prostate
tissue. Holmium laser enucleation of the prostate (HoLEP) is yet
another type of surgery. This is a newer laser procedure used for
men with urinary retention due to enlarged prostate and is similar
to PVP.
[0211] FIG. 106 through FIG. 115 illustrate various apparatuses and
methods for performing prostate surgery. FIG. 106 illustrates a
prostate (10604) with benign prostatic hyperplasia. As illustrated,
the channel about the lateral lobe (10606) in the prostate gland
(10604) through which the bladder (10602) empties out to the
urethra (10608) is narrowed in the region of the median lobe
(10610). FIG. 107 illustrates a steerable sheath (422) and guide
catheter (424) traveling up the urethra (10608). FIG. 108
illustrates a close-up view of the prostate gland (1604) and the
external urethral sphincter tissue (10612) near the prostate gland.
In one embodiment, the steerable guide catheter (424) includes an
imaging fiber (10802) and laser (10804). As discussed above, the
laser (10804) may be used to perform the various types of laser
surgery for addressing BPH. The imaging fiber (10802) may be a
fiberscope, CCD chip, infrared imaging device, such as those
available from CardioOptics Incorporated, ultrasound device, or any
other image capture device, for example, to search for objects or
to view tissue.
[0212] FIG. 109 illustrates another close-up view of the prostate
gland (10604) with one embodiment of a catheter (424) that includes
an imaging fiber (10802), laser (10804), and flush port (10902). In
this embodiment, a flush port (10902) is also available in the
catheter (424) for supplying irrigating fluid and to flush the
prostate (10604) during a laser surgery procedure. FIG. 110
illustrates yet another close-up view of the prostate (10604) with
another embodiment of a catheter (424) that includes an imaging
fiber (10802), laser (10804), and flush port (11002). In this
embodiment, the flush port (11002) points in an opposite from the
imaging fiber (10802) and laser (10804). During a procedure, the
solution from the flush port can travel down the urethra (10608) to
carry away prostate tissue chipped away by the laser (10804) while
the imaging fiber (10802) provides a user, operator, or surgeon a
view of the procedure from a viewpoint near the laser. FIG. 111
illustrates an additional close-up view of the prostate (10604)
with yet another embodiment of a catheter (424) that includes an
imaging fiber (10802), laser (10804), and flush port (10902). In
this embodiment, the imaging fiber (10802) and flush port (10902)
point downward towards the urethra (10608) and opposite to the
laser (10804). The imaging fiber (10802) provides a user a better
view of the laser (10804) in operation as the solution from the
flush port flushes debris away from the imaging fiber (10802). FIG.
112 illustrates a further close-up view of the prostate (10604)
with still another embodiment of a catheter (424) that includes an
imaging fiber (10802), laser (10804), and flush port (10902). In
this embodiment, the laser (10804) and flush port (10902) are
directed downward toward the urethra, whereas the imaging fiber
(10802) is directed upward towards the bladder (10602).
[0213] FIG. 113 illustrates a yet further close-up view of the
prostate (10604) with one embodiment of a catheter (424) that
includes a laser (10804) and grasper (11302). This embodiment
includes a grasper (11302) to grasp and remove any tissue samples
as desired. FIG. 114 illustrates another close-up view of the
prostate (10604) with one embodiment of a resectoscope (11402)
deployed within the working lumen of a steerable guide catheter
(424). As discussed above, some embodiments of a resectoscope can
also include an image capture device, flush ports, or other tools.
Thus with an implementation as shown in FIG. 114, a TURP procedure
can be conducted. Tiny cutting blades deployed by the resectoscope
(11402) can scrape away excess prostate tissue. FIG. 115
illustrates yet another close-up view of the prostate (10804) with
one embodiment of a catheter (424) that includes a wire loop tool
(11502), imaging fiber (10802), and flush port (10902). This wire
loop tool (11502) may be configured such that it may be electrified
to chip away or remove and cauterize the excess tissue for treating
BPH.
[0214] All of the aforementioned balloons, ablation tools,
electrodes, etc. apparatuses are configured to be operatively
coupled to the instrument assembly (108) in combination with the
sheath catheter (422) and guide catheter (424). In some
embodiments, the tools or instruments, e.g., balloons, ablation
tools, electrodes, etc., may be used with the guide catheter (424)
without the sheath catheter (422). In other embodiments, additional
catheters may be used with the tools or instruments. As apparent to
one skilled in the art, the tools and instruments are configured to
be either manually operated or robotically operated by the
instrument driver (106) in connection with the instrument (108).
Some of the circuitry, electrical, and mechanical systems for
controlling and operating all of the aforementioned tools and
instruments may be configured at the instrument driver (106) and
the system electronics rack (114).
[0215] FIG. 116 illustrates another embodiment of a robotic
surgical system (100). As illustrated in FIG. 116, this embodiment
of the robotic surgical system (100) includes both a master input
device (118) and a pair of data gloves (11602) for providing input
to the system (100). The data gloves (11602) may be connected to
the operator control station (102) or the electronics rack (114) by
a wire or wireless connection. This embodiment essentially provides
two input system for one or more operators (116) to provide input
to the system (100). For example, a first operator or surgeon (116)
may provide input to system (100) by manipulating the master input
device (118) and a second operator or surgeon (116) may provide
input to system (100) by the wireless data glove (99) either near
control station (102) or a some distance away from both the
operator control station (102) and the operation table (104).
[0216] Accordingly, the instrument driver (106) and instrument
(108) may be controlled by one or more operators via the
manipulation of the master input device (118) or pair of data
gloves (11602), or a combination of both the master input device
(118) and the data gloves (11602). For example, the insertion and
removal of an instrument (108) mounted on the instrument driver
(106) may be controlled via the data gloves (11602) and/or the
master input device (118). Instrument (108) may include steerable
catheters (422, 424). In addition, tools or other types of
end-effectors may be mounted or inserted through the working lumens
at the end of the instrument assembly (108), such as the sheath
(422) and guide (424). In some embodiments, the data gloves are
configured to also control and manipulate these tools and
end-effectors. In other embodiments, the data gloves simply control
the steering (pitch, yaw, rotation, etc) for the instrument
assembly, e.g., sheath (422) and/or guide (424). In yet another
embodiment, the data gloves (11602) may maneuver an imaging fiber
located at the tip of instrument (108) such that the field of view
can be changed based on movements of a data glove
[0217] A data glove (11602) is generally defined as a glove
equipped with sensors that sense the movements of the hand and
interfaces those movements with a computer in the electronics rack
(114). Data gloves may interactive devices that resemble gloves
worn on the hands, which may facilitate tactile sensing and
fine-motion control in robotics and virtual reality. Data gloves
are commonly used in virtual reality environments where the user
sees an image of the data glove and can manipulate the movements of
the virtual environment using the glove. Data gloves are one of
several types of electromechanical devices used in haptics
applications. Tactile sensing involves simulation of the sense of
human touch and includes the ability to perceive pressure, linear
force, torque, temperature, and surface texture. Fine-motion
control involves the use of sensors to detect the movements of the
user's hand and fingers, and the translation of these motions into
signals that can be used by a virtual hand (for example, in gaming)
or a robotic hand (for example, in remote-control surgery).
Sophisticated data gloves also measure movement of the wrist and
elbow. A data glove may also contain control buttons or act as an
output device, e.g. vibrating under control of the computer. The
user usually sees a virtual image of the data glove and can point
or grip and push objects.
[0218] FIG. 117 illustrates one embodiment of the operator control
station of the system (100). The operator control station (102) of
this embodiment includes three display monitors (122), a
touch-screen user interface (11702), a control button console
(11704), a master input device (118), and a pair of data gloves
(11602). Master input device (118) and wireless data gloves (11602)
serve as user interfaces through which the user can control the
operation of the instrument driver (106), the instrument (108), and
any additional attachments, tools, instruments, etc. As shown in
FIG. 117, the master input device (118) is located about the center
of the operator control station (102) just under the center screen.
The data gloves (11602) are coupled to the control station (102)
via a cable or wireless connection. Wireless data gloves enables a
user or surgeon to provide command or operate the system (100)
substantially untethered remotely from the operator station (102).
Also depicted is a device disabling switch (11706) configured to
disable activity of the instrument temporarily. As illustrated in
FIG. 118, the electronics rack (114) may be support by a cart or
configured with wheels for easy movability within the operating
room or catheter lab, one advantage of which is location of the
operator control station (102) which may be moved away from the
operation table (104) and radiation sources, thereby substantially
decrease or eliminate the potential for exposure to radiation or
reduce the radiation dosage to the operator.
[0219] Referring to FIG. 119, one embodiment of an operator control
station (102) is depicted showing a control button console (11704),
which may include a computer, a computer control interface device,
such as a mouse, a visual display system (122), a master input
device (118), and a pair of data gloves (11602). In addition to
buttons on the button console (11704), footswitches and other known
types of user control interfaces may be utilized to provide an
operator interface with the system controls.
[0220] Still referring to FIG. 119, the master input device (118)
of this embodiment may be a multi-degree-of-freedom device having
multiple joints and associated encoders. An operator interface
(11902) may be configured for comfortable interface with the hand
or fingers or the operator 116. The depicted embodiment of the
operator interface (11902) is substantially spherical. Further, the
master input device may have integrated haptics capability for
providing tactile feedback to the user. Also illustrated in FIG.
119 is a pair of data gloves (11602) coupled to the operator
control station. In this embodiment, a single user can utilize the
master input device (11902) or the pair of data gloves (11602), or
even a combination of both, to control the instrument driver (106)
and one or more instruments (108). However, it is also possible for
two users to take turns controlling the instrument driver (106) and
associated instruments (108). For instance, one person may be
seated at the control station in position to manipulate the master
input device (118) while a second person may be wearing the data
gloves. By gating or multiplexing which master device is active at
a given time, the two people can switch off running or operating
the system (100). One scenario where this may be useful is where a
resident is working at the control station and a chief surgeon
wearing the data gloves is ready to step in as needed. Even though
the examples illustrated with these figures show data gloves in
close proximity to the control station, the operating distance of
the gloves may vary depending on the implementation. For example,
the gloves can be configured to operate away from the control
station or a remote location, such as a different room from which
the current procedure is happening. Thus, the operating range may
be limited by the physical length of a cable connection, if any, or
by the wireless connectivity.
[0221] FIG. 120 illustrates one embodiment of a robotic catheter
system (100) that includes data gloves (11602). In this embodiment,
the user (116) is seated at a station without a master input device
and input is provided through the data gloves (11602). FIG. 121
illustrates the operator control station (102) of FIG. 120. As
shown in this example, the data gloves (11602) are connected to the
console with cables. Note that this system (100) also has the data
gloves (11602) in lieu of a master input device (118). FIG. 122
illustrates another embodiment of an operator control station (102)
including a pair of wireless data gloves (11602) wherein the user
(116) can remotely operate the station (102) and instrument driver
(106) away from the station (102). FIG. 123 illustrate the input
devices of the control station (102) of FIG. 122 with a wireless
data glove (11602) resting on the table top.
[0222] The data gloves (11602) of implementation for part of a hand
data motion capturing solution for the receiving user input. In one
embodiment, the data gloves (11602) can measure finger flexure as
well as the abduction between the fingers. Finger flexure is
measured at two places on the finger: at the first finger joint
(knuckle) and at the second finger joint. Abduction sensors can be
located between fingers. In another embodiment, the data gloves
(11602) measure finger flexure, but not abduction. In this
instance, each sensor measures finger flexure as an average of
knuckle and the first joint. A plurality of sensitive data sensors
is mounted on the gloves to accurately sense/detect user movements
and communicate data signals to system software and hardware.
Although one embodiment employs data gloves having five or fourteen
data sensors, different numbers of data sensors can be used
depending on the resolution desired. One embodiment of the data
gloves (11602) features an auto calibration function, 8-bit flexure
and abduction resolution, and low drift. Greater resolution can be
achieved in sensed movements by increasing the number of data bits
in the sensor resolution and increasing the sampling rate. In one
embodiment, the glove data can also be captured and recorded at the
system for later evaluation. In another embodiment, multiple gloves
can be supported simultaneously. Similarly, a single data glove can
be employed with other embodiments.
[0223] The data gloves (11602) may be a preferable user input
device in some instances because this solution can offer comfort,
ease of use, and a small form factor, especially when compared to
other types of input devices. In one implementation, the data
gloves (11602) are constructed with stretch Lycra.RTM. fiber (as
marketed by INVISTA of Wichita, Kans.), but other types of material
such as cotton and nylon are also suitable. Although different
sizes of data gloves can be manufactured and utilized, one
implementation makes use of a one size fits all design wherein the
glove can stretch to fit different users without comprising the
integrity or sensitivity of the data gloves. Furthermore, various
physical aspects of the data glove can differ based upon the
design. For instance, some gloves may be manufactured without
finger tips. Other gloves may extend beyond a user's wrist. Another
glove may include control buttons or switches.
[0224] For the embodiments described in these examples, the pair of
data gloves (11602) includes a left hand glove and a right hand
glove. In some embodiments, a single data glove may be used,
instead of two gloves. Depending on the system architecture and the
user software, the data gloves (11602) can be used for a variety of
functions. Note that the data gloves are not limited to controlling
the instrument driver (106) and associated instruments (108). For
example, one embodiment of system may employ the data gloves in
combination with a head mounted display. In essence, the user may
be given the experience of working within a virtual environment.
Thus a user wearing the combination of the head mounted display can
visualize operating conditions and scenery at distal end of an
catheter and to manipulate a tool or tissue at the distal end of
the catheter with the data gloves. In one implementation, the data
gloves are capable of providing tactile feedback to the user in
response to contact at the distal tip of the catheter. In yet
another embodiment, the display from the screens (122) and a set of
virtual controls may be projected into the head mounted display. By
using the data gloves (11602), a user may be able to operate
various virtual system controls within the virtual environment in
addition to controlling the instrument driver and catheters. In
some aspects, the data gloves may serve as a more instinctive or
intuitive type of control as a user may be more comfortable with
the concept of virtually grasping or manipulating objects by simple
hand motions and having an item being virtually controlled respond
as if the user was physically touching the item.
[0225] The data gloves (11602) can employ a high speed connectivity
interface to communicate with the control system. In one
embodiment, the signals are transmitted from the data gloves
(11602) to the system via a physical cable such as an RS-232 cable,
USB cable, or serial data cable, but are not limited to these
examples. For one embodiment, the data gloves are designed without
any magnetic parts so that the data gloves can be safely used in a
magnetic resonance imaging (MRI) environment. In this case, the
sensed data is communicated to the system by way of an optical
fiber. In another embodiment, the data signals are transmitted from
the data gloves (11602) to the system wireless via radio waves or
infrared transmissions through protocols such as, but not limited
to, Bluetooth, WiFi, ZigBee, IEEE 802.11, IrDa, 3G, and RFID.
Depending on the particular implementation, the sensors may be
powered by the system via the cable connection. In a wireless
embodiment, the sensors may be powered by a rechargeable or
disposable battery pack coupled to the gloves. Data gloves, such as
the data gloves in the 5DT Data Glove Ultra series or the 5DT Data
Glove MRI series, are available from manufacturers such as 5DT
(Fifth Dimension Technologies), Inc. of Irvine, Calif. Additional
data gloves include the ShapeHand.TM. available from Measurand Inc.
of Fredericton, NB, Canada and the CyberGlove.RTM. II Wireless Data
Glove available from Immersion Corporation of San Jose, Calif.
[0226] Similarly, master input devices are available from
manufacturers such as SensAble Technologies, Inc. of Woburn, Mass.
under the trade name Phantom.RTM. Haptic Devices or from Force
Dimension of Lausanne, Switzerland under the trade name Omega
Haptic Device. In one embodiment featuring an Omega-type master
input device, the motors of the master input device are utilized
for gravity compensation. In other words, when the operator
releases the master input device from his hands, the master input
device is configured to stay in position, or hover around the point
at which is was left, or another predetermined point, without
gravity taking the handle of the master input device to the portion
of the master input device's range of motion closest to the center
of the earth. In another embodiment, haptic feedback is utilized to
provide feedback to the operator that he has reached the limits of
the pertinent instrument workspace. In another embodiment, haptic
feedback is utilized to provide feedback to the operator that he
has reached the limits of the subject tissue workspace when such
workspace has been registered to the workspace of the instrument
(i.e., should the operator be navigating a tool such as an ablation
tip with a guide instrument through a 3-D model of a heart
imported, for example, from CT data of an actual heart, the master
input device is configured to provide haptic feedback to the
operator that he has reached a wall or other structure of the heart
as per the data of the 3-D model, and therefore help prevent the
operator from driving the tool through such wall or structure
without at least feeling the wall or structure through the master
input device). In another embodiment, contact sensing technologies
configured to detect contact between an instrument and tissue may
be utilized in conjunction with the haptic capability of the master
input device to signal the operator that the instrument is indeed
in contact with tissue.
[0227] FIG. 124 illustrates one embodiment of the data glove
(12402). In this implementation, one sensor (12404) is located on
each finger. In an alternative embodiment, two sensors are located
on each finger, in addition to a sensor at the abduction between
each finger. FIG. 125 illustrates one embodiment of a wired data
glove (12502). In this example, the data glove (12502) is
physically connected to the system (100) and communicates via the
cable (12504). FIG. 126 illustrates one embodiment of a wireless
data glove arrangement. In this embodiment, the data gloves (12602)
are coupled to a wireless transmitting unit (12604). Wireless
transmitting unit (12604) transmits data wirelessly from the gloves
(12602) via radio or infrared transmissions or other suitable form
of wireless transmission to the system (100). FIG. 127 illustrates
a display screen showing the sensor data signals received by the
system (100) from the data gloves in accordance to one
embodiment.
[0228] Referring to FIG. 128, an overview of an embodiment of a
controls system flow diagram is depicted. As illustrated, a master
computer (12800) runs master input device software (12804), data
glove software (12802), visualization software, instrument
localization software, and software to interface with operator
control station buttons and/or switches. In this embodiment, a data
glove input device (11602) and a master input device (118) are
coupled to the master computer (12800). The master computer (12800)
processes the commands and forwards instructions to the control and
instrument driver computer, which maneuvers the instrument driver
and mounted instruments in response.
[0229] In one embodiment, the master input device software is a
proprietary module packaged with an off-the-shelf master input
device system, such as the Phantom.RTM. from SensAble Technologies,
Inc., which is configured to communicate with the Phantom.RTM.
Haptic Device hardware at a relatively high frequency as prescribed
by the manufacturer. Other suitable master input devices are
available from suppliers such as Force Dimension of Lausanne,
Switzerland. The master input device (118) may also have haptics
capability to facilitate feedback to the operator, and the software
modules pertinent to such functionality may also be operated on the
master computer (12800). In one embodiment, the data glove software
is a device driver or software model, such as a driver for the 5DT
Data Glove. In other embodiments, software support for the data
glove master input device is provided through application drivers
such as Kaydara MOCAP, Discreet 3D Studio Max, Alias Maya, and
SoftImage|XSI.
[0230] While multiple embodiments and variations of the many
aspects of the invention have been disclosed and described herein,
such disclosure is provided for purposes of illustration only. Many
combinations and permutations of the disclosed system, apparatus,
and methods are useful in minimally invasive medical diagnosis and
intervention, and the invention is configured to be flexible and
adaptable. The foregoing illustrated and described embodiments of
the invention are suitable for various modifications and
alternative forms, and it should be understood that the invention
generally, as well as the specific embodiments described herein,
are not limited to the particular forms or methods disclosed, but
also cover all modifications, alternatives, and equivalents as
defined by the scope of the appended claims. Further, the various
features and aspects of the illustrated embodiments may be
incorporated into other embodiments, even if not so described
herein, as will be apparent to those skilled in the art. In
addition, although the description describes data being mapped to a
three dimensional model, data may be mapped to any mapping or
coordinate system, including two dimensional, static or dynamic
time-varying map, coordinate system, model, image, etc. All
directional references (e.g., upper, lower, upward, downward, left,
right, leftward, rightward, top, bottom, above, below, vertical,
horizontal, clockwise, counterclockwise, etc.) are only used for
identification purposes to aid the reader's understanding of the
invention without introducing limitations as to the position,
orientation, or applications of the invention. Joining references
(e.g., attached, coupled, connected, and the like) are to be
construed broadly and may include intermediate members between a
connection of elements (e.g., physically, electrically, optically
as by an optically fiber, and/or wirelessly connected) and relative
physical movements, electrical signals, optical signals, and/or
wireless signals transmitted between elements. Accordingly, joining
references do not necessarily infer that two elements are directly
connected in fixed relation to each other. It is intended that all
matters contained in the description or shown in the accompanying
drawings shall be interpreted as illustrative only and not
limiting. Modifications, alternatives, and equivalents in the
details, structures, or methodologies may be made without departing
from the spirit and scope of the invention as defined by the
appended claims.
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