U.S. patent application number 13/687294 was filed with the patent office on 2014-05-29 for method of anchoring pullwire directly articulatable region in catheter.
This patent application is currently assigned to HANSEN MEDICAL, INC.. The applicant listed for this patent is HANSEN MEDICAL, INC.. Invention is credited to Joseph Bogusky.
Application Number | 20140148673 13/687294 |
Document ID | / |
Family ID | 50773857 |
Filed Date | 2014-05-29 |
United States Patent
Application |
20140148673 |
Kind Code |
A1 |
Bogusky; Joseph |
May 29, 2014 |
METHOD OF ANCHORING PULLWIRE DIRECTLY ARTICULATABLE REGION IN
CATHETER
Abstract
A catheter comprises a flexible polymer catheter body including
a proximal shaft section and a distal working section, a wire
support structure embedded within the distal working section of the
catheter body, a proximal adapter mounted to the proximal shaft
section of the catheter body, and a wire disposed within the
catheter body. The wire has a proximal end and a distal end. The
proximal end of the wire being operably connected to the proximal
adapter, and the distal end of the wire is anchored to the wire
support structure.
Inventors: |
Bogusky; Joseph; (San Jose,
CA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
HANSEN MEDICAL, INC. |
Mountain View |
CA |
US |
|
|
Assignee: |
HANSEN MEDICAL, INC.
Mountain View
CA
|
Family ID: |
50773857 |
Appl. No.: |
13/687294 |
Filed: |
November 28, 2012 |
Current U.S.
Class: |
600/374 ;
29/455.1; 29/825; 604/526; 604/527; 604/95.04 |
Current CPC
Class: |
A61B 18/1492 20130101;
A61M 25/0012 20130101; Y10T 29/49117 20150115; A61M 25/0052
20130101; A61M 2025/015 20130101; A61M 25/0147 20130101; A61B 34/30
20160201; A61M 2025/0161 20130101; Y10T 29/49879 20150115; A61B
2034/301 20160201; A61M 2209/01 20130101; A61M 2205/50
20130101 |
Class at
Publication: |
600/374 ;
604/526; 604/527; 604/95.04; 29/455.1; 29/825 |
International
Class: |
A61M 25/00 20060101
A61M025/00; A61B 5/042 20060101 A61B005/042; A61M 25/01 20060101
A61M025/01 |
Claims
1. A catheter, comprising: a flexible polymer catheter body
including a proximal shaft section and a distal working section; a
wire support structure embedded within the distal working section
of the catheter body; a proximal adapter mounted to the proximal
shaft section of the catheter body; and a wire disposed within the
catheter body, the wire having a proximal end operably connected to
the proximal adapter, and a distal end anchored to the wire support
structure.
2. The catheter of claim 1, wherein the wire support structure is a
braided tubular structure.
3. The catheter of claim 1, wherein the wire support structure is a
coiled structure.
4. The catheter of claim 1, wherein the wire support structure
comprises a plurality of tubular layers, wherein the distal end of
the wire is anchored between the tubular layers of the wire support
structure.
5. The catheter of claim 1, further comprising a lumen disposed
within the catheter body, wherein the wire is a pullwire extending
through the lumen, the distal working section of the catheter body
is a distal articulatable section, and the proximal adapter is a
proximal steerable interface that is manipulatable to selectively
tension the pullwire to bend the distal articulating section.
6. The catheter of claim 1, further comprising an electrode mounted
to the distal working section of the catheter body, wherein the
wire is an electrical wire, the distal end of which is electrically
coupled to the electrode.
7. The catheter of claim 1, wherein the cross-sectional shape of
the catheter body is either circular or rectangular.
8. The catheter of claim 1, further comprising a lumen extending
through the catheter body.
9. A method of constructing a catheter, comprising: disposing a
wire support structure over an inner polymer tube; disposing at
least one outer polymer tube over the wire support structure and
wire; applying heat to the melt the at least one outer polymer
tube, thereby flowing the at least one melted outer polymer tube
into the wire support structure; allowing the at least one melted
outer polymer tube to solidify, thereby integrating the wire
support structure, inner polymer tube, and at least one solidified
outer polymer tube together into a catheter body; disposing a wire
through the catheter body; and anchoring a distal end of the wire
to the wire support structure at a distal end of the catheter
body.
10. The method of claim 9, wherein the wire support structure is
disposed on the inner polymer tube by braiding filament onto the
inner polymer tube.
11. The method of claim 9, wherein the wire support structure
comprises a plurality of tubular layers, wherein the distal end of
the wire is anchored between the tubular layers of the wire support
structure.
12. The method of claim 9, further comprising: mounting a proximal
adapter to a proximal end of the catheter body; and operatively
coupling a proximal end of the wire to the proximal adapter.
13. The method of claim 9, further comprising disposing a barrier
over the wire support structure prior to melting the at least one
outer tube, wherein the melting temperature of the barrier is
greater than the temperature of the heat applied to the at least
one outer polymer tube, and removing the barrier from the catheter
body subsequent to allowing the at least one melted outer tube to
solidify, thereby exposing a portion of the wire support structure,
wherein the distal end of the wire is anchored to the exposed
portion of the wire support structure.
14. The method of claim 13, wherein the barrier is a tubular
barrier, and the exposed portion of the wire support structure is
cylindrical.
15. The method of claim 13, further comprising: disposing another
outer polymer tube over the exposed cylindrical portion of the wire
support structure; melting the other polymer tube, thereby flowing
the other outer polymer tube into the exposed cylindrical portion
of the wire support structure; and allowing the other melted outer
polymer tube to solidify.
16. The method of claim 9, further comprising forming a lumen
within the catheter body, wherein the wire is a pullwire extending
through the lumen, and the proximal adapter is a proximal steerable
interface.
17. The method of claim 16, wherein forming a lumen within the
catheter body comprises disposing a process mandrel over the inner
polymer tube prior to melting the at least one outer tube, and
removing the process mandrel from the catheter body subsequent to
allowing the at least one melted outer tube to solidify; and
wherein disposing the wire through the catheter body comprises
threading the wire through the lumen.
18. The method of claim 9, wherein the wire is an electrical wire,
and the method further comprises forming an electrode to the
catheter body in electrical communication with the wire.
19. The method of claim 18, wherein forming the electrode on the
catheter body comprises disposing a barrier over the wire support
structure prior to melting the at least one outer tube, removing
the barrier from the catheter body subsequent to allowing the at
least one melted outer tube to solidify, thereby exposing a portion
of the wire support structure, and disposing the electrode on the
exposed portion of the wire support structure.
20. The method of claim 9, wherein anchoring the distal end of the
wire to the wire support structure comprising soldering, welding,
brazing, or gluing the distal end of the wire to the wire support
structure.
21. The method of claim 9, wherein the inner polymer tube has a
lumen extending therethrough.
Description
FIELD OF INVENTION
[0001] The invention relates generally to minimally-invasive
instruments and systems, such as manually or robotically steerable
catheter systems, and more particularly to steerable catheter
systems for performing minimally invasive diagnostic and
therapeutic procedures.
BACKGROUND
[0002] Minimally invasive procedures are preferred over
conventional techniques wherein the patient's body cavity is open
to permit the surgeon's hands access to internal organs. Thus,
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 accessed via
naturally-occurring pathways, such as blood vessels, other lumens,
via surgically-created wounds of minimized size, or combinations
thereof.
[0003] Currently known minimally invasive procedures for the
treatment of cardiac, vascular, and other disease conditions use
manually or robotically actuated instruments, which may be inserted
transcutaneously into body spaces such as the thorax or peritoneum,
transcutaneously or percutaneously into lumens such as the blood
vessels, through natural orifices and/or lumens such as the mouth
and/or upper gastrointestinal tract, etc. Manually and
robotically-navigated interventional systems and devices, such as
steerable catheters, are well suited for performing a variety of
minimally invasive procedures. Manually-navigated catheters
generally have one or more handles extending from their proximal
end with which the operator may steer the pertinent instrument.
Robotically-navigated catheters may have a proximal interface
configured to interface with a catheter driver comprising, for
example, one or more motors configured to induce navigation of the
catheter in response to computer-based automation commands input by
the operator at a master input device in the form of a work
station.
[0004] In the field of electrophysiology, robotic catheter
navigation systems, such as the Sensei.RTM. Robotic Catheter System
(manufactured by Hansen Medical, Inc.), have helped clinicians gain
more catheter control that accurately translates the clinician's
hand motions at the workstation to the catheter inside the
patient's heart, reduce overall procedures (which can last up to
four hours), and reduce radiation exposure due to fluoroscopic
imaging necessary to observe the catheter relative to the patient
anatomy, and in the case of electrophysiology, within the relevant
chamber in the heart. The Sensei.RTM. Robotic Catheter System
employs a steerable outer catheter and a steerable inner
electrophysiology (EP) catheter, which can be manually introduced
into the patient's heart in a conventional manner. The outer and
inner catheters are arranged in an "over the wire" telescoping
arrangement that work together to advance through the tortuous
anatomy of the patient. The outer catheter, often referred to as a
guiding sheath, provides a steerable pathway for the inner
catheter. Proximal adapters on the outer guide sheath and inner EP
catheter can then be connected to the catheter driver, after which
the distal ends of the outer sheath and inner EP catheter can be
robotically manipulated in the heart chamber within six degrees of
freedom (axial, roll, and pitch for each) via operation of the
Sensei.RTM. Robotic Catheter System.
[0005] While the Sensei.RTM. Robotic Catheter System is quite
useful in performing robotic manipulations at the operational site
of the patient, it is desirable to employ robotic catheter systems
capable of allowing a physician to access various target sites
within the human vascular system. In contrast to the Sensei.RTM.
Robotic Catheter System, which is designed to perform robotic
manipulations within open space (i.e., within a chamber of the
heart) after the outer guide sheath and inner catheter are manually
delivered into the heart via a relatively non-tortuous anatomical
route (e.g., via the vena cava), and therefore may be used in
conjunction with sheaths and catheters that are both axially and
laterally rigid, robotic catheter systems designed to facilitate
access to the desired target sites in the human vascular system
require simultaneous articulation of the distal tip with continued
insertion or retraction of an outer guide sheath and an inner
catheter. As such, the outer guide sheath and inner catheter should
be laterally flexible, but axially rigid to resist the high axial
loads being applied to articulate the outer guide sheath or inner
catheter, in order to track through the tortuous anatomy of the
patient. In this scenario, the inner catheter, sometimes called the
leader catheter extends beyond the outer sheath and is used to
control and bend a guide wire that runs all the way through the
leader catheter in an over-the-wire configuration. The inner
catheter also works in conjunction with the outer guide sheath and
guide wire in a telescoping motion to inchworm the catheter system
through the tortuous anatomy. Once the guide wire has been
positioned beyond the target anatomical location, the leader
catheter is usually removed so that a therapeutic device can be
passed through the steerable sheath and manually operated.
[0006] Increasing the lateral flexibility of the sheath and
catheter, however, introduces catheter navigation problems that may
not otherwise occur when the sheath and catheter are laterally
stiff. For example, many steerable catheters available today rely
on the capability of the user to articulate the distal end of the
catheter to a desired anatomical target. The predominant method for
articulating the distal end of a catheter is to circumferentially
space a multitude of free floating pullwires (e.g., four pullwires)
into the wall of the catheter and attach them to a control ring
embedded in the distal end of the catheter. The anchoring of each
pullwire to the control ring is usually performed by soldering,
welding, brazing, or gluing the pullwire to the control ring. If
four pullwires are provided, the pullwires may be orthogonally
spaced from each other. Each of these pullwires are offset from the
center line of the catheter, and so when the wires are tensioned to
steer the catheter tip, the resulting compressive forces cause the
distal tip of the catheter to articulate in the direction of the
pullwire that is tensioned. However, the compressive forces on the
relatively flexible catheter shaft also cause undesired
effects.
[0007] For example, the axial compression on the catheter shaft
during a steering maneuver that bends the distal end of the
catheter may cause undesired lateral deflection in the catheter
shaft, thereby rendering the catheter mechanically unstable.
[0008] As another example, the curvature of the catheter shaft may
make the articulation performance of the catheter unrepeatable and
inconsistent. In particular, because the pullwires are offset from
the neutral axis of the catheter shaft, bending the catheter shaft
will tighten the pullwires on the outside of the curve, while
slackening the pullwires on the inside of the curve. As a result,
the amount of tension that should be applied to the pullwires in
order to effect the desired articulation of the catheter distal end
will vary in accordance with the amount of curvature that is
already applied to the catheter.
[0009] As still another example, when bent, the articulate catheter
distal end will tend to curve align with the catheter shaft. In
particular, as shown in FIGS. 1A and 1B, operating or tensioning a
pullwire on the outside edge of a bend may cause the catheter to
rotate or twist as the pullwire may tend to rotate the distal
articulating section of the catheter until the pullwire is at the
inside edge of the bend. This rotation or twist phenomenon or
occurrence is known as curve alignment.
[0010] That is, when the proximal shaft section of the catheter is
curved (as it tracked through curved anatomy), and the distal
section is required to be articulated in a direction that is not
aligned with the curvature in the shaft, a wire on the outside of
the bend is pulled, as shown in FIG. 1A. A torsional load (T) is
applied to shaft as tension increases on the pull-wire on the
outside of the bend. This torsional load rotates the shaft until
the wire being pulled is on the inside of the bend, as shown in
FIG. 1B. In effect, the tensioned wire on the outside of the bend
will take the path of least resistance, which may often be to
rotate the shaft to the inside of the bend rather than articulate
the tip of the catheter adequately.
[0011] This un-intentional rotation of the shaft causes instability
of the catheter tip and prevents the physician from being able to
articulate the catheter tip in the direction shown in FIG. 1A. That
is, no matter which direction the catheter tip is intended to be
bent, it will ultimately bend in the direction of the proximal
curve. The phenomenon is known as curve alignment because the wire
that is under tension is putting a compressive force on both the
proximal and distal sections and so both the proximal and distal
curvature will attempt to align in order to achieve lowest energy
state. The operator may attempt to roll the entire catheter from
the proximal end in order to place the articulated distal tip in
the desired direction. However, this will placed the tensioned
inside pullwire to the outside of the proximal bend causing further
tensioning of the pullwire, and possibly causing the distal end of
the catheter to whip around.
[0012] All of these mechanical challenges contribute to the
instability and poor control of the catheter tip, as well as
increased catheter tracking forces. Some steerable catheters
overcome these problems by increasing the axial stiffness of the
entire catheter shaft (e.g., by varying wall thickness, material
durometer, or changing braid configuration) or alternatively by
incorporating axially stiff members within the catheter shaft to
take the axial load. But these changes will also laterally stiffen
the catheter shaft, thereby causing further difficulties in
tracking the catheter through the vasculature of the patient.
Therefore, the catheter designer is faced with having to make a
compromise between articulation performance and shaft tracking
performance. Other steerable catheters overcome this problem by
using free floating coil pipes in the wall of the catheter to
respectively housing the pullwires (as described in U.S. patent
application Ser. No. 13/173,994, entitled "Steerable Catheter",
which is expressly incorporated herein by reference), thereby
isolating the articulation loads from the catheter shaft. However,
the use of coil pipes adds to the cost of the catheter and takes up
more space in the result, resulting in a thicker catheter wall.
Furthermore, because the relatively stiff coil pipes are spaced
away from the neutral axis of the catheter, its lateral stiffness
may be unduly increased.
[0013] There, thus remains a need to provide a different means for
minimizing the above-described mechanical challenges in a laterally
flexible, but axially rigid, catheter.
[0014] Furthermore, although a single region of articulation is
typically sufficient to allow a user to track and steer the
catheter though the vasculature, it is sometimes inadequate for
tortuous anatomies, navigation of larger vessels, or for providing
stability during therapy deployment.
[0015] For example, it may be desirable to access either the right
coronary artery or the left coronary artery from the aorta of the
patient in order to remove a stenosis in the artery by, e.g.,
atherectomy, angioplasty, or drug delivery. The proximal curve of a
catheter may be pre-shaped in a manner that locates the distal end
of the catheter in an optimal orientation to access the ostium of
the right coronary artery via the aorta, as shown in FIG. 2A.
However, in the case where it is desirable to access the ostium of
the left coronary artery, the proximal curve of the catheter
locates the distal end of the catheter too far from the left
coronary artery, which therefore cannot be easily accessed via
manipulation of the distal end of the catheter, as shown in FIG.
2B. Alternatively, the proximal curve of a catheter may be
pre-shaped in a manner that locates the distal end of the catheter
in an optimal orientation to access the ostium of the left coronary
artery via the aorta, as shown in FIG. 2C. However, in the case
where it is desirable to access the ostium of the left coronary
artery, the proximal curve of the catheter locates the distal end
of the catheter too close to the right coronary artery, such that
the distal end would be seated too deeply within the ostium of the
right coronary artery, as shown in FIG. 2D. Thus, it can be
appreciated that multiple catheters may have to be used to treat
both the left coronary artery and right coronary artery, thereby
increasing the cost and time for the procedure.
[0016] To complicate matters even further, the articulating distal
end of the catheter needs to be long enough to cross the aorta from
the patient right side to the left coronary artery. However, there
are varying anatomies in the population with respect to the
positioning of the left coronary artery in the aorta. For example,
FIG. 3A illustrates the proximal curve required for a catheter to
place the distal end within the ostium of the left coronary artery
in a "normal" anatomy; FIG. 3B illustrates the proximal curve
required for a catheter to place the distal end within the ostium
of the left coronary artery in a "wide" anatomy; and FIG. 3C
illustrates the proximal curve required for a catheter to place the
distal end within the ostium of the left coronary artery in an
"unfolded" anatomy. It can be appreciated that, even if is desired
to only treat the left coronary artery, the clinician may have to
be supplied with multiple catheters, one of which can only be used
for the particular anatomy of the patient.
[0017] One way to address this problem in conventional catheters is
to have multiple unique or independent regions of articulation in
the catheter shaft by, e.g., adding a control ring and a set of
pullwires for each articulation region. Thus, both a proximal
region and a distal region of the catheter can be articulated. When
manufacturing a catheter within only a single region of
articulation, this task is not overly complex, typically requiring
a single lamination of a polymer extrusion to form an outer jacket
over an inner polymer tube (or liner) and the installation of the
control ring with associated pullwires onto the assembly. A braided
material can be installed between the inner polymer tube and outer
polymer jacket to provide select region of the catheter with
increased rigidity.
[0018] However, when manufacturing a catheter that has two regions
of articulation, this task can be difficult and usually requires
the lamination of an outer polymer jacket extrusion up to the
proximal articulation region, then the installation of the most
proximal control ring with attached pullwires, and then the
lamination of an outer polymer jacket for the remaining portion of
the catheter. For catheters with more than two regions of
articulation, this process would have to be repeated for each and
every additional region of articulation. Another issue with respect
to the use of control rings is that the laminated polymer extrusion
or extrusions need to be carefully sized at the control ring, since
the ring itself consumes volume in the wall that not only requires
thinner extrusions so as to not have a bulge in the catheter at the
control ring, but also creates a significantly stiffer region the
length of the control ring, which causes a "knuckle" where there
should be a gradual stiffness change required to achieve good
catheter performance during tracking through the vasculature.
[0019] There, thus, remains a need to provide a more efficient
means for anchoring the distal ends of the pullwires at the
articulating region or regions of a catheter.
[0020] As briefly mentioned above, the inner catheter and guide
wire may be arranged in an "over-the-wire" configuration. However,
such a configuration requires the guide wire to be at least twice
as long as the inner catheter in order to allow the user to
continuously hold the guide wire in place as the inner catheter is
removed from the outer guide sheath. For example, the inner
catheter can have a length up to 160 cm, with 140 cm of the
catheter being inside the patient. Therefore, to ensure that the
position of the guide wire is maintained, the physician will
typically require a guide wire to be over 300 cm long. However,
guide wires longer than 300 cm are not readily available in sterile
catheter laboratories. Additionally, long guide wires require an
extra assistant at the bedside to manage the guide wire and ensure
it remains in a fixed position and always remains sterile.
Furthermore, such a configuration disadvantageously increases the
length of the robot required to axially displace the guide wire
within the inner catheter to the fullest extent. The increased size
of the robot may be impractical and too big and heavy to be mounted
on a table in a catheter lab environment. Additionally, because the
inner catheter passes entirely "over-the-wire," the inner catheter
cannot be robotically removed while holding the guide wire in
place. Instead, the physician needs to remove the guide wire from
the robot, and then slide the inner catheter proximally while
holding the position of the guide wire fixed. The procedure time
for removing the inner catheter from the outer guide sheath is
increased for an over-the wire configuration (typically greater
than one minute), thereby increasing fluoroscopic time and
radiation exposure to the physician and staff.
[0021] A "rapid exchange" leader catheter would alleviate these
concerns. Rapid exchange catheter designs have been described and
documented in balloon angioplasty catheters, filters, and stent
delivery system applications. These designs provide a rapid
exchange port on the distal portion of the catheter shaft, which
allows the guide wire to exit and run parallel to the proximal
portion of the catheter shaft. However, no known designs exist for
rapid exchange steerable catheters due to the challenge of
navigating the pullwires proximal of the exit port. In addition, no
known designs exist for the robotic interface for rapid exchange
catheters.
[0022] There, thus, remains a need to provide the inner steerable
catheter of a telescoping catheter assembly with a rapid exchange
architecture.
SUMMARY OF THE INVENTION 2
[0023] In accordance with one aspect of the present inventions, a
catheter comprises a flexible polymer catheter body including a
proximal shaft section and a distal working section. The
cross-sectional shape of the catheter body may be any suitable
shape, such as circular or rectangular. The catheter may optionally
comprise a lumen extending through the catheter body. The catheter
further comprises a wire support structure (e.g., a braided tubular
structure or a coiled structure) embedded within the distal working
section of the catheter body, and a proximal adapter mounted to the
proximal shaft section of the catheter body. The catheter further
comprises a wire disposed within the catheter body. The wire has a
proximal end operably connected to the proximal adapter, and a
distal end anchored to the wire support structure. The wire support
structure comprises a plurality of tubular layers, in which case,
the distal end of the wire may be anchored between the tubular
layers of the wire support structure.
[0024] In one embodiment, the catheter further comprises a lumen
disposed within the catheter body, in which case, the wire is a
pullwire extending through the lumen, the distal working section of
the catheter body is a distal articulatable section, and the
proximal adapter is a proximal steerable interface that is
manipulatable to selectively tension the pullwire to bend the
distal articulating section. In another embodiment, the catheter
further comprises an electrode mounted to the distal working
section of the catheter body, in which case, the wire is an
electrical wire, the distal end of which is electrically coupled to
the electrode.
[0025] In accordance with another aspect of the present inventions,
a method of constructing a catheter comprises disposing a wire
support structure over an inner polymer tube (e.g., one having a
lumen extending therethrough). The wire support structure may be
disposed on the inner polymer tube by braiding filament onto the
inner polymer tube. The method further comprises disposing at least
one outer polymer tube over the wire support structure and wire,
applying heat to the melt the outer polymer tube(s), thereby
flowing the melted outer polymer tube(s) into the wire support
structure. The method further comprises allowing the melted outer
polymer tube(s) to solidify, thereby integrating the wire support
structure, inner polymer tube, and solidified outer polymer tube(s)
together into a catheter body, disposing a wire through the
catheter body, and anchoring (e.g., soldering, welding, brazing, or
gluing) a distal end of the wire to the wire support structure at a
distal end of the catheter body. In one method, the wire support
structure comprises a plurality of tubular layers, in which case,
the distal end of the wire may be anchored between the tubular
layers of the wire support structure. The method may further
comprise mounting a proximal adapter to a proximal end of the
catheter body, and operatively coupling a proximal end of the wire
to the proximal adapter.
[0026] An optional method may comprise disposing a barrier over the
wire support structure prior to melting the outer tube(s), with the
melting temperature of the barrier being greater than the
temperature of the heat applied to the outer polymer tube(s). This
method may further comprise removing the barrier from the catheter
body subsequent to allowing the melted outer tube(s) to solidify,
thereby exposing a portion of the wire support structure. In this
case, the distal end of the wire is anchored to the exposed portion
of the wire support structure. The barrier may be a tubular
barrier, in which case, the exposed portion of the wire support
structure may be cylindrical. The optional method may further
comprise disposing another outer polymer tube over the exposed
cylindrical portion of the wire support structure, melting the
other polymer tube, thereby flowing the other outer polymer tube
into the exposed cylindrical portion of the wire support structure,
and allowing the other melted outer polymer tube to solidify.
[0027] Another method further comprises forming a lumen within the
catheter body, the wire is a pullwire extending through the lumen,
and the proximal adapter is a proximal steerable interface. In this
case, forming the lumen in the catheter body may comprise disposing
a process mandrel over the inner polymer tube prior to melting the
at least one outer tube, and removing the process mandrel from the
catheter body subsequent to allowing the melted outer tube(s) to
solidify, and disposing the wire through the catheter body may
comprise threading the wire through the lumen.
[0028] In still another method, the wire is an electrical wire, and
the method further comprises forming an electrode to the catheter
body in electrical communication with the wire. In this case,
forming the electrode on the catheter body may comprise disposing a
barrier over the wire support structure prior to melting the outer
tube(s), removing the barrier from the catheter body subsequent to
allowing the melted outer tube(s) to solidify, thereby exposing a
portion of the wire support structure, and disposing the electrode
on the exposed portion of the wire support structure.
[0029] Other and further aspects and features of the invention will
be evident from reading the following detailed description of the
preferred embodiments, which are intended to illustrate, not limit,
the invention.
BRIEF DESCRIPTION OF THE DRAWINGS
[0030] The drawings illustrate the design and utility of various
embodiments of the present invention, in which similar elements are
referred to by common reference numerals. In order to better
appreciate how the above-recited and other advantages and objects
of the present inventions are obtained, a more particular
description of the present inventions briefly described above will
be rendered by reference to specific embodiments thereof, which are
illustrated in the accompanying drawings. Understanding that these
drawings depict only typical embodiments of the invention and are
not therefore to be considered limiting of its scope, the invention
will be described and explained with additional specificity and
detail through the use of the accompanying drawings in which:
[0031] FIGS. 1A and 1B are plan views showing a curve alignment
phenomenon that may occur when articulating a prior art steerable
catheter;
[0032] FIGS. 2A-2D are plan views showing possible issues related
to using a prior art catheter having a single region of
articulation for accessing both the left coronary artery and a
right coronary artery of a patient's anatomy;
[0033] FIGS. 3A-3C are plan views showing possible issues related
to using a prior art catheter having a single region of
articulation for accessing different left coronary artery
anatomies;
[0034] FIG. 4 is a perspective view of a medical robotic system
constructed in accordance with one embodiment of the present
inventions;
[0035] FIG. 5 is a perspective view of a robotic catheter assembly
used in the medical robotic system of FIG. 4;
[0036] FIG. 6 is a perspective view of the catheter assembly used
in the robotic catheter assembly of FIG. 5;
[0037] FIG. 7 is a plan view of one catheter having a single region
of articulation with four pullwires for use in the catheter
assembly of FIG. 6;
[0038] FIGS. 7A-7C are cross-sectional views of the catheter of
FIG. 7, respectively taken along the lines 7A-7A, 7B-7B, and
7C-7C;
[0039] FIG. 8 is a perspective view of an adapter used to
transition pullwires from one circumferential orientation to
another circumferential orientation in the catheter of FIG. 7;
[0040] FIG. 9 is another perspective view of the adapter of FIG.
8;
[0041] FIG. 10 is a diagram showing the neutral axis of the bend in
a distal articulating section of the catheter of FIG. 7;
[0042] FIG. 11 is a cross-sectional view of the proximal shaft of
the catheter of claim 7, particularly showing the location of a
neural bending axis relative to the pullwires;
[0043] FIG. 12 is a cross-sectional view of the proximal shaft of a
prior art catheter of claim 7, particularly showing the location of
a neural bending axis relative to the pullwires;
[0044] FIG. 13 is a plan view of one catheter having a single
region of articulation with three pullwires for use in the catheter
assembly of FIG. 6;
[0045] FIGS. 13A-13C are cross-sectional views of the catheter of
FIG. 13, respectively taken along the lines 13A-13A, 13B-13B, and
13C-13C;
[0046] FIG. 14 is a perspective view of an adapter used to
transition pullwires from one circumferential orientation to
another circumferential orientation in the catheter of FIG. 13;
[0047] FIG. 15 is a top view of the adapter of FIG. 14;
[0048] FIG. 16 is another perspective view of the adapter of FIG.
14;
[0049] FIG. 17 is a plan view of a rapid exchange catheter having a
single region of articulation with four pullwires for use in the
catheter assembly of FIG. 18;
[0050] FIGS. 17A-17C are cross-sectional views of the catheter of
FIG. 17, respectively taken along the lines 17A-17A, 17B-17B, and
17C-17C;
[0051] FIG. 18 is a side view of a rapid exchange catheter assembly
that can alternatively be used in the robotic catheter assembly of
FIG. 5;
[0052] FIG. 19 is a plan view of one catheter having two regions of
articulation with four pullwires for use in the catheter assembly
of FIG. 6;
[0053] FIGS. 19A-19C are cross-sectional views of the catheter of
FIG. 19, respectively taken along the lines 19A-19A, 19B-19B, and
19C-19C;
[0054] FIGS. 20 and 21 are plan views showing one method of
accessing the left coronary artery of an anatomy using the catheter
of FIG. 19;
[0055] FIG. 20A is a cross-sectional view of the distal
articulating region of the catheter shown in FIG. 20, respectively
taken along the line 20A-20A;
[0056] FIG. 21A is a cross-sectional view of the proximal
articulating region of the catheter shown in FIG. 21, respectively
taken along the line 21A-21A;
[0057] FIGS. 22 and 23 are plan views showing one method of
accessing the right coronary artery of an anatomy using the
catheter of FIG. 19;
[0058] FIG. 22A is a cross-sectional view of the distal
articulating region of the catheter shown in FIG. 20, respectively
taken along the line 22A-22A;
[0059] FIG. 23A is a cross-sectional view of the proximal
articulating region of the catheter shown in FIG. 23, respectively
taken along the line 23A-23A;
[0060] FIGS. 24A-24C are plan views showing methods of accessing
the left coronary arteries of different anatomies using the
catheter of FIG. 19;
[0061] FIG. 25 is a plan view of another catheter having two
regions of articulation with four pullwires for use in the catheter
assembly of FIG. 6;
[0062] FIGS. 25A-25D are cross-sectional views of the catheter of
FIG. 25, respectively taken along the lines 25A-25A, 25B-25B,
25C-25C, and 25D-25D;
[0063] FIG. 26 is a plan view of a multi-bend segment of the
catheter of FIG. 25, particularly showing a distal articulation
angle and a proximal articulation angle;
[0064] FIG. 27 is a plan view showing a method of accessing a renal
artery using the catheter of FIG. 25;
[0065] FIG. 28 is a control diagram illustrating a multi-bend
algorithm that control the distal articulating section and proximal
articulating section of the catheter of FIG. 25;
[0066] FIG. 29 is a diagram illustrating the moment applied to the
transition section of the catheter of FIG. 25 caused by the
pullwires extending through the transition section;
[0067] FIGS. 30A and 30B are plan views showing one method of
accessing the right coronary artery of an anatomy using the
catheter of FIG. 25;
[0068] FIGS. 31A-31I are plan views illustrating one method of
directly anchoring a pullwire to the braid of a steerable
catheter;
[0069] FIG. 32 is a plan view illustrating one embodiment of a
braiding machine that can be used to braid a catheter for use in
the catheter assembly of FIG. 6;
[0070] FIGS. 33A and 33B are front views of interchangeable nose
cones that can be used in the braiding machine of FIG. 32;
[0071] FIG. 34 is a plan view illustrating another embodiment of a
braiding machine that can be used to braid a catheter for use in
the catheter assembly of FIG. 6;
[0072] FIG. 35 is a front view of a nose cone that can be used in
the braiding machine of FIG. 34;
[0073] FIG. 36 is a perspective view of an iris assembly that can
be used in the nose cone of FIG. 35;
[0074] FIG. 37 is a side view of the iris assembly of FIG. 36;
[0075] FIG. 38 is an axial view of the iris assembly of FIG. 36,
particularly showing the iris assembly in a first position that
groups three wire mandrels circumferentially adjacent each
other;
[0076] FIG. 39 is an axial view of the iris assembly of FIG. 36,
particularly showing the iris assembly in a second position that
spaces three wire mandrels equidistant from each other;
[0077] FIG. 40 is an axial view of a first iris plate for use in
the iris assembly of FIG. 36;
[0078] FIG. 41 is an axial view of a second iris plate for use in
the iris assembly of FIG. 36; and
[0079] FIG. 42 is an axial view of a third iris plate for use in
the iris assembly of FIG. 36.
DETAILED DESCRIPTION OF THE ILLUSTRATED EMBODIMENTS
[0080] Referring to FIG. 4, one embodiment of a robotic catheter
system 10 constructed in accordance with the present invention will
now be described. The system 10 generally comprises an operating
table 12 having a movable support-arm assembly 14, an operator
control station 16 located remotely from the operating table 12,
and a robotic catheter assembly 18 mounted to the support-arm
assembly 14 above the operating table 12. Exemplary robotic
catheter systems that may be modified for constructing and using
embodiments of the present invention are disclosed in detail in the
following U.S. patent applications, which are all expressly
incorporated herein by reference in their entirety: U.S. patent
application Ser. No. 11/678,001, filed Feb. 22, 2007; U.S. patent
application Ser. No. 11/073,363, filed Mar. 4, 2005; U.S. patent
application Ser. No. 11/179,007, filed Jul. 6, 2005; U.S. patent
application Ser. No. 11/418,398, filed May 3, 2006; U.S. patent
application Ser. No. 11/481,433, filed Jul. 3, 2006; U.S. patent
application Ser. No. 11/637,951, filed Dec. 11, 2006; U.S. patent
application Ser. No. 11/640,099, filed Dec. 14, 2006; U.S. Patent
Application Ser. No. 60/833,624, filed Jul. 26, 2006; and U.S.
Patent Application Ser. No. 60/835,592, filed Aug. 3, 2006.
[0081] The control station 16 comprises a master input device 20
that is operatively connected to the robotic catheter assembly 18.
A physician or other user 22 may interact with the master input
device 20 to operate the robotic catheter assembly 18 in a
master-slave arrangement. The master input device 20 is connected
to the robotic catheter assembly 18 via a cable 24 or the like,
thereby providing one or more communication links capable of
transferring signals between the control station 16 and the robotic
catheter assembly 18. Alternatively, the master input device 20 may
be located in a geographically remote location and communication is
accomplished, at least in part, over a wide area network such as
the Internet. The master input device 20 may also be connected to
the robotic catheter assembly 18 via a local area network or even
wireless network that is not located at a geographically remote
location.
[0082] The control station 16 also comprises one or more monitors
26 used to display various aspects of the robotic instrument system
10. For example, an image of the sheath and leader catheter
(described in further detail below) may be displayed in real time
on the monitors 26 to provide the physician 22 with the current
orientation of the various devices as they are positioned, for
example, within a body lumen or region of interest. The control
station 16 further comprises a processor in the form of a computer
28, which may comprise a personal computer or other type of
computer work station for accurately coordinating and controlling
actuations of various motors within robotic catheter assembly
18.
[0083] The support-arm assembly 14 is configured for movably
supporting the robotic catheter assembly 18 above the operating
table 12 to provide convenient access to the desired portions of
the patient (not shown) and provide a means to lock the catheter
assembly 18 into position subsequent to the preferred placement. In
this embodiment, the support-arm assembly 14 comprises a series of
rigid links 30 coupled by electronically braked joints 32, which
prevent joint motion when unpowered, and allow joint motion when
energized by the control station 16. In an alternative embodiment,
the rigid links 30 may be coupled by more conventional mechanically
lockable joints, which may be locked and unlocked manually using,
for example, locking pins, screws, or clamps. The rigid links 30
preferably comprise a light but strong material, such as high-gage
aluminum, shaped to withstand the stresses and strains associated
with precisely maintaining three-dimensional position of the weight
of the catheter assembly 18.
[0084] Referring further to FIGS. 5 and 6, the robotic catheter
assembly 18 will now be described in detail. The robotic catheter
assembly 18 comprises a robotic instrument driver 34, a robotic
guide sheath 36, a robotic leader catheter 38, and a guide wire 40
mounted to the instrument driver 34 in a coaxial relationship. The
robotic catheter assembly 18 may also include a drape (not shown)
that covers the instrument driver 34. As will be described in
further detail below, the instrument driver 34 provides robotic
steering actuation, as well as robotic insertion and retraction
actuation, to the guide sheath 36, working catheter 38, and guide
wire 40 in accordance with control signals transmitted from the
control station 16 (shown in FIG. 4). The guide sheath 36 generally
includes a sheath body 42 having a proximal end 44 and a distal end
46, as well as a proximal interface in the form of a guide sheath
steering adapter 48 ("splayer") operably coupled to the proximal
end 44 of the sheath body 42. The leader catheter 38 generally
includes a catheter body 50 having a proximal end 52 and a distal
end 54, as well as a proximal interface in the form of a leader
catheter steering adapter 56 operably mounted to the proximal end
52 of the catheter body 50. The guide wire 40 generally includes a
guide wire body 58 having a proximal end 60 and a distal end
62.
[0085] The instrument driver 34 comprises a housing 64 that
contains motors (not shown). The respective adapters 48, 56 and the
proximal end 60 of the guide wire body 58 are mechanically
interfaced to the housing 64 in such a manner that they may be
axially displaced relative to each other via operation of the
motors, thereby effecting insertion or retraction movements of the
respective guide sheath 36, leader catheter 38, and guide wire 40
relative to each other, and thus, relative to the operating table
12 (shown in FIG. 4).
[0086] To this end, the guide sheath 36 comprises a working lumen
(not shown in FIGS. 5 and 6) that extends all the way through the
sheath body 42. The geometry and size of the working lumen will be
selected in accordance with the cross-sectional geometry and size
of the lead catheter 38. The sheath body 42 may be composed of a
low-friction inner layer (e.g., a coating of silicone or
polytetrafluoroethylene) to provide a low-friction surface to
accommodate movement of the leader catheter 38 within the working
lumen. The lead catheter 38 passes through the lumen of the guide
sheath 36, and is thus, moveable relative thereto. As shown in
FIGS. 5 and 6, the leader catheter 38 projects distally with
respect to the distal end 46 of the sheath body 42. Of course, the
leader catheter 38 may be withdrawn proximally such that its distal
end 54 is substantially flush with the distal end 46 of the sheath
body 42, or withdrawn proximally even further such that its distal
end 54 is disposed within the distal end 46 of the sheath body 42.
The leader catheter 38 may be movably positioned within the working
lumen of the guide sheath 36 to enable relative insertion of the
two devices, relative rotation, or "roll" of the two devices, and
relative steering or bending of the two devices relative to each
other, particularly when the distal end 54 of the leader catheter
38 is inserted beyond the distal tip of the guide sheath 36.
[0087] Similarly, the leader catheter 38 comprises a working lumen
(not shown in FIGS. 5 and 6) that extends at least partially
through the catheter body 50. The geometry and size of the working
lumen will be selected in accordance with the cross-sectional
geometry and size of the guide wire 40. The catheter body 50 may be
composed of a low-friction inner layer (e.g., a coating of silicone
or polytetrafluoroethylene) to provide a low-friction surface to
accommodate movement of the guide wire 40 within the working lumen.
The guide wire 40 passes through the lumen of the leader catheter
38, and is thus, moveable relative thereto. As shown in FIGS. 5 and
6, the guide wire 40 projects distally with respect to the distal
end 54 of the catheter body 50. Of course, the guide wire 40 may be
withdrawn proximally such that its distal end 62 is substantially
flush with the distal end 54 of the catheter body 50, or withdrawn
proximally even further such that its distal end 62 is disposed
within the distal end 62 of the catheter body 50. The guide wire 40
may be movably positioned within the working lumen of the leader
catheter 38 to enable relative insertion of the two devices,
relative rotation, or "roll" of the two devices, and relative
steering or bending of the two devices relative to each other,
particularly when the distal end 62 of the guide wire 40 is
inserted beyond the distal tip of the leader catheter 38. Notably,
by movably positioning the guide wire 40 relative to the leader
catheter 38, and movably positioning the leader catheter 38
relative to the guide sheath 36, the bending stiffness of the
assembly may be varied as needed to optimize the tracking ability
of the leader catheter 38.
[0088] Each of the adapters 48, 56 also comprises one or more
rotating spools or drums 66 that can selectively tension or release
pullwires (not shown in FIG. 6) disposed within the respective
sheath body 42 and catheter body 50, thereby effecting a single
articulation (and optionally, multiple articulations) of the distal
ends 46, 54 of the sheath and catheter bodies 42, 50. In the
illustrated embodiment, each of the adapters 48, 56 comprises four
rotating spools or drums 66 (only one shown for the proximal
adapter 48, and only three shown for the proximal adapter 56) for
four corresponding pullwires. The instrument driver 34 further
comprises a guide wire driver 68 to which the proximal end of the
guide wire body 58 is affixed. The distal end 62 of the guide wire
body 58 may have a J-shape as is conventional for guide wires. Each
of the adapters 48, 56 and guide wire driver 68 may optionally be
capable of rotating or rolling the sheath body 42, catheter body
50, and guide wire body 58 relative to each other.
[0089] With reference now to FIG. 7, an embodiment of a flexible
and steerable elongate catheter 100 will be described. The catheter
100 can be used as either of the guide sheath 36 or leader catheter
38 illustrated in FIGS. 5 and 6, and can be operably coupled to the
instrument driver 34 via a proximal adapter 101 (e.g., either of
proximal adapters 48, 56). The catheter 100 is substantially
pliable or flexible, such that when it is advanced into a patient,
an operator or surgeon may easily manipulate the catheter 100 to
conform, adopt, or match the shape or curvatures of the internal
pathways (e.g., gastrointestinal tract, blood vessels, etc.) of the
patient.
[0090] The catheter 100 generally includes an elongate catheter
body 102, which in the illustrated embodiments, has a circular
cross-section, although other cross-sectional geometries, such as
rectangular, can be used. As will be described in further detail
below, the catheter body 102 may be comprised of multiple layers of
materials and/or multiple tube structures that exhibit a low
bending stiffness, while providing a high axial stiffness along the
neutral axis. Typical designs include a nitinol spine encapsulated
in braid and any flexible, pliable, or suitable polymer material or
bio-compatible polymer material or a braided plastic composite
structure composed of low durometer plastics (e.g., nylon-12,
Pebax.RTM., polyurethanes, polyethylenes, etc.).
[0091] The catheter 100 further includes a working lumen 104
disposed through the entire length of the catheter body 102 for
delivering one or more instruments or tools from the proximal end
of the catheter body 102 to the distal end of the catheter body
102. The nature of the working lumen 104 will depend on the
intended use of the catheter 100. For example, if the catheter 100
is to be used as the guide sheath 36 (shown in FIG. 6), the working
lumen 104 will serve to accommodate the leader catheter or working
catheter 38 (shown in FIG. 6). If the catheter 100 is to be used as
a leader catheter or working catheter, the working lumen 104 will
serve to accommodate a guide wire 40 (shown in FIG. 6).
[0092] To enable steering, the catheter 100 further includes a
control ring 106 (shown in phantom) secured around the working
lumen 104 at any location, section, portion, or region along the
length of the catheter body 102, a plurality of pullwires 108
housed within one or more lumens 110 extending through the catheter
body 102, and a proximal adapter (not shown). Each of pullwires 108
may be a metallic wire, cable or filament, or it may be a polymeric
wire, cable or filament. The pullwire 108 may also be made of
natural or organic materials or fibers. The pullwire 108 may be any
type of suitable wire, cable or filament capable of supporting
various kinds of loads without deformation, significant
deformation, or breakage.
[0093] The distal ends of the pullwires 108 are anchored or mounted
to the control ring 106, such that operation of the pullwires 108
may apply force or tension to the control ring 106, which may steer
or articulate (e.g., up, down, pitch, yaw, or any direction
in-between) the pertinent location, section, portion, or region of
the catheter 100, which may in effect provide or define various
bend radii for the articulated portion of the catheter 100. In the
illustrated embodiment, the control ring 106 is secured to the
distal end of the catheter 100, and therefore, the distal end of
the catheter 100 will articulate when any of the pullwires 108 are
tensioned. The proximal ends of the pullwires 108 terminate in the
proximal adapter 101, and in particular, spools or drums 103
located within the proximal adapter 101. Thus, robotic or manual
actuation of the proximal interface will cause the pertinent
location, section, portion, or region of the catheter 100 to
articulate in the direction of the pullwire or pullwires 108 that
are tensioned. The catheter 100 may alternatively be manually
controlled, in which case, it may include a conventional manually
controlled steerable interface (not shown).
[0094] In other embodiments, no control ring may be used. Instead,
the distal ends of the pullwires 108 may be attached directly to a
section or portion of the catheter body 102 where it may be
steered, articulated, or bent, as described in an alternative
embodiment below. The wires may be crimped, soldered, welded or
interlocked in any suitable manner to a specific location on a
bending section or portion of the catheter body 102. In some
embodiments there may be more than one control ring 106 secured to
the catheter body 102 or more than one control wire attachment
control locations, sections, or portions for controlling, steering,
or articulating more than one section or portion of the catheter
body 102, e.g., into various complex shapes or curvatures (e.g.,
"S" curved shapes or "J" curved shapes, etc.). For example, the
catheter 100 may be steered, articulated, or deflected into various
complex shapes or curvatures that may conform to various complex
shapes or curvatures of internal pathways of a patient to reach a
target tissue structure of an organ inside the patient.
[0095] In this embodiment, the catheter 100 is functionally divided
into four sections: a distal tip 112, a distal articulating section
114, a transition section 116, and a proximal shaft section
120.
[0096] The distal tip 112 includes an atraumatic rounded tip
portion 122 and a control portion 124 in which the control ring 106
is mounted. The distal tip 112 also includes an exit port (not
shown) in communication with the working lumen 104 and from which a
working catheter or guidewire may extend distally therefrom. In one
embodiment, the atraumatic rounded tip portion 122 is 2 mm in
length and is composed of a suitable polymer material (e.g.,
Pebax.RTM. 55D/35D); and the control portion 124 is 1 mm in length
and is composed of a suitable polymer material (e.g., Pebax.RTM.
35D).
[0097] In the distal articulating section 114, there are four
pullwire lumens 110 that are equally spaced in an arcuate manner
(i.e., ninety degrees apart), and thus, the four corresponding
pullwires 108 are equally spaced as well. In an alternative
embodiment, a different number of pullwires lumens 110, and thus,
pullwires 108, can be used. For example, three pullwire lumens 110,
and thus three pullwires 108, can be equally spaced in an arcuate
manner (i.e., one hundred twenty degrees apart) in the distal
articulating section 114. Thus, the pullwires 108 are mounted to
the control ring 106 in orthogonal positions (i.e., ninety degrees
apart), such that tensioning one of the pullwires 108 will
selectively articulate the distal articulating section 114 in one
of four orthogonal directions. Tensioning two of the pullwires 108
will allow the pertinent section to be articulated in an infinite
number of directions (effectively, providing two degrees of
freedom: pitch and roll).
[0098] The distal articulating section 114 preferably allows for a
moderate degree of axial compression and optimal lateral
flexibility. In one embodiment, the distal articulating section 114
is 30 mm in length. The pullwire lumens 110 extend through the
distal articulating section 114 and may be constructed of a low
friction material or may simply be unsupported tubular cavities in
which the pullwires 108 respectively float. The entire working
lumen 104 within the distal articulating section 114 is formed by
an inner polymer tube (e.g., 0.001'' thick PTFE). The distal
articulating section 114 has a several portions of differing
rigidities formed by having different polymer outer tubes. For
example, the distal articulating section 114 may include a 5 mm
rigid portion 126 having a moderately rigid outer polymer tube
(e.g., Pebax.RTM. 55D) and a 25 mm articulatable portion 128 having
an outer tube composed of a relatively flexible outer polymer tube
(e.g., Pebax.RTM. 35D). The length of the articulatable portion 128
can vary depending on the performance requirements for the catheter
100. A longer articulatable portion 128 may be beneficial to
increase the area of reach, while a shorter articulatable portion
128 may be beneficial for cannulating tight side branches in the
anatomical vasculature. To increase its axial rigidity and elastic
properties, the articulatable portion 128 comprises a double
braided layer (e.g., sixteen 0.0005''.times.0.003'' spring temper
304V stainless steel wires braided at 68 picks per inch (ppi) in a
2 over 2 pattern) embedded within the outer polymer tube. As will
be described in further detail below, the distal ends of the
pullwires 108 may be directly anchored between the two layers of
the braid.
[0099] The transition section 116 resists axial compression to
clearly define the proximal end of the distal articulating section
114 and transfer the motion of the pullwires 110 to the distal
articulating section 114, while maintaining lateral flexibility to
allow the catheter 100 to track over tortuous anatomies. The
transition section 136 may be 28 mm in length and be composed of an
outer polymer tube (e.g., Pebax.RTM. 55D). Significantly, the
transition section 116 transitions the four lumens 110 in the
distal articulating section 114 to a single hollow stiffening tube
130 in the proximal shaft section 120. With further reference to
FIGS. 8 and 9, the illustrated embodiment accomplishes this by
using a molded adapter 138, which may be mounted within the outer
polymer tube of the transition body section 120.
[0100] The adapter 138 includes an adapter body 140 having a
proximal end 142 that interfaces with stiffening tube 130 in the
proximal shaft section 120, and a distal end 144 that interfaces
with the four pullwire lumens 110 in the distal articulating
section 114. The adapter body 140 may be composed of a suitable
rigid material, such as stainless steel or a glass-filled or high
durometer plastic. The adapter 138 further includes a plurality of
channels 146 formed in the external surface of the adapter body
140, a square-shaped boss 148 formed at the distal end 144 of the
adapter body 140, a plurality of lumens 150 extending through boss
148, and a single port 152 formed in the proximal end 142 of the
adapter body 140. The lumens 150 within the boss 148 are equally
spaced from each other in coincidence with the equally spaced
lumens 110 in the distal articulating section 114 of the catheter
100. In particular, the four lumens 150 are respectively disposed
through the four corners of the boss 148. The lumens 150 within the
boss 148 are also respectively coincident with the distal ends of
the channels 146, and the single port 152 is coincident with the
proximal ends of the channels 146. One of the channels 146 linearly
extends along the length of the adapter body 140, while the
remaining three channels 146 spiral around the length of the
adapter body 140, so that the proximal ends of all four channels
146 converge into the single port 152. Thus, the four pullwires 108
extend proximally from the distal articulating section 114, into
the lumens 150 formed in the boss 148 of the adapter body 140,
along the channels 146, into the single port 152, and then into the
stiffening tube 130.
[0101] The adapter 138 further includes a working lumen 154
extending through the boss 148 and a distal portion of the adapter
body 140. The distal end of the working lumen 154 is in coincidence
with the portion of the working lumen 104 extending through the
distal articulating section 114. The proximal end of the working
lumen 130 exits the adapter body 140 just proximal to the single
port 152, such that it is in coincidence with the lumen of the
transition section 136, which, in turn, is in coincidence with the
working lumen 104 extending through the proximal shaft section 120.
In the same manner that the working lumen 104 and stiffening tube
130 are offset from the axis of the proximal shaft section 120 (as
described below), the working lumen 154 and single port 152 are
offset from the axis of the adapter body 140. It should be
appreciated that the use of the adapter 138 allows the four
pullwires 108 to be transitioned from the respective lumens 110 of
the distal articulating section 114 into the single stiffening tube
130 without having to spiral the pullwires 108 and corresponding
lumens through the wall of the catheter tube 102, thereby allowing
the thickness of the wall to be uniform and minimizing the
possibility of weakened regions in the catheter tube 102 and
possible inadvertent kinking. Therefore, it is particularly
suitable for thin walled catheters.
[0102] As will be described below in further embodiments, where
wall thicknesses are not as thin, instead of using the adapter 140,
the equally spaced pullwire lumens 110 from the distal articulating
section 114 may be gradually converged via the transition section
116 onto one side of the proximal shaft section 120 and into the
stiffening tube 130.
[0103] Referring back to FIG. 7, the proximal shaft section 120
combines lateral flexibility (which is needed for optimal tracking)
with axial stiffness (which is needed for optical articulation
performance). The proximal shaft section 120 represents the
majority of the length of the catheter 100. The entire working
lumen 104 within the proximal shaft section 120 is formed by an
inner polymer tube (e.g., 0.001'' thick PTFE).
[0104] The proximal shaft section 120 gradually transitions the
catheter 100 from the transition section 118 to the more rigid
remaining portion of the catheter 100 by having several portions of
differing rigidities formed by having different polymer outer
tubes. For example, the proximal shaft section 120 may include a
first 6 mm proximal portion 132 including outer polymer tube (e.g.,
Pebax.RTM. 55D); a second 7.5 mm proximal portion 134 including an
outer polymer tube (e.g., Pebax.RTM. 72D) that is more laterally
rigid than the outer polymer tube in the first proximal portion
128; and a third lengthy (e.g., 1 meter long) proximal shaft
section 136 including an outer polymer tube (e.g., Nylon-12) that
is resistant to rotational forces to reduce the effect of curve
alignment when the catheter 100 is contorted to the tortuous
anatomy. To increase its axial rigidity, the proximal shaft section
120 comprises a double braided layer (e.g., sixteen
0.0005''.times.0.003'' spring temper 304V stainless steel wires
braided at 68 picks per inch (ppi) in a 2 over 2 pattern) embedded
within the outer polymer tube.
[0105] Significantly, unlike with the distal articulating section
114 in which the pullwires 108 are disposed in equally spaced apart
lumens, the pullwires 108 in the proximal shaft section 120 are
disposed in one or more lumens on one arcuate side of the proximal
shaft section 120. In the illustrated embodiment, the one or more
lumens takes the form of the previously mentioned stiffening tube
130 disposed along the catheter body 102 along the proximal shaft
section 120, and through which the pullwires 108 are housed and
passed back to the proximal adapter 101. As will be described in
further embodiments below, the one or more lumens may take the form
of a plurality of tubes that respectively house the pullwires
108.
[0106] The inner diameter of the stiffening tube 130 is preferably
large enough to allow the pullwires 108 to slide freely without
pinching each other. The stiffening tube 130 is composed of a
material that is more axially rigid than the surrounding material
in which the catheter body 102 is composed. For example, the
stiffening tube 130 may take the form of a stainless steel hypotube
or coil pipe, while the catheter body 102 along the proximal shaft
section 120 may be composed of a more flexible polymer or polymer
composite, as will be described in further detail below. The
stiffening tube 130 must be laminated into the catheter body 102,
thereby allowing the stiffening tube 130 to support the axial loads
on the catheter 100 from the tensioning of the pullwires 108. Due
to the non uniform stiffness in the catheter cross section, the
neutral axis will no longer be in the geometric center of the
catheter body 102 along the proximal shaft section 120, but rather
be shifted closer to the axis of the stiffening tube 130, thereby
minimizing the impact on bending stiffness. Thus, by locating the
pullwires 108 in one lumen (i.e., the stiffening tube 130) in the
catheter body 102, and designing the catheter body 102 to be
relatively flexible, thereby controlling the location of the
neutral axis, an axially stiff, but laterally flexible, proximal
shaft section 120 can be achieved.
[0107] The effects of bending stiffness relative to the neutral
axis will now be described. The neutral axis can be considered the
axis in the cross-section of a beam or shaft along which there are
no longitudinal stresses or strains when the beam or shaft is bent.
If the cross-section of the beam or shaft is symmetrical,
isotropic, and is not curved before a bend occurs, then the neutral
axis is at the geometric centroid of the cross-section. When the
bend occurs, all fibers on one side of the neutral axis are in a
state of tension, while all fibers on the other side of the neutral
axis are in a state of compression. As shown in FIG. 10, the axial
strain E is given by the ratio y/R, where y is the distance from
the neutral axis, and R is the radius of curvature of the neutral
axis. It follows that the axial stress .sigma. at any point is
given by EKy, where E is the modulus of elasticity and K is the
curvature of the beam or shaft. Thus, the axial stress .sigma. is
also proportional to the distance from the neutral axis y.
Therefore, when high stiffness members are further from the neutral
axis, the bending stress and hence bending stiffness is higher.
[0108] It follows that when the pullwires 108 (and any axially
stiff compressive members that provide the reaction force) are
located closer to the neutral axis, the bending stiffness of the
proximal shaft section 120 is decreased. That is, as shown in FIG.
11, there is only one stiff member (i.e., the stiffening tube 130)
that supports the axial load of the pullwires 108, and therefore,
the neutral axis (represented by the asterisk) of the proximal
shaft section 120 will be close to the location of the stiffening
tube 130. Ultimately, the exact location of the neutral axis will
depend on the relative stiffness of the stiffening tube 130
relative to the remainder of the material in the proximal shaft
section 120. Therefore, each of the pullwires 108 will be
relatively close to the neutral axis. Notably, the working lumen
104 is offset from the geometric center of the proximal shaft
section 120 in order to accommodate the stiffening tube 130. In
contrast, as shown in FIG. 12, a conventional symmetrical
arrangement may distribute four stiffening members 130a about the
geometric center of the proximal shaft section 130a, and therefore,
the neutral axis of the proximal shaft section 130a will
essentially be at its geometric center. As a result, the pullwires
108a will be relatively far from this neutral axis. Thus, it can be
appreciated from a comparison between FIGS. 11 and 12 that the
maximum distance from any of the pullwires 108 to the neutral axis
in the preferred embodiment is far shorter than the pullwires 108a
to the neutral axis in the conventional design.
[0109] Therefore, by having the pullwires 108 close to or on the
neutral axis, the pullwires 108 will have a minimum change in
length during an externally applied shaft curvature. This achieves
consistent articulation of the distal articulating section 114
independent of the curvature of the proximal shaft section 120. In
other words, the proximal shaft section 120 does not need to be
maintained substantially straight in contrast to the conventional
pullwire arrangement, which requires the operator to maintain the
proximal shaft section relatively straight. Thus, locating the
pullwires 108 close to the neutral axis of the proximal shaft
section 120 allows the operator to traverse anatomical features,
such as the iliac bifurcation or the aortic arch--not just with the
flexible distal articulating section 108, but with the entire
catheter 100 as required, while at the same time having full
control of the distal tip of the catheter 100.
[0110] Furthermore, because the proximal shaft section 120 is
relatively axially stiff, articulation of the distal articulating
section 114 by tensioning one or more of the pullwires 108 will not
cause significant lateral deflection of the proximal shaft section
120, thereby improving instrument stability. Furthermore, because
the pullwires 108 are close to the neutral axis in the proximal
shaft section 120, there is only a small radial distance between
the pullwires 108 and the neutral axis. This radial distance is
what causes the bending moment that leads to articulation of the
distal articulating section 114 (or any other articulating
section). With small bending moments generated by tensioning the
pullwires 108, there will be minimal articulation of the proximal
shaft section 120. Therefore, varying the position of the neutral
axis with respect to the position of the pullwires 108 in any
section of the catheter 100 can influence how much the distal
articulating section 114 will bend when a given load is applied to
a pullwire 108. For example, the distal articulation section 114
has the neutral axis in the geometric center and when any tension
is applied to one or more pullwires 108, a moment will be generated
and the distal tip 112 will articulate. On the other hand, the
proximal shaft section 120 will not tend to bend and hence twist
during tensioning of those same pullwires 108 of the distal
articulating section 114 because of the smaller moment arm, thereby
minimizing the tendency for the catheter 100 to curve align.
Notably, even if a tensioned pullwire 108 initially causes curve
alignment by moving to the inside of the curved proximal shaft
section 120, the catheter 100 will be stable thereafter, since all
the pullwires 108 are located on one arcuate side of the catheter
body 102. That is, once the stiffening tube 130, and thus the
pullwires 108, move to the inside of the curved proximal shaft
section 120, any of the pullwires 108 can be tensioned without
causing further rotation of the curved proximal shaft section 120,
thereby allowing the distal articulating section 114 to be
articulated in the desired direction. Furthermore, because only one
stiffening tube 130 is utilized, as opposed to four separate
stiffening tubes or coil pipes, for the respective four pullwires
108, there is a significant reduction in cost and a consistent low
bending stiffness irrespective of the articulation loads applied to
the pullwires 108.
[0111] Having described the construction of the catheter 100, one
method of manufacturing the catheter 100 will now be described. In
this method, the distal articulating section 114 and proximal shaft
section 120 are fabricated separately, and then mounted to each
other when the transition section 136 is fabricated. The distal tip
112 can then be formed onto the assembly to complete the catheter
300.
[0112] The distal articulating section 114 can be fabricated by
first inserting a copper wire process mandrel through a lumen of an
inner polymer tube (e.g., a PTFE extrusion) having the intended
length of the distal articulating section 114. Then, using a
braiding machine (embodiments of which will be described in further
detail below), a first layer of braiding is laid down over the
length of the inner polymer tube. Next, four PTFE-coated stainless
steel wire process mandrels are respectively disposed over the
length of the braided inner polymer tube in four equally spaced
circumferential positions (i.e., clocked ninety degrees from each
other), and a second layer of braiding is laid down over the four
wire process mandrels. Next, outer polymer tubes having different
durometers and lengths corresponding to the lengths of the
different portions of the distal articulating section 114 (e.g., a
Pebax.RTM. 55D extrusion for the rigid section 120 and a Pebax.RTM.
35D extrusion for the articulatable section 122) are slid over the
fully braided inner polymer tube, and then heat shrink tubing is
slid over the outer polymer tubes. The assembly is then heated to a
temperature above the melting temperature of the outer polymer
tubes, but below the melting temperature of the heat shrink tubing.
As a result, the outer polymer tubes are laminated to the assembly.
In particular, the outer polymer tubes melt and flow, while the
heat shrink tubing shrinks and compresses the melted polymer tubes
into the braid and around the four stainless steel process
mandrels. The assembly then cools and solidifies to integrate the
inner polymer tube, braid, and outer polymer tubes together. Then,
the center copper wire can be pulled from the assembly to create
the working lumen 104, and the four stainless steel wires can be
pulled from the assembly to respectively create the four pullwire
lumens 110.
[0113] In a similar manner, the proximal shaft section 120 can be
fabricated by first inserting a copper wire process mandrel and the
stiffening tube 130 through respective offset lumens of an inner
polymer tube (e.g., a PTFE extrusion) having the intended length of
the proximal shaft section 120. Then, using a conventional braiding
machine, two layers of braiding are laid down over the length of
the inner polymer tube. Next, outer polymer tubes having different
durometers and lengths corresponding to the lengths of the
different portions of the first proximal shaft section 120 (e.g., a
Pebax.RTM. 55D extrusion for the proximal portion 130, a Pebax.RTM.
72D extrusion for the second proximal portion 132, and a Nylon-12
extrusion for the third proximal portion 134) are slid over the
fully braided inner polymer tube, and then heat shrink tubing is
slid over the outer polymer tubes. The assembly is then heated to a
temperature above the melting temperature of the outer polymer
tubes, but below the melting temperature of the heat shrink tubing.
As a result, the outer polymer tubes are laminated to the assembly.
In particular, the outer polymer tubes melt and flow, while the
heat shrink tubing shrinks and compresses the melted polymer tubes
into the braid and around the four stainless steel process
mandrels. The assembly then cools and solidifies to integrate the
inner polymer tube, braid, stiffening tube 130, and outer polymer
tubes together. Then, the center copper wire can be pulled from the
assembly to create the working lumen 104.
[0114] Next, the distal articulating section 114 and proximal shaft
section 120 are coupled to each other by fabricating the transition
section 136 between the distal articulating section 114 and
proximal shaft section 120. In particular, a center wire process
mandrel is inserted through the working lumen 154 of the adapter
138 and four wire process mandrels are inserted through the single
port 152, four channels 146, and four lumens 150 of the adapter
138. The proximal end of the center wire process mandrel is then
inserted through the working lumen 104 in the proximal shaft
section 120, and the distal end of the center wire process mandrel
is then inserted through the working lumen 104 in the distal
articulating section 114. The proximal ends of the four wire
process mandrels are inserted through the stiffening tube 130 in
the proximal shaft section 120, and the distal ends of the four
wire process mandrels are inserted through the pullwire lumens 110
in the distal articulating section 114. The proximal shaft section
120 and distal section 116 are then moved towards each other until
they abut the opposite ends of the adapter 138.
[0115] Next, an outer polymer tube having a durometer and length
corresponding to the length of the transition catheter 136 (e.g.,
Pebax.RTM. 55D) is slid over the adapter 138, and then heat shrink
tubing is slid over the outer polymer tube. The assembly is then
heated to a temperature above the melting temperature of the outer
polymer tube, but below the melting temperature of the heat shrink
tubing. As a result, the outer polymer tube is laminated to the
assembly. In particular, the outer polymer tube melts and flows,
while the heat shrink tubing shrinks and compresses the melted
polymer tube into the desired cylindrical shape. The assembly then
cools and solidifies to integrate the inner polymer tube, adapter
138, and outer polymer tube together. Then, the center copper wire
can be pulled from the assembly to create the working lumen
104.
[0116] Then, the proximal ends of the pullwires 108, which may be
pre-fastened (e.g., soldered, welded, brazed, or glued) to the
control ring 106, are inserted into the pullwire lumens 110 at the
distal end of the catheter body 102, and advanced through the
lumens 110 until they exit the proximal end of the catheter body
102. The control ring 106 is then slid over the distal end of the
central wire process mandrel extending from the distal articulating
section 114 until it abuts the rigid portion 120 of the distal
articulating section 114. Then, outer polymer tubes having
different durometers and lengths corresponding to the lengths of
the different portions at the distal tip 112 (e.g., a Pebax.RTM.
55D/35D extrusion for the tip portion 122, and a Pebax.RTM. 35D
extrusion for the control portion 124) are slid over the center
wire process mandrel and control ring 106, and then heat shrink
tubing is slid over the outer polymer tubes. The assembly is then
heated to a temperature above the melting temperature of the outer
polymer tube, but below the melting temperature of the heat shrink
tubing. As a result, the outer polymer tube melts and flows, while
the heat shrink tubing shrinks and compresses the melted polymer
tube into the desired cylindrical shape. The assembly then cools
and solidifies to integrate the inner polymer tube, adapter 138,
and outer polymer tube together. Then, the distal tip 122 can be
cut to a rounded shape, and the center wire process mandrel can be
pulled from the catheter 100. The proximal end of the catheter tube
102 can then be mounted to the proximal adapter 100, and the
proximal ends of the pullwires 108 can be installed on the spools
or drums 103 of the proximal adapter 101.
[0117] As briefly discussed above, instead of utilizing a control
ring 106, the distal ends of the pullwires 108 may be attached
directly to a section or portion of the catheter body 102 where it
may be steered, articulated, or bent. In particular, the working
lumen 104 and pullwire lumens 110 are formed and the braid and
outer polymer tubes are applied to the inner polymer tube in the
same manner described above, with the exception that the distal
ends of the pullwires 108 are anchored between the braid layers (or
alternatively, layers of a different type of wire support
structures, such as a coil or mesh), as illustrated in FIGS.
31A-31J. The wire support structure may be made of metal, plastic,
fabric, thread, or any other suitable material.
[0118] The distal articulating section 114 is fabricated by
disposing a first layer of braiding over the length of the inner
polymer tube (FIG. 31A), four PTFE-coated stainless steel wire
process mandrels (only one shown for purposes of clarity) are
respectively disposed over the length of the braided inner polymer
tube in four equally spaced circumferential positions (i.e.,
clocked ninety degrees from each other) (FIG. 31B), and a second
layer of braiding is laid down over the four wire process mandrels
the length of the inner polymer tube (FIG. 31C).
[0119] Next, the outer polymer tubes are slid over the fully
braided inner polymer tube in the same manner as discussed above,
with the exception that a barrier is disposed over a region of the
braided inner polymer tube to which the pullwires 108 will
eventually be anchored (FIG. 31D). In the illustrated embodiment,
the barrier is a cylindrical, and in particular, takes the form of
a short section of heat shrink tubing that is disposed over a
corresponding short cylindrical region of the braided inner polymer
tube. Additional heat shrinking (not shown) is then disposed over
the outer polymer tubes and barrier, and the assembly is then
heated to a temperature above the melting temperature of the outer
tube tubes, but below the melting temperature of the heat shrink
tubing and barrier.
[0120] As a result, the outer polymer tubes are laminated to the
assembly. In particular, the outer polymer tubes melt and flow,
while the heat shrink tubing shrinks and compresses the melted
polymer tubes into the braid and around the four stainless steel
process mandrels. Because the barrier has a melting temperature
above the temperature of the applied heat, the barrier does not
melt and prevents the melted outer polymer tubes from being
compressed into the circumferential region of the braid. The
assembly then cools and solidifies to integrate the inner polymer
tube, braid, and outer polymer tubes together. The barrier is then
removed from the catheter body 102, thereby exposing the
circumferential region of the braid (FIG. 31E). The center copper
wire (not shown) can then be pulled from the assembly to create the
working lumen 104, and the four stainless steel wires can be pulled
from the assembly to respectively create the four pullwire lumens
110 in the same manner discussed above (FIG. 31F). The proximal
shaft section 120 and transition section 136 are then fabricated
with the distal articulating section 114 in the same manner
described above.
[0121] Then, the proximal ends of the pullwires 108 are inserted
into the pullwire lumens 110 at the distal end of the catheter body
102, and advanced through the lumens 110 until they exit the
proximal end of the catheter body 102 and the distal ends of the
pullwires 108 are disposed within the exposed circumferential
region of the braid (FIG. 31G). The distal ends of the pullwires
108 are then anchored to the exposed circumferential region of the
braid via, e.g., soldering, welding, brazing, or gluing (FIG. 31H).
In the case where the distal ends of the pullwires 108 are anchored
via soldering, 80/20 Au/Sn, which has a melting temperature below
the temperature required to damage adjacent components, namely the
inner PTFE polymer tube and the stainless steel braid, can be used.
Because the distal ends of the pullwires 108 are anchored between
the two layers of braid by virtue of the disposition of the
pullwire lumens 110 between the two layers of braid, the distal
ends of the pullwires 108 are more firmly anchored to the braid,
since the bonding material anchored the pullwires 108 above and
below the pullwires 108. In contrast, if the pullwires 108 are
anchored only to one side of the braid, the pullwires 108 would
tend to pull away from the braid by either pushing toward the inner
polymer tube or being forced outwardly from the inner polymer
tube.
[0122] Once the distal ends of the pullwires 108 are anchored to
the braid, an outer polymer tube (e.g., a Pebax.RTM. 35D extrusion)
can then be slid over the exposed circumferential region of the
braid, and then heat shrink tubing (not shown) is slid over the
outer polymer tube (FIG. 31I). The assembly is then heated to a
temperature above the melting temperature of the outer polymer
tube, but below the melting temperature of the heat shrink tubing.
As a result, the outer polymer tube melts and flows, while the heat
shrink tubing shrinks and compresses the melted polymer tube into
the circumferential portion of the braid. The assembly then cools
and solidifies. The proximal end of the catheter tube 102 can then
be mounted to the proximal adapter 100, and the proximal ends of
the pullwires 108 can be installed on the spools or drums 103 of
the proximal adapter 101.
[0123] It should be appreciated the technique of directly anchoring
the distal ends of the wires to the braid eliminates the need for
the control ring, thereby reducing the cost and fabrication process
time for the catheter 100. Furthermore, the resulting catheter has
a less abrupt stiffness characteristic. Although, the technique of
directly anchoring the distal ends of wires to the braid has been
disclosed in the context of pullwires, it should be appreciated
that this technique can be performed in the context of other types
of wires. For example, the wires can be electrical signal wires
and/or radio frequency (RF) ablation wires in an electrophysiology
catheter. In this case, an electrode, rather than an outer polymer
tube, can be disposed over the exposed portion of the braid in
electrical communication with the wire or wires. The electrode can
be used as a conductive surface that either measures a localized
electrical potential or delivers RF ablation energy. In the case
where the distal end of the wire or wires are soldered to the
braid, the electrode can, e.g., be formed by flowing solder into
and over the exposed portion of the braid during the same procedure
used to solder the distal end of the wire or wires to the
braid.
[0124] With reference now to FIG. 13, an embodiment of another
flexible and steerable elongate catheter 200 will be described. The
catheter 200 is similar to the previously described catheter 100,
with the exception that the catheter 200 is designed with three,
instead of four pullwires. The catheter 200 may be used in the
robotic catheter assembly 18 illustrated in FIGS. 5 and 6.
[0125] The catheter 200 generally includes an elongate catheter
body 202, a working lumen 204 disposed through the entire length of
the catheter body 202 for delivering one or more instruments or
tools from the proximal end of the catheter body 202 to the distal
end of the catheter body 202, a control ring 206 secured the distal
end of the catheter body 202, a plurality of pullwires 208 housed
within one or more lumens 210 extending through the catheter body
202, and a proximal adapter 201 (with associated spools or drums
203 to which the proximal ends of the pullwires 208 are coupled).
The working lumen 204, control ring 206, pullwires 208, and
pullwire lumens 210 may be constructed and function in a similar
manner as the working lumen 104, control ring 106, pullwires 108,
and pullwire lumens 110 described above.
[0126] Like the catheter 100, the catheter 200 is functionally
divided into four sections: a distal tip 212, a distal articulating
section 214, a transition section 216, and a proximal shaft section
220.
[0127] The distal tip 212, distal articulating section 214,
proximal shaft section 220, and proximal adapter 201 may be
respectively identical to the distal tip 112, distal articulating
section 114, proximal shaft section 120, and proximal adapter 103
of the catheter 100, with the exception that three pullwires 208,
instead of three, are accommodated. Thus, three pullwire lumens
210, and thus three pullwires 208, are equally spaced in an arcuate
manner (i.e., one hundred twenty degrees apart) within the distal
articulating section 214, and the stiffening tube 230 within the
proximal shaft section 220 houses the three pullwires 208. The
proximal adapter 201 includes three spools or drums 203 to which
the proximal ends of the pullwires 208 terminate.
[0128] Like the transition section 116, the transition section 216
transitions the equal spacing of the lumens 210 in the distal
articulating section 214 to a single stiffening tube 230 within the
proximal shaft section 214. With further reference to FIGS. 14-16,
the illustrated embodiment accomplishes this by using an adapter
238, which may be mounted within the outer polymer tube of the
transition body section 220. The adapter 238 is similar to the
adapter 138 of the catheter 100, with the exception that it is
designed to transition three, instead of four, pullwires 208.
[0129] In particular, the adapter 238 includes an adapter body 240
having a proximal end 242 that interfaces with the stiffening tube
230 in the proximal shaft section 220, and a distal end 244 that
interfaces with the three pullwire lumens 210 in the distal
articulating section 214. The adapter body 240 may be composed of a
suitable rigid material, such as stainless steel. The adapter 238
further includes a plurality of channels 246 formed in the external
surface of the adapter body 240, and a single channel 248 formed in
the external surface of the adapter body 240 in communication with
the plurality of channels 246. The distal ends of the channels 246
are equally spaced from each other in coincidence with the equally
spaced lumens 210 in the distal articulating section 214, and the
proximal end of the single channel 248 is in coincidence with the
stiffening tube 230 in the proximal shaft section 220. One of the
channels 246 linearly extends along the length of the adapter body
140, while the remaining two channels 246 spirals around the length
of the adapter body 240, so that the proximal ends of all three
channels 246 converge into the single channel 248. Thus, the three
pullwires 208 extend proximally from the distal articulating
section 214, along the three channels 246, converge into the single
channel 248, and then into the stiffening tube 230.
[0130] The adapter 238 further includes a working lumen 254
extending entirely through the adapter body 240. The distal end of
the working lumen 254 is in coincidence with the portion of the
working lumen 204 extending through the distal articulating section
214, and the proximal end of the working lumen 254 is in coincident
with the portion of the working lumen 204 extending through the
proximal shaft section 220. In the same manner that the working
lumen 204 and stiffening tube 230 are offset from the axis of the
proximal shaft section 120, the working lumen 254 and single
channel 248 are offset from the axis of the adapter body 240. Like
with the adapter 138 of the catheter 100, the adapter 238 allows
the three pullwires 208 to be transitioned from the respective
lumens 210 of the distal articulating section 214 into the single
stiffening tube 230 of the proximal shaft section 220 without
having to spiral the pullwires 208 and corresponding lumens through
the wall of the catheter tube 202, thereby allowing the thickness
of the wall to be uniform and minimizing the possibility of
weakened regions in the catheter tube 202 and possible inadvertent
kinking.
[0131] With reference now to FIG. 17, an embodiment of another
flexible and steerable elongate catheter 300 will be described. The
catheter 300 is similar to the previously described catheter 100,
with the exception that the catheter 300 is designed as a rapid
exchange catheter, which is facilitated by the placement of the
pullwires on one arcuate side of the proximal shaft section, and in
particular, within the stiffening tube. The catheter 300 may be
used in a robotic catheter assembly 358, which is similar to the
robotic catheter assembly 18 illustrated in FIGS. 5 and 6, with the
exception that the robotic catheter assembly 358 includes a
guidewire manipulator 360 that is in a side-by-side arrangement
with a leader catheter manipulator 362, as shown in FIG. 18, which
is facilitated by the rapid exchange architecture of the catheter
300.
[0132] The design of the catheter 300 applies to a leader catheter
of a telescoping catheter pair; e.g., a leader catheter 300 and
outer guide sheath 36. With a pair of telescoping catheters, the
therapy will usually be delivered through the outer catheter after
the inner catheter has been removed. Therefore, the inner catheter
does not need to have a lumen extending through its center the
entire length of its shaft. The purpose of the outer catheter is to
facilitate access to the site of interest and then to provide a
stable, controllable (steerable) lumen to deliver a therapeutic
device. Therefore, the outer catheter needs to have a lumen through
the center the entire length of its shaft. The purpose of the inner
catheter is to work in conjunction with the outer catheter and
guide wire in a telescoping motion to inchworm the catheter system
through the anatomy. This can be achieved by just having a short
section at the distal end of the leader catheter supporting the
guide wire, and allowing the remainder of the wire to run parallel
to the leader catheter.
[0133] The catheter 300 generally includes an elongate catheter
body 302, a working lumen 304 disposed through the entire length of
the catheter body 302 for delivering one or more instruments or
tools from the proximal end of the catheter body 302 to the distal
end of the catheter body 302, a control ring 306 secured the distal
end of the catheter body 302, a plurality of pullwires 308 housed
within one or more lumens 310 extending through the catheter body
302, and a proximal adapter 301 (with associated spools or drums
302 to which the proximal ends of the pullwires 308 are coupled).
The working lumen 304, control ring 306, pullwires 308, and
pullwire lumens 310, and proximal adapter 301 may be constructed
and function in a similar manner as the working lumen 104, control
ring 106, pullwires 108, pullwire lumens 110, and proximal adapter
101 described above.
[0134] Like the catheter 100, the catheter 300 is functionally
divided into four sections: a distal tip 312, a distal articulating
section 314, a proximal shaft section 320, and a transition section
318. The distal tip 312 and distal articulating section 314 of the
catheter 300 may be identical to the distal tip 112 and distal
articulating section 114 of the catheter 100. The transition
section 318 of the catheter 300 is identical to the transition
section 118 of the catheter 100 with the exception that the
transition section 318 includes a rapid exchange port 322 that is
in communication with a guidewire lumen 304. The exact location of
the rapid exchange port 322 relative to the distal tip of the
catheter 300 can vary by varying the length of the distal
articulating section 314 and transition section 318. Ultimately,
the location of the rapid exchange port 322 will depend on the
required distance that the catheter 300 needs to extend beyond the
distal tip of the outer guide sheath 36. However, the rapid
exchange port 322 should never exit the distal tip of the outer
guide sheath 36--else it would be difficult to retract the distal
end of the catheter 300 back into the outer guide sheath 36. Thus,
the length of the over-the-wire segment of the catheter 300 (i.e.,
the total length of the distal tip 312, distal articulating section
314, and transition section 318) should always be greater than the
maximum extension of the catheter 300 from the outer guide sheath
36. A shorter the over-the-wire segment length, however, will be
easier and faster to use, because the robot may control more of the
insertion and withdrawal of the catheter 300.
[0135] The proximal end of transition section 318 is tapered to
provide a smooth rapid exchange port 322. This allows the guide
wire 40 to be front-loaded through the proximal end of the outer
guide sheath 36 and then exit out through the exit port (not shown)
at the distal tip 312 of the catheter 300. The proximal shaft
section 320 of the catheter 300 is composed of a stiffening tube
330, which is in communication with the pullwire lumens 310 via the
transition section 316 (e.g., via use of the adapter 138
illustrated in FIGS. 8 and 9).
[0136] Thus, when the catheter 300 is used with the outer guide
sheath 36, the guide wire 40 will travel outside the catheter 300
within the outer guide sheath 36, until it enters the rapid
exchange port 322, and then through the guide wire lumen 304, and
then out through the guide wire exit port. Thus, the catheter 300
and the guide wire 40 will travel parallel to each other through
the outer guide sheath 36 until the guide wire 40 enters the rapid
exchange port 322, after which they travel concentrically relative
to each other. In addition, contrast agents can also be injected
through a flush port (not shown) at the proximal end of the outer
guide sheath 36, which may enter the rapid exchange port 322, and
exit out the guide wire exit port.
[0137] The design of the rapid exchange leader catheter 300 allows
for significantly greater robotic control of position. In
particular, because the catheter 300 and guide wire 40 are not
concentrically arranged relative to each other, but instead are two
independent devices, at the proximal end of the assembly, greater
independent robotic control is enabled without the need for an
excessively long instrument driver. That is, the guidewire
manipulator 260 can now be placed in a side-by-side arrangement
with the leader catheter manipulator 262. The instrument driver has
separate drive trains for the catheter 300 and guide wire 40,
allowing the user to have full independent insertion and withdrawal
control of both the catheter 300 and the guide wire 40 at all
times. This results in less fluoroscopic time and radiation
exposure, faster procedure time, greater length of robotic
insertion and retraction of the catheter 300 and guide wire 40,
less risk of losing guide wire position, less risk of breaching the
sterile field, and allows for use of shorter guide wires and
therefore one less person in the sterile field.
[0138] It should be appreciated that this rapid exchange design is
applicable to other non-steerable catheters (e.g., atherectomy
devices or graspers) that require the routing of wires from the
proximal end to an operative element at the distal end of the
catheter. The method of manufacturing the catheter 100 may be
similar to the method of manufacturing the catheter 300 described
above, with the exception that the proximal end of the transition
section 318 is tapered, and the stiffening tube 330 forms the
entirety of the catheter proximal shaft section 320 and is suitably
bonded within the proximal end of the transition section 318.
[0139] One method of using the robotic catheter assembly 358
illustrated in FIG. 18 to access a diseased site within the
vasculature of a patient will now be described. First, an incision
in a blood vessel of the patient (e.g., a femoral artery) is made
using a conventional techniques, and a starter wire is advanced
into the artery. Next, the leader catheter 300 is preloaded into
the outer guide sheath 36, ensuring that the rapid exchange port
322 remains inside the outer guide sheath 36. Then, the guide wire
40 is backloaded into the tip of the leader catheter 300. When the
guide wire 40 exists the rapid exchange port 322, the guide wire 40
is advanced through the outer guide sheath 36 next to the leader
catheter 300 until it exits at the back of the proximal adapter 48
of the outer guide sheath 36. Next, the guide wire 40 is held in a
fixed position, while the leader catheter 300 is advanced several
centimeters into the femoral artery over the guide wire 40. Then,
the proximal adapter 301 of the leader catheter 300 and guide wire
40 are loaded onto the robotic instrument driver 34.
[0140] Then, the guide wire 40 and leader catheter 300 can be
robotically driven remotely to the site of interest using the
operator control station 16. If a selective angiogram is required
when driving the guide wire 40 and leader catheter 300, a contrast
agent may be injected through an injection port on the outer guide
sheath 36. If the guide wire 40 is 0.035'' in diameter and occupies
most of the available space through the leader catheter, almost all
of the contrast agent will exit the distal tip of the outer guide
sheath 36. In contrast, if guide wire 40 is 0.018'' in diameter,
some of the contrast agent will exit out the distal tip of the
leader catheter 300, and some of the contrast agent will exit out
the distal tip of the outer guide sheath 36. Either way, the
physician will be capable of obtaining a selective angiogram for
the vessel of interest.
[0141] Once the guide wire 40 is at the site of interest, the
physician may then robotically withdraw the leader catheter 300
until the "over-the-wire" section exits at the back of the proximal
adapter 48 of the outer guide sheath 36. This can be accomplished
without the use of fluoroscopy, since the robotic catheter system
358 will ensure that the position of the guide wire 40 relative to
the patient is maintained. Depending on the robotic configuration
used (i.e., the travel distance of the leader catheter carriage),
this leader catheter 300 removal step may be accomplished entirely
remotely or part manually and part robotically.
[0142] The physician may then manually remove the guide wire 40
from the guide wire manipulator 360, slide out the last few inches
of the leader catheter 300 under fluoroscopy, and remove leader
catheter 300 from the patient. A therapeutic device may then be
manually delivered through the outer guide sheath 36. If the
therapeutic device is itself a rapid exchange catheter, after the
"over-the-wire" section has been manually passed into the outer
guide sheath 36, the guide wire 40 may then be positioned back onto
the guide wire manipulator 30, and the robot can be used to hold
the position of the guide wire 40 while the therapeutic device is
manually advanced. If the leader catheter 300 needs to be
reinstalled to access another site of interest within the patient,
it may be backloaded over the guide wire 40 until the guide wire 40
exits the rapid exchange port 322. The guide wire 40 may then be
loaded onto the guide wire manipulator 360 and the leader catheter
300 is reinstalled on the instrument driver 34. The guide wire 40
and leader catheter 300 can then be robotically driven remotely to
the new site of interest using the operator control station 16.
[0143] With reference now to FIG. 19, an embodiment of yet another
flexible and steerable elongate catheter 400 will be described. The
catheter 400 is similar to the previously described catheter 100,
with the exception that the catheter 400 has multiple regions of
articulation, and in particular, a distal region of articulation
and a proximal region of articulation. The catheter 400 enables two
regions of articulation by altering the axial stiffness, flexural
stiffness, and torsional stiffness of the catheter body in very
specific locations. The catheter 400 may be used in the robotic
catheter assembly 18 illustrated in FIGS. 5 and 6.
[0144] The catheter 400 generally includes an elongate catheter
body 402, which like the catheter body 102, may be comprised of
multiple layers of materials and/or multiple tube structures that
exhibit a low bending stiffness, while providing a high axial
stiffness along the neutral axis. Also like the catheter 100, the
catheter 400 further includes a working lumen 404 disposed through
the entire length of the catheter body 402 for delivering one or
more instruments or tools from the proximal end of the catheter
body 402 to the distal end of the catheter body 402, a control ring
406 secured the distal end of the catheter body 402, a plurality of
pullwires 408 housed within one or more lumens 410 extending
through the catheter body 402, and a proximal adapter 401 (with
associated spools or drums 403 to which the proximal ends of the
pullwires 408 are coupled). The working lumen 404, control ring
406, pullwires 408, pullwire lumens 410, and proximal adapter 401
may be constructed and function in a similar manner as the working
lumen 104, control ring 106, pullwires 108, pullwire lumens 110,
and proximal adapter 101 described above.
[0145] The catheter 400 is functionally divided into five sections:
a distal tip 412, a distal articulating section 414, a transition
section 416, a proximal articulating section 418, and a proximal
shaft section 420.
[0146] The distal tip 412 includes an atraumatic rounded tip
portion 422, a control portion 424 in which the control ring 406 is
mounted, and an exit port (not shown) in communication with the
working lumen 404 and from which a working catheter or guidewire
may extend distally therefrom. The distal tip 412 may be
constructed and function in a similar manner as the distal tip 112
described above.
[0147] Like the distal articulating section 114, four pullwire
lumens 410 are equally spaced in an arcuate manner (i.e., ninety
degrees apart) within the distal articulating section 414 to allow
the distal articulating section 414 to be articulated in an
infinite number of directions within the same plane (effectively,
providing two degrees of freedom: pitch and roll). In an
alternative embodiment, another number of pullwires lumens 410, and
thus, pullwires 408, can be used. For example, three pullwire
lumens 410 can be equally spaced in an arcuate manner (i.e., one
hundred twenty degrees apart). The distal articulating section 414
preferably allows for a moderate degree of axial compression and
optimal lateral flexibility. The distal articulating section 414
includes a rigid portion 426 and an articulatable portion 428. The
distal articulating section 414 may be constructed and function in
a similar manner as the distal articulating section 114 described
above, with the pullwire lumens 410 extending through the rigid
portion 426 and articulatable portion 428 as unsupported cavities
in which the four pullwires 408 are respectively disposed.
[0148] The transition section 416 transitions the equal spacing of
the lumens 410 in the distal articulating section 414 too close
spacing of the lumens 410 in the proximal articulating section 418.
Instead of using an adapter 138, as illustrated in FIGS. 8 and 9,
the lumens 410 in the transition section 416 are gradually
displaced about the axis of the catheter body 402 within the wall
of the transition section 416. In particular, the one lumen 410
that is on the same side as the closely spaced lumens 410 in the
proximal articulating section 418 may extend linearly along the
length of the transition section 416, while the remaining three
lumens spiral around the length of the transition section 416 until
they converge onto the same side of the proximal articulating
section 418. The transition section 416 is more rigid than the
distal articulating section 414 to allow the distal articulating
section 414 to bend about the transition section 416.
[0149] The transition section 416 resists axial compression to
clearly define the proximal end of the distal articulating section
414 and transfer the motion of the pullwires 408 to the distal
articulating section 414, while maintaining lateral flexibility to
allow the catheter 400 to track over tortuous anatomies. In one
embodiment, the transition section 416 is 33 mm in length. The
pullwire lumens 410 extending through the transition section 416
take the form of 0.007''.times.0.009'' polyimide tubes
circumferentially oriented relative to each other by ninety
degrees, and thus, can be considered stiffening members in which
the pullwires 408 are respectively disposed. The entire working
lumen 404 within the transition section 416 is formed by an inner
polymer tube (e.g., 0.001'' thick PTFE). The transition section 416
has a several portions of differing rigidities formed by having
different polymer outer tubes. In one embodiment, the transition
section 416 includes a 1 mm pullwire lumen anchoring portion 430
having a relatively rigid outer polymer tube (e.g., Nylon-12) that
increases the support for holding the distal ends of the polyimide
pullwire lumens 410. The transition section 416 further includes a
4 mm flexible portion 432 having a relatively flexible outer
polymer tube (e.g., Pebax.RTM. 40D) that transitions from the
relatively flexible distal section 314 to a 28 mm stiff portion 434
having a relatively stiff outer polymer tube (e.g., Pebax.RTM.
55D).
[0150] To increase its axial rigidity, the transition section 416
comprises a double braided layer (e.g., sixteen
0.0005''.times.0.003'' spring temper 304V stainless steel wires
braided at 140 ppi in a 2 over 2 pattern) embedded within the outer
polymer tubes of all three of the anchoring portion 430, flexible
portion 432, and rigid portion 434. Three of the polyimide pullwire
lumens 410 spiral around the stiff portion 434 of the transition
section 416, which along with the remaining polyimide pullwire
lumen 410, converge to the same side of the catheter body 402.
[0151] The proximal articulating section 418 significantly allows
for a moderate degree of axial compression and optimal lateral
flexibility. The pullwire lumens 410 are grouped on one arcuate
side of the proximal articulating section 418 to allow it to be
articulated in one direction. Preferably, the pullwire lumens 410
are grouped in a manner that locates their centers within an
arcuate angle relative to the geometric cross-sectional center of
the proximal shaft section of less than one hundred eighty degrees,
and more preferably, less than ninety degrees, and most preferably,
less than forty-five degrees.
[0152] In one embodiment, the proximal articulating section 418 is
16 mm in length. Preferably, the proximal articulating section 418
is more rigid than the distal articulating section 414, such that
independent control of the distal articulating section 414 and the
proximal articulating section 418 can be achieved, as discussed in
further detail below. Like in the transition section 416, the
pullwire lumens 410 extending through the proximal articulating
section 418 take the form of 0.007''.times.0.009'' polyimide tubes,
and thus, can be considered stiffening members in which the
pullwires 408 are respectively disposed. The entire working lumen
404 within the proximal articulating section 418 comprises an inner
polymer tube (e.g., 0.001'' thick PTFE). The proximal articulating
section 418 has two portions of differing rigidities formed by
having different polymer outer tubes. In one embodiment, the
proximal articulating section 418 includes a 15 mm articulatable
portion 436 having a relatively flexible outer polymer tube (e.g.,
Pebax.RTM. 40D) and a 1 mm pullwire lumen anchoring portion 438
having a relatively rigid polymer tube (e.g., Nylon) that increases
the support for holding the polyimide pullwire lumens 410. To
increase its axial rigidity and elastic properties, the proximal
articulating section 418 comprises a double braided layer (e.g.,
sixteen 0.0005''.times.0.003'' spring temper 304V stainless steel
wires braided at 140 ppi in a 2 over 2 pattern) embedded within the
outer polymer tubes.
[0153] The proximal shaft section 420 resists axial compression to
clearly define the proximal end of the proximal articulating
section 418 and transfer the motion of the pullwires 408 to the
proximal articulating section 314, while maintaining lateral
flexibility to allow the catheter 400 to track over tortuous
anatomies. Like with the proximal articulating section 314, the
pullwire lumens 410 are grouped on one arcuate side of the proximal
shaft section 420. Because the pullwire lumens 410 are more rigid
than the remaining material of the proximal articulating section
418 (i.e., the pullwire lumens 410 are composed of a polyimide,
whereas the remaining portion of the proximal articulating section
418 is composed of a low durometer polymer composite), the neutral
axis will be shifted closer to the axis of the grouping of pullwire
lumens 410, thereby providing the aforementioned advantages
discussed above with respect to the catheter 100.
[0154] The proximal shaft section 420 represents the majority of
the length of the catheter 400, and gradually transitions the
catheter 400 from the more flexible proximal articulating section
418 to the more rigid remaining portion of the catheter 400. For
example, the proximal shaft section 420 may include three proximal
portions 440, 442, 444 that increase in rigidity in the proximal
direction. The proximal shaft section 420 may be constructed and
function in a similar manner as the proximal shaft section 120
described above.
[0155] Having described its function and construction, one method
of manufacturing the catheter 400 will now be described. Like the
method of manufacturing the catheter 100, in this method, the
distal articulating section 414 and the combined proximal
articulating section 418/proximal shaft section 420 are fabricated
separately, and then mounted to each other when the transition
section 416 is fabricated. The distal tip 412 can then be formed
onto the assembly to complete the catheter 400.
[0156] The distal articulating section 414 can be fabricated in the
same manner as the distal articulating section 114 described above.
The proximal articulating section 418 and proximal shaft section
420 are fabricated together by first inserting a copper wire
process mandrel through a lumen of an inner polymer tube (e.g., a
PTFE extrusion) having the intended length of the combined proximal
articulating section 418/proximal shaft section 420. Then, using a
conventional braiding machine, a first layer of braiding is laid
down over the length of the inner polymer tube. Next, four
PTFE-coated stainless steel wire process mandrels with polyimide
tubing are respectively disposed over the length of the braided
inner polymer tube in a group on one side of the inner polymer
tube, and a second layer of braiding is laid down over the four
wire process mandrels the length of the inner polymer tube. Next,
outer polymer tubes having different durometers and lengths
corresponding to the lengths of the different portions of the
proximal articulating section 418 and the proximal shaft section
420 (e.g., a Pebax.RTM. 40D extrusion for the articulatable portion
436 and a Nylon-12 extrusion for the anchoring portion 438 of the
proximal articulating section 418, and Pebax.RTM. 55D, Pebax.RTM.
72D, and Nylon-12 extrusions for the respective proximal portions
440, 442, 444 of the proximal shaft section 420) are slid over the
fully braided inner polymer tube, and then heat shrink tubing is
slid over the outer polymer tubes.
[0157] The assembly is then heated to a temperature above the
melting temperature of the outer polymer tubes, but below the
melting temperature of the heat shrink tubing. As a result, the
outer polymer tubes melt and flows, while the heat shrink tubing
shrinks and compresses the melted outer polymer tubes into the
braid and around the four stainless steel process mandrels. The
assembly then cools and solidifies to integrate the inner polymer
tube, braid, and outer polymer tubes together. Then, the center
copper wire can be pulled from the assembly to create the working
lumen 404, and the four stainless steel wires can be pulled from
the assembly, thereby leaving the polyimide tubing with the
assembly to respectively create the four pullwire lumens 410.
[0158] Next, the distal articulating section 414 and the combined
proximal articulating section 418/proximal shaft section 420 are
coupled to each other by fabricating the transition section 416
between the distal articulating section 414 and the combined
proximal articulating section 418/proximal shaft section 420. In
particular, the transition section 416 is partially fabricated by
first inserting a PTFE-coated copper wire process mandrel through a
lumen of an inner polymer tube (e.g., a PTFE extrusion) having the
intended length of the transition section 416. Then, using a
conventional braiding machine, a first layer of braiding is laid
down over the length of the inner polymer tube. Then, each of four
PTFE-coated stainless steel wire process mandrels is inserted
through a lumen of a polyimide tube having the intended length of
the transition section 416. The linear length of one of these wire
process mandrels will equal the length of the transition section
416, while the linear lengths of the remaining three wire process
mandrels will be slightly greater than the length of the transition
section 416 to compensate for the additional length required to
spiral these wire process mandrels around the transition section
416.
[0159] Next, the opposing ends of the center wire process mandrel
are respectively inserted through the working lumens 404 of the
distal articulating section 414 and the combined proximal
articulating section 418/proximal shaft section 420, and the
opposing ends of four wire process mandrels are inserted through
the pullwire lumens 410 of the distal articulating section 414 and
the pullwire lumens 410 of the combined proximal articulating
section 418/proximal shaft section 420. The distal articulating
section 414 and the combined proximal articulating section
418/proximal shaft section 420 are then slid together until the
inner polymer tube of the transition section 416 abuts the inner
polymer tubes of the distal articulating section 414 and the
proximal articulating section 418, and the polyimide tubing on the
four wire process mandrels abuts the pullwire lumens 410 of the
distal articulating section 414 and the pullwire lumens 410 of the
proximal articulating section 418. Three of the wire process
mandrels are then spiraled around and bonded to the inner polymer
tube, and a second layer of braiding is laid down over the four
wire process mandrels the length of the inner polymer tube.
[0160] Next, outer polymer tubes having different durometers and
lengths corresponding to the lengths of the different portions of
the transition section 416 (e.g., a Nylon-12 extrusion for the
anchoring portion 430, a Pebax.RTM. 40D extrusion for the flexible
portion 432, and a Pebax.RTM. 55D extrusion for the rigid portion
434) are slid over the fully braided inner polymer tube, and then
heat shrink tubing is slid over the outer polymer tubes. The
assembly is then heated to a temperature above the melting
temperature of the outer polymer tubes, but below the melting
temperature of the heat shrink tubing. As a result, the outer
polymer tubes melt and flows, while the heat shrink tubing shrinks
and compresses the melted outer polymer tubes into the braid and
around the four stainless steel process mandrels. The assembly then
cools and solidifies to integrate the inner polymer tube, braid,
and outer polymer tubes together. Then, the center copper wire can
be pulled from the assembly to create the working lumen 404 within
the transition section 416, and the four stainless steel wires can
be pulled from the assembly, thereby leaving the polyimide tubing
within the assembly to respectively create the four pullwire lumens
410 within the transition section 416.
[0161] The control ring 406, pullwires 408, and distal tip 412 may
be installed on the assembly in the same manner as the control ring
106, pullwires 108, and distal tip 112 described above.
Alternatively, in a similar manner discussed above, instead of
utilizing a control ring 106, the distal ends of the pullwires 108
may be attached directly to a section or portion of the catheter
body 102 where it may be steered, articulated, or bent, and in this
case, to the distal end of the distal articulating section 414.
[0162] Significantly, the catheter 400 may be operated in a manner
that independently controls the articulation of the distal
articulating section 414 and proximal articulating section 418. The
theory behind the design of the catheter 400 is that if only one
pullwire 408 is tensioned, only the distal articulating section 414
will bend. If all four pullwires 408 are uniformly tensioned
(common mode), then only the proximal articulating section 418 will
bend. Any variation in wire tension from these two scenarios will
result in the bending of both the distal articulating section 414
and proximal articulating section 418 assuming at least two of the
pullwires 408 are tensioned. Effectively, the distal articulating
section 414 provides the catheter 400 with two degrees of freedom
(bend and roll), and the proximal articulating section 418 provides
the catheter 400 with one degree of freedom (bend).
[0163] In particular, when two or less of the pullwires 408 are
tensioned at relatively small amount, the distal articulating
section 414 articulates in the direction of the tensioned
pullwire(s) 310. Because the proximal articulating section 418 is
designed to be more laterally rigid than the distal articulating
section 414, the net moment created at the distal tip 412 nominally
articulates only the distal articulating section 414, but is not
sufficient to overcome the lateral stiffness of the proximal
articulating section 418 in a manner that would cause a significant
bend in the proximal articulating section 418. This feature
therefore facilitates independent articulation of the distal
articulating section 414 relative to the proximal articulating
section 418 even through the pullwires used to articulate the
distal articulating section 414 extend through the proximal
articulating section 418.
[0164] When all four of the pullwires 408 are uniformly tensioned,
there will be no net moment created at the distal tip 412 due to
the equal arcuate distribution of the pullwires 408 at the distal
tip 412. As such, the distal articulating section 414 will not
articulate. However, because all four of the pullwires 408 are
grouped together on one side of the proximal articulating section
418, a net moment is created at the distal end of the proximal
articulating section 418. As such, the proximal articulating
section 418 will articulate in the direction of the grouped
pullwires 408. This feature therefore facilitates independent
articulation of the proximal articulating section 418 relative to
the distal articulating section 414 even through the pullwires used
to articulate the proximal articulating section 418 extend through
the distal articulating section 414.
[0165] When two or less than the pullwires 408 are tensioned a
relatively large amount, and the remaining pullwires 408 are also
tensioned but not as much as the initially tensioned pullwires 408
are tensioned, then the net moment is created at the distal tip 412
greatly articulates the distal articulating section 414 in the
direction of the initially tensioned pullwire(s) 410, while the
combined moment created at the distal end of the proximal
articulating section 418 moderately articulates the proximal
articulating section 418 in the direction of the grouped pullwires
408, thereby causing a large bend in the distal articulating
section 414 while causing a small bend in the proximal articulating
section 418.
[0166] When two or less of the pullwires 408 are tensioned a
relatively small amount, then all of the pullwires 408 are
uniformly tensioned an additional amount, a net moment is created
at the distal tip 412 to moderately articulate the distal
articulating section 414 in the direction of the tensioned
pullwire(s) 410, while the additional tensioning of all of the
pullwires 408 greatly articulates the proximal articulating section
418, thereby causing a small bend in the distal articulating
section 414 while causing a large bend in the proximal articulating
section 418.
[0167] The computer 28 within the control station 16 may be
programmed with algorithms that take into account the elastic
behavior of the distal articulating section 414 and proximal
articulating section 418 and catheter stiffness when computing the
displacements of the pullwires 408 required to enable complete and
independent control of both the distal articulating section 414 and
proximal articulating section 418.
[0168] By achieving independent articulation control over the
distal articulating section 414 and the proximal articulating
section 418, anatomical sites of interest can be more easily
accessed. The catheter 400 can be used to access either the left
coronary artery or the right coronary artery from the aorta of the
patient.
[0169] To access the left coronary artery, the pullwire or
pullwires 408 in the direction of the left coronary artery (in this
case, pullwire 1) can be tensioned to bend the distal articulating
section 414 ninety degrees towards the left coronary artery, as
illustrated in FIG. 20. Then, all four of the pullwires 408 can be
tensioned an additional amount to bend the proximal articulating
section 418 to seat the distal tip 412 of the catheter 400 within
the ostium of the left coronary artery, as shown in FIG. 21. For
example, if the pullwire 1 is initially tensioned at a force of 7
units to bend the distal articulating section 414, an additional
force of 3 units can be used to tension all four pullwires 1-4
(resulting in a 10 unit tension in pullwire 1, and a 3 unit tension
in pullwires 2-4). There is now 19 units of force on the proximal
articulating section 418, which is adequate to bend the proximal
articulating section 418. But there remains a delta of 7 units of
tension more on pullwire 1 than on all other wires, and therefore
there is no further bending of the distal articulating section
414.
[0170] To access the right coronary artery, the pullwire or
pullwires 408 in the direction of the right coronary artery (in
this case, pullwire 4) can be tensioned to bend the distal
articulating section 414 ninety degrees to seat the distal tip 412
within the ostium of the right coronary artery, as illustrated in
FIG. 22. If the distal tip 412 is seated too deeply within the
ostium of the right coronary artery, then all four of the pullwires
408 can be tensioned an additional amount to bend the proximal
articulating section 418 to properly seat the distal tip 412 within
the ostium of the right coronary artery, as shown in FIG. 23. For
example, if the pullwire 4 is initially tensioned at a force of 7
units to bend the distal articulating section 414, an additional
force of 1 unit can be used to tension all four pullwires 1-4
(resulting in an 8 unit tension in pullwire 1, and a 1 unit tension
in pullwires 2-4) to slightly bend the proximal articulating
section 418.
[0171] As another example, by independently articulating the
catheter 400, the left coronary artery of a patient can be accessed
regardless of the type of anatomy. In particular, FIG. 24A
illustrates independent articulation of the proximal articulating
section 418 and distal articulating section 414 of the catheter 400
to access the left coronary artery in a "normal" anatomy; FIG. 24B
illustrates independent articulation of the proximal articulating
section 314 and distal articulating section 418 of the catheter 400
to access the left coronary artery in a "wide" anatomy; and FIG.
24C illustrates independent articulation of the proximal
articulating section 418 and distal articulating section 414 of the
catheter 400 to access the left coronary artery in an "unfolded"
anatomy.
[0172] Significantly, by taking advantage of the geometric
construction and variation in catheter flexibility to achieve
independent control over multiple articulation segments, several
advantages are achieved using the catheter 400. First, repeatable
and consistent articulation performance at two unique locations in
the catheter 400 can be achieved. Second, while other dual
articulating catheters achieve independent control over multiple
articulation segments by employing multiple control rings and
having dedicated pullwire or articulation mechanisms, the catheter
400 does not require a second control ring or dedicated control
mechanism to effect a second articulation within the catheter, but
rather only utilizes the distal-most control ring and the pullwires
that are already installed for the distal articulation of the
catheter. Thus, by eliminating the need for a second control ring
and a separate set of pullwires, few components are needed. Third,
the need for a procedure to fasten a second set of wires to a
second control ring is eliminated, thereby decreasing the cost of
manufacturing the catheter. Fourth, an existing driver instrument
initially designed for a catheter having a single region of
articulation (e.g., the catheter 100 or catheter 400) can be
utilized for a catheter having dual regions of articulation (e.g.,
the catheter 400), since no additional pullwires are needed, and
thus the proximal adapter of the catheter remains the same. It
should also be noted that robotic control of the catheter 400
efficiently and quickly manages the tensioning of the pullwires to
effect the articulation of the catheter 400, and therefore, there
is no need for the physician to think about which of the pullwires
to tension and the magnitude of the tension to be placed on the
pullwires.
[0173] With reference now to FIG. 25, an embodiment of yet another
flexible and steerable elongate catheter 500 will be described. The
catheter 500 is similar to the previously described catheter 400,
with the exception that the catheter 400 has a proximal region of
articulation that bi-directionally bends in a plane. The catheter
500 may be used in the robotic catheter assembly 18 illustrated in
FIGS. 5 and 6.
[0174] The catheter 500 generally includes an elongate catheter
body 502 (which may have any suitable cross-section, such as
circular or rectangular), which like the catheter body 502, may be
comprised of multiple layers of materials and/or multiple tube
structures that exhibit a low bending stiffness, while providing a
high axial stiffness along the neutral axis. Also, like the
catheter 400, the catheter 500 further includes a working lumen 504
disposed through the entire length of the catheter body 502 for
delivering one or more instruments or tools from the proximal end
of the catheter body 502 to the distal end of the catheter body
502, a control ring 506 secured the distal end of the catheter body
502, a plurality of pullwires 508 housed within one or more lumens
410 extending through the catheter body 502, and a proximal adapter
501 (with associated spools or drums 503 to which the proximal ends
of the pullwires 508 are coupled). The working lumen 504, control
ring 506, pullwires 508, pullwire lumens 510, and proximal adapter
501 may be constructed and function in a similar manner as the
working lumen 404, control ring 406, pullwires 408, pullwire lumens
410, and proximal adapter 401.
[0175] The working lumen 504, control ring 506, pullwires 508, and
pullwire lumens 510 may be constructed and function in a similar
manner as the working lumen 404, control ring 406, pullwires 408,
and pullwire lumens 410 described above, except that one of the
pullwires 508 is used to provide proximal bi-directional
articulation.
[0176] In particular, as previously stated, tensioning one or more
of the pullwires 408 in the catheter 400 may cause the proximal
articulating section 418 to bend somewhat. Such proximal bend can
be increased by uniformly increasing the tension in the pullwires
408, but cannot be decreased. Thus, the proximal articulating
section 418 can only bend in a single direction (i.e., in the
direction of the grouped pullwires 408).
[0177] In contrast, the catheter 500 utilizes a counteracting
pullwire 508' that circumferentially opposes the group of pullwires
508 in the proximal articulating section, such that tensioning the
counteracting pullwire 508 bends the proximal articulating section
in one direction, while uniformly tensioning the three remaining
pullwires 508 bends the proximal articulating section in an
opposite direction. Notably, an existing driver instrument
initially designed for a catheter having four pullwires for a
single region of articulation (e.g., the catheters 100, 200, and
300) or a distal region of articulation and a proximal region of
uni-directional articulation (e.g., the catheter 400) can be
utilized for a catheter having a distal region of articulation
(using 3 of the pullwires) and a proximal region of bi-directional
articulation with the remaining wire (e.g., the catheter 500),
since no additional pullwires are needed, and thus the proximal
adapter of the catheter remains the same.
[0178] The catheter 500 is functionally divided into five sections:
a distal tip 512, a distal articulating section 514, a transition
section 416, a proximal articulating section 418, and a proximal
shaft section 420.
[0179] The distal tip 512 is identical to the distal tip 412, and
the distal articulating section 514 is identical to the distal
articulating section 414 of the catheter 400, with the exception
that three pullwire lumens 510 (rather than four), and thus, three
pullwires 508, are equally spaced in an arcuate manner (i.e., one
hundred twenty degrees apart) within the distal articulating
section 514 to allow it to be articulated in an infinite number of
directions within the same plane (effectively, providing two
degrees of freedom: bend and roll).
[0180] The transition section 516 is identical to the transition
section 416 of the catheter 400, with the exception that the distal
end of the counteracting pullwire 508' is anchored within the
proximal end of the transition section 516, and the three remaining
pullwire lumens 510 and associated pullwires 508 are equally spaced
in an arcuate manner (i.e., one hundred twenty degrees apart).
[0181] The proximal articulating section 518 is identical to the
proximal articulating section 418 of the catheter 500, with the
exception that the counteracting pullwire 508' is oriented one
hundred eighty degrees from the group of the remaining three
pullwires 508, and the counteracting pullwire lumen 510' in which
the counteracting pullwire 508' is disposed takes the form of an
unsupported cavity. The proximal shaft section 520 is identical to
the proximal shaft section 420 of the catheter 400, which has the
feature of shifting the neutral axis closer to the axis of the
grouping of pullwire lumens 510, thereby providing the
aforementioned advantages discussed above with respect to the
catheter 100.
[0182] The method of manufacturing the catheter 500 is the same as
the method of manufacturing the catheter 500 described above, with
the exception that the distal end of the counteracting pullwire
508' is anchored within the pullwire lumen 510' in the proximal end
of the transition section 516, and the pullwire lumen 510' is
unsupported through the transition section 516 and the proximal
articulating section 518 until it reaches the distal end of the
proximal shaft section 520, at which point it is composed of a
polyimide tube that is grouped with the remaining three polyimide
lumens 510. The counteracting pullwire 508' may be anchored in the
proximal end of the transition section 516 by using another control
ring or anchoring it directly to braid.
[0183] Like with the catheter 500, the computer 28 within the
control station 16 (shown in FIG. 4) may be programmed with
algorithms that take into account the elastic behavior of the
distal articulating section 514 and proximal articulating section
518 and catheter stiffness when computing the displacements of the
pullwires 508 required to enable complete and independent control
of both the distal articulating section 514 and proximal
articulating section 518. To fully utilize the multi-bend
architecture of the catheter 500, it is important for the physician
to independently control the distal articulating section 514 and
proximal articulating section 518. However, because the any distal
moment created at the distal tip 512 of the catheter 500 will cause
bending of the proximal articulating section 518 as small as it may
be, the computer 28 employs a multi-bend control algorithm that
takes into account the inadvertent bending of the proximal
articulating section 518 in order to ensure full independent
articulation of the distal articulating section 514 and the
proximal articulating section 518. Ideally, when only bending of
the distal articulating section 514 is desired, the proximal
articulating section 518 should not bend, and when only bending of
the proximal articulating section 518 is desired, the distal
articulating section 514 should not bend.
[0184] With reference to FIG. 26, a multi-bend segment of the
catheter 500 is shown having a distal articulation angle
.alpha..sub.d and a proximal articulation angle .alpha..sub.p. The
multi-bend segment of the catheter also has a distal articulation
roll .theta.. Thus, the catheter 500 has two articulation Degrees
of Freedom (DOFs) in the distal bend and a single articulation DOF
in the proximal bend. From a controls perspective, the transition
section 516 of the catheter 500 couples the distal articulating
section 514 and the proximal articulating section 518 in such a way
that the coupling can be counteracted by the counteracting pullwire
508'. The multi-bend control algorithm employed by the computer 28
utilizes this configuration to independently control the bends in
the distal articulating section 514 and the proximal articulating
section 518.
[0185] The following relation can be used to calculate the number
of independently controllable DOFs (m) in a catheter based on the
number of pullwires (n):
m.ltoreq.n-1 [1]
[0186] Thus, the four pullwires 508 of the catheter 500 can be used
to independently control three DOFs, in particular, the distal
articulation angle .alpha..sub.d, proximal articulation angle
.alpha..sub.p, and distal articulation roll .theta.. These DOFs
allow the orientation and position of the distal tip 512 of the
catheter 500 to be controlled by the distal articulating section
514, then fine-tuned via the proximal articulating section 518. One
example of the catheter's utility is the procedure for cannulating
the renal artery when an occlusion is located at the ostium, as
shown in FIG. 27. In this case, the physician would bend the distal
articulating section 514 to orient the distal tip 512 towards the
ostium, while bending the proximal articulating section 518 to
ensure that the distal tip 512 does not contact the occlusion.
[0187] The multi-bend algorithm leverages the counteracting
pullwire 508' and the common mode (uniformly tensioning the
remaining three pullwires 508) to independently control the distal
articulating section 514 and proximal articulating section 518. In
particular, with reference to FIG. 28, the multi-bend algorithm
that maps articulation commands (.alpha..sub.d, .theta., and
.alpha..sub.p) to pullwire distances {right arrow over (w)} will be
described.
[0188] The commanded distal articulations .alpha..sub.d and .theta.
are mapped to distal pullwire distances {right arrow over
(w)}.sub.d through a distal articulating section solid mechanics
model. The three pullwires 508 fastened to the control ring 506 are
used to produce the desired bend at the distal articulating section
514. Based on the commanded distal articulations .alpha..sub.d and
.theta., a bending force is computed using a constant moment
assumption, as disclosed in D. B. Camarillo, C. F. Milne, C. R.
Carlson, M. R. Zinn, and J. K. Salisbury; Mechanics Modeling of
Tendon-Driven Continuum Manipulators; IEEE Transaction on Robotics,
24(6): 1262-1273 (2008). A series spring model of the catheter is
then used to compute the distal pullwire distances {right arrow
over (w)}.sub.d that will produce the desired moment. However, the
computed distal pullwire distances {right arrow over (w)}.sub.d may
be negative, which is not physically feasible, since this indicates
that the pullwires 508 must be pushed. Thus, a null space of
control is added to the distal pullwire distances {right arrow over
(w)}.sub.d until all distal pullwire distances {right arrow over
(w)}.sub.d are positive. For the distal articulating section 514,
the null space involves adding the same pullwire distance to all
three pullwires 508, which does not modify the distal articulations
.alpha..sub.d and .theta..
[0189] These pullwire distances {right arrow over (w)}.sub.d are
input to a proximal motion predictor that produces an expected
proximal articulation angle {tilde over (.alpha.)}.sub.p. There are
two effects: a distal moment effect and a common mode effect, that
contribute to the expected proximal articulation angle {tilde over
(.alpha.)}.sub.p based on the pullwire distances {right arrow over
(w)}.sub.d. With respect to the distal moment effect, when a distal
pullwire is tensioned, a moment is applied at the control ring 506.
Based on the constant moment assumption disclosed in D. B.
Camarillo, this moment is transferred to the proximal articulating
section 518. With respect to the common mode effect, when one of
the non-straight pullwires 508 (i.e., spiraled around the
transition section 516) is tensioned, the path of the pullwire 508
through the transition section 516 causes a moment M to be applied
to the transition section 516 in the direction of the side of the
catheter on which the pullwires 508 are grouped, as best
illustrated in FIG. 29. This moment M causes the proximal
articulating section 518 to bend in the direction of the grouped
pullwires 508. To decouple the proximal and distal bend motions
from each other, both of these effects must be taken into
account.
[0190] The expected proximal articulation angle {tilde over
(.alpha.)}p due to the distal moment effect can be computed by
applying the material properties of the proximal articulating
section 518 to the basic moment-bending relation:
.alpha. ~ p = M d L p K p , [ 2 ] ##EQU00001##
where M.sub.d is the moment applied to the control ring 506,
L.sub.p is the length of the proximal articulating section 518, and
K.sub.p is the bending stiffness of the proximal articulating
section 518.
[0191] The magnitude of the common mode effect depends upon the
path of the non-straight pullwires 508 through the transition
section 516. To understand this effect, it should be noted that the
lowest energy configuration for a pullwire of a given unloaded
length under tension between two points is a straight path.
However, the non-straight pullwires have non-zero curvature, and
will exert forces on the catheter 500 based on the magnitude of the
curvature. These forces can be integrated to calculate an
equivalent force and moment that a non-straight pullwire applied to
the transition section 516 based on wire tension. Integrating the
forces along the wire paths in the transition section 516 shows
that the wire curvatures exert no net force and a moment
proportional to the wire tension. As a result, a pure moment is
transferred from the stiff transition section 516 to the flexible
proximal articulating section 518, causing a constant-curvature
proximal bend.
[0192] The magnitude of this moment M.sub.t can be modeled by a
gain K.sub.t on the wire tension F.sub.w in a non-straight
pullwire, as follows:
M.sub.t=K.sub.tF.sub.w [3]
The gain K.sub.t can either be derived from a path integral over
the geometry of a given pullwire, or tuned empirically to
experimentally dial in a stiffness or gain. Since the transition
section 516 is relatively rigid, the pullwire geometry in this
section does not change and the gain K.sub.t remains constant.
[0193] The estimated proximal articulation angle {tilde over
(.alpha.)}.sub.p due to the common mode effect can be computed by
applying the material properties of the proximal articulating
section 518 to the basic moment-bending relation:
.alpha. ~ p = M t L p K p , [ 4 ] ##EQU00002##
The total proximal articulation angle due to the pullwire distances
{right arrow over (w)}.sub.d can be obtained by combining equations
[2]-[4], as follows:
.alpha. ~ p = ( M d + i K t ( i ) F w ( i ) ) L p K p [ 5 ]
##EQU00003##
The summation in the numerator of equation [5] operates over all
transition section gains K.sub.t.sup.(i) and F.sub.w.sup.(i)
corresponding to the bent pullwires I=1, 2, . . . . The estimated
proximal articulation angle {tilde over (.alpha.)}.sub.p is then
subtracted from the commanded proximal articulation .alpha..sub.p
to produce the amount of additional proximal articulation angle
.alpha..sub.p.sup.+ required to achieve the command using the
relation:
.alpha..sub.p.sup.+=.alpha..sub.p-{tilde over (.alpha.)}.sub.p.
[6]
[0194] The pullwire distance {right arrow over (w)}.sub.p required
to achieve the additional proximal articulation angle
.alpha..sub.p.sup.+ is computed by using a proximal articulating
section solid mechanics model. The pullwire distance {right arrow
over (w)}.sub.p is different based on the direction of the
articulation.
[0195] That is, if the additional proximal articulation angle
.alpha..sub.p.sup.+ is positive (toward the pullwire grouping),
then an additional common mode is commanded by tensioning each of
the distal pullwires 508 by the same distance:
w.sub.p=K.sub.cm.alpha..sub.p.sup.+, [7]
where K.sub.cm is a gain that can be set empirically, or can be
derived from the transition section gain K.sub.t and proximal
articulating section material properties.
[0196] If the additional proximal articulation angle
.alpha..sub.p.sup.+ is negative (away from the pullwire grouping),
then the counteracting pullwire 108' is tensioned to achieve the
articulation.
[0197] The distal pullwire distances {right arrow over (w)}.sub.d
and proximal pullwire distances {right arrow over (w)}.sub.p are
summed to produce the final set of pullwire distances {right arrow
over (w)}.
[0198] By achieving independent articulation control over the
distal articulating section 514 and the proximal articulating
section 518 using the proximal pullwire 108', greater control when
accessing anatomical sites of interest. For example, the distal
pullwire or pullwires 508 in the direction of the right coronary
artery (in this case, pullwire 3) can be tensioned to bend the
distal articulating section 514 ninety degrees to attempt to seat
the distal tip 512 within the ostium of the right coronary artery,
as illustrated in FIG. 30A. However, the tension on the distal
pullwire(s) 408 will create a moment at the proximal articulating
section 518, and without proper compensation, may cause the
proximal articulating section 518 to inadvertently bend in a manner
that pulls the distal tip 512 away from the right coronary artery
ostium. By tensioning the proximal pullwire 508', the proximal
articulating section 518 may be bent back towards the right
coronary artery ostium to properly seat the distal tip 512 within
the ostium, as illustrated in FIG. 30B. For example, if pullwire 3
is initially tensioned at a force of 7 units to bend the distal
articulating section 514 to create the 90 degree bend in the distal
articulating section 514, pullwire 4 may be tensioned at a force of
9 units to seat the distal tip 512 into the right coronary artery
ostium.
[0199] Although the catheter 500 has been described as having only
one counteracting pullwire 508' oriented 180 degrees from the
common mode pullwires 508 to effect bending of the proximal
articulating section 518 in only one plane, it should be
appreciated that the catheter 500 may optionally have two
counteracting pullwires 508'. For example, two counteracting
pullwires can be respectively oriented 120 degrees and 240 degrees
from the common mode pullwires, thereby allowing bending of the
proximal articulating section 518 in all planes.
[0200] Furthermore, although the catheter 500 has been described as
having only proximal articulating section 518, the catheter 500 may
have multiple proximal articulating sections that have increasing
lateral flexibility from the most distal articulating section to
the most proximal articulating section. For example, in the case
where a catheter has two proximal articulating sections, a second
transition section similar to the transition section 516 of the
catheter 500 can be incorporated between the two proximal
articulating sections. This second transition section would
transition the counteracting pullwire 508' to an orientation that
is adjacent the common mode pullwires 508, so that counteracting
pullwire 508' and remaining three pullwires 508 would be in a
common mode within the added proximal articulating section. The
distal articulating section 514 and first proximal articulating
section 518 can be independently bent relative to each other in the
same manner as described above. However, in this case, applying the
same tension on the counteracting pullwire 508' as the combined
tension on the three remaining pullwires 508 will bend the
additional proximal articulating section without bending the first
articulating section 518, thereby decoupling the two articulating
sections 518 from each other. Another counteracting pullwire can be
circumferentially disposed 180 degrees from the three pullwires 508
and counteracting pullwire 508' (which are adjacent to each other
in the additional proximal articulating section) to
bi-directionally bend the additional proximal articulating section
in one plane.
[0201] As previously discussed above, distal and proximal regions
of the catheters 100, 200, 400, and 500 may be fabricated
separately, and then mounted to each other when the transition
section is fabricated. The reason for fabricating the distal and
proximal regions separately is due, in large part, because the
circumferential orientations of the pullwire lumens differ between
these proximal and distal regions (i.e., equally circumferentially
spaced from each other in the distal region, and adjacent to each
other in the proximal region). To accommodate the different
circumferential orientations of the pullwire lumens, the braid may
be incorporated into the catheters using specially designed
braiding machines.
[0202] Referring to FIG. 32, one embodiment of a braiding machine
600 capable of braiding three wires 602 (only two shown) having one
of two selectable circumferential orientations to a tube 604 will
be described. The braiding machine 600 generally comprises two
interchangeable nose cones 606a, 606b, a feeder assembly 608, and a
braiding assembly 610.
[0203] As further shown in FIGS. 33A and 33B, each of the nose
cones 606a, 606b includes a distal tip 614, an external conical
surface 616, and a circular tube aperture 618. The nose cone 606a
includes an oblong wire orifice 620 radially outward from
coincident with the top of the circular tube aperture 618 (or
alternatively, three circular wire orifices (not shown) separate
from the circular tube aperture 618 and spaced closely to each
other), and the nose cone 606 includes three circular wire orifices
622 radially outward and separate from the circular tube aperture
618 that are equally spaced in an arcuate manner (i.e., one hundred
twenty degrees apart) about the circular tube aperture 618. As will
be described in further detail below, the nose cone 606a can be
used to apply braid over a tube 604 with the three wires 602
positioned adjacent to each other, and the nose cone 606b can be
used to apply braid over a tube 604 with the three wires 602
positioned circumferentially equidistant from each other (i.e. 120
degrees from each other). The size of the tube aperture 618 is
preferably large enough to just accommodate the tube 604 and any
layers that it may carry, the size of the oblong wire orifice 620
is preferably large enough to just accommodate the wires 604 and
any layers that they may carry in a side-by-side relationship, and
the sizes of the circular wire orifices 622 are preferably large
enough to just accommodate the respective wires 604 and any layers
that they may carry.
[0204] The feeder assembly 608 is configured for advancing the tube
604 through the circular tube aperture 618 and the three wires 602
through the oblong wire orifice 620 or the circular wire orifices
622 at the top of the circular tube aperture 618. The feeder
assembly 608 may be conventional and include a set of drive rollers
624 distal to the nose cone 606 that pull the tube 604 and wires
602, and a set of tensioning rollers (not shown) proximal to the
nose cone 606 that maintain tension on the tube 604 and wires 602
as they are fed through the nose cone 606. The feeder assembly 608
can be programmed to change the speed at which the tube 604 and
wires 602 are advanced through the nose cone 606, such that the pic
count of the braid may be varied.
[0205] The braiding assembly 610 is configured for braiding a
plurality of filaments 628 around the tube 604 and wires 602 as
they are advanced through nose cone 606. To this end, the braiding
assembly 610 includes a plurality of spindles 630, each of which
wraps a respective filament 628 around the tube 604 and wires 602.
The spindles 630 rotate around each other and move in and out in a
coordinated manner, such that the filaments 628 form a braid on the
tube 604 and wires 602. The braiding assembly 610 and either of the
nose cones 606a, 606b are arranged relative to each other, such
that the external surface 616 of the respective nose cone 606a,
606b serves as a bearing surface for the filaments 628 as they are
braided around the tube 604 and the wires 602 at the distal tip 614
of the nose cone 606a, 606b. In the illustrated embodiment, sixteen
spindles 630 and corresponding filaments 628 (only two shown) are
provided to create the braid, although any number of spindles 630
and filaments 628 can be used.
[0206] As briefly discussed above, the nose cones 606a, 606b can be
interchanged with one another to apply braid over tubes 604 and
three wires 602 of two different orientations. In particular, the
first nose cone 606a will be installed on the braiding machine 600
when fabricating a braided assembly having wires 602 that are
adjacent to each other. That is, the oblong wire orifice 620 of the
first nose cone 606a will maintain a set of three wires 602 in a
closely grouped fashion, such that they remain circumferentially
adjacent to each other as the filaments 628 are braided over a tube
604 and the wires 602. In contrast, the second nose cone 606a will
be installed on the braiding machine 600 when fabricating a braided
assembly having wires 602 that circumferentially equidistant from
each other. That is, the three separate wire orifices 622 of the
second nose cone 606b will maintain another set of three wires 602
circumferentially equidistant from each other (in this case, 120
degrees from each other), such that they remain equidistant from
each other as the filaments 628 are braided over another tube 604
and the wires 602. It should be appreciated that additional or
alternative nose cones with different numbers of wire orifices or
wire orifices of different orientations can be used to fabricate
different braided assemblies.
[0207] Having described the structure and function of the braiding
machine 600, one method of using the braiding machine 600 to
fabricate a catheter will now be described. In this embodiment, the
fabricated catheter can be similar to the catheter 400 described
above, with the exception that this catheter has three, instead of
four, pullwires.
[0208] A distal articulating section can be fabricated by first
inserting a copper wire process mandrel through a lumen of an inner
polymer tube (e.g., a PTFE extrusion) 604 having the intended
length of the distal articulating section. Then, using the braiding
machine 600 with the second nose cone 606b, a first layer of
braiding is laid down over the length of the inner polymer tube
604. Notably, this step only requires the inner polymer tube to be
advanced through the tube aperture 618 without advancing any of the
three wires 602 through the wire orifices 622 of the second nose
cone 606b. Next, the three wires 602 (which take the form of
PTFE-coated stainless steel wire process mandrels) are respectively
disposed over the length of the braided inner polymer tube 604 in
three equally spaced circumferential positions (i.e., clocked 120
degrees from each other), and a second layer of braiding is laid
down over the three wires 602. This step requires both the braided
inner polymer tube 604 to be advanced through the tube aperture 618
and the wires 602 to be advanced through the wire orifices 622 of
the second nose cone 606b during the braiding process. Next, one or
more outer tubular polymer tubes are laminated over the fully
braided inner polymer tube. Then, the center copper wire can be
pulled from the assembly to create a working lumen, and the three
stainless steel wires 602 can be pulled from the assembly to
respectively create three pullwire lumens.
[0209] In a similar manner, a proximal shaft section can be
fabricated by first inserting a copper wire process mandrel the
lumen of an inner polymer tube (e.g., a PTFE extrusion) 604 having
the intended length of the proximal shaft section. Then, using the
braiding machine 600 with the first nose cone 606a, a first layer
of braiding is laid down over the length of the inner polymer tube
604. Notably, this step only requires the inner polymer tube 604 to
be advanced through the tube aperture 618 without advancing any of
the three wires 602 through the oblong aperture 12 of the first
nose cone 606a. Next, the three wires 602 (which take the form of
PTFE-coated stainless steel wire process mandrels with polyimide
tubing) are respectively disposed over the length of the braided
inner polymer tube 604 in adjacent positions, and a second layer of
braiding is laid down over the three wires 602. This step requires
both the braided inner polymer tube 604 to be advanced through the
tube aperture 618 and the wires 602 to be advanced through the
oblong aperture of the first nose cone 606a during the braiding
process. Next, one or more outer tubular polymer tubes are
laminated over the fully braided inner polymer tube. Then, the
center copper wire can be pulled from the assembly to create a
working lumen, and the three stainless steel wires 602 can be
pulled from the assembly to respectively create three pullwire
lumens.
[0210] Next, the distal articulating section and the proximal shaft
section are coupled to each other by fabricating a transition
section between the distal articulating section and proximal shaft
section and pullwires with the control ring are installed in the
same manner described above with respect to fabricating the
transition section 416 to couple the distal articulating section
414 and the combined proximal articulating section 418/proximal
shaft section 420 together, with the exception that three pullwire
lumens and corresponding pullwires, instead of four pullwire lumens
and corresponding pullwires, are incorporated into the
catheter.
[0211] Referring to FIGS. 34 and 35, another embodiment of a
braiding machine 700 capable of braiding three wires 602 having two
different circumferential orientations to a single tube 604 will be
described. The braiding machine 700 is similar to the previously
described braiding machine 600, with the exception that it is
capable of applying the braid to a single tube with different
circumferential orientations of the wires 602. In this manner, the
wires 602, and thus the pullwire lumens, need not be bonded to any
portion of the inner polymer tube. That is, one continuous braid
and three continuous wires 602 with varying circumferential
orientations can be applied over a single tube 604. In this manner,
not only does this eliminate the processing time required to
independently fabricate and subsequently join the separate sections
of the catheter together, it eliminates the inherent variation that
may result in manually positioning the lumens of the separate
catheter sections together. Furthermore, the step of bonding wires
to the transition section that would otherwise be needed to join
the distal articulating section and proximal shaft section together
is eliminated. Since the wires must be otherwise weakly bonded to
the inner polymer tube as a stronger bond would negatively affect
the performance of the completed catheter, this may be significant,
since the braiding process is not gentle and could break or shift
the bonds between the wires and the inner polymer tube.
[0212] The braiding machine 700 generally comprises the feeder
assembly 608 and a braiding assembly 610, the details of which have
been described above. The braiding machine 700 differs from the
braiding machine 600 in that it comprises a single nose cone 706
and an iris assembly 712 (shown in phantom), which in the
illustrated embodiment, is installed within the nose cone 706.
[0213] Like the previously described nose cones 606a, 606b, the
nose cone 706 includes a distal tip 714, an external conical
surface 716, and a circular tube aperture 718. In the illustrated
embodiment, the nose cone 706 does not include a wire aperture per
se. Rather, the size of the tube aperture 718 is preferably large
enough to accommodate both the tube 604 and any layers that it may
carry, as well as the wires 602 and any layers that they may carry
(i.e., the diameter of the tube aperture 718 is equal to or
slightly greater than the combined diameters of the tube 604 and
one of the wires 602). The iris assembly 712 is operable to adjust
the relative circumferential positions of the wires 704 as the exit
from the tube aperture 718 around the tube 702, and in the
illustrated embodiment, between a relative circumferential position
where the wires 704 are adjacent to each other in a side-by-side
relationship and a relative circumferential position where the
wires 704 are positioned circumferentially equidistant from each
other (i.e. 120 degrees from each other).
[0214] To this end, and with reference to FIGS. 36-41, the iris
assembly 712 comprises three stacked iris plates 720a, 720b, and
720c, each of which includes a center aperture 722, a wire orifice
724 disposed radially outward from the center aperture 722, and at
least one arcuate channel 726 in circumferential alignment with the
respective wire orifice 724. The feeder assembly 608 is configured
for advancing the tube 604 through the center apertures 722 of the
iris assembly 712, as well as through the tube aperture 718 of the
nose cone 706, and the for advancing the wires 602 through the
respective wire orifices 724 of the iris assembly 712, as well as
through the periphery of the tube aperture 718 of the nose cone
706.
[0215] The iris plates 720 are rotatable relative to each other to
adjust the circumferential orientation of the wire orifices 724
relative to each other, while the arcuate channel(s) 726 of each
respective iris plate 720 is coincident with the wire orifices 724
of the remaining two iris plates 720. In this manner, any wire
orifice 724 may be adjusted via rotation of the respective iris
plate 720 without blocking the path of the wire orifices 724 of the
other iris plates 720. The braiding assembly 610 is configured for
braiding the filaments 628 around the tube 604 and the wires 602 as
they are fed through the iris assembly 712 and as the respective
iris plates 720 are rotated relative to each other to create the
braided tube assembly. Thus, the iris assembly 712 may be operated
to circumferentially orient the wires 602 relative to each other
differently along the braided tube assembly.
[0216] In the illustrated embodiment, the iris plate 720a is
rotationally fixed relative to the nose cone 706, while the
remaining two iris plates 720b, 720c are capable of being rotated
relative to the nose cone 706. To facilitate their rotation, each
of the two iris plates 720b, 720c includes a lever 728 that can be
manipulated to rotate the respective iris plate 720b, 720c. The
levers 728 may be manipulated, such that rotation of the respective
iris plates 720b, 720c can be synchronously automated with the
feeder assembly 608. To accommodate the levers 728, the nose cone
706 may include a slot 730 through which the levers 728 for
connection to the motor and linkage assembly. To facilitate
rotation of the iris plates 720 relative to each other, the iris
assembly 712 further comprises thrust bearings 730 (shown in
phantom in FIG. 36) mounted between the iris plates 720, and in
particular, a first thrust bearing 730a mounted between the
respective iris plates 720a, 720b, a second thrust bearing 730b
mounted between the respective iris plates 720b, 720c, and a third
thrust bearing 730c mounted between the iris plate 720c and the
distal tip 714 of the nose cone 706. Each of the bearings 730
includes a center aperture 732 that accommodates the tube 604 and
wires 602 as they pass through the iris assembly 712.
[0217] Referring back to FIG. 34, the braiding machine 700 further
comprises a mechanical driver 734 (which may include a motor and
appropriate linkage) connected to the levers 728 for rotating the
iris plates 720 relative to each other, and a controller 736
configured, while the braiding assembly 610 is braiding the
filaments 628 around the tube 604 and the wires 602 over a period
of time, instructing the mechanical driver 734 to maintain an
initial relative rotational orientation of the iris plates 720,
such that spacings between the respective wire orifices 724 are
equal over a first portion of the time period, instructing the
mechanical driver 734 to gradually change the rotational
orientation of the iris plates 720, such that spacings between the
respective wire orifices 724 decrease over a second portion of the
time period until the respective wire orifices 724 are adjacent to
each other, and instructing the mechanical driver 734 to maintain
the changed relative rotational orientation of the iris plates 720,
such that the respective wire orifices 724 are adjacent to each
other over a third portion of the time period.
[0218] As briefly discussed above, the wire orifices 724 and
arcuate channel(s) 726 of the respective iris plates 720 are
arranged in a manner that allows the three wire orifices 724 to be
placed between an adjacent circumferential orientation and an
equally spaced circumferential orientation without blocking the
paths of the wire orifices 724.
[0219] To this end, the first iris plate 720a has two arcuate
channels 726a that straddle the respective wire orifice 724a (FIG.
40) The furthest extent of each of these arcuate channels 726a is
at least 120 degrees from the wire orifice 724a. The second iris
plate 720b has a single arcuate channel 720b with a furthest extent
of at least 240 degrees counterclockwise from the wire orifice 724b
of the second iris plate 720b (FIG. 41). The third iris plate 720c
has a single arcuate channel 720c with a furthest extent of at
least 120 degrees clockwise from the wire orifice 724c of the third
iris plate 720c (FIG. 42). It can be appreciated that, when the
levers 728 of the respective iris plates 720b, 720c are moved to
their downward position, the wire orifices 724a-724c are located
circumferentially adjacent to each other, as shown in FIG. 38. In
contrast, when the levers 728 of the respective iris plates 720b,
720c are moved to their upward position, the wire orifices
724a-724c are circumferentially spaced equidistant from each other,
as shown in FIG. 39.
[0220] The right arcuate channel 726a of the first iris plate 720a
remains coincident with the wire orifice 724b of the second iris
plate 720b as the lever 728 of the second iris plate 720b is moved
between the upward and downward positions. Thus, the right arcuate
channel 726a prevents the first iris plate 720a from blocking the
path of the wire orifice 724b of the second iris plate 720b.
Similarly, the left arcuate channel 726a of the first iris plate
720a remains coincident with the wire orifice 724c of the third
iris plate 720c as the lever 728 of the third iris plate 720c is
moved between the upward and downward positions. Thus, the left
arcuate channel 726a prevents the first iris plate 720a from
blocking the path of the wire orifice 724c of the third iris plate
720c.
[0221] The arcuate channel 726b of the second iris plate 720b
remains coincident with the wire orifice 724a of the first iris
plate 720a and the wire orifice 724c of the third iris plate 720c
as the lever 728 of the second iris plate 720b is moved between the
upward and downward positions. Thus, the arcuate channel 726b
prevents the second iris plate 720b from blocking the paths of the
wire orifice 724a of the first iris plate 720a and the wire orifice
724c of the third iris plate 720c. The arcuate channel 726c of the
third iris plate 720c remains coincident with the wire orifice 724a
of the first iris plate 720a and the wire orifice 724b of the
second iris plate 720b as the lever 728 of the third iris plate
720c is moved between the upward and downward positions. Thus, the
arcuate channel 726c prevents the third iris plate 720c from
blocking the paths of the wire orifice 724a of the first iris plate
720a and the wire orifice 724b of the second iris plate 720b.
[0222] Having described the structure and function of the braiding
machine 700, one method of using the braiding machine 700 to
fabricate a catheter will now be described. The catheter can be
fabricated by first inserting a copper wire process mandrel through
a lumen of an inner polymer tube (e.g., a PTFE extrusion) having
the intended length of the catheter. Then, a first layer of
braiding is laid down over the length of the inner polymer tube.
Notably, this step only requires the inner polymer tube to be
advanced through the center aperture 722 of the iris assembly 712
and the tube aperture 718 of the nose cone 706 without advancing
any of the three wires 602 through the wire orifices 724 of the
iris assembly 712 or the tube aperture 718 of the nose cone 706.
Next, the three wires 602 (which take the form of PTFE-coated
stainless steel wire process mandrels) are respectively disposed
over the length of the braided inner polymer tube in varying
circumferential positions, and a second layer of braiding is laid
down over the three wires 602.
[0223] This step requires both the braided inner polymer tube to be
advanced through the center aperture 722 of the iris assembly 712
and the tube aperture 618 of the nose cone 706, and the wires 602
to be advanced through the wire orifices 724 of the iris assembly
712 and the tube aperture 718 of the nose cone 706 during the
braiding process. Furthermore, during this step, the levers 728 of
the iris plates 720b, 720c are manipulated to change the relative
circumferential positions of the wire orifices 724 of the iris
assembly 712, and thus, the wires 602 on which the braid is laid.
In particular, during the length of the distal articulating section
of the catheter, the levers 728 of the respective iris plates 720b,
720c are moved to their downward position, such that the wire
orifices 724a-724c, and thus, the wires 602, are located
circumferentially adjacent to each other. During the length of the
transition section of the catheter, the levers 728 of the
respective iris plates 720b, 720c are gradually moved to their
upward position, such that the wire orifices 724a-724c, and thus,
the wires 602, are gradually moved from a position where they are
circumferentially adjacent to each other at the distal-most extent
of the transition section to a position where they are
circumferentially spaced equidistant from each other at the
proximal-most extent of the transition section. During the length
of the proximal shaft section of the catheter, the levers 728 of
the respective iris plates 720b, 720c are maintained in their
upward position, such that the spacings of the wire orifices
724a-724c, and thus, the wires 602, is maintained circumferentially
equidistant from each other. Next, one or more outer tubular
polymer tubes are laminated over the fully braided inner polymer
tube. Then, the center copper wire can be pulled from the assembly
to create a working lumen, and the three stainless steel wires 602
can be pulled from the assembly to respectively create three
pullwire lumens.
[0224] Although the iris assembly has been described as comprising
three iris plates for respectively accommodating three wires 602,
it should be appreciated that the number of iris plates can be less
or more than three, depending on the number of wires 602 that are
to be incorporated into the catheter.
[0225] For example, in the case where two wires 602 are to be
accommodated, the iris assembly may comprise only two iris plates.
In this case, one of the iris plates will have a single arcuate
channel with a furthest extent at least 180 degrees clockwise from
the wire orifice, and the other iris plate will have a single
arcuate channel with a furthest extent at least 180 degrees
counterclockwise from the wire orifice. Thus, the wire orifices in
this iris assembly may be selectively located circumferentially
adjacent to each other or circumferentially spaced equidistant from
each other by 180 degrees.
[0226] In the case where four wires 602 are to be accommodated, the
iris assembly may comprise four iris plates. In this case, the
first iris plate has a single arcuate channel that extends
virtually all the way around the respective iris plate from one
side of the wire orifice to the other side of the wire orifice. The
second iris plate has a single arcuate channel with a furthest
extent of at least 270 degrees counterclockwise from the wire
orifice of the second iris plate. The third iris plate has a single
arcuate channel with a furthest extent of at least 270 degrees
clockwise from the wire orifice of the third iris plate. The fourth
iris plate has a single arcuate channel that extends virtually all
the way around the respective iris plate from one side of the wire
orifice to the other side of the wire orifice. Thus, the wire
orifices in this iris assembly may be selectively located
circumferentially adjacent to each other or circumferentially
spaced equidistant from each other by 90 degrees.
[0227] Although particular embodiments of the present inventions
have been shown and described, it will be understood that it is not
intended to limit the present inventions to the preferred
embodiments, and it will be obvious to those skilled in the art
that various changes and modifications may be made without
departing from the spirit and scope of the present inventions.
Thus, the present inventions are intended to cover alternatives,
modifications, and equivalents, which may be included within the
spirit and scope of the present inventions as defined by the
claims.
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