U.S. patent application number 13/481536 was filed with the patent office on 2013-11-28 for low friction instrument driver interface for robotic systems.
This patent application is currently assigned to HANSEN MEDICAL, INC.. The applicant listed for this patent is Travis Covington, J. Scot Hart, JR., Enrique Romo. Invention is credited to Travis Covington, J. Scot Hart, JR., Enrique Romo.
Application Number | 20130317519 13/481536 |
Document ID | / |
Family ID | 49622177 |
Filed Date | 2013-11-28 |
United States Patent
Application |
20130317519 |
Kind Code |
A1 |
Romo; Enrique ; et
al. |
November 28, 2013 |
LOW FRICTION INSTRUMENT DRIVER INTERFACE FOR ROBOTIC SYSTEMS
Abstract
A medical robotic system includes a base having a first opening,
and a first protrusion next to the first opening, a first rotary
member configured for detachably coupling to a component of the
medical robotic system in a manner such that the first rotary
member is rotatable relative to the base and at least a part of the
first rotary member is located in the first opening of the base
when the first rotary member is coupled to the system component,
and a cover coupled to the base, wherein the first rotary member
comprises a first end, a second end, a body extending between the
first and second ends, and a flange disposed circumferentially
around a part of the body, the flange having a first
circumferential slot for receiving the first protrusion.
Inventors: |
Romo; Enrique; (Dublin,
CA) ; Hart, JR.; J. Scot; (Menlo Park, CA) ;
Covington; Travis; (Sunnyvale, CA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Romo; Enrique
Hart, JR.; J. Scot
Covington; Travis |
Dublin
Menlo Park
Sunnyvale |
CA
CA
CA |
US
US
US |
|
|
Assignee: |
HANSEN MEDICAL, INC.
Mountain View
CA
|
Family ID: |
49622177 |
Appl. No.: |
13/481536 |
Filed: |
May 25, 2012 |
Current U.S.
Class: |
606/130 |
Current CPC
Class: |
A61B 90/06 20160201;
A61B 17/00 20130101; A61B 2034/301 20160201; A61B 2090/064
20160201; A61B 34/30 20160201; A61B 2090/066 20160201; A61B
2018/00029 20130101; A61B 2017/00477 20130101; A61B 18/1492
20130101 |
Class at
Publication: |
606/130 |
International
Class: |
A61B 19/00 20060101
A61B019/00 |
Claims
1. A medical robotic system, comprising: a base having a first
opening, and a first protrusion next to the first opening; a first
rotary member configured for detachably coupling to a component of
the medical robotic system, the first rotary member rotatable
relative to the base and at least a part of the first rotary member
is located in the first opening of the base; and a cover coupled to
the base; wherein the first rotary member comprises a first end, a
second end, a body extending between the first and second ends, and
a flange disposed circumferentially around a part of the body, the
flange having a first circumferential slot for receiving the first
protrusion.
2. The medical robotic system of claim 1, wherein the base has a
second opening, and the system further comprises a second rotary
member that is at least partially located in the opening.
3. The medical robotic system of claim 1, further comprising the
component, wherein the component comprises an instrument driver
configured for actuating the first rotary member when the first end
of the first rotary member is coupled to the instrument driver.
4. The medical robotic system of claim 3, wherein the instrument
driver is configured to actuate the first rotary member in response
to a command signal received from a user interface.
5. The medical robotic system of claim 3, wherein the instrument
driver comprises an actuatable member for actuating the first
rotary member, and a sensor for sensing a characteristic that
corresponds with an amount of force or torque being applied to the
actuatable member.
6. The medical robotic system of claim 5, wherein the sensor
comprises a force sensor.
7. The medical robotic system of claim 1, wherein the first end of
the first rotary member comprises a slot for mating with an
actuatable member of the component.
8. The medical robotic system of claim 1, wherein the first end of
the first rotary member comprises a protrusion for mating with an
actuatable member of the component.
9. The medical robotic system of claim 1, wherein the base, the
first rotary member, and the cover are respective parts of a
sterile adaptor, the sterile adaptor further comprising a flexible
sheet coupled to the base.
10. The medical robotic system of claim 9, wherein the cover has a
first opening sized and configured for allowing the second end of
the first rotary member to extend therethrough when the first
rotary member is coupled to the component.
11. The medical robotic system of claim 9, further comprising: a
splayer assembly having a first splayer rotary member; and an
instrument driver, wherein the second end of the first rotary
member is configured to detachably couple to the first splayer
rotary member, and the first end of the first rotary member is
configured to detachably couple to the instrument driver.
12. The medical robotic system of claim 11, wherein the second end
of the first rotary member extends through an opening at the cover,
and comprises a plurality of keys configured for mating with
corresponding slots in the first splayer rotary member.
13. The medical robotic system of claim 11, wherein when the first
rotary member of the sterile adaptor is coupled to the first slayer
rotary member, the instrument driver is configured to actuate the
first rotary member in response to a command signal received from a
user interface to thereby rotate the first splayer rotary
member.
14. The medical robotic system of claim 1, wherein the base has a
second protrusion, and the flange has a second circumferential slot
for receiving the second protrusion.
15. A medical robotic system, comprising: an instrument driver
having an actuatable element; a sensor coupled to the instrument
driver; and a device configured for detachably coupling to the
instrument driver, the device comprising: a base having a first
opening, and a rotary member configured for detachably coupling to
the actuatable element of the instrument driver, wherein the rotary
member is rotatable relative to the base, and at least a portion of
the rotary member is located within the first opening of the base;
wherein when the device is coupled to the instrument driver, the
actuatable element is configured to rotate the rotary member in
response to a command signal received from a user interface; and
wherein the sensor is configured to sense a characteristic that
corresponds with an amount of force or torque being applied to the
actuatable element in order to rotate the rotary member.
16. The medical robotic system of claim 15, wherein the base
comprises a protrusion next to the first opening; and the rotary
member comprises a first end, a second end, a body extending
between the first and second ends, and a flange disposed
circumferentially around at least a portion of the body, the flange
having a first circumferential slot for receiving the
protrusion.
17. The medical robotic system of claim 16, wherein the base has a
second protrusion, and the flange has a second circumferential slot
for receiving the second protrusion.
18. The medical robotic system of claim 15, wherein the sensor
comprises a force sensor.
19. The medical robotic system of claim 15, wherein the rotary
member has a slotted end configured for mating with the actuatable
member of the instrument driver.
20. The medical robotic system of claim 15, wherein the rotary
member comprises a protrusion configured for mating with the
actuatable member of the instrument driver.
21. The medical robotic system of claim 15, wherein the base and
the rotary member are respective parts of a sterile adaptor, the
sterile adaptor further comprising a flexible sheet coupled to the
base.
22. The medical robotic system of claim 21, further comprising a
splayer assembly having a splayer rotary member, wherein the rotary
member has a first end configured for detachably coupling to the
actuatable element of the instrument driver, and a second end
configured for detachably coupling to the splayer rotary
member.
23. The medical robotic system of claim 22, wherein the second end
of the rotary member comprises a plurality of keys configured for
mating with corresponding slots in the splayer rotary member.
24. The medical robotic system of claim 22, wherein when the
sterile adaptor rotary member is coupled to the splayer rotary
member and to the actuatable element, the instrument driver is
configured to actuate the actuatable element to thereby indirectly
rotate the splayer rotary member through the sterile adaptor rotary
member.
25. The medical robotic system of claim 22, wherein the splayer
assembly further comprises: an elongate member having a distal end,
a proximal end, and a lumen extending between the distal and
proximal ends of the elongate member; and a first control wire
having a distal end coupled to the distal end of the elongate
member, and a proximal end coupled to the splayer rotary
member.
26. A method of steering a distal end of an elongate member,
comprising: determining a desired bending to be achieved by the
distal end of the elongate member; determining an amount of tension
to be applied to a steering wire located within the elongate member
based on the desired bending to be achieved; using an actuatable
element to apply a torque to turn a rotary member that is
detachably coupled to the actuatable element, the steering wire
having one end is secured to the rotary member and another end
secured to the elongate member, wherein the application of the
torque by the actuatable element causes tension to be applied to
the steering wire; and using a sensor coupled to the actuatable
element to sense a characteristic that corresponds with an amount
of force or torque being applied by the actuatable element to turn
the rotary member.
27. The method of claim 26, wherein the act of using the actuatable
element to apply the torque comprises increasing the amount of
force or torque being applied by the actuatable element until the
sensed characteristic indicates that the amount of tension at the
steering wire has been achieved.
28. The method of claim 26, wherein the sensor is coupled
indirectly to the actuatable element through a mechanical
component.
Description
INCORPORATION BY REFERENCE
[0001] All of the following U.S. Patent Applications are expressly
incorporated by reference herein for all purposes: [0002] U.S.
patent application Ser. No. 13/173,994, filed on Jun. 30, 2011,
[0003] U.S. patent application Ser. No. 11/179,007, filed on Jul.
6, 2005, [0004] U.S. patent application Ser. No. 12/079,500, filed
on Mar. 26, 2008, [0005] U.S. patent application Ser. No.
11/678,001, filed on Feb. 22, 2007, [0006] U.S. Patent Application
No. 60/801,355, filed on May 17, 2006, [0007] U.S. patent
application Ser. No. 11/804,585, filed on May 17, 2007, [0008] U.S.
patent application Ser. No. 11/640,099, filed on Dec. 14, 2006,
[0009] U.S. patent application Ser. No. 12/507,727, filed on Jul.
22, 2009, [0010] U.S. patent application Ser. No. 12/106,254, filed
on Apr. 18, 2008, [0011] U.S. patent application Ser. No.
12/192,033, filed on Aug. 14, 2008, [0012] U.S. patent application
Ser. No. 12/236,478, filed on Sep. 23, 2008, [0013] U.S. patent
application Ser. No. 12/833,935, filed on Jul. 9, 2010, [0014] U.S.
patent application Ser. No. 12/822,876, filed on Jun. 24, 2010,
[0015] U.S. patent application Ser. No. 12/614,349, filed on Nov.
6, 2009, [0016] U.S. patent application Ser. No. 11/690,116, filed
Mar. 22, 2007, [0017] U.S. patent application Ser. No. 11/176,598,
filed Jul. 6, 2005, [0018] U.S. patent application Ser. No.
12/012,795, filed Feb. 1, 2008, [0019] U.S. patent application Ser.
No. 12/837,440, Jul. 15, 2010, [0020] U.S. Patent Application No.
61/513,488, filed Jul. 8, 2011, and [0021] U.S. patent application
Ser. No. 13/174,605, filed Jun. 30, 2011.
FIELD
[0022] The application relates generally to robotically controlled
surgical systems, and more particularly to flexible instruments and
instrument drivers that are responsive to a master controller for
performing surgical procedures to treat tissue, such as tissue in
the livers.
BACKGROUND
[0023] Robotic surgical systems and devices are well suited for use
in performing minimally invasive medical procedures, as opposed to
conventional techniques wherein the patient's body cavity is open
to permit the surgeon's hands access to internal organs. For
example, there is a need for a highly controllable yet minimally
sized system to facilitate imaging, diagnosis, and treatment of
tissues which may lie deep within a patient, and which may be
preferably accessed only via naturally-occurring pathways such as
blood vessels or the gastrointestinal tract.
[0024] In some cases, a robotic surgical system may include a
steerable catheter with a steering wire, and an instrument driver
for applying tension to the steering wire to steer the catheter.
Applicant of the subject application determines that it would be
desirable to sense a characteristic that corresponds with an amount
of force or torque being applied to pull a steering wire of a
robotic surgical system.
SUMMARY
[0025] In accordance with some embodiments, a medical robotic
system includes a base having a first opening, and a first
protrusion next to the first opening, a first rotary member
configured for detachably coupling to a component of the medical
robotic system in a manner such that the first rotary member is
rotatable relative to the base and at least a part of the first
rotary member is located in the first opening of the base when the
first rotary member is coupled to the system component, and a cover
coupled to the base, wherein the first rotary member comprises a
first end, a second end, a body extending between the first and
second ends, and a flange disposed circumferentially around a part
of the body, the flange having a first circumferential slot for
receiving the first protrusion.
[0026] In accordance with other embodiments, a medical robotic
system includes an instrument driver having an actuatable element,
a sensor coupled to the instrument driver, and a device configured
for detachably coupling to the instrument driver, the device
comprising a base having a first opening, and a rotary member
configured for detachably coupling to the actuatable element of the
instrument driver, wherein the rotary member is rotatable relative
to the base, and at least a portion of the rotary member is located
within the first opening of the base, wherein when the device is
coupled to the instrument driver, the actuatable element is
configured to rotate the rotary member in response to a command
signal received from a user interface, and wherein the sensor is
configured to sense a characteristic that corresponds with an
amount of force or torque being applied to the actuatable element
in order to rotate the rotary member.
[0027] In accordance with other embodiments, a method of steering a
distal end of an elongate member includes determining a desired
bending to be achieved by the distal end of the elongate member,
determining an amount of tension to be applied to a steering wire
located within the elongate member based on the desired bending to
be achieved, using an actuatable element to apply a torque to turn
a rotary member that is detachably coupled to the actuatable
element, the steering wire having one end is secured to the rotary
member and another end secured to the elongate member, wherein the
application of the torque by the actuatable element causes tension
to be applied to the steering wire, and using a sensor coupled to
the actuatable element to sense a characteristic that corresponds
with an amount of force or torque being applied by the actuatable
element to turn the rotary member.
[0028] Other and further aspects and features will be evident from
reading the following detailed description of the embodiments.
BRIEF DESCRIPTION OF THE DRAWINGS
[0029] The drawings illustrate the design and utility of
embodiments, in which similar elements are referred to by common
reference numerals. These drawings are not necessarily drawn to
scale. In order to better appreciate how the above-recited and
other advantages and objects are obtained, a more particular
description of the embodiments will be rendered, which are
illustrated in the accompanying drawings. These drawings depict
only typical embodiments and are not therefore to be considered
limiting of its scope.
[0030] FIG. 1 illustrates a robotic surgical system in which
apparatus, system and method embodiments may be implemented.
[0031] FIG. 2 illustrates how the adapter base plate assembly is
utilized to attach a support assembly and instrument driver to an
operating table or surgical bed.
[0032] FIG. 3 a sheath and guide catheter assembly, and an elongate
member manipulator mounted on an instrument driver
[0033] FIG. 4 illustrates an example of an operator workstation of
the robotic surgical system shown in FIG. 1 with which a catheter
instrument can be manipulated using different user interfaces and
controls.
[0034] FIG. 5A further illustrates the instrument driver shown in
FIG. 3 without the elongate member manipulator mounted on an
instrument driver.
[0035] FIG. 5B further illustrates the instrument driver shown in
FIG. 5A without the sheath and guide catheter assembly.
[0036] FIG. 5C further illustrates the instrument driver shown in
FIG. 5B with skins removed.
[0037] FIGS. 6A and 6B illustrate a sheath and guide catheter
assembly positioned over respective sterile adaptors and mounting
plates from top and bottom perspectives respectively
[0038] FIGS. 7A and 7B illustrate top and bottom perspectives
respectively of a portion of an instrument driver with a sheath
splayer positioned over a sterile adaptor.
[0039] FIG. 7C illustrates an exploded view of the sheath splayer
shown in FIG. 7A without a purge tube.
[0040] FIG. 7D illustrates top and bottom views of a pulley
assembly positioned over a floating shaft.
[0041] FIG. 7E illustrates the floating shaft of FIG. 7D installed
and un-installed onto a sleeve receptacle.
[0042] FIG. 8 illustrates a guide carriage of the instrument driver
shown in FIG. 5C with pulleys and guide articulation motors.
[0043] FIG. 9 is a perspective view of a slidable carriage or
funicular assembly of an instrument driver and sleeve receptacles
configured to receive and engage with floating shafts.
[0044] FIG. 10 illustrates a sheath block, sheath insert motor,
guide insert motor and leadscrews removed from the instrument
driver shown in FIG. 5C.
[0045] FIGS. 10A and 10B illustrate different perspective views of
the sheath block with sheath output plate positioned over
receptacle sleeves.
[0046] FIG. 10C illustrates sheath articulation motors coupled to
motor driven interfaces and receptacle sleeves.
[0047] FIGS. 11A-11H illustrate side and cross-sectional views of a
catheter bent in various configurations with pull wire
manipulation.
[0048] FIG. 12 illustrates an open loop control model.
[0049] FIG. 13 illustrates a control system in accordance with some
embodiments.
[0050] FIG. 14 illustrates a user interface for a master input
device.
[0051] FIG. 15 illustrates some components of a robotic system that
includes tension sensing capability in accordance with some
embodiments;
[0052] FIG. 16 illustrates some components of a robotic system that
includes tension sensing capability in accordance with other
embodiments;
[0053] FIG. 17 illustrates some components of a robotic system that
includes tension sensing capability in accordance with other
embodiments;
[0054] FIG. 18 illustrates a frictionless interface at a sterile
adaptor in accordance with some embodiments;
[0055] FIG. 19 illustrates some components of a robotic system that
includes tension sensing capability in accordance with other
embodiments;
[0056] FIG. 20 illustrates some components of a robotic system that
includes tension sensing capability in accordance with other
embodiments;
[0057] FIG. 21 illustrates some components of a robotic system that
includes tension sensing capability in accordance with other
embodiments;
[0058] FIG. 22A illustrates driving mode(s) in accordance with some
embodiments.
[0059] FIG. 22B illustrates driving mode(s) in accordance with
other embodiments.
[0060] FIG. 22C illustrates driving mode(s) in accordance with
other embodiments.
[0061] FIG. 22D illustrates driving mode(s) in accordance with
other embodiments.
[0062] FIG. 23A-23F illustrates a method of using a robotic system
to treat tissue in accordance with some embodiments.
DESCRIPTION OF THE EMBODIMENTS
[0063] Various embodiments are described hereinafter with reference
to the figures. It should be noted that the figures are not drawn
to scale and that elements of similar structures or functions are
represented by like reference numerals throughout the figures. It
should also be noted that the figures are only intended to
facilitate the description of the embodiments. They are not
intended as an exhaustive description of the invention or as a
limitation on the scope of the invention. In addition, an
illustrated embodiment needs not have all the aspects or advantages
shown. An aspect or an advantage described in conjunction with a
particular embodiment is not necessarily limited to that embodiment
and can be practiced in any other embodiments even if not so
illustrated.
[0064] I. Robotic system
[0065] Embodiments described herein generally relate to apparatus,
systems and methods for robotic surgical systems. A robotic
surgical system in which embodiments described herein may be
implemented is described with reference to FIGS. 1-10C.
[0066] Referring to FIG. 1, a robotically controlled surgical
system 10 in which embodiments of apparatus, system and method may
be implemented includes an operator workstation 2, an electronics
rack 6 and associated bedside electronics box 9, a setup joint or
support assembly 20 (generally referred to as "support assembly"),
and a robotic instrument driver 16 (generally referred to as
"instrument driver"). A surgeon is seated at the operator
workstation 2 and can monitor the surgical procedure, patient
vitals, and control one or more robotic surgical devices.
[0067] Referring to FIG. 2, the instrument driver 16, setup joint
mounting brace 20, and bedside electronics box are shown in greater
detail. Referring to FIG. 3, the instrument driver 16 is
illustrated including an elongate member manipulator 24 and a
robotic catheter assembly 11 installed. The robotic catheter
assembly 11 includes a first or outer robotic steerable complement,
otherwise referred to as a sheath instrument 30 (generally referred
to as "sheath" or "sheath instrument") and/or a second or inner
steerable component, otherwise referred to as a robotic catheter or
guide or catheter instrument 18 (generally referred to as
"catheter" or "catheter instrument"). The sheath instrument 30 and
catheter instrument 18 are controllable using the instrument driver
16. During use, a patient is positioned on an operating table or
surgical bed 22 (generally referred to as "operating table") to
which the support assembly 20, instrument driver 16, and robotic
catheter assembly 11 are coupled or mounted.
[0068] In the illustrated embodiments, the elongate member
manipulator 24 (generally referred to as "manipulator") is
configured for manipulating an elongate member 26. In some
embodiments, the elongate member 26 may be a guidewire. In other
embodiments, the elongate member 26 may be a treatment device
(e.g., an ablation catheter) that is configured to deliver energy
to treat tissue, such as tissue at a liver. In further embodiments,
the elongate member 26 may be any of other instruments for medical
use. During use, at least a part of the elongate member 26 is
disposed within a lumen of the catheter instrument 18, and the
proximal end of the elongate member 26 is removably coupled to the
manipulator 24. In some embodiments, the manipulator 24 is
configured to advance and retract the elongate member 26 relative
to the catheter instrument 18. In other embodiments, the
manipulator 24 may also be configured to roll the elongate member
26 so that it rotates about its longitudinal axis.
[0069] Various system components in which embodiments described
herein may be implemented are illustrated in close proximity to
each other in FIG. 1, but embodiments may also be implemented in
systems 10 in which components are separated from each other, e.g.,
located in separate rooms. For example, the instrument driver 16,
operating table 22, and bedside electronics box 9 may be located in
the surgical area with the patient, and the operator workstation 2
and the electronics rack 6 may be located outside of the surgical
area and behind a shielded partition. System 10 components may also
communicate with other system 10 components via a network to allow
for remote surgical procedures during which the surgeon may be
located at a different location, e.g., in a different building or
at a different hospital utilizing a communication link transfers
signals between the operator control station 2 and the instrument
driver 16. System 10 components may also be coupled together via a
plurality of cables or other suitable connectors 14 to provide for
data communication, or one or more components may be equipped with
wireless communication components to reduce or eliminate cables 14.
In this manner, a surgeon or other operator may control a surgical
instrument while being located away from or remotely from radiation
sources, thereby decreasing the operator's exposure to
radiation.
[0070] Referring to FIG. 4, one example of an operator workstation
2 that may be used with the system 10 shown in FIG. 1 includes
three display screens 4, a touch screen user interface 5, a control
button console or pendant 8, and a master input device (MID) 12.
The MID 12 and pendant 8 serve as user interfaces through which the
surgeon can control operation of the instrument driver 16 and
attached instruments. By manipulating the pendant 8 and the MID 12,
a surgeon or other operator can cause the instrument driver 16 to
remotely control the catheter instrument 18 and/or the sheath
instrument 30 mounted thereon. Also, in some embodiments, by
manipulating one or more controls at the station 2, the surgeon or
operator may cause the manipulator 24 to remotely move the elongate
member 26. A switch 7 may be provided to disable activity of an
instrument temporarily. The console 2 in the illustrated system 10
may also be configurable to meet individual user preferences. For
example, in the illustrated example, the pendant 8 and the touch
screen 5 are shown on the left side of the console 2, but they may
also be relocated to the right side of the console 2. Various
numbers of display screens may be provided. Additionally or
alternatively, a bedside console 3 may be provided for bedside
control of the of the instrument driver 16 if desired. Further,
optional keyboard may be connected to the console 2 for inputting
user data. The workstation 2 may also be mounted on a set of
casters or wheels to allow easy movement of the workstation 2 from
one location to another, e.g., within the operating room or
catheter laboratory. Further aspects of examples of suitable MID
12, and workstation 2 arrangements are described in further detail
in U.S. patent application Ser. No. 11/481,433 and U.S. Provisional
Patent Application No. 60/840,331, the contents of which were
previously incorporated herein by reference.
[0071] As shown in FIG. 1, the support assembly 20 is configured
for supporting or carrying the instrument driver 16 over the
operating table 22. One suitable support assembly 20 has an arcuate
shape and is configured to position the instrument driver 16 above
a patient lying on the table 22. The support assembly 20 may be
configured to movably support the instrument driver 16 and to allow
convenient access to a desired location relative to the patient.
The support assembly 20 may also be configured to lock the
instrument driver 16 into a certain position.
[0072] In the illustrated example, the support assembly 20 is
mounted to an edge of the operating table 22 such that a catheter
and sheath instruments 18, 30 mounted on the instrument driver 16
can be positioned for insertion into a patient. The instrument
driver 16 is controllable to maneuver the catheter and/or sheath
instruments 18, 30 within the patient during a surgical procedure.
The distal portion of the setup joint 20 also includes a control
lever 33 for maneuvering the setup joint 20. Although the figures
illustrate a single guide catheter 18 and sheath assembly 30
mounted on a single instrument driver 16, embodiments may be
implemented in systems 10 having other configurations. For example,
embodiments may be implemented in systems 10 that include a
plurality of instrument drivers 16 on which a plurality of
catheter/sheath instruments 18, 30 can be controlled. Further
aspects of a suitable support assembly 20 are described in U.S.
patent application Ser. No. 11/481,433 and U.S. Provisional Patent
Application No. 60/879,911, the contents of which are expressly
incorporated herein by reference. Referring to FIG. 2, the support
assembly 20 may be mounted to an operating table 22 using a
universal adapter base plate assembly 39, similar to those
described in detail in U.S. Provisional Patent Application No.
60/899,048, incorporated by reference herein in its entirety. The
adapter plate assembly 39 mounts directly to the operating table 22
using clamp assemblies, and the support assembly 20 may be mounted
to the adapter plate assembly 39. One suitable adapter plate
assembly 39 includes two large, flat main plates which are
positioned on top of the operating table 22. The assembly 39
provides for various adjustments to allow it to be mounted to
different types of operating tables 22. An edge of the adapter
plate assembly 39 may include a rail that mimics the construction
of a traditional surgical bedrail. By placing this rail on the
adapter plate itself, a user may be assured that the component
dimensions provide for proper mounting of the support assembly 20.
Furthermore, the large, flat surface of the main plate provides
stability by distributing the weight of the support assembly 20 and
instrument driver 16 over an area of the table 22, whereas a
support assembly 20 mounted directly to the operating table 22 rail
may cause its entire load to be placed on a limited and less
supportive section of the table 22. Additionally or alternatively,
a bedside rail 13 may be provided which may couple the support
assembly 20 to the operating table 22. The bedside rail may include
a leadscrew mechanism which will enable the support assembly to
translate linearly along the edge of the bed, resulting in a
translation of the instrument driver 16 and ultimately a
translation in the insert direction of the catheter and sheath
instruments 18/30.
[0073] FIGS. 5A-C illustrate the instrument drive 16 with various
components installed. FIG. 5A illustrates the instrument driver 16
with the instrument assembly 11 installed including the sheath
instrument 30 and the associated guide or catheter instrument 18
while FIG. 5B illustrates the instrument driver 16 without an
attached instrument assembly 11. The sheath instrument 30 and the
associated guide instrument 18 are mounted to associated mounting
plates 37, 38 on a top portion of the instrument driver 16. FIG. 5C
illustrates the instrument driver 16 with skins removed to
illustrate internal components. Embodiments described are similar
to those described in detail in U.S. patent application Ser. Nos.
11/678,001, 11/678,016, and 11/804,585, each incorporated by
reference herein in its entirety.
[0074] Referring to FIGS. 6A-B, the assembly 11 that includes the
sheath instrument 30 and the guide or catheter instrument 18
positioned over their respective mounting plates 38, 37 is
illustrated removed from the instrument driver 16. Additionally a
sterile adaptor 41 can be used to couple each of the sheath and
guide instruments to their respective mounting plates. The catheter
instrument 18 includes a guide catheter instrument member 61a, and
the sheath instrument 30 includes a sheath instrument member 62a.
The guide catheter instrument member 61a is coaxially interfaced
with the sheath instrument member 62a by inserting the guide
catheter instrument member 61a into a working lumen of the sheath
catheter member 62a. As shown in FIG. 6A, the sheath instrument 30
and the guide or catheter instrument 18 are coaxially disposed for
mounting onto the instrument driver 16. However, it should be
understood that the sheath instrument 16 may be used without a
guide or catheter instrument 18, or the guide or catheter
instrument 18 may be used without a sheath instrument 30. In such
cases, the sheath instrument 16 or the catheter instrument 18 may
be mounted onto the instrument driver 16 individually. With the
coaxial arrangement as shown in FIG. 6A, a guide catheter splayer
61 is located proximally relative to, or behind, a sheath splayer
62 such that the guide catheter member 61a can be inserted into and
removed from the sheath catheter member 61b.
[0075] The splayers 61, 62 are configured to steer the members 61a,
61b, respectively. In the illustrated embodiments, each of the
splayers 61, 62 includes drivable elements therein configured to
apply tension to different respective wires inside the member
61a/61b to thereby steer the distal end of the member 61a/61b. In
some embodiments, the drivable elements may be actuated in response
to a control signal from a controller, which receives an input
signal from the work station 2, and generates the control signal in
response to the input signal. Also, in the illustrated embodiments,
the splayers 61, 62 may be translated relative to the instrument
driver 16. In some embodiments, the instrument driver 16 may be
configured to advance and retract each of the splayers 61, 62, so
that the catheter instrument 18 and the sheath instrument 30 may be
advanced distally and retracted proximally.
[0076] FIGS. 7A and 7B illustrate the sheath splayer 62 of one
embodiment illustrated with the sterile adaptor 41 and mounting
plate 38 coupled to a portion of the instrument driver shown with
only a set of actuation mechanisms that will be described later in
detail. As shown in FIG. 6A, the sheath and guide splayers 62, 61,
appear similar physically in construction with the exception of
differences in a valve purge tube 32. It should be noted that the
purge tube 32 may or may not be included for either the guide or
sheath splayer. The sheath splayer 62 will be described herein.
However it should be understood that the guide splayer 61 is of
similar construction, and components of the sheath splayer 62 can
be repeated for the guide splayer 61.
[0077] As illustrated in FIG. 7C, the splayer 62 includes a splayer
cover 72 fixably coupled to a splayer base assembly 78 using four
screws 79. The splayer base 78 having four cavities to receive and
house pulley assemblies 80 is used for both the guide splayer 61
and sheath splayer 62. For this embodiment of a sheath splayer 62,
four cavities of the splayer base 78 are populated with pulley
assemblies 80 but it should be understood that varying numbers of
cavities may be populated leaving remaining cavities open. The
guide splayer 61 may have all its cavities populated with four
pulley assemblies 80 for pulling four respective wires, as can be
seen in FIG. 6B. The splayer base 78 of this implementation can be
constructed from injection molded polycarbonate.
[0078] During splayer 62 assembly, the pulley assembly 80 is put
together and mated with a catheter pull wire or control element
(not shown). The pull wire (not shown) runs down the length of a
catheter from distal to proximal end then is wound about the
pulley. By rotating the pulley, the pull wire bends the distal tip
of the catheter controlling its bend.
[0079] Referring back to FIGS. 6A-6B, when a catheter is prepared
for use with an instrument, its splayer is mounted onto its
appropriate mounting plate via a sterile adaptor. In this case, the
sheath splayer 62 is placed onto the sheath mounting plate 38 and
the guide splayer 61 is place onto the guide mounting plate 37 via
sterile adaptors 41. Referring to FIG. 7A-B, the pulley assemblies
80 are configured to couple to floating shafts 82 on the splayer
adaptor 41 which in turn are configured to couple to sleeve
receptacles 90. In the illustrated example, each mounting plates
37, 38 has four openings 37a, 38a that are designed to receive the
corresponding floating shafts 84 attached to and extending from the
sterile adaptors 41 coupled to the splayers 61, 62. In the example
illustrated in FIG. 6B, four floating shafts 82 of the sterile
adaptor 41 are insertable within the openings 38a of the sheath
mounting plate 38 as the splayer 62 is mounted onto the RCM.
Similarly, four floating shafts 82 of the sterile adaptor 41 are
insertable within the four apertures or openings 37a of the guide
interface plate 37. Referring to FIGS. 7D-E, the coupling of the
pulley assemblies 80 to floating shafts 82 and floating shafts 82
to sleeve receptacles 90 is illustrated. FIG. 7D illustrates top
and bottom perspective views of the pulley assembly 80 positioned
above the floating shaft 82 where the bottom of the pulley assembly
80 is configured to mate with splines on the top of the floating
shaft 82. FIG. 7E illustrates the floating shaft 82 installed and
un-installed onto the sleeve receptacle 90. The sleeve receptacles
can include a notch 90a shaped to accept a pin 84 on the floating
shaft 82.
[0080] Referring back to FIGS. 7A-B, the sheath splayer 62 is shown
having latches 73 which may couple to hooks 86. By depressing the
latches 73, the splayer 62 may be locked and unlocked to the
sterile adaptor 41. The sterile adaptor in turn is configured
having mounting hooks 88 which couple to sliding latches 77 on the
mounting plate 83. The sliding latches 77 can be spring loaded to
allow the adaptor plate 41 to be locked to the mounting plate 38 by
applying downward force on the adaptor plate 41. The sliding
latches can be depressed to release the adaptor plate 41 when
desired.
[0081] The sheath interface mounting plate 38 as illustrated in
FIGS. 6A and 6B is similar to the guide interface mounting plate
37, and thus, similar details are not repeated. One difference
between the plates 37, 38 may be the shape of the plates. For
example, the guide interface plate 37 includes a narrow, elongated
segment, which may be used with, for example, a dither mechanism or
the elongate member manipulator 24. Both plates 37, 38 include a
plurality of openings 37a, 38a to receive floating shafts 82 and
latches 73 from sterile adaptors 41. The splayers 61/62, sterile
adaptors 41, and mounting plates 37/38 are all described in greater
detail in U.S. patent application Ser. No. 13/173,994, filed on
Jun. 30, 2011, the entire disclosure of which is expressly
incorporated by reference herein.
[0082] Referring back to FIG. 5C the instrument driver 16 is
illustrated with mounting plates 37,38 fixably coupled to a guide
carriage 50, and a sheath drive block 40, respectively. FIG. 8
illustrates the guide carriage 50 removed from the instrument
driver 16 coupled to cabling (not shown) and associated guide
motors 53. The guide carriage 50 includes a funicular assembly 56
which is illustrated in FIG. 9. The funicular assembly 56 includes
the four sleeve receptacles 90. As previously described, the
floating shafts 82 of the sterile adaptor 41 first insert through
the openings 37a in the mounting plate 37. They then engage with
the sleeve receptacles 90
[0083] Referring back to FIG. 8, a set of cables (not shown) wound
around a set of pulleys 52, are coupled on one end to a set of
guide motors 53 and the other end to the sleeve receptacles 90.
Note that only two of four motors can be seen in FIG. 8. The drive
motors 53 are actuated to rotationally drive the sleeves 90. The
catheter assembly 18 with its splayer 61 mounted onto the
instrument drive 16 would have its pulley assemblies 80 coupled to
corresponding sleeves 90 via floating shafts 82. As the sleeves 90
are rotated, the pins 84 of the floating shafts 82 are seated in
the V-shaped notches and are engaged by the rotating sleeves 90,
thus causing the floating shafts 82 and associated pulley
assemblies 80 to also rotate. The pulley assemblies 80 in turn
cause the control elements (e.g., wires) coupled thereto to
manipulate the distal tip of the catheter instrument 30 member in
response thereto. FIGS. 10A and 10B illustrate top and bottom
perspective views of the sheath output plate 38 exploded from the
sheath block 40 and motor driven interfaces 42 which are coupled to
sheath articulation motors 43. FIG. 10C illustrates sheath
articulation motors 43 coupled to the motor driven interfaces 42
which includes a set of belts, shafts, and gears which drive
receptacle sleeves 90 (which are similar in construction and
functionality to the receptacle sleeves previously described for
the guide funicular assembly). When the sheath splayer pulley
assemblies 80 and sterile adaptor floating shafts 82 are coupled to
the receptacle sleeves 90, the sheath articulation motors 43 drive
the receptacle sleeves 90 causing the sheath instrument 30 to bend
in the same manner described for the guide instrument.
[0084] During use, the catheter instrument 18 is inserted within a
central lumen of the sheath instrument 30 such that the instruments
18, 30 are arranged in a coaxial manner as previously described.
Although the instruments 18, 30 are arranged coaxially, movement of
each instrument 18, 30 can be controlled and manipulated
independently. For this purpose, motors within the instrument
driver 16 are controlled such that the drive and sheath carriages
coupled to the mounting plates 37, 38 are driven forwards and
backwards independently on linear bearings each with leadscrew
actuation. FIG. 10 illustrates the sheath drive block 40 removed
from the instrument driver coupled to two independently-actuated
lead screw 45, 46 mechanisms driven by guide and sheath insert
motors 47a,47b. Note the guide carriage is not shown. In the
illustrated embodiment, the sheath insertion motor 47b is coupled
to a sheath insert leadscrew 46 that is designed to move the sheath
articulation assembly forwards and backwards, thus sliding a
mounted sheath catheter instrument (not shown) forwards and
backwards. The insert motion of the guide carriage can be actuated
with a similar motorized leadscrew actuation where a guide insert
motor 47a is coupled to the guide insert leadscrew 45 via a
belt.
[0085] Referring back to FIGS. 1, 4 and 6A, in order to accurately
steer the robotic sheath 62a or guide catheter 61a from an operator
work station 2, a control structure may be implemented which allows
a user to send commands through input devices such as the pendant 8
or MID 12 that will result in desired motion of the sheath 62a and
guide 61a. In some embodiments, the sheath 62a and/or the guide 61a
may each have four control wires for bending the instrument in
different directions. Referring to FIGS. 11A-H, the basic
kinematics of a catheter 120 with four control elements 122a, 122b,
122c, 122d is shown. The catheter 120 may be component 61a or
component 62a in some embodiments. Referring to FIGS. 11A-B, as
tension is placed only upon the bottom control element 122c, the
catheter bends downward, as shown in FIG. 11A. Similarly, pulling
the left control element 122d in FIGS. 11C-D bends the catheter
left, pulling the right control element 122b in FIGS. 11E-F bends
the catheter right, and pulling the top control element 122a in
FIGS. 11G-H bends the catheter up. As will be apparent to those
skilled in the art, well-known combinations of applied tension
about the various control elements results in a variety of bending
configurations at the tip of the catheter member 120.
[0086] The kinematic relationships for many catheter instrument
embodiments may be modeled by applying conventional mechanics
relationships. In summary, a control-element-steered catheter
instrument is controlled through a set of actuated inputs. In a
four-control-element catheter instrument, for example, there are
two degrees of motion actuation, pitch and yaw, which both have +
and - directions. Other motorized tension relationships may drive
other instruments, active tensioning, or insertion or roll of the
catheter instrument. The relationship between actuated inputs and
the catheter's end point position as a function of the actuated
inputs is referred to as the "kinematics" of the catheter.
[0087] To accurately coordinate and control actuations of various
motors within an instrument driver from a remote operator control
station such as that depicted in FIG. 1, a computerized control and
visualization system may be employed. The control system
embodiments that follow are described in reference to a particular
control systems interface, namely the SimuLink.TM. and XPC.TM.
control interfaces available from The Mathworks Inc., and PC-based
computerized hardware configurations. However, one of ordinary
skilled in the art having the benefit of this disclosure would
appreciate that many other control system configurations may be
utilized, which may include various pieces of specialized hardware,
in place of more flexible software controls running on one or more
computer systems.
[0088] FIGS. 12-13 illustrate examples of a control structure for
moving the catheter 61a and/or the sheath 62a in accordance with
some embodiments. In one embodiment, the catheter (or other
shapeable instrument) is controlled in an open-loop manner as shown
in FIG. 12. In this type of open loop control model, the shape
configuration command comes in to the beam mechanics, is translated
to beam moments and forces, then is translated to tendon tensions
given the actuator geometry, and finally into tendon displacement
given the entire deformed geometry.
[0089] Referring to FIG. 13, an overview of other embodiment of a
control system flow is depicted. A master computer 400 running
master input device software, visualization software, instrument
localization software, and software to interface with operator
control station buttons and/or switches is depicted. 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.TM. from Sensible Devices Corporation, which is
configured to communicate with the Phantom.TM. hardware at a
relatively high frequency as prescribed by the manufacturer. Other
suitable master input devices, such as the master input device 12
depicted in FIG. 2 are available from suppliers such as Force
Dimension of Lausanne, Switzerland. The master input device 12 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 126.
[0090] Referring to FIG. 13, in one embodiment, visualization
software runs on the master computer 126 to facilitate real-time
driving and navigation of one or more steerable instruments. In one
embodiment, visualization software provides an operator at an
operator control station, such as that depicted in FIG. 2, with a
digitized "dashboard" or "windshield" display to enhance
instinctive drivability of the pertinent instrumentation within the
pertinent tissue structures. Referring to FIG. 14, a simple
illustration is useful to explain one embodiment of a preferred
relationship between visualization and navigation with a master
input device 12. In the depicted embodiment, two display views 142,
144 are shown. One preferably represents a primary 142 navigation
view, and one may represent a secondary 144 navigation view. To
facilitate instinctive operation of the system, it is preferable to
have the master input device coordinate system at least
approximately synchronized with the coordinate system of at least
one of the two views. Further, it is preferable to provide the
operator with one or more secondary views which may be helpful in
navigating through challenging tissue structure pathways and
geometries.
[0091] Referring still to FIG. 14, if an operator is attempting to
navigate a steerable catheter in order to, for example, contact a
particular tissue location with the catheter's distal tip, a useful
primary navigation view 142 may comprise a three dimensional
digital model of the pertinent tissue structures 146 through which
the operator is navigating the catheter with the master input
device 12, along with a representation of the catheter distal tip
location 148 as viewed along the longitudinal axis of the catheter
near the distal tip. This embodiment illustrates a representation
of a targeted tissue structure location 150, which may be desired
in addition to the tissue digital model 146 information. A useful
secondary view 144, displayed upon a different monitor, in a
different window upon the same monitor, or within the same user
interface window, for example, comprises an orthogonal view
depicting the catheter tip representation 148, and also perhaps a
catheter body representation 152, to facilitate the operator's
driving of the catheter tip toward the desired targeted tissue
location 150.
[0092] In one embodiment, subsequent to development and display of
a digital model of pertinent tissue structures, an operator may
select one primary and at least one secondary view to facilitate
navigation of the instrumentation. By selecting which view is a
primary view, the user can automatically toggle a master input
device 12 coordinate system to synchronize with the selected
primary view. In an embodiment with the leftmost depicted view 142
selected as the primary view, to navigate toward the targeted
tissue site 150, the operator should manipulate the master input
device 12 forward, to the right, and down. The right view will
provide valued navigation information, but will not be as
instinctive from a "driving" perspective.
[0093] To illustrate: if the operator wishes to insert the catheter
tip toward the targeted tissue site 150 watching only the rightmost
view 144 without the master input device 12 coordinate system
synchronized with such view, the operator would have to remember
that pushing straight ahead on the master input device will make
the distal tip representation 148 move to the right on the
rightmost display 144. Should the operator decide to toggle the
system to use the rightmost view 144 as the primary navigation
view, the coordinate system of the master input device 12 is then
synchronized with that of the rightmost view 144, enabling the
operator to move the catheter tip 148 closer to the desired
targeted tissue location 150 by manipulating the master input
device 12 down and to the right. The synchronization of coordinate
systems may be conducted using fairly conventional mathematic
relationships which are described in detail in the aforementioned
applications incorporated by reference.
[0094] Referring back to embodiment of FIG. 13, the master computer
126 also comprises software and hardware interfaces to operator
control station buttons, switches, and other input devices which
may be utilized, for example, to "freeze" the system by
functionally disengaging the master input device as a controls
input, or provide toggling between various scaling ratios desired
by the operator for manipulated inputs at the master input device
12. The master computer 126 has two separate functional connections
with the control and instrument driver computer 128: one connection
132 for passing controls and visualization related commands, such
as desired XYZ (in the catheter coordinate system) commands, and
one connection 134 for passing safety signal commands. Similarly,
the control and instrument driver computer 128 has two separate
functional connections with the instrument and instrument driver
hardware 130: one connection 136 for passing control and
visualization related commands such as required-torque-related
voltages to the amplifiers to drive the motors and encoders, and
one connection 138 for passing safety signal commands. Also shown
in the signal flow overview of FIG. 13 is a pathway 140 between the
physical instrument and instrument driver hardware 130 back to the
master computer 126 to depict a closed loop system embodiment
wherein instrument localization technology is utilized to determine
the actual position of the instrument to minimize navigation and
control error.
[0095] II. Tension Sensing.
[0096] As discussed with reference to FIGS. 6-7, the robotic system
10 includes an instrument driver (or drive assembly) 16 with sleeve
receptacles 90 for turning the respective shafts 82 at the sterile
adaptor 41, which in turn, rotates the respective pulley assemblies
80 at the splayer 61/62. In some embodiments, the robotic system 10
may further include a sensor for sensing a characteristic that
corresponds with an amount of force or torque being applied to turn
the sleeve receptacles 90. FIG. 15 illustrates some components of
the robotic system 10 that includes tension sensing capability in
accordance with some embodiments. As shown in the figure, the
instrument driver 16 includes the sleeve receptacles 90, which are
actuatable elements that are actuated by respective motors 200. The
instrument driver 16 also includes sensors 202 coupled to the
respective motors 200. Each sensor 202 is configured to sense a
characteristic that corresponds with an amount of force or torque
being applied to the actuatable element 90. The sensor 202 is
illustrated schematically as being coupled to the motor 200. In
some embodiments, the sensor 202 may be located internally inside a
motor. In other embodiments, the sensor 202 may be secured to an
exterior of a motor. In other embodiments, the sensor 202 may be
attached to a component that is coupled to the motor. For example,
in some embodiments, the motor 200 may be mounted to a ring
structure (like the ring structure 300 shown in FIG. 19) that is
attached to the instrument driver 16. In such cases, the sensor 202
may be attached to the ring structure, and the sensor 202 may be
considered as being coupled to the motor 200 (indirectly, in this
example).
[0097] The robotic system 10 also includes the sterile adaptor 41,
which has a base 220 with a plurality of openings 224 for housing
respective rotary members 82. In the illustrated embodiments, the
rotary members 82 are shafts configured for detachably coupling to
respective sleeve receptacles 90. In particular, each rotary member
82 has a first end 210 for insertion into the sleeve receptacle 90,
a second end 212, and a body 214 extending between the first and
second ends 210, 212. The sterile adaptor 41 also includes a cover
222 that is coupled to the base 220, and a flexible sheet
(membrane) 226 for providing a sterile barrier so that after the
splayer assembly 61/62 is used, the sterile adaptor 41 and the
splayer assembly 61/62 may be discarded, while leaving the
instrument driver 16 sterile.
[0098] The robotic system 10 also includes the splayer 61/62, which
includes a base 78 with a plurality of openings 230 for housing
respective pulley assemblies 80, and a cover 72 for coupling to the
base 78. When the cover 72 is coupled to the base 78, it covers the
pulley assemblies 80. The splayer 61/62 also includes an elongate
member 61a /62a coupled to the base 78 (e.g., either directly to
the base 78, or indirectly to the base 78 through the cover 72).
The elongate member 61a /62a may be a catheter, a sheath, or any
elongate instrument having a lumen extending therethrough. The
robotic system 10 also includes a plurality of steering wires 204
disposed in the elongate member 61a/62a. Each steering wire 204 has
a distal end coupled to a distal end of the elongate member, and a
proximal end coupled to one of the pulley assemblies 80. During
use, the pulley assembly may be rotated to apply tension to the
steering wire 204 to thereby apply tension to the steering wire
204, which in turn, causes the distal end of the elongate member
61a /62a to bend. Although two pulley assemblies 80 are shown, it
should be understood that in other embodiments, the splayer 61/62
may have more than two pulley assemblies 80 (e.g., four pulley
assemblies 80), with respective steering wires 204 connected
thereto. Also, in other embodiments, the splayer 61/62 may have
only one pulley assembly 80, and the elongate member 61a /62a may
have only one steering wire 204 connected to the pulley assembly
80.
[0099] As shown in the figure, the actuatable element 90 is
configured to turn the pulley assembly 80 indirectly through the
rotary member 82 at the sterile adaptor 41 to thereby apply tension
to the steering wire 204 at the catheter 61a /sheath 62a. The
sensor 202 is configured to sense a characteristic that corresponds
with an amount of force being applied to the actuatable element 90.
By means of non-limiting examples, the characteristic may be an
actual force, a torque (which is force times distance), a strain, a
stress, an acceleration, etc. The sensed characteristic may be used
to correlate an amount of tension being applied to the steering
wire 204. In some embodiments, the sensed characteristic may be
transmitted from the sensor 202 to the user interface 2, and the
value of the sensed characteristic may be displayed on a screen for
presentation to a user. Also, in some embodiments, the sensed
characteristic may be transmitted from the sensor 202 in a form of
a signal to a processor, which processes the signal, and controls
an amount of torque/force being applied to the motor 200 in
response to the processed signal.
[0100] In some embodiments, in order to accurately correlate the
sensed characteristic by the sensor 202 with an amount of tension
being applied at the steering wire 204, it may be desirable to
minimize, or at least reduce an amount of friction between the
shaft 82 and the base 220 at the sterile adaptor 41. In the
illustrated embodiments, the sterile adaptor 41 includes an
interface between each rotary member 82 and the base 220 for
reducing an amount of friction therebetween (i.e., between the
shaft body 214 of the rotary member 82 and the wall in the opening
224 defined by the base 220). As shown in the figure, each rotary
member 82 includes a flange 240 disposed circumferentially around
the shaft body 214, and a plurality of slots 242 at the flange 240.
Two slots 242 are shown, which are defined by a partition 244
extending round the shaft body 214 of the rotary member 82. The
partition 244 may have a ring configuration. For example, the
partition 244 may have a continuous ring structure, or
alternatively, a plurality of structures that form a ring
configuration. Each slot 242 has a ring configuration that extends
around the shaft body 214 of the rotary member 82. Also, as shown
in the figure, the base 220 includes a protrusion 246 next to
(e.g., within 5 cm or less from) the opening 224. The protrusion
246 has a ring configuration around the opening 224, and extends
into a slot 242. For example, the protrusion 246 may have a
continuous ring structure, or alternatively, may have a plurality
of structures that form into a ring configuration. Although one
protrusion 246 is shown in the example, in other embodiments, the
sterile adaptor 41 may include a plurality of protrusions 246 that
extend into respective ones of the slots 242 at the flange 240.
Also, in other embodiments, the flange 240 of the rotary member 82
may include more than two slots 242, or less than two slots 242
(e.g., only one slot 242).
[0101] In the illustrated embodiments, the cross sectional
dimension of the shaft body 214 is less than the cross sectional
dimension of the opening 224 (e.g., by 3 mm, and more preferably by
2 mm, and even more preferably by 1 mm or less). The partition(s)
244 at the flange 240 and the protrusion(s) 246 at the base 220
cooperate with each other (e.g., engage with each other) to prevent
the shaft 214 from touching the surrounding wall at the opening
224. Accordingly, the shaft body 214 essentially "floats" within
the space defined by the opening 224. In the illustrated
embodiments, the partition 244 abuts against the protrusion 246
while the shaft body 214 is maintained within the opening 224 so
that it is spaced away from the wall of the opening 224. In other
embodiments, the partition 244 may not abut against the protrusion
246. Instead, there may be a small gap between the partition 244
and the protrusion 246 to reduce friction between the partition 244
and the protrusion 246. The gap may be large enough to allow some
movement of the shaft body 214 relative to the base 220, while
small enough to prevent the shaft body 214 from touching the wall
at the opening 224.
[0102] In some embodiments, to further provide a frictionless
interface, the partition(s) 244 and/or the protrusion(s) 246 may be
coated with a hydrophobic material to allow fluid to glide easily
along the surfaces of these components. Also, in some embodiments,
a lubricant, such as oil, may be applied to the surface of the
partition(s) 244 and/or the protrusion(s) 246.
[0103] During use, the sterile adaptor 41 is detachably coupled to
the instrument driver 16. Such may be accomplished by inserting the
first ends 210 of the respective rotary members 82 into respective
openings at the acutatable elements 90 (like that shown in FIG.
7E). The membrane 226 provides a barrier to prevent the instrument
driver 16 from being contaminated during a medical procedure. Also,
during use, the splayer 61 is detachably coupled to the sterile
adaptor 41. Such may be accomplished by inserting the second ends
212 of the respsective rotary members 82 into respective openings
at the end of the rotary members 80 (like that shown in FIG.
7D).
[0104] The same setup may be performed for the splayer 62. In
particular, during use, another sterile adaptor 41 is detachably
coupled to the instrument driver 16. Such may be accomplished by
inserting the first ends 210 of the respective rotary members 82
into respective openings at the acutatable elements 90 (like that
shown in FIG. 7E). Also, the splayer 62 is detachably coupled to
the sterile adaptor 41. Such may be accomplished by inserting the
second ends 212 of the respective rotary members 82 into respective
openings at the end of the rotary members 80 (like that shown in
FIG. 7D).
[0105] After the splayers 61, 62 are mounted to respective sterile
adaptors 41, and after the sterile adaptors 41 are mounted to the
instrument driver 16, the robotic system 10 may then be used to
perform a medical procedure. For example, in some embodiments, the
splayer 61 and/or splayer 62 may be controlled to position the
catheter 61a and/or the sheath 62a at desired position(s) within
the patient. Once the catheter 61a and/or the sheath 62a have been
desirably positioned, the catheter 61a and/or the sheath 62a may
then be used to deliver an instrument (e.g., an ablation device) or
a substance (e.g., occlusive device, drug, etc.) to treat the
patient.
[0106] Various techniques may be employed to move the catheter 61a
and/or the sheath 62a to thereby place these instruments at desired
positions(s) in the patient. In some embodiments, the instrument
driver 16 may be configured to translate the splayer 61 to thereby
translate the catheter 61a in an axial direction. Also, the
instrument driver 16 may be configured to translate the splayer 62
to thereby translate the sheath 62a in an axial direction. Thus, by
moving the splayer 61 and/or splayer 62, the instrument driver 16
may advance or retract the catheter 61a relative to the sheath 62a,
and vice versa. Also, if the movements of the splayers 61, 62 are
synchronized, both the catheter 61a and the sheath 62a may be moved
by the same amount in some embodiments. In some embodiments, the
translation of the splayer 61 and/or the splayer 62 may be
performed by the instrument driver 16 in response to a command
signal received from the user interface. For example, in some
embodiments, the instrument driver 16 may be configured to receive
a command signal input from a user at the user interface, and
generate a control signal in response to the command signal to move
one or both of the splayers 61, 62.
[0107] Also, in some embodiments, the instrument driver 16 may be
configured to bend a distal end of the catheter 61a, a distal end
of the sheath 62a, or both. For example, in some embodiments, the
instrument driver 16 may actuate one or more motors at the
instrument driver 16 to turn one or more respective actuatable
elements 90, thereby turning one or more respective rotary members
80 at the splayer 61 indirectly through the one or more respective
rotary members 82 at the sterile adaptor 41. The turning of the one
or more rotary members 80 at the splayer 61 applies tension to one
or more respective steering wires to thereby bend the catheter 61a
towards a certain direction.
[0108] Similarly, in some embodiments, the instrument driver 16 may
actuate one or more motors at the instrument driver 16 to turn one
or more respective actuatable elements 90, thereby turning one or
more respective rotary members 80 at the splayer 62 indirectly
through the one or more respective rotary members 82 at the sterile
adaptor 41. The turning of the one or more rotary members 80 at the
splayer 62 applies tension to one or more respective steering wires
to thereby bend the sheath 62a towards a certain direction.
[0109] In some embodiments, as the rotary member 80 is being turned
to apply tension to the steering wire 204, the sensor 202 senses a
characteristic that correlates with an amount of force or torque
being applied by the actuatable element 90. For example, in some
embodiments, the sensor 202 may be a torque sensor configured to
measure an amount of torque being applied to the actuatable element
90. The measured torque may be divided by a moment arm (e.g., a
radius of the actuatable element 90) to derive a force value. In
some embodiments, the force value may correlate with an amount of
tension being applied to the steering wire 204. For example, in
some cases, the force value may be considered to be the amount of
tension being applied to the steering wire 204. In other
embodiments, the sensor 202 may be a force sensor configured to
measure a force vector that is in opposite direction as the tension
force at the steering wire 204. Because of the frictionless
interface at the sterile adaptor 41, the force sensed by the sensor
202 may be substantially equal to (e.g., at least 80%, and more
preferably at least 90%, and even more preferably at least 99% of)
the amount of tension at the steering wire 204.
[0110] In some embodiments, the sensed characteristic by the sensor
202 may be used in a process to steer the distal end of the
catheter 61a/sheath 62a so that the distal end achieves a desired
amount of bending. For example, in some embodiments, in a method of
steering the distal end of the catheter 61a/sheath 62a (elongate
member), an amount of bending to be achieved by the distal end of
the elongate member may first be determined. Such may be
accomplished by a user of the system 10. Alternatively, such may be
accomplished automatically by a processor based on an anatomy of
the patient, and the location of the elongate member 61a/62a. Next,
an amount of tension to be applied to the steering wire 204 located
within the elongate member 61a/62a may be determined based on the
amount of bending that is desired to be achieved. In general, the
more tension is being applied to the steering wire 204, the more
the amount of bending will be achieved at the distal end of the
elongate member 61a/62a. In some embodiments, the amount of tension
may be calculated automatically by the processor based on
structural properties (e.g., bending stiffness) of the elongate
member 61a/62a. Next, the instrument driver 16 actuates the
actuatable element 90 to apply a torque to turn the rotary member
80 that is detachably coupled (directly or indirectly through
element 82) to the actuatable element 90. The application of the
torque by the actuatable element 90 causes tension to be applied to
the steering wire 204. While the actuatable element 90 is being
actuated, the sensor 202 senses a characteristic that corresponds
with an amount of force or torque being applied by the actuatable
element 90 to turn the rotary member 80. In the illustrated
embodiments, the act of using the actuatable element 90 to apply
the torque comprises increasing the amount of force or torque being
applied by the actuatable element 90 until the sensed
characteristic by the sensor 202 indicates that the determined
amount of tension at the steering wire 204 has been achieved. The
above technique for bending the elongate member 61a/62a is
advantageous because it obviates the need to determine how much
axial movement (e.g., due to axial strain of the steering wire 204,
and relative movement between the steering wire 204 and the
elongate member 61a/62a) needs to be achieved by the steering wire
204 in order to achieve a certain desired amount of bending. In
particular, the above technique involving use of the sensor 202 is
advantageous over another technique of achieving a desired amount
of bending, which involve determining how much tension is needed at
the steering wire 204, and then determining a required amount of
axial movement by the steering wire 204 that corresponds with the
determined tension. Then the system monitors an amount of axial
movement by the steering wire 204 until the required amount of
axial movement by the steering wire 204 is achieved. However,
calculating the required amount of axial movement needs to be
achieved by the steering wire based on the required tension may be
difficult, computational intensive, and may not be accurate.
[0111] Also as illustrated in the above embodiments, the
frictionless interface at the sterile adaptor 41 is advantageous
because it significantly remove all or most of the friction between
the rotary member 82 and its surrounding wall in the opening 224.
Thus, the frictionless interface at the sterile adaptor 41 is
preferred over rubber seal, and the robotic system 10 does not
include any rubber seal between the rotary member 82 and the base
220 of the sterile adaptor 41.
[0112] In the above embodiments, the rotary member 80 at the
splayer 61/62 has been described as having an opening at one end of
the rotary member 80 for receiving the second end 212 of the rotary
member 82 at the sterile adaptor 41. In other embodiments, the
configuration of the coupling may be reversed. For example, in
other embodiments, the rotary member 80 at the splayer 61/62 may
have an end for insertion into an opening at the second end 212 of
the rotary member 82 at the sterile adaptor 41 (FIG. 16).
[0113] Also, in the above embodiments, the first end 210 of the
rotary member 82 at the sterile adaptor 41 has been described as
being inserted into an opening at the actuatable element 90 at the
instrument driver 16. In other embodiments, the configuration of
the coupling may be reversed. For example, in other embodiments,
the first end 210 of the rotary member 82 at the sterile adaptor 41
may have an opening for receiving an end of the actuatable element
90 at the instrument driver 16 (FIG. 17). Furthermore, in other
embodiments, the second end 212 of the rotary member 82 in the
embodiments of FIG. 17 may be configured for insertion into an
opening at the end of the rotary member 80 (like that shown in FIG.
15).
[0114] In the above embodiments, the frictionless interface at the
sterile adaptor 41 includes two slots 242 and a protrusion 246
inserted into one of the slots 242. In other embodiments, the
frictionless interface may include an additional protrusion 246
extending into the second slot 242. Also, in further embodiments,
the frictionless interface may include only one slot 242 (FIG.
18).
[0115] As discussed, the sensor 202 is coupled to the motor 200,
either directly or indirectly. Various techniques may be employed
for coupling the sensor 202 to the motor 200. In some embodiments,
the sensor 202 may be a strain gauge mounted to an output shaft. In
other embodiments, the sensor 202 may be a torque sensor mounted in
series with the output shaft.
[0116] In further embodiments, the motor 200 (with optional
gearbox) may be mounted to the instrument driver 16 (e.g., to a
chassis of the instrument driver) through a mounting structure 300
(FIG. 19). In such cases, the sensor 202 may be attached to the
mounting structure 300. Such configuration is advantageous because
it allows torque to be measured at the output shaft by measuring
the reaction forces from the entire gear train. This is because at
static equilibrium, the measured reaction torque may be equal to
the output shaft torque. The mounting structure 300 has a ring
configuration in some embodiments. In other embodiments, the
mounting structure 300 may have other configurations. Also, in some
embodiments, the mounting structure 300 may be considered to be a
part of the sensor 202. The sensor 202 (and optionally with the
mounting structure 300) may be a torque sensor, a hinge or flexure
based structure with integrated load cell(s) or strain gauge(s), or
a strain gauge mounted to an otherwise rigid mounting
structure.
[0117] In some cases, the sensor 202 may pick up inertial forces
from the acceleration and deceleration of the motor 200. Options
for minimizing this contamination include (1) low-pass filtering
the measured signal, (2) using only data collected when the motor
200 is stationary or moving at an approximately constant velocity,
and/or (3) modeling the inertial effects of the motor 200, and
compensating the measured signal based upon a measured acceleration
by an encoder at the motor 200 and/or motor back-EMF.
[0118] In other embodiments, by mounting the axis of the motor 200
at 90.degree. relative to the axis of the output shaft, the inertia
forces due to acceleration and deceleration of the motor 200 will
be decoupled from the measured reaction torque (FIG. 20). As shown
in the figure the robotic system 10 may optionally further include
a gear box 310 for transmitting torque from the motor 200 to the
output shaft that is axially aligned with the actuatable element
90. In such cases, the acceleration of the output shaft, pulley,
etc., may still contaminate the measurement of wire tension, but
these contributions will be relatively small compared to the
acceleration of the motor rotor, especially because of the effects
of gear reduction between motor and output shaft. The sensor 202
(and optionally with the mounting structure 300) may be a torque
sensor, a hinge or flexure based structure with integrated load
cell(s) or strain gauge(s), or a strain gauge mounted to an
otherwise rigid mounting structure.
[0119] In further embodiments, the instrument driver 16 may include
a differential gearbox 320 mechanically coupled to the motor 200
(FIG. 21). The gearbox 320 is configured to turn a first output
shaft 322 that is coupled to the actuatable element 90, while a
second output shaft 324 extending from the gearbox 320 is fixed to
the instrument driver 16 (e.g., to a chassis of the instrument
driver 16). In some embodiments, the second output shaft 324 may be
fixed to the instrument driver 16 through the sensor 202 (see
option A in figure), which may be a torque sensing element in some
embodiments. Alternatively, the second output shaft 324 may be
fixed to the instrument driver 16 without using the sensor 202, in
which cases, the sensor 202 (which may be a strain gauge in some
embodiments) may be secured to the second output shaft 324 (see
option B in figure). The gearbox 320 is advantageous because it
allows the sensor 202 to be coupled to a component that experiences
torque from the gearbox 320, but does not spin (which is beneficial
because it obviates the need to implement complicated signal
connection, such as a slip connection, that may otherwise be needed
if the sensor 202 is coupled to a spinning shaft). In some
embodiments, the gearbox 320 may be similar to that used in
transferring power to both wheels of an automobile while allowing
them to rotate at different speeds. In some cases, the difference
between the torque in the upper and lower output shafts 322, 324
may be due to inefficiencies of the differential gearbox 320. In
such cases, by maximizing the efficiency of the differential
gearbox 320, the sensor 202 may provide a good estimate of the
pullwire tension without having to deal with routing signal
connections to a sensor that is moving. Also, in some embodiments,
the configuration of the embodiments shown in FIG. 21 may be
simplified by incorporating the secondary (fixed) output shaft 324
and the sensor 202 entirely within a housing of the differential
gearbox 320. This may provide for a compact gearbox with integrated
output shaft torque sensing and no limitations on output shaft
motion.
[0120] III. Driving Modes
[0121] As discussed, the system 10 may be configured to move the
sheath 62a distally or proximally, move the catheter 61a distally
or proximally, and to move the elongate member 26 distally or
proximally. In some cases, the movement of the sheath 62a may be
relative to the catheter 61a, while the catheter 61a remains
stationary. In other cases, the movement of the catheter 61a may be
relative to the sheath 62a while the sheath 62a remains stationary.
Also, in other cases, the sheath 62a and the catheter 61a may be
moved together as a unit. The elongate member 26 may be moved
relative to the sheath 62a and/or the catheter 61a. Alternatively,
the elongate member 26 may be moved together with the sheath 62a
and/or the catheter 61a.
[0122] In some embodiments, the workstation 2 is configured to
provide some or all of the following commanded motions (driving
modes) for allowing the physician to choose. In some embodiments,
each of the driving modes may have a corresponding button at the
workstation 2 and/or the bedside control 402.
[0123] Elongate member Insert--When this button/command is
selected, the manipulator 24 inserts the elongate member 26 at a
constant velocity.
[0124] Elongate member Roll--When this button/command is selected,
the manipulator 24 rolls the elongate member 26 at a constant
angular velocity
[0125] Elongate member Size--When the size or gauge of the elongate
member 26 is inputted into through the user interface, the system
will automatically alter roll and insert actuation at the proximal
end of the elongate member 26 accordingly to achieve desired
commanded results. In one implementation, when a user inputs the
elongate member's size, the system automatically changes its
kinematic model for driving that elongate member 26. So if the user
commands the elongate member 26 to move to a certain position, the
system will calculate, based on the kinematic model, roll and
insert commands, which may be different for different elongate
member sizes (e.g., elongate members 26 with different diameters).
By inputting the elongate member's size, the system knows which
kinematic model to use to perform the calculation. Such feature is
beneficial because different sized elongate members 26 behave
differently.
[0126] Leader/Sheath Select--When this button/command is selected,
it allows the user to select which device (e.g., catheter 61a,
sheath 62a, elongate member 26, or any combination of the
foregoing) is active.
[0127] Leader/Sheath Insert/Retract--When this button/command is
selected, the instrument driver assembly inserts or retracts the
catheter 61a/sheath 62a while holding the elongate member 26 and
any non-active device fixed relative to the patient. When this
motion causes the protruding section of the catheter 61a to
approach zero (due to insertion of the sheath 62a or retraction of
the catheter 61a), the system automatically relaxes the catheter
61a as part of the motion.
[0128] Leader/Sheath Bend--When this button/command is selected,
the instrument driver assembly bends the articulating portion of
the catheter 61a/sheath 62a within its currently commanded
articulation plane.
[0129] Leader/Sheath Roll--When this button/command is selected,
the instrument driver assembly uses the pullwires to "sweep" the
articulation plane of the device (catheter 61a and/or sheath 62a)
around in a circle through bending action of the device. Thus, this
mode of operation does not result in a true "roll" of the device in
that the shaft of the device does not roll. In other embodiments,
the shaft of the device may be configured to rotate to result in a
true roll. Thus, as used in this specification, the term "roll" may
refer to an artificial roll created by seeping a bent section, or
may refer to a true roll created by rotating the device.
[0130] Leader/Sheath Relax--When this button/command is selected,
the instrument driver assembly gradually releases tension off of
the pullwires on the catheter 61a/sheath 62a. If in free space,
this results in the device returning to a straight configuration.
If constrained in an anatomy, this results in relaxing the device
such that it can most easily conform to the anatomy.
[0131] Elongate Member Lock--When this button/command is selected,
the elongate member 26 position is locked to the catheter 61a
position. As the leader is articulated or inserted, the elongate
member 26 moves with the catheter 61a as one unit.
[0132] System Advance/Retract--When this button/command is
selected, the instrument driver assembly advances/retracts the
catheter 61a and sheath 62a together as one unit. The elongate
member 26 is controlled to remain fixed relative to the
patient.
[0133] Autoretract--When this button/command is selected, the
instrument driver assembly starts by relaxing and retracting the
catheter 61a into the sheath 62a, and then continues by relaxing
and retracting the sheath 62a with the catheter 61a inside it. The
elongate member 26 is controlled to remain fixed relative to the
patient.
[0134] Initialize Catheter--When this button/command is selected,
the system confirms that the catheter 61a and/or the sheath 62a has
been properly installed on the instrument driver assembly, and
initiates pretensioning. Pretensioning is a process used to find
offsets for each pullwire to account for manufacturing tolerances
and the initial shape of the shaft of the catheter 61a and/or the
sheath 62a.
[0135] Leader/Sheath Re-calibration--When this button/command is
selected, the instrument driver assembly re-pretensions the
catheter 61a and/or the sheath 62a in its current position. This
gives the system the opportunity to find new pretension offsets for
each pullwire and can improve catheter driving in situations where
the proximal shaft of the catheter 61a has been placed into a
significant bend. It is activated by holding a relax button down
for several seconds which ensures that the device is fully
de-articulated. Alternatively the re-calibration may be activated
without holding down the relax button to de-articulate the
device.
[0136] Leader Relax Remove--When this button/command is selected,
the instrument driver assembly initiates a catheter removal
sequence where the catheter 61a is fully retracted into the sheath
62a, all tension is released from the pullwires, and the splayer
shafts (at the drivable assembly 61 and/or drivable assembly 62)
are driven back to their original install positions so that the
catheter 61a can be reinstalled at a later time.
[0137] Leader Yank Remove--When this button/command is selected,
the instrument driver assembly initiates a catheter removal
sequence where the catheter 61a is removed manually.
[0138] Emergency Stop--When this button/command is selected, the
instrument driver assembly initiates a gradual (e.g., 3 second)
relaxation of both the catheter 61a and the sheath 62a. The
components (e.g., amplifier) for operating the catheter 61a,
elongate member 26, or another device are placed into a "safe-idle"
mode which guarantees that no power is available to the motors that
drive these elements, thereby bringing them rapidly to a stop, and
allowing them to be manually back-driven by the user. Upon release
of the emergency stop button, the system ensures that the catheter
61a is still in its allowable workspace and then returns to a
normal driving state.
[0139] Segment control: In some embodiments, the workstation 2
allows a user to select individual segment(s) of a multi-segment
catheters (such as the combination of the catheter 61a and the
sheath 62a), and control each one. The advantage of controlling the
catheter in this way is that it allows for many options of how to
control the movement of the catheter, which may result in the most
desirable catheter performance. To execute this method of catheter
steering, the user selects a segment of the catheter to control.
Each segment may be telescoping or non-telescoping. The user may
then control the selected segment by bending and inserting it using
the workstation 2 to control the position of the end point of the
catheter. Other segment(s) of the catheter will either maintain
their previous position (if it is proximal of the selected section)
or maintain its previous configuration with respect to the selected
section (if it is distal of that section) (FIG. 22A).
[0140] Follow mode: In some embodiments, the workstation 2 allows
the user to control any telescoping section while the more proximal
section(s) follows behind automatically. This has the advantage of
allowing the user to focus mostly on the movement of a section of
interest while it remains supported proximally. To execute this
method of catheter steering, the user first selects a telescoping
section of the elongate instrument (e.g., catheter 61a and sheath
62a) to control. This section is then controlled using the
workstation 2 to prescribe a location of the endpoint of the
segment. Any segment(s) distal of the section of interest will
maintain their previous configuration with respect to that section.
When the button on the workstation 2 is released, any segment(s)
proximal of the section of interest will follow the path of the
selected section as closely as possible until a predefined amount
of the selected section remains (FIG. 22B). As an alternative to
this driving mode, the segment(s) of the elongate instrument which
is proximal of the section of interest could follow along as that
segment is moved instead of waiting for the button to be released.
Furthermore, with either of these automatic follow options, the
system may optionally be configured to re-pretension the sections
that have been driven out and re-align the sections that are
proximal of the driven section.
[0141] Follow mode may be desirable to use to bring the more
proximal segments of the elongate instrument towards the tip to
provide additional support to the distal segment. In cases where
there are three or more controllable sections of the elongate
instrument, there are several options for how to execute a "follow"
command. Consider the example in FIG. 22D where the distal segment
(which may be a guidewire or a steerable instrument in some
embodiments) has been driven out as shown in frame 1. The "follow"
command could be executed by articulating and/or inserting only the
middle segment (which may be the catheter 61a in some embodiments)
of the elongate instrument as shown in frame 2. The "follow"
command could be executed by articulating and/or inserting only the
most proximal segment (which may be the sheath 62a in some
embodiments) of the elongate instrument as shown in frame 3. The
"follow" command could also be executed by coordinating the
articulation and/or insertion of multiple proximal segments of the
elongate instrument as shown in frame 4. Combining the motion of
multiple sections has several potential advantages. First, it
increases the total degrees-of-freedom available to the algorithm
that tries to fit the shape of the following section(s) to the
existing shape of the segment being followed. Also, in comparison
to following each segment sequentially, a multi-segment follow mode
simplifies and/or speeds up the workflow. In addition,
multi-segment increases the distance that can be followed compared
to when only one proximal segment is used to follow the distal
segment.
[0142] Mix-and-match mode: In some embodiments, the workstation 2
allows the user to have the option of mixing and matching between
articulating and inserting various sections of a catheter. For
example, consider the illustration in FIG. 22C, and assuming that
the distal most section of the elongate instrument is the "active"
segment. If the user commands a motion of the tip of the elongate
instrument as indicated by the arrow in Frame 1, there are several
options available for how to achieve this command: (1) Articulate
and extend the "active" segment, which is illustrated in frame 3
and is likely considered the normal or expected behavior; (2)
Articulate the active distal most segment and insert one of the
other proximal segments, as illustrated in frames 2 and 4; (3)
Articulate the active distal most segment and combine inserting
motion of some or all of the segments, as illustrated in frame
5.
[0143] There are multiple potential reasons why the user might want
to choose some of these options. First, by "borrowing" insert
motion from other segments, some of the segments could be
constructed with fixed lengths. This reduces the need for segments
to telescope inside of each other, and therefore reduces the
overall wall thickness. It also reduces the number of insertion
degrees-of-freedom needed. Also, by combining the insert motion
from several segments, the effective insert range-of-motion for an
individual segment can be maximized. In a constrained space such as
the vasculature, the operator may likely be interested in
"steering" the most distal section while having as much effective
insertion range as possible. It would simplify and speed up the
workflow to not have to stop and follow with the other
segments.
[0144] In other embodiments, the "follow" mode may be carried out
using a robotic system that includes a flexible elongated member
(e.g., a guidewire), a first member (e.g., the catheter 61a)
disposed around the flexible elongated member, and a second member
(e.g., the sheath 62a) disposed around the first member. The
flexible elongated member may have a pre-formed (e.g., pre-bent)
configuration. In some embodiments, the flexible elongated member
may be positioned inside a body. Such may be accomplished using a
drive mechanism that is configured to position (e.g., advance,
retract, rotate, etc.) the flexible elongated member. In one
example, the positioning of the flexible elongated member comprises
advancing the flexible elongated member so that its distal end
passes through an opening in the body.
[0145] Next, the first member is relaxed so that it has sufficient
flexibility that will allow the first member to be guided by the
flexible elongated member (that is relatively more rigid than the
relaxed first member). In some embodiments, the relaxing of the
first member may be accomplished by releasing tension in wires that
are inside the first member, wherein the wires are configured to
bend the first member or to maintain the first member in a bent
configuration. After the first member is relaxed, the first member
may then be advanced distally relative to the flexible elongated
member. The flexible elongated member, while being flexible, has
sufficient rigidity to guide the relaxed first member as the first
member is advanced over it. The first member may be advanced until
its distal end also passes through the opening in the body.
[0146] In some embodiments, the second member may also be relaxed
so that it has sufficient flexibility that will allow the second
member to be guided by the flexible elongated member (that is
relatively more rigid than the relaxed second member), and/or by
the first member. In some embodiments, the relaxing of the second
member may be accomplished by releasing tension in wires that are
inside the second member, wherein the wires are configured to bend
the second member or to maintain the second member in a bent
configuration. After the second member is relaxed, the second
member may then be advanced distally relative to the flexible
elongated member. The flexible elongated member, while being
flexible, has sufficient rigidity to guide the relaxed second
member as the second member is advanced over it. The second member
may be advanced until its distal end also passes through the
opening in the body. In other embodiments, instead of advancing the
second member after the first member, both the first member and the
second member may be advanced simultaneously (e.g., using a drive
mechanism) so that they move together as a unit. In further
embodiments, the acts of advancing the flexible elongated member,
the first member, and the second member may be repeated until a
distal end of the flexible elongated member, the first member, or
the second member has passed through an opening in a body.
[0147] In the above embodiments, tension in pull wires in the
second elongated member is released to make it more flexible than
the first elongated member, and the second elongated member is then
advanced over the first elongated member while allowing the first
elongated member to guide the second elongated member. In other
embodiments, the tension in the pull wires in the first elongated
member may be released to make it more flexible than the second
elongated member. In such cases, the more flexible first elongated
member may then be advanced inside the more rigid second elongated
member, thereby allowing the shape of the second elongated member
to guide the advancement of the first elongated member. In either
case, the more rigid elongated member may be locked into shape by
maintaining the tension in the pull wires.
[0148] In some of the embodiments described herein, the flexible
elongated member may be a guidewire, wherein the guidewire may have
a circular cross section, or any of other cross-sectional shapes.
Also, in other embodiments, the guidewire may have a tubular
configuration. In still other embodiments, instead of a guidewire,
the flexible elongated member may be the member 26. In further
embodiments, the robotic system may further include a mechanism for
controlling and/or maintaining the preformed configuration of the
guidewire. In some embodiments, such mechanism may include one or
more steering wires coupled to a distal end of the guidewire. In
other embodiments, such mechanism may be the catheter 61a, the
sheath 62a, or both. In particular, one or both of the catheter 61a
and the sheath 62a may be stiffened (e.g., by applying tension to
one or more wires inside the catheter 61a and/or the sheath 62a).
The stiffened catheter 61a and/or the sheath 62a may then be used
to provide support for the guidewire.
[0149] Also, in some of the embodiments described herein, any
movement of the elongate member 26, the catheter 61a, and/or the
sheath 62a may be accomplished robotically using a drive assembly.
In some embodiments, the drive assembly is configured to receive a
control signal from a processor, and actuate one or more driveable
elements to move the elongate member 26, the catheter 61a, and/or
the sheath 62a.
[0150] It should be noted that the driving modes for the system are
not limited to the examples discussed, and that the system may
provide other driving modes in other embodiments.
[0151] IV. Treatment Methods
[0152] FIGS. 23A-23F illustrate a method of treating tissue using
the robotic system 10 in accordance with some embodiments. As an
example, the method will be described with reference to treating
liver tissue. However, it should be understood that the system 10
may be used to treat other types of tissue.
[0153] First, the robotic system 10 is setup by placing the
catheter 61 into the lumen of the sheath 62, and by placing the
elongate member 26 into the lumen of the catheter 61. Next, an
incision is then made at a patient's skin, and the distal end of
the catheter 61 is then inserted into the patient through the
incision. In particular, the distal end of the catheter 61 is
placed inside a vessel 2000 (e.g., a vein or an artery) of the
patient. In some embodiments, the liver may be accessed from the
femoral vein or femoral artery from either groin. In other
embodiments, the liver may be accessed from the right sub-clavin in
vein or the right jugular vein. In some embodiments, the initial
insertion of the catheter 61 into the patient may be performed
manually. In other embodiments, the initial insertion of the
catheter 61 may be performed robotically using the system 10. In
such cases, the user may enter a command at the workstation 2,
which then generates a user signal in response thereto. The user
signal is transmitted to a controller, which then generates a
control signal in response to the user signal. The control signal
is transmitted to the driver to drive the catheter 61 so that it
advances distally into the patient. In some embodiments, while the
catheter 61 is being inserted into the patient, the distal end 2300
of the elongate member 26 may be housed within the lumen of the
catheter 61. In other embodiments, the distal end 2300 of the
elongate member 26 may extend out of the lumen of the catheter 61
(which the flexible section 320 of the elongate member 26 is housed
within the lumen of the catheter 61) as the catheter 61 is being
inserted. In such cases, the sharp distal tip of the elongate
member 26 may facilitate insertion through the patient's skin. In
other embodiments, the tip of the elongate member 26 may not be
sharp enough, or the distal section of the elongate member 26 may
not be stiff enough, to puncture the patient's skin. In such cases,
a separate tool may be used to create an incision at the patient's
skin first, as discussed.
[0154] In some embodiments, after the catheter 61a is placed inside
the patient, the sheath 62a may be advanced distally over the
catheter 61a. Alternatively, both the catheter 61a and the sheath
62a may be advanced simultaneously to enter into the patient.
[0155] Once the catheter 61a and the sheath 62a are inserted into
the patient, they can be driven to advance through the vasculature
of the patient. At sections of the vessel 2000 that are relatively
straight, both the catheter 61a and the sheath 62a may be driven so
that they move as one unit. Occasionally, the catheter 61a and/or
the sheath 62a may reach a section of the vessel 2000 that has a
bend (e.g., a sharp bend). In such cases, the catheter 61a and the
sheath 62a may be driven in a telescopic manner to advance past the
bend.
[0156] FIGS. 23A-23B illustrate such telescopic technique for
advancing the sheath 62a and the catheter 61a over a bend 2002
along a length of the vessel 2000. In this technique, the catheter
61a is positioned with its distal articulation section traversing
the bend 2002 and it is locked in this position (FIG. 23A). Next,
the sheath 62a is advanced over the catheter 61a (FIG. 23B), and
the catheter 61a acts as a rail held in a fixed shape for the
sheath 62a to glide over. As the sheath 62a is advanced further,
sections with higher bending stiffness on the sheath 62a will pass
over the articulated section of the catheter 61a, putting an
increase load on the catheter 61a. The increase in load on the
catheter 61a may tend to straighten the catheter 61a. In some
embodiments, the drive assembly of the robotic system 10 maintains
the bent shape of the catheter 61a by tightening the control
wire(s), which has the effect of stiffening the catheter 61a. In
some embodiments, the robotic system 10 is configured to detect the
increased load on the control wires (due to the placement of the
sheath 62a over the catheter 61a) to be detected. The operator, or
the robotic system 10, can then apply an equal counteracting load
on all the control wires of the catheter 61a to ensure that its
bent shape is maintained while the sheath 62a is advanced over the
bend. In other embodiments, the sheath 62a may be extremely
flexible so that it does not put any significant load on the
catheter 61a as the sheath 62a is advanced over the catheter 61a,
and/or distort the anatomy.
[0157] Once the distal end of the catheter 61a reaches the target
location (FIG. 23C), the distal end of the catheter 61a may be
steered to create a bend so that the distal opening at the catheter
61a faces towards a tissue 2010 that is desired to be treated (FIG.
23D). The steering of the distal end of the catheter 61a may be
accomplished by receiving a user input at the workstation 2, which
generates a user signal in response to the user input. The user
signal is transmitted to the controller, which then generates a
control signal in response to the user signal. The control signal
causes the drive assembly to apply tension to one or more wires
inside the catheter 61a to thereby bend the distal end of the
catheter 61a at the desired direction.
[0158] Next, the distal end 2300 of the elongate member 26 is
deployed out of the lumen of the catheter 61a by advancing the
elongate member 26 distally (FIG. 23E). This may be accomplished
robotically using the manipulator 24, and/or manually. The sharp
distal tip of the elongate member 26 allows the distal end 2300 to
penetrate into the target tissue 2010. Also, the flexible section
320 of the elongate member 26 allows the elongate member 26 to
follow the curvature of the catheter 61a as the elongate member 26
is advanced out of the lumen of the catheter 61a. In some
embodiments, the distal advancement of the elongate member 26 may
be accomplished by receiving a user input at the workstation 2,
which generates a user signal in response to the user input. The
user signal is transmitted to the controller, which then generates
a control signal in response to the user signal. The control signal
causes the elongate member manipulator 24 to turn its roller(s) to
thereby advance the elongate member 26 distally.
[0159] After the distal end 2300 of the elongate member 26 is
desirably positioned, the RF generator 350 is then activated to
cause the distal end 2300 to deliver RF ablation energy to treat
the target tissue 2010. In some embodiments, if the system 10
includes the return electrode 352 that is placed on the patient's
skin, the system 10 then delivers the energy in a monopolar
configuration. In other embodiments, if the elongate member 26
includes the two electrodes 370a, 370b, the system 10 may then
deliver the energy in a bipolar configuration. The energy is
delivered to the target tissue 2010 for a certain duration until a
lesion 2020 is created at the target site (FIG. 23E).
[0160] In some embodiments, while energy is being delivered by the
elongate member 26, cooling fluid may be delivered to the target
site through the lumen in the elongate member 26, and out of the
distal port 310 and/or side port(s) 312 at the elongate member 26.
The cooling fluid allows energy to be delivered to the target
tissue in a desired manner so that a lesion 3020 of certain desired
size may be created. In other embodiments, the delivery of cooling
fluid is optional, and the method does not include the act of
delivering cooling fluid.
[0161] After the lesion 3020 has been created, the elongate member
26 may be removed from the catheter 61a, and a substance 2030 may
then be delivered to the target site through the lumen of the
catheter 61a (FIG. 23F). In some embodiments, the removal of the
elongate member 26 from the catheter 61a may be accomplished by
receiving a user input at the workstation 2, which generates a user
signal in response to the user input. The user signal is
transmitted to the controller, which then generates a control
signal in response to the user signal. The control signal causes
the elongate member manipulator 24 to turn its roller(s) to thereby
retract the elongate member 26 proximally until the entire elongate
member 26 is out of the lumen of the catheter 61a.
[0162] In some embodiments, the substance 2030 may be an embolic
material for blocking supply of blood to the target site. In other
embodiments, the substance 2030 may be a drug, such as a
chemotherapy drug, for further treating tissue at the target site.
In further embodiments, the substance 2030 may be one or more
radioactive seeds for further treating tissue at the target site
through radiation emitted from the radioactive seed(s). In other
embodiments, the delivery of the substance 2030 may be optional,
and the method may not include the act of delivering the substance
2030.
[0163] In some embodiments, if there is another target tissue
(e.g., tumor) that needs to be treated, any or all of the above
actions may be repeated. For example, in some embodiments, after
the first tumor has been ablated, the distal end of the catheter
61a may be steered to point to another direction, and the elongate
member 26 may be deployed out of the catheter 61a again to ablate
the second tumor. Also, in other embodiments, the catheter 61a may
be moved distally or retracted proximally along the length of the
vessel 2000 to reach different target sites.
[0164] In other embodiments, instead of the telescopic
configuration, the robotic system 10 may be configured to drive the
catheter 61a and the sheath 62a in other configurations. For
example, in some embodiments, the sheath 62a may be bent and acts
as guide for directing the catheter 61a to move in a certain
direction. In such cases, the robotic system 10 may be configured
to relax the wires in the catheter 61a so that the catheter 61a is
flexible as it is advanced distally inside the lumen of the sheath
62a. Also, in other embodiments, the sheath 62a may not be involved
in the method. In such cases, the robotic system 10 may be
configured to drive the catheter 61a without the sheath 62a to
advance the catheter 61a through the vasculature of the
patient.
[0165] Also, in other embodiments, a guidewire may be used in
combination with the catheter 61a and/or the sheath 62a for
advancement of the catheter 61a and/or the sheath 62a inside the
vessel of the patient. In such cases, the elongate member 26 is not
inserted into the catheter 61a. Instead, the guidewire is coupled
to the elongate member manipulator 24, and the guidewire is placed
inside the lumen of the catheter 61a. The manipulator 24 may then
be used to drive the guidewire to advance and/or retract the
guidewire. In some cases, the robotic system 10 may advance the
guidewire, the catheter 61a, and the sheath 62a in a telescopic
configuration, as similarly discussed.
[0166] If a guidewire is initially used to access the interior of
the patient, the guidewire may be later exchanged for the elongate
member 26. For example, in some embodiments, the guidewire may be
exchanged for the elongate member 26 after initial access of the
main hepatic artery (or vein). After the distal end of the catheter
61a reaches the target site, the guidewire may then be removed from
the lumen of the catheter 61a, and decoupled from the elongate
member manipulator 24. The proximal end of the elongate member 26
is coupled to the elongate member manipulator 24, and the elongate
member 26 is then inserted into the lumen of the catheter 61a. The
elongate member manipulator 24 is then used to drive the elongate
member 26 distally until the distal end 2300 of the elongate member
26 exits out of the distal end of the catheter 61a, as similarly
discussed.
[0167] In further embodiments, the elongate member 26 may not be
needed to treat tissue. For example, in other embodiments, after
the distal end of the catheter 61a is desirably placed at a target
site, the catheter 61a may then be used to deliver a substance
(e.g., an agent, a drug, radioactive seed(s), embolic material,
etc.) to treat tissue at the target site without ablating the
tissue. In some embodiments, the catheter 61a itself may be
directly used to deliver the substance. In other embodiments,
another delivery device (e.g., a tube) may be placed inside the
lumen of the catheter 61a, and the delivery device is then used to
deliver the substance. In such cases, the catheter 61a is used
indirectly for the delivery of the substance.
[0168] In some embodiments, during the treatment method, a
localization technique may be employed to determine a location of
the instrument inside the patient's body. The term "localization"
is used in the art in reference to systems for determining and/or
monitoring the position of objects, such as medical instruments, in
a reference coordinate system. In one embodiment, the instrument
localization software is a proprietary module packaged with an
off-the-shelf or custom instrument position tracking system, which
may be capable of providing not only real-time or near real-time
positional information, such as X-Y-Z coordinates in a Cartesian
coordinate system, but also orientation information relative to a
given coordinate axis or system. For example, such systems can
employ an electromagnetic based system (e.g., using electromagnetic
coils inside a device or catheter body). Other systems utilize
potential difference or voltage, as measured between a conductive
sensor located on the pertinent instrument and conductive portions
of sets of patches placed against the skin, to determine position
and/or orientation. In another similar embodiment, one or more
conductive rings may be electronically connected to a
potential-difference-based localization/orientation system, along
with multiple sets, preferably three sets, of conductive skin
patches, to provide localization and/or orientation data.
Additionally, "Fiberoptic Bragg grating" ("FBG") sensors may be
used to not only determine position and orientation data but also
shape data along the entire length of a catheter or shapeable
instrument. In other embodiments, imaging techniques may be
employed to determine a location of the instrument inside the
patient's body. For examples, x-ray, ultrasound, computed
tomography, MRI, etc., may be used in some embodiments.
[0169] In other embodiments not comprising a localization system to
determine the position of various components, kinematic and/or
geometric relationships between various components of the system
may be utilized to predict the position of one component relative
to the position of another. Some embodiments may utilize both
localization data and kinematic and/or geometric relationships to
determine the positions of various components. The use of
localization and shape technology is disclosed in detail in U.S.
Patent application Ser. Nos.: 11/690,116, 11/176,598, 12/012,795,
12/106,254, 12/507,727, 12/822,876, 12/823,012, and 12/823,032, the
entirety of all of which is incorporated by reference herein for
all purposes.
[0170] Also, in one or more embodiments described herein, the
system may further include a sterile barrier positioned between the
drive assembly and the elongate member holder, wherein the drive
assembly is configured to transfer rotational motion, rotational
motion, or both, across the sterile barrier to the rotary members
to generate the corresponding linear motion of the elongate member
along the longitudinal axis of the elongate member, rotational
motion of the elongate member about the longitudinal axis, or both
linear motion and rotational motion.
[0171] As illustrated in the above embodiments, the robotic
technique and system 10 for treating liver tissue is advantageous
because it allows the ablation device to reach certain part(s) of
the liver through the vessel that may otherwise not be possible to
reach using conventional rigid ablation probe. For example, in some
embodiments, using the robotic system 10 and the above technique
may allow the distal end of the elongate member 26 to reach the
lobus quatratus or the lobus spigelii of the liver, which may not
be possible to reach by conventional ablation probe. Also, using
the elongate member manipulator 24 to position the elongate member
26 is advantageous because it allows accurate positioning of the
distal end 2300 of the elongate member 26.
[0172] V. Other Clinical Applications
[0173] The different driving modes and/or different combinations of
driving modes are advantageous because they allow an elongate
instrument (catheter 61a, sheath 61b, elongate member 26, or any
combination thereof) to access any part of the vasculature. Thus,
embodiments of the system described herein may have a wide variety
of applications. In some embodiments, embodiments of the system
described herein may be used to treat thoracic aneurysm,
thoracoabdominal aortic aneurysm, abdominal aortic aneurysm,
isolated common iliac aneurysm, visceral arteries aneurysm, or
other types of aneurysms. In other embodiments, embodiments of the
system described herein may be used to get across any occlusion
inside a patient's body. In other embodiments, embodiments of the
system described herein may be used to perform contralateral gait
cannulation, fenestrated endograft cannulation (e.g., cannulation
of an aortic branch), cannulation of internal iliac arteries,
cannulation of superior mesenteric artery (SMA), cannulation of
celiac, and cannulation of any vessel (artery or vein). In further
embodiments, embodiments of the system described herein may be used
to perform carotid artery stenting, wherein the tubular member may
be controlled to navigate the aortic arch, which may involve
complex arch anatomy. In still further embodiments, embodiments of
the system described herein may be used to navigate complex iliac
bifurcations.
[0174] In addition, in some embodiments, embodiments of the system
described herein may be used to deliver a wide variety of devices
within a patient's body, including but not limited to: stent (e.g.,
placing a stent in any part of a vasculature, such as the renal
artery), balloon, vaso-occlusive coils, any device that may be
delivered over a wire, an ultrasound device (e.g., for imaging
and/or treatment), a laser, any energy delivery devices (e.g., RF
electrode(s)), etc. In other embodiments, embodiments of the system
described herein may be used to deliver any substance into a
patient's body, including but not limited to contrast (e.g., for
viewing under fluoroscope), drug, medication, blood, etc. In one
implementation, after the catheter 61a (leader) is placed at a
desired position inside the patient, the catheter 61a and the
elongate member 26 may be removed, leaving the sheath 61b to
provide a conduit for delivery of any device or substance. In
another implementation, the elongate member 26 may be removed,
leaving the catheter 61a to provide a conduit for delivery of any
device or substance. In further embodiments, the elongate member 26
itself may be used to deliver any device or substance.
[0175] In further embodiments, embodiments of the system described
herein may be used to access renal artery for treating
hypertension, to treat uterine artery fibroids, atherosclerosis,
and any peripheral artery disease. Also, in other embodiments,
embodiments of the system described herein may be used to access
the heart. In some embodiments, embodiments of the system may also
be used to deliver drug or gene therapy.
[0176] In still further embodiments, embodiments of the system
described herein may be used to access any internal region of a
patient that is not considered a part of the vasculature. For
example, in some cases, embodiments of the system described herein
may be used to access any part of a digestive system, including but
not limited to the esophagus, liver, stomach, colon, urinary tract,
etc. In other embodiments, embodiments of the system described
herein may be used to access any part of a respiratory system,
including but not limited to the bronchus, the lung, etc.
[0177] In some embodiments, embodiments of the system described
herein may be used to treat a leg that is not getting enough blood.
In such cases, the tubular member may access the femoral artery
percutaneously, and is steered to the aorta iliac bifurcation, and
to the left iliac. Alternatively, the tubular member may be used to
access the right iliac. In one implementation, to access the right
iliac, the drive assembly may be mounted to the opposite side of
the bed (i.e., opposite from the side where the drive assembly is
mounted in FIG. 1). In other embodiments, instead of accessing the
inside of the patient through the leg, the system may access the
inside of the patient through the arm (e.g., for accessing the
heart).
[0178] In any of the clinical applications mentioned herein, the
telescopic configuration of the catheter 61a and the sheath 61b
(and optionally the elongate member 26) may be used to get past any
curved passage way in the body. For example, in any of the clinical
applications mentioned above, a guidewire placed inside the
catheter 61a may be advanced first, and then followed by the
catheter 61a, and then the sheath 61b, in order to advance the
catheter 61a and the sheath 61b distally past a curved (e.g., a
tight curved) passage way. Once a target location is reached, the
guidewire may be removed from the catheter 61a, and the elongate
member 26 may optionally be inserted into the lumen of the catheter
61a. The elongate member 26 is then advanced distally until its
distal exits from the distal opening at the catheter 61a. In other
embodiments, the catheter 61a may be advanced first, and then
followed by the sheath 61b, in order to advance the catheter 61a
and the sheath 61b distally past a curved (e.g., a tight curved)
passage way. In still further embodiments, the guidewire may be
advanced first, and then followed by the catheter 61a the sheath
61b (i.e., simultaneously), in order to advance the catheter 61a
and the sheath 61b distally past a curved (e.g., a tight curved)
passage way.
[0179] Each of the individual variations described and illustrated
herein has discrete components and features which may be readily
separated from or combined with the features of any of the other
variations. Modifications may be made to adapt a particular
situation, material, composition of matter, process, process act(s)
or step(s) to the objective(s), spirit or scope of the present
application. Also, any of the features described herein with
reference to a robotic system is not limited to being implemented
in a robotic system, and may be implemented in any non-robotic
system, such as a device operated manually.
[0180] Methods recited herein may be carried out in any order of
the recited events which is logically possible, as well as the
recited order of events. Furthermore, where a range of values is
provided, every intervening value between the upper and lower limit
of that range and any other stated or intervening value in that
stated range is encompassed. Also, any optional feature described
may be set forth and claimed independently, or in combination with
any one or more of the features described herein.
[0181] All existing subject matter mentioned herein (e.g.,
publications, patents, patent applications and hardware) is
incorporated by reference herein in its entirety except insofar as
the subject matter may conflict with that described herein (in
which case what is present herein shall prevail). The referenced
items are provided solely for their disclosure prior to the filing
date of the present application. Nothing herein is to be construed
as an admission that any claimed invention is not entitled to
antedate such material by virtue of prior invention.
[0182] Reference to a singular item, includes the possibility that
there are plural of the same items present. More specifically, as
used herein and in the appended claims, the singular forms "a,"
"an," "said" and "the" include plural referents unless the context
clearly dictates otherwise. It is further noted that the claims may
be drafted to exclude any optional element. As such, this statement
is intended to serve as antecedent basis for use of such exclusive
terminology as "solely," "only" and the like in connection with the
recitation of claim elements, or use of a "negative" limitation.
Unless defined otherwise, all technical and scientific terms used
herein have the same meaning as commonly understood by one of
ordinary skill in the art in the field of this application.
[0183] Although particular embodiments have been shown and
described, it will be understood that they are not intended to
limit the claimed inventions, and it will be obvious to those
skilled in the art having the benefit of this disclosure that
various changes and modifications may be made. The specification
and drawings are, accordingly, to be regarded in an illustrative
rather than restrictive sense. The claimed inventions are intended
to cover alternatives, modifications, and equivalents.
* * * * *