U.S. patent application number 13/839967 was filed with the patent office on 2014-09-18 for vascular remote catheter manipulator.
The applicant listed for this patent is Hansen Medical, Inc.. Invention is credited to Alan Yu.
Application Number | 20140276647 13/839967 |
Document ID | / |
Family ID | 51530843 |
Filed Date | 2014-09-18 |
United States Patent
Application |
20140276647 |
Kind Code |
A1 |
Yu; Alan |
September 18, 2014 |
VASCULAR REMOTE CATHETER MANIPULATOR
Abstract
A robotic instrument driver for elongate members includes a
first elongate member, and at least one manipulator mechanism
configured to manipulate the first elongate member, and at least
one articulating drive configured to articulate the first elongate
member, positionable on a bed and beside a patient access site. The
manipulator and articulating drive are positioned relative to each
other a distance less than the insertable length of the first
elongate member, stationary in position.
Inventors: |
Yu; Alan; (Union City,
CA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Hansen Medical, Inc. |
Mountain View |
CA |
US |
|
|
Family ID: |
51530843 |
Appl. No.: |
13/839967 |
Filed: |
March 15, 2013 |
Current U.S.
Class: |
604/528 |
Current CPC
Class: |
A61M 25/0113 20130101;
A61B 2017/00292 20130101; A61B 34/30 20160201; A61B 2034/304
20160201; A61B 2034/301 20160201 |
Class at
Publication: |
604/528 |
International
Class: |
A61M 25/01 20060101
A61M025/01 |
Claims
1. A robotic instrument driver for elongate members, comprising: a
first elongate member; and at least one manipulator mechanism
configured to manipulate the first elongate member; and at least
one articulating drive configured to articulate the first elongate
member, positionable on a bed and beside a patient access site,
wherein the manipulator and articulating drive are positioned
relative to each other a distance less than the insertable length
of the first elongate member, stationary in position.
2. The robotic instrument drive of claim 1 wherein the feed axis is
configured to change the orientation of the first elongate member
when the first elongate member is disposed within the feed
mechanism.
3. The robotic instrument driver of claim 1, further comprising a
second elongate member, and a second manipulator mechanism wherein
the second elongate member is coaxially disposed within the first
elongate member along a catheter axis, and the second manipulator
mechanism is configured to manipulate the second elongate
member.
4. The robotic instrument driver of claim 3, further comprising a
second articulating drive wherein the second articulating drive is
configured to articulate the second elongate member.
5. The robotic instrument driver of claim 4, further comprising a
third elongate member, and a third manipulator mechanism wherein
the third elongate member is coaxially disposed within the second
elongate member along a catheter axis, and the third manipulator
mechanism is configured to manipulate the third elongate
member.
6. The robotic instrument driver of claim 5, wherein the first,
second and third manipulator mechanisms may be operated
independently so as to move the second elongate member
independently of the first or third elongate members.
7. The robotic instrument driver of claim 5, wherein the axis of
the first and second elongate members are laterally spaced apart
from and is parallel to the feed axis of the manipulator such that
the first and second elongate members are bent 180.degree..
8. The robotic instrument driver of claim 5, further comprising of
a movable carriage, wherein the carriage is configured to
articulate the second elongate member, wherein the carriage is
movable independent from the first elongate member.
9. The instrument driver of claim 5 where the second elongate
member can be inserted or removed telescopically through the first
elongate member over the third elongate without the third elongate
member moving relative to the first elongate member.
10. The robotic instrument driver of claim 1, wherein the
manipulator mechanism is fixed to a lateral side edge of the
robotic instrument driver.
11. The robotic instrument driver of claim 1, wherein the
manipulator mechanisms are mounted to the instrument driver such
that the manipulator mechanism may be selectively rotated towards
the manipulator as the elongate member is advanced to reduce the
length of the elongate member outside the patient.
12. The robotic instrument driver of claim 1, wherein the feed
mechanism is mounted on a shaft that extends from the instrument
driver, wherein the feed mechanism is configured to pivot with
respect to an axis extending through the shaft.
13. The robotic instrument driver of claim 1, further comprising: a
robotic instrument driver, a first splayer and a second splayer,
wherein the first splayer and second splayer are operatively
engaged with the robotic instrument driver, and wherein the first
splayer articulates the first elongate member, and the second
splayer articulates the second elongate member, and wherein the at
least one manipulator mechanism further comprises at least a first
and a second manipulator mechanism, the first manipulator mechanism
being positioned between the first splayer and the second splayer
and configured to orient the first elongate member approximately
180.degree. from the second elongate member operational axis so as
to be coaxial with the first elongate member operational axis; and
wherein the second manipulator mechanism is positioned distally of
the first splayer and is configured to orient the first elongate
member about 180.degree. from the first elongate member operational
axis so as to be coaxial with a feed axis that is oriented parallel
to the first elongate member operational axis.
14. The robotic instrument driver of claim 12, wherein the first,
second and third manipulator mechanisms may be operated
independently so as to move the guide catheter independently of the
catheter sheath and move the guide wire independently of the guide
catheter and the catheter sheath.
15. The robotic instrument driver of claim 1, further comprising: a
robotic instrument driver, a sheath splayer and a guide splayer,
wherein the sheath splayer and guide splayer are operatively
engaged with the robotic instrument driver, and wherein the sheath
splayer carries the catheter sheath, and the guide splayer carries
the guide catheter, and wherein the guide catheter is positioned
over the sheath splayer in a stacked relationship, and wherein the
guide catheter is defined by a catheter sheath operational axis and
the guide splayer is defined by an guide catheter operational axis,
wherein the sheath operational axis and guide catheter operational
axis are oriented parallel to one another and spaced apart from one
another, and wherein the at least one feed mechanism further
comprises at least a first and a second feed mechanism, the first
feed mechanism being positioned between an entrance of the sheath
splayer and an exit of the guide splayer and configured to orient
the guide catheter about 180.degree. from the guide catheter
operational axis so as to be coaxial with the catheter sheath
operational axis; and wherein the second feed mechanism is
positioned distally of the sheath splayer and is configured to
orient the sheath catheter about 180.degree. from the catheter
sheath operational axis so as to be coaxial with a feed axis that
is oriented parallel to the catheter sheath operational axis.
16. The robotic instrument driver of claim 14, wherein the first
and second feed mechanisms may be operated independently so as to
move the guide catheter independently of the catheter sheath.
17. The robotic instrument driver of claim 14, further comprising a
third feed mechanism disposed proximally of the guide splayer and
defining a third feed axis that is coaxial with guide catheter
operational axis, wherein the third feed mechanism operatively
engages a guide wire.
18. The robotic instrument driver of claim 14, wherein the first,
second and third feed mechanisms may be operated independently so
as to move the guide catheter independently of the catheter sheath
and move the guide wire independently of the guide catheter and the
catheter sheath.
19. The robotic instrument driver of claim 14, wherein the first
feed mechanism is mounted on a shaft that extends from the
instrument driver, wherein the feed mechanism is configured to
pivot with respect to an axis extending through the shaft.
Description
BACKGROUND
[0001] Robotic interventional systems and devices are well suited
for 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. Advances
in technology have led to significant changes in the field of
medical surgery such that less invasive surgical procedures, in
particular, minimally invasive surgery (MIS), are increasingly
popular.
[0002] MIS is generally defined as surgery that is performed by
entering the body through the skin, a body cavity, or an anatomical
opening utilizing small incisions rather than large, open incisions
in the body. With MIS, it is possible to achieve less operative
trauma for the patient, reduced hospitalization time, less pain and
scarring, reduced incidence of complications related to surgical
trauma, lower costs, and a speedier recovery.
[0003] MIS devices and techniques have advanced to the point where
an elongated catheter instrument is controllable by selectively
operating tensioning control elements within the catheter
instrument. In one example, a remote catheter manipulator (RCM) or
robotic instrument driver utilizes four opposing directional
control elements which extend to the distal end of the catheter.
When selectively placed in and out of tension, the opposing
directional control elements may cause the distal end to steerably
maneuver within the patient. Control motors are coupled to each of
the directional control elements so that they may be individually
controlled and the steering effectuated via the operation of the
motors in unison.
[0004] At least two types of catheters may be employed for surgical
procedures. One type includes an electrophysiology (EP) catheter
that only requires a navigating distance of 15 cm or less. EP
catheters also may be relatively thick and stiff and thus, due
their short navigating length and high stiffness, EP catheters
typically do not suffer from a tendency to buckle during use.
[0005] In comparison to EP procedures, vascular procedures include
a greater amount of catheter insertion length, a greater number of
catheter articulation degrees of freedom (DOFs), and a mechanism
for manipulation of a guide wire. For that reason, known bedside
systems provides mounting for splayer actuation hardware configured
to provide the catheter insertion lengths, mounting which accounts
for an increase in splayer size due to added DOFs, and mounting for
a guide wire manipulator. Thus, vascular catheters typically
include a relatively long stroke, such as one meter or more.
Relative to EP catheters, vascular catheters are typically smaller,
thinner and more flexible, and therefore have a greater tendency to
buckle than EP catheters. As such, it is typically desirable to
feed vascular catheters into the patient with minimal bending to
reduce the tendency to buckle. Known vascular robotic catheter
systems are therefore typically suspended over the patient that is
lying prone on a bed.
[0006] A vascular catheter (elongate member) catheter system
typically includes elongate members that include an outer catheter
(sheath), an inner catheter (leader), and a guidewire. Each is
separately controllable and therefore they can telescope with
respect to one another. For instance, a sheath carriage controls
operation of the sheath and is moveable about a generally axial
motion along the patient, and a leader carriage controls operation
of the guidewire and is likewise moveable about the generally axial
direction of the patient. Typically, the leader carriage and the
sheath carriage are positioned on a remote catheter manipulator
(RCM), which is supported by a setup joint (SUJ). Because the
sheath carriage and leader carriage are traditionally aligned along
the insertion axis, this configuration results in the RCM taking up
significant space and the RCM being restricted to a specific
orientation and alignment based on the insertion location. The SUJ
is typically positioned on a rail that is itself mounted to the
bed, below which the patient is positioned.
[0007] The RCM typically carries the weight of both carriages as
well as the other hardware that are used to operate the system.
And, to provide a full stroke, the SUJ is passed through the full
range of motion which, as stated, can exceed one meter. To do so,
typically the SUJ is moved or rotated with respect to the rail and
the rail is stationary. For this reason, a bedside system is
typically included that provides mounting for splayer actuation
hardware configured to provide catheter insertion lengths, and
mounting for a guide wire manipulator. Because this hardware is
supported by the SUJ, the system can not only be cumbersome to work
with, but it can interfere with other system operation (such as the
C-arm and monitors), as well as provide significant weight that is
carried by the bed.
[0008] However, in some clinical situations, it is difficult, if
not impossible to orient the RCM such that it is aligned along the
insertion axis. For instance, in some MIS procedures an imaging
device may be required in addition to the RCM. In order for the
imaging device to scan the entire body, the RCM should be oriented
so that it is not obstructing the imaging devices ability to
capture the entire body. For example, if the insertion location is
at the patient's thigh and catheter is directed towards the
patient's heart, the current RCM configuration would require the
RCM to be located at the base of the patient's bed below their
feet. The likelihood of the catheter buckling between the RCM and
the insertion location also increases as the distance between the
RCM and the insertion location increases and often requires more
than one person to assist in operation of the RCM, especially
during tool exchanges.
[0009] As such, there is a need for an improved catheter system
that can handle functional challenges experienced with long
catheters and provides greater flexibility with regard to the
orientation of the RCM with regard to the insertion axis. There is
also a need to for an improved catheter system that operates over a
smaller footprint and weighs less.
SUMMARY
[0010] A medical device comprising a sheath catheter and at least
one feed mechanism is disclosed herein. The feed mechanism includes
a pair of radially arranged drive wheels opposite one another, each
wheel having a wheel rotation axis. The drive wheels cooperate to
define a feed axis along which the sheath catheter is advanced and
retracted. The feed axis is oriented generally orthogonal to the
wheel rotation axes. The feed axis is configured to change the
orientation of the sheath catheter when the sheath catheter is
disposed within the feed mechanism.
[0011] An alternative configuration for a medical apparatus
comprises a robotic instrument driver, a sheath splayer and a guide
splayer. The sheath splayer and guide splayer are operatively
engaged with the robotic instrument driver. The sheath splayer
carries the catheter sheath, and the guide splayer carries the
sheath catheter. The sheath splayer is defined by a catheter sheath
operational axis and the guide splayer is defined by a guide
catheter operational axis, wherein the sheath operational axis and
guide catheter operational axis are oriented parallel to one
another and laterally spaced apart from one another. First and
second feed mechanisms are also provided. The first feed mechanism
is positioned between the sheath splayer and the guide splayer and
configured to orient the guide catheter about 180.degree. from the
guide catheter operational axis so as to be coaxial with the
catheter sheath operational axis. The second feed mechanism is
positioned distally of the sheath splayer and is configured to
orient the sheath catheter about 180.degree. from the catheter
sheath operational axis so as to be coaxial with a feed axis that
is oriented parallel to the catheter sheath operational axis.
[0012] A further alternative configuration of a medical device
comprises a robotic instrument driver, a sheath splayer and a guide
splayer. The sheath splayer and guide splayer are operatively
engaged with the robotic instrument driver. The sheath splayer
carries the sheath catheter, and the guide splayer carries the
guide catheter. The guide splayer is positioned over the sheath
splayer in a stacked relationship. The sheath catheter is defined
by a sheath catheter operational axis and the guide splayer is
defined by a guide catheter operational axis and the sheath
operational axis and guide operational axis are oriented parallel
to one another and spaced apart from one another. First and second
feed mechanisms are also provided. The first feed mechanism is
positioned between an entrance of the sheath splayer and an exit of
the guide splayer and configured to orient the guide catheter about
180.degree. from the guide catheter operational axis so as to be
coaxial with the catheter sheath operational axis. The second feed
mechanism is positioned distally of the sheath splayer and is
configured to orient the sheath catheter about 180.degree. from the
catheter sheath operational axis so as to be coaxial with a feed
axis that is oriented parallel to the catheter sheath operational
axis.
BRIEF DESCRIPTION OF THE DRAWINGS
[0013] While the claims are not limited to a specific illustration,
an appreciation of the various aspects is best gained through a
discussion of various examples thereof. Referring now to the
drawings, exemplary illustrations are shown in detail. Although the
drawings represent the illustrations, the drawings are not
necessarily to scale and certain features may be exaggerated to
better illustrate and explain an innovative aspect of an example.
Further, the exemplary illustrations described herein are not
intended to be exhaustive or otherwise limiting or restricted to
the precise form and configuration shown in the drawings and
disclosed in the following detailed description. Exemplary
illustrations are described in detail by referring to the drawings
as follows:
[0014] FIG. 1 illustrates an exemplary robotic surgical system.
[0015] FIG. 2 is an illustration of an exemplary catheter assembly
of the surgical system of FIG. 1.
[0016] FIG. 3 is a schematic plan view of an embodiment of a
robotically controlled medical apparatus.
[0017] FIG. 4A illustrates a schematic plan view of a robotically
controlled medical apparatus having a selectively positionable feed
mechanism.
[0018] FIG. 4B is a partial elevational view of a distal end of the
robotically controlled medical apparatus of FIG. 4A.
[0019] FIG. 5 illustrates a schematic plan view of an alternative
configuration for a robotically controlled medical apparatus having
operational axes of catheter splayers and guide splayers oriented
parallel to one another.
[0020] FIG. 6 illustrates a schematic plan view of an alternative
configuration for a robotically controlled medical apparatus of
FIG. 5, wherein the catheter splayer and guide splayer are
configured as a combined unit.
[0021] FIG. 7 illustrates a schematic perspective view of an
alternative configuration for an exemplary robotically controlled
medical apparatus including a guide splayer and sheath splayer
assembled together in a stacked relationship.
[0022] FIG. 8A-8C illustrates an exemplary process for removing a
tool from the robotically controlled medical apparatus of FIG.
5.
DETAILED DESCRIPTION
[0023] Referring to FIG. 1, a robotic surgical system 100 is
illustrated in which an apparatus, a system, and/or method may be
implemented according to various exemplary illustrations. System
100 may include a robotic catheter assembly 102 having a sheath
instrument 104 and/or a catheter instrument 106. Catheter assembly
102 is controllable using a robotic instrument driver 108
(generally referred to as "instrument driver"). During use, a
patient is positioned on an operating table or surgical bed 110 to
which robotic instrument driver 108 is coupled or mounted. In the
illustrated example, system 100 includes an operator workstation
112, an electronics rack 114 including a control system, such as a
computer (not shown). In some instances, a setup joint mounting
brace 116 may be used to support the robotic catheter assembly 102.
In certain procedures, a surgeon is seated at operator workstation
112 and can monitor the surgical procedure, patient vitals, and
control one or more catheter devices.
[0024] Operator workstation 112 may include a computer monitor to
display a three dimensional object, such as a catheter displayed
within or relative to a three dimensional space, such as a body
cavity or organ, e.g., a chamber of a patient's heart. In one
example, an operator uses one or more input devices 120 to control
the position of a catheter or other elongate instrument. In
response to actuation of the input device by a user, the input
device can output positioning information for the desired position
of the catheter instrument, including the three-dimensional spatial
position of the distal end of a steerable catheter. System
components, including the operator workstation, electronics rack
and the instrument driver, may be coupled together via a plurality
of cables or other suitable connectors 118 to provide for data
communication, or one or more components may be equipped with
wireless communication components to reduce or eliminate cables
118. Communication between components may also be implemented over
a network or over the internet. In this manner, a surgeon or other
operator may control a surgical instrument while located away from
or remotely from radiation sources. Because of the option for
wireless or networked operation, the surgeon may even be located
remotely from the patient in a different room or building.
[0025] An exemplary instrument driver 108 is illustrated in FIG. 2.
The instrument driver 108 may robotically insert/retract a leader
catheter 103 relative to a sheath catheter 105. To this end, the
proximal ends of sheath catheter 105 and leader catheter 103 are
mechanically interfaced to a housing of the instrument driver 108
in such a manner that the sheath and leader catheters 105, 103 may
be axially translated relative to each other via operation of
motors, thereby effecting insertion or retraction movements of the
respective sheath catheter 105 and leader catheter 103. In the
illustrated embodiment, the sheath catheter 105 and leader catheter
103 respectively include proximal steering adapters 104, 106
("splayers") mounted to associated mounting plates 202, 204 on a
top portion of the instrument driver 108. The mounting plate 202 is
affixed to the distal end of the instrument driver 108, whereas the
mounting plate 204 is affixed to a carriage (not shown) within the
housing of the instrument driver 108 that can be translated
relative to the mounting plate 202 via one or more motors (not
shown) within the housing of the instrument driver 1, thereby
allowing the splayer 106 to be translated relative to the splayer
104, and thus, the associated leader catheter 103 to be
inserted/retracted within the sheath catheter 105. In the
illustrated embodiment, each of the splayers 104, 106 can be
actuated via motors (not shown) within the housing of the
instrument driver 108 to deflect or articulate the distal ends of
the respective catheters 103, 104 in any direction.
[0026] It is desirable to have the instrument driver 108 positioned
close to the patient for a number of reasons, including, for
example to facilitate tool removal over the table 110 rather than
risk tools falling to the floor. However, the instrument drivers
108 are generally heavy, due to the internal components required to
advance and articulate the catheters. Moreover, for procedures
where a relatively long stroke of a catheter is used, the
instrument driver 108 has a sufficient length to operate the
catheter system. Thus, known systems use a setup joint 116 to
support the instrument driver 108 close to the patient. The
positioning of the instrument driver 108 on the setup joint,
however, may lead to other issues, such as blocking intra-operative
imaging equipment, such as a C-arm or monitor (not shown).
[0027] Further, certain issues are experienced when tool exchanges
are required during a procedure. For example, therapeutic tools are
inserted into the sheath catheter 105. To accomplish this task, the
guide catheter 103 is removed from the sheath catheter 105. A
separate guide wire (not shown) is also included, but the tool is
advanced over the guide wire for delivery, which takes two
people.
[0028] To address some of these issues, alternative arrangements of
the guide and sheath splayers are proposed herein, which serve to
minimize the length and weight of the instrument driver, thereby
eliminating the requirement of a SUJ, and even permitting the
instrument driver to be mounted directly to a bed rail. Moreover,
the exemplary arrangements disclosed herein also provide for
positioning of the instrument driver close to the patient, thus
permitting the instrument driver to be positioned adjacent an
introducer.
[0029] Referring to FIG. 3, a first exemplary configuration will be
described. FIG. 3 illustrates a schematic plan view of an exemplary
configuration of an instrument driver 308. A guide splayer 306 and
a sheath splayer 304 are operatively mounted to the instrument
drive 308. Guide splayer 306 is mounted on a carriage 313 that can
translate relative to sheath splayer 304. Operatively connected to
the guide splayer 306 is a guide catheter 303, and operatively
connected to the sheath splayer 304 is a sheath catheter 305. The
carriage 313 inserts the guide catheter 303 into the sheath
catheter 305. A guide wire 307 may extend proximally of the guide
splayer 306 and further include a guide wire manipulator 309.
[0030] In the embodiment illustrated in FIG. 3, sheath splayer 304
and guide splayer 306 are arranged to be generally aligned along a
common axis A-A. In this manner, the guide catheter 303 is
positioned within the sheath catheter 305, such that the guide
catheter 303 and the sheath catheter 305 are arranged in a coaxial
manner. Although splayers 304 and 306 are axially aligned, movement
of guide catheter 303 and catheter sheath 305 can be controlled and
manipulated independently, as will be explained in further detail
below. The instrument driver 308 articulates guide and sheath
splayer driveshafts by motors positioned in the rear of the
instrument driver 308.
[0031] In the exemplary arrangement illustrated in FIG. 3, as the
sheath catheter 305 exits the sheath splayer 304, the sheath
catheter 305 is positioned within a manipulator or feed mechanism
330. This manipulator 330 may be configured to advance, retract or
roll sheath catheter 305. It may also be configured to orientate
the sheath catheter 305 such that it bends 180.degree. into the
feed mechanism 330. More specifically, the mechanism 330 is
oriented such that an axis B-B extending through the mechanism 330
is generally parallel with the axis A-A along which the sheath and
guide splayers 304, 306 are arranged. The sheath catheter 305 exits
the mechanism 330 and can be directed into an introducer 335. This
configuration permits a compact design, which can reduce the
required length of the instrument driver 308, and also allow for
easy draping of the surgical system. Surgical draping is in
reference to the use of a curtain, bag, cloth or other acceptable
sterile items that may be utilized to separate a sterile area from
an unsterile area. It is advantageous to be able to place a
surgical drape over items that are difficult to clean or items that
need to be in the sterile field but are not sterile. By placing a
surgical drape over these items, these items are prevented from
coming into contact with sterile items. For example, the instrument
driver 308 contains delicate and sensitive parts, so by placing a
surgical drape over the instrument driver 308, it will not come
into contact with blood or other contaminating materials and may
not require cleaning.
[0032] In one embodiment, the manipulator mechanism 330 includes
two radially oppositely arranged drive wheels 340. The drive wheels
340 may include an idle wheel 342 and an active wheel 344. The
drive wheels 340 are each configured to rotate about an axes C-C
that are orthogonal to the feed mechanism axis B-B. In one
exemplary arrangement, the feed mechanism 330 may be fixedly
connected to the instrument driver 308, along a side surface of the
instrument driver 308. This configuration permits the feed
mechanism to be placed next to the axis A-A so as to minimize
wasted catheter length. As the drive wheels 340 are rotated in a
first direction, the feed mechanism 330 serves to propel the sheath
catheter 305, the guide catheter 303 inserted therein, and the
guide wire 307 toward the patient. As the drive wheels 340 are
rotated in a second direction, the catheter assembly is moved away
from the patient. A similar manipulator mechanism (not shown)
disposed within the instrument driver 308 proximal of the sheath
splayer 304 serves to propel guide catheter 303. This manipulation
may also involve insertion retraction or roll of the guide catheter
relative to the sheath. In addition, a similar manipulator
mechanism (not shown) disposed within the instrument driver 308
proximal of the leader splayer 306, or disposed proximal of
instrument driver 308 (as shown) serves to propel the guide wire
307. It should be understood that sheath catheter 305, guide
catheter 303 and guide wire 307 may all be manipulated
independently from each other. Manipulation may involve insertion,
retraction and roll for all 3 manipulators but preferred
embodiments involve just insertion and retract for the sheath and
guide manipulators and insertion, retraction and roll for the
guidewire manipulator. It should be understood that while drive
wheels are shown for the sheath manipulator 330 and a gripping pad
309 is shown for the guidewire manipulator, any active drive or
manipulation device such as rotating pads, grippers, rollers,
chucks etc. may be used in all cases
[0033] In one alternative embodiment, the manipulator 330 may be
configured to pitch with respect to the drive wheels axes C-C,
while the sheath splayer 304 and guide splayer 306 remain generally
level with respect to the table 110. With this configuration, the
opposing drive wheels 340 may be configured to selectively adjust
an insertion angle of the catheter assembly as the catheter sheath
305 passes through the manipulator 340.
[0034] An alternative configuration of an instrument driver 408 is
illustrated in FIG. 4A. Instrument driver 408 is substantially
similar to the instrument driver 308 of FIG. 3 and may include
corresponding features identified with reference numerals in the
400 series. More specifically, the instrument driver 408 includes a
guide splayer 406 and a sheath splayer 404 operatively connected
thereto. A guide catheter 403 is connected to the guide splayer 406
and the catheter sheath 405 is operatively connected to the sheath
splayer 404. The guide splayer 406 is installed on a slidable
carriage 413 that translates relative to sheath splayer 404. A
guide catheter manipulator (not shown) is placed proximal to the
sheath splayer to manipulate the guide catheter A guide wire 407
may extend proximally from the guide splayer 406 and further
include a guide wire manipulator 409.
[0035] In the exemplary arrangement illustrated in FIG. 4A, as the
sheath catheter 405 exits the sheath splayer 404, the sheath
catheter 405 is positioned within a manipulator 430. However, in
this embodiment, the manipulator 430 is connected to the instrument
driver 408 such that the manipulator 430 may be selectively rotated
about axis A-A along an arc. In one exemplary arrangement, the feed
mechanism 430 may be mounted to a shaft 433 that is secured to a
wheel 437 (shown in FIG. 4B) mounted for rotation about an axis
D-D. With this configuration, feed mechanism 430 may be selectively
repositioned from one side of the instrument driver 408 to the
other, as illustrated by feed mechanism 440 displayed in phantom in
FIG. 4A. The selective positioning of feed mechanism 440 allows for
repositioning of the instrument driver 408 during a procedure to
clear the surgical site so as to allow for fluoroscopy imaging. The
selective positioning of feed mechanism 440 also allows for
selective placement of the instrument driver 408 on either side of
patient.
[0036] In another exemplary arrangement, sheath splayer 404 may
rotate about an axis D-D to minimize wasted length on the sheath
catheter. For example, as sheath 405 is inserted into the patient,
via manipulator 409, the sheath splayer 404 may be configured to
rotate toward the manipulator to minimize the length of catheter
outside of the patient.
[0037] In one exemplary arrangement, the manipulator 430 may be
configured to pitch with respect to an axis E-E that extends
through the shaft 433, while the sheath splayer 404 and guide
splayer 406 remain generally level with respect to the table 110.
With this configuration, the opposing drive wheels 440 may be
configured to selectively adjust an insertion angle of the catheter
assembly as the catheter sheath 405 passes through the mechanism
440.
[0038] An alternative configuration of an instrument driver 508 is
illustrated in FIG. 5. Instrument driver 508 has similar elements
to the instrument driver 408 of FIG. 4 and may include
corresponding features identified with reference numerals in the
500 series. More specifically, the instrument driver 508 includes
guide splayer 506 and a sheath splayer 504 operatively connected
thereto. A guide catheter 503 is connected to the guide splayer 506
and the catheter sheath 505 is operatively connected to the sheath
splayer 504. A guide wire 507 may extend proximally of the guide
splayer 506 and further include a guide wire manipulator 560.
[0039] The configuration of the instrument driver 508 in FIG. 5
differs from the arrangements shown in FIGS. 3-4 in that the guide
splayer 506 and the sheath splayer 504 are arranged parallel to one
another, as opposed to in-line with one another. In addition, the
guide splayer 506 does not translate relative to sheath splayer
504. The guide catheter 503 bends 180.degree. and feeds into the
sheath splayer 504 by a guide manipulator mechanism 550 that is
disposed at the entrance of the sheath splayer 504. The sheath
catheter 505 also bends 180.degree., but in the opposite direction
than the guide catheter 503, such that the catheter assembly is
arranged in a general "S-shape". The sheath catheter 505 feeds into
an introducer 535 by a sheath manipulator mechanism 540.
[0040] The guide feed mechanism 550 is configured to orient the
guide catheter 503 such that it bends 180.degree. into the guide
mechanism 550. More specifically, the mechanism 550 is oriented
such that an axis extending through the guide mechanism 550 is
generally coaxial with an axis A'-A' along which the sheath splayer
504 is positioned. The sheath mechanism 540 is configured to orient
the sheath catheter 505 such that it bends 180.degree. into the
sheath mechanism 540. More specifically, the sheath mechanism 540
is oriented such that an axis B-B extending through the sheath
mechanism 540 is generally parallel to the axis A'-A' along which
the sheath splayer 504 is positioned at the start of a procedure.
The sheath splayer 504 may be configured to rotate towards
manipulator 540 as the sheath 505 is inserted through introducer
535 and the available sheath length outside the patient gets
shorter.
[0041] A guidewire manipulator mechanism 560 is positioned adjacent
an entrance to the guide splayer 506. The guidewire mechanism 560
is oriented such that an axis extending through the guide feed
mechanism 560 is generally coaxial with an axis A.sup.2-A.sup.2
along which the guide splayer 506 is positioned. The guidewire
manipulator 560 may also be configured to insert, retract and roll
a guidewire. It should be understood that the feed roller
embodiment of the guidewire manipulator 560 shown here and the
gripper embodiment 409 shown above are representative embodiments
of active drive manipulators. Any of these manipulation mechanisms
may be used in any of the configurations.
[0042] The orientation of the sheath and guide splayers 504, 506
eliminates a linear insertion axis of the catheter sheath 505 and
guide catheter 503, thereby reducing the size of the instrument
driver 508. Reducing the size of the instrument driver 508 lends
itself to a simple surgical drape of the catheter system.
[0043] The configuration of a catheter system with three different
manipulator mechanisms 540, 550, 560 also allows the guide wire
507, guide catheter 503 and/or the sheath catheter 505 to be
propelled or held in place individually. More specifically, the
sheath mechanism 540 may be configured to insert, retract or roll
the sheath catheter 505. The guide mechanism 550 inserts, retracts
or rolls the guide catheter 503 and the guide wire mechanism 560
inserts, retracts or rolls guidewire 507. Thus, the combination of
the three feed mechanisms 540, 550, and 560 allows the guide wire
507, sheath catheter 505, and/or guide catheter 503 (as shown in
FIG. 5) to be propelled or held in place individually, altering the
shape of the catheter system relative to a tip of the guide wire
507.
[0044] In such fashion and in one example, a robotic instrument
driver for elongate members 508 includes a first elongate member
505, and at least one manipulator mechanism 540 configured to
manipulate the first elongate member 505, and at least one
articulating drive 504 configured to articulate the first elongate
member 505, positionable on a bed 110 and beside a patient access
site, wherein the manipulator 540 and articulating drive 504 are
positioned relative to each other a distance less than the
insertable length of the first elongate member, stationary in
position. That is, a distance between manipulator 540 (and
particularly between wheels 542, 544) and articulating drive 504 is
less than a length of the first elongate member 505 that passes
between them--i.e., the insertable length.
[0045] In one exemplary configuration, the sheath mechanism 540 may
be configured to pitch with respect to an axis B-B that is
generally transverse to the feed axis B-B, while the sheath splayer
504 and guide splayer 506 remain generally level with respect to
the table 110. With this configuration, opposing drive wheels 542,
544 may be configured to selectively adjust an insertion angle of
the catheter assembly as the catheter sheath 505 passes through the
catheter feed mechanism 540.
[0046] The configuration in FIG. 5 also provides for ease of tool
exchange during an intra-operative procedure. In fact, tool
exchange can be performed by a single individual with the
configuration set forth in FIG. 5, allowing for improved workflow.
The tool exchange operation will be explained in further detail
below.
[0047] Referring to FIG. 6, another alternative configuration for
an exemplary instrument driver 608 is illustrated. Instrument
driver 608 is substantially similar to the instrument driver 508 of
FIG. 5 and may include corresponding features identified with
reference numerals in the 600 series. However, the instrument
driver 608 includes a combined sheath splayer 604/guide splayer
606, which are oriented in a parallel manner creating an S-shape
catheter configuration similar to that which is shown and discussed
above in connection with FIG. 5.
[0048] Referring to FIG. 7, a further exemplary arrangement of for
an instrument driver 708 will now be described. Instrument driver
708 is similar to the configuration of instrument driver 608 of
FIG. 6 and may include corresponding features identified with
reference numerals in the 700 series. The instrument driver 708 has
the guide splayer 706 and sheath splayer 704 stacked on top of one
another. Stacking the guide splayer 706 on top of the sheath
splayer 704 may further reduce the size of the instrument driver
708 as compared to other configurations. The guider catheter 703,
as it exits the guide splayer 706, bends approximately 180.degree.
to where it is received by the sheath manipulator mechanism 750 and
directed into the sheath splayer 704, orienting the guide catheter
703 in a generally vertical C-shape guide. The catheter sheath 705
exits the sheath splayer 704 and bends approximately 180.degree. to
where it is received by the sheath mechanism 740, orienting the
catheter sheath 705 in a generally horizontal C-shape.
[0049] Referring to FIG. 8A-8C, an exemplary process for removing
guide 503 or any other tool robotically or manually from the sheath
catheter 505 will now be explained. For ease of description, the
configuration of the instrument driver 508 will be used to explain
the tool exchange process. FIGS. 8A-C illustrate the instrument
driver 508 including guide or tool 503 connected to the guide
splayer 506, sheath splayer 504, catheter manipulator mechanism 540
and tool (guide) manipulator mechanism 550 arranged so as to
configure the catheter system in a generally S-shape configuration.
To remove the guide or tool 503, the tool 503 and the guide wire
507 are both pulled in unison in direction R. In other words, the
guide wire is inserted into the tool or guide at the same rate as
the tool or guide is retracted from the sheath. This action will
cause the guide wire 507 to be pulled through the guide splayer
506, as indicated by the phantom lines. This results in maintaining
the tip of the guidewire in a fixed position relative to the sheath
or relative to the patient. Once the guide catheter 503 is free
from the sheath splayer 504, clamping or pinching 810 of the tool
(guide) feed mechanism 550 may be applied to the wire 507 at the
rear of the sheath splayer 504 to hold the tip of the wire 507 at
the distal end thereof (located in the introducer 535 and thus not
visible). The guide or tool may then be slid along the guide wire
507, until the guide or tool 503 is free from the guide wire 507,
thereby removing the guide or tool 503 from the instrument driver
508. Once the guide or tool 503 is removed from the guide wire 507,
a new tool may be installed over the guide wire 507. A similar but
opposite sequence of moves enables the new tool to be loaded
robotically into the sheath 505. This time, the guidewire 507 is
retracted through manipulator 560 at the same rate as the new tool
is inserted through manipulator 550 resulting in the distal tip of
the wire not moving relative to the patient. The ability to change
tools may allow the user to perform multiple procedures without
having to remove the catheter sheath 505 from the patient between
procedures. For example, a patient may require multiple therapeutic
devices to be delivered at the same location. The ability to
maintain the tip of the guide wire 507 at a deployed location in
the body after a first tool is delivered allows the user to switch
the tool 503 and insert the second therapeutic device without
removing the entire catheter. Using a robotic system to exchange
tools enable the tool exchange procedure to be carried out without
image guidance such as fluoroscopy. With a manual procedure, the
doctor would need to retract the guide with one hand at the same
rate as he is inserting the wire with the other hand to ensure the
wire tip stays in a fixed position. It is not possible for a human
to coordinate movement of both hands reliably with long catheters
and so fluoroscopic guidance is used to ensure the wire is not
moving. Fluoroscopic imaging exposes doctors and staff to
significant radiation. A robotic system with active drive
manipulators as described here addresses this issue
[0050] With regard to the processes, systems, methods, heuristics,
etc. described herein, it should be understood that, although the
steps of such processes, etc. have been described as occurring
according to a certain ordered sequence, such processes could be
practiced with the described steps performed in an order other than
the order described herein. It further should be understood that
certain steps could be performed simultaneously, that other steps
could be added, or that certain steps described herein could be
omitted. In other words, the descriptions of processes herein are
provided for the purpose of illustrating certain embodiments, and
should in no way be construed so as to limit the claims.
[0051] Accordingly, it is to be understood that the above
description is intended to be illustrative and not restrictive.
Many embodiments and applications other than the examples provided
would be apparent upon reading the above description. The scope
should be determined, not with reference to the above description,
but should instead be determined with reference to the appended
claims, along with the full scope of equivalents to which such
claims are entitled. It is anticipated and intended that future
developments will occur in the technologies discussed herein, and
that the disclosed systems and methods will be incorporated into
such future embodiments. In sum, it should be understood that the
application is capable of modification and variation.
[0052] All terms used in the claims are intended to be given their
broadest reasonable constructions and their ordinary meanings as
understood by those knowledgeable in the technologies described
herein unless an explicit indication to the contrary in made
herein. In particular, use of the singular articles such as "a,"
"the," "said," etc. should be read to recite one or more of the
indicated elements unless a claim recites an explicit limitation to
the contrary.
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