U.S. patent application number 13/186192 was filed with the patent office on 2012-03-29 for means for securing a catheter into a vessel.
This patent application is currently assigned to C.R. Bard. Invention is credited to Dustin Dufour, Charles A. Gibson, David P. MacAdam.
Application Number | 20120078078 13/186192 |
Document ID | / |
Family ID | 45871318 |
Filed Date | 2012-03-29 |
United States Patent
Application |
20120078078 |
Kind Code |
A1 |
MacAdam; David P. ; et
al. |
March 29, 2012 |
MEANS FOR SECURING A CATHETER INTO A VESSEL
Abstract
An electrophysiology catheter, e.g., a coronary sinus catheter,
for insertion into a cardiac vessel, such as the coronary sinus,
includes a handle and a catheter shaft coupled at one end to the
handle. The catheter shaft has a distal end and an anchor is
associated with the catheter shaft and is movable between a
deployed position and a collapsed position. In the deployed
position, the anchor extends radially outward from an outer surface
of the catheter shaft for contacting a wall and temporarily
anchoring the catheter shaft within the coronary sinus. The
catheter also includes an actuator for causing deployment and
collapsing of the anchor upon manipulation of the actuator.
Inventors: |
MacAdam; David P.;
(Millbury, MA) ; Gibson; Charles A.; (Millbury,
MA) ; Dufour; Dustin; (Salem, NH) |
Assignee: |
C.R. Bard
Murray Hill
NJ
|
Family ID: |
45871318 |
Appl. No.: |
13/186192 |
Filed: |
July 19, 2011 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
61386281 |
Sep 24, 2010 |
|
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Current U.S.
Class: |
600/381 |
Current CPC
Class: |
A61B 5/287 20210101;
A61M 25/04 20130101; A61B 5/6858 20130101; A61B 5/283 20210101;
A61B 5/6853 20130101 |
Class at
Publication: |
600/381 |
International
Class: |
A61B 5/05 20060101
A61B005/05 |
Claims
1. An electrophysiology catheter for insertion into a cardiac
vessel comprising: a handle; a catheter shaft coupled at one end to
the handle, the catheter shaft having a distal end, an anchor
associated with the catheter shaft and movable between a deployed
position and a collapsed position, wherein in the deployed
position, the anchor extends radially outward from an outer surface
of the catheter shaft for contacting a wall of the cardiac vessel
and temporarily anchoring the electrophysiology catheter shaft
within the cardiac vessel; and an actuator for causing deployment
and collapsing of the anchor within the cardiac vessel.
2. The catheter of claim 1, wherein the electrophysiology catheter
comprises a coronary sinus catheter and the cardiac vessel
comprises a coronary sinus.
3. The catheter of claim 1, wherein the anchor comprises a mesh
structure.
4. The catheter of claim 3, wherein the mesh structure is formed of
wires that are electrically isolated from electrodes that are
disposed along the catheter shaft.
5. The catheter of claim 1, further including a plurality of
electrodes that are disposed along the catheter shaft, wherein the
anchor is disposed between a first set of electrodes and a second
set of electrodes.
6. The catheter of claim 1, wherein the actuator is operatively
coupled to the anchor with a mechanical attachment member.
7. The catheter of claim 6, wherein the mechanical attachment
member comprises a flexible elongated mandrel that extends within
the catheter shaft and is coupled at one end to the actuator and at
an opposite end to the anchor.
8. The catheter of claim 7, wherein the opposite end is connected
to a slidable collar that is disposed about the outer surface of
the catheter shaft, wherein a proximal end of the anchor is fixedly
attached to the catheter shaft and a distal end of the anchor is
attached to the collar such that when the collar moves in a
proximal direction, the distal end of the anchor moves in a
proximal direction and the anchor is deployed by extending radially
outward relative to the catheter shaft.
9. The catheter of claim 6, wherein the actuator is a slide
actuator disposed within the handle and coupled to an elongated
mandrel that comprises the mechanical attachment member, wherein a
sliding action of the actuator is translated through the mandrel to
the anchor being moved between the deployed position and the
collapsed position.
10. The catheter of claim 9, further including an actuator lock
mechanism for locking the actuator in first and second positions
that correspond respectively to the anchor being in a fully
deployed position and a fully collapsed as well as intermediate
positions therebetween.
11. The catheter of claim 1, wherein at least a portion of the
anchor is electrically connected to an electronic amplifier to
permit the anchor to function as a recording electrode.
12. The catheter of claim 1, wherein the catheter shaft includes a
proximal section and a distal section that is slidably movable
relative to the proximal section and the actuator is operatively
connected to the distal catheter section such that movement of the
distal section is translated into movement of the anchor between
the deployed and collapsed positions.
13. The catheter of claim 12, wherein the anchor comprises a mesh
structure that has a proximal end fixedly attached to the proximal
section and a distal end fixedly attached to the distal
section.
14. The catheter of claim 1, wherein the anchor comprises a
plurality of splines that are disposed within an interior of the
catheter shaft and project through openings formed in the catheter
shaft when in the deployed position.
15. The catheter of claim 14, wherein each spline is disposed
within a lumen that is formed within the catheter shaft, the
splines being operatively coupled to the actuator such that
movement of the actuator is translated into the splines moving
between the deployed position where the splines move through the
openings and extend radially outward from the catheter shaft and
the collapsed position where the splies lie within the lumens.
16. The catheter of claim 14, further including a plurality of
flexible membranes that extend along the outer surface of the
catheter shaft and cover the openings formed in the catheter shaft,
wherein in the deployed position, the splines push the membranes
radially outward.
17. The catheter of claim 14, wherein the splines comprise
wires.
18. An electrophysiology catheter for insertion into a cardiac
vessel comprising: a handle; a catheter shaft coupled at one end to
the handle, the catheter shaft having a distal end, an inflatable
balloon disposed along an outer surface of the catheter shaft in a
location proximal to the distal end, the balloon being inflatable
between a deployed position and a collapsed position, wherein in
the deployed position, the balloon extends radially outward from
the outer surface of the catheter shaft for contacting a wall and
temporarily anchoring the catheter shaft within the cardiac vessel;
and an actuator for causing deployment and collapsing of the
anchor; wherein the catheter shaft has an entrance port formed at
the distal end that forms an entrance into a conduit that passes
through the inflatable balloon and at least one exit port that is
formed proximal to the balloon and in communication with the
conduit such that the entrance port is formed on one side of the
inflatable balloon and the exit port is formed on the other side of
the inflatable balloon, whereby when the inflatable balloon is
fully deployed, blood flows into the entrance port through the
conduit and out the exit port.
19. The catheter of claim 18, wherein the conduit comprises a shunt
tube.
20. The catheter of claim 18, wherein the electrophysiology
catheter comprises a coronary sinus catheter and the cardiac vessel
comprises a coronary sinus.
21. An electrophysiology catheter for insertion into a cardiac
vessel comprising: a handle; a catheter shaft coupled at one end to
the handle, the catheter shaft having a distal end, the catheter
shaft having at least two windows formed therein and open along an
outer surface of the catheter shaft and at least one internal lumen
that is in fluid communication with the at least two windows; and
an inflatable balloon disposed about an outer surface of the
catheter shaft overlying the at least two windows, the inflatable
balloon being in fluid communication with the internal lumen to
permit inflation of the balloon at least in areas where the windows
are present.
22. The catheter of claim 21, wherein the balloon has an ovoid
shape.
23. The catheter of claim 21, wherein each window comprises an
elongated slot formed in the catheter shaft.
24. The catheter of claim 21, wherein each window has its own
corresponding lumen.
25. The catheter of claim 21, wherein the balloon is securely
attached to the outer surface of the catheter shaft in regions
surrounding the windows, these regions being areas where the
balloon is collapsed even when the balloon is inflated in regions
overlying the windows.
Description
TECHNICAL FIELD
[0001] The present invention relates medical equipment, and in
particular, to an electrophysiology catheter, such as a coronary
sinus catheter, that includes an actuatable mechanism for anchoring
the catheter at a desired location.
BACKGROUND
[0002] The human heart is a very complex organ, which relies on
both muscle contraction and electrical impulses to function
properly. The electrical impulses travel through the heart walls,
first through the atria and then the ventricles, causing the
corresponding muscle tissue in the atria and ventricles to
contract. Thus, the atria contract first, followed by the
ventricles. This order is essential for proper functioning of the
heart. The coronary sinus is a collection of veins joined together
to form a large vessel that collects blood from the myocardium of
the heart. It delivers deoxygenated blood to the right atrium in
conjunction with the superior and inferior vena cava. The coronary
sinus opens into the right atrium, between the inferior vena cava
and the auriculo-ventricular opening. It returns the blood from the
heart, and is protected by a semicircular fold of the lining
membrane of the auricle, the coronary valve.
[0003] An indwelling positioned coronary sinus catheter is used as
a reference site for electrophysiology studies due to its tubular
shape and anatomical positioning on the atrioventricular groove
(AV) groove. Catheters are inserted into the coronary sinus ostium
and advanced distally to provide both left sided (most distal) and
right sided (most proximal) signals. Because the coronary sinus is
located in the AV groove, the signals uniquely show both atrial and
ventricular activity. The current state of the art CS catheter uses
ten (10) poles for recording signals throughout the coronary sinus.
Because these catheters are stationary they make a good choice for
a timing reference when performing a mapping procedure while a
second or third catheter is in the chambers of the heart. They are
also used as location or position references with 3D mapping
systems such as Velocity.TM., NAVX.TM. sold by St. Jude Medical or
the CARTO XP and CARTO3 systems sold by BioSense-Webster division
of Johnson and Johnson.
[0004] Unfortunately, current coronary sinus catheters suffer from
a number of disadvantages and in particular, physicians have
reported that the coronary sinus catheter can move during the
electrophysiology procedure and, when it does, there will be a
change in the reference signal. This creates inaccuracies in maps
and makes comparisons from one map to another very difficult. There
is therefore a need for an improved coronary sinus catheter that
overcomes the disadvantages associated with the conventional
coronary sinus catheter.
SUMMARY
[0005] According to one embodiment, an electrophysiology catheter,
such as a coronary sinus catheter, for insertion into a cardiac
vessel, such as a coronary sinus, includes a handle and a catheter
shaft coupled at one end to the handle. The catheter shaft has a
distal end and an anchor is associated with the catheter shaft and
is movable between a deployed position and a collapsed position. In
the deployed position, the anchor extends radially outward from an
outer surface of the catheter shaft for contacting a wall and
temporarily anchoring the catheter shaft within the coronary sinus.
The catheter also includes an actuator for causing deployment and
collapsing of the anchor upon manipulation of the actuator.
[0006] The anchor can be in the form of a wire mesh structure and
the actuator is operatively coupled to the mesh using a mechanical
attachment or link member. The link can be in the form of a
flexible elongated mandrel that extends within the catheter shaft
and is coupled at one end to the actuator and at an opposite end is
connected to a slidable collar that is disposed about the outer
surface of the catheter shaft. A proximal end of the wire mesh
structure can be fixedly attached to the catheter shaft and a
distal end of the wire mesh structure can be attached to a collar
such that when the collar moves in a proximal direction, the distal
end of the wire mesh structure moves in a proximal direction and
the wire mesh structure is deployed by extending radially outward
relative to the catheter shaft. Conversely, a distal end of the
wire mesh structure can be fixedly attached to the catheter shaft
and a proximal end of the wire mesh structure can be attached to
the collar such that when the collar moves in a distal direction,
the proximal end of the wire mesh structure moves in a distal
direction and the wire mesh structure is deployed by extending
radially outward relative to the catheter shaft.
[0007] The anchor can also be in the form of a plurality of splines
that are disposed within an interior of the catheter shaft and
project through openings formed in the catheter shaft when in the
deployed position. Each spline is disposed within a lumen that is
formed within the catheter shaft and the splines are operatively
coupled to the actuator such that movement of the actuator is
translated into the splines moving between the deployed position in
which the splines extend through the openings and extend radially
outward from the catheter shaft and the collapsed position in which
the splines lie within the lumens.
[0008] In yet another embodiment, an electrophysiology catheter,
such as a coronary sinus catheter for insertion into a cardiac
vessel, such as a coronary sinus, includes a handle and a catheter
shaft coupled at one end to the handle. The catheter shaft has a
distal end and an inflatable balloon is disposed along an outer
surface of the catheter shaft in a location proximal to the distal
end. The balloon is inflatable between a deployed position and a
collapsed position. In the deployed position, the balloon extends
radially outward from the outer surface of the catheter shaft for
contacting a wall and temporarily anchoring the catheter shaft
within the coronary sinus. The catheter also includes an actuator
for causing deployment and collapsing of the anchor upon
manipulation of the actuator.
[0009] The catheter shaft has an entrance port formed at the distal
end that forms an entrance into a conduit that passes within the
shaft beneath the inflatable balloon and at least one exit port
that is formed proximal to the balloon and in communication with
the conduit such that the entrance port is formed on one side of
the inflatable balloon and the exit port is formed on the other
side of the inflatable balloon. When the inflatable balloon is
fully deployed, blood flows into the entrance port through the
conduit and out the exit port. The balloon can be ovoid in shape in
one implementation.
[0010] It will be appreciated that in the various embodiments
disclosed herein, the anchoring mechanism does not occlude fluid
(e.g., blood) flow within the vessel when the catheter is in the
deployed position.
[0011] Various arrangements are disclosed that can be combined and
still be within the scope of the present disclosure. These and
other aspects, features and advantages shall be apparent from the
accompanying Drawings and description of certain embodiments of the
invention.
BRIEF DESCRIPTION OF THE DRAWINGS
[0012] FIG. 1 is a side view of an electrophysiology catheter
(e.g., a coronary sinus catheter) with an anchor mechanism
according to a first exemplary embodiment of the present
invention;
[0013] FIG. 2 is a local side view of a distal end of the catheter
shaft of the catheter of FIG. 1 showing the anchor in a collapsed
position;
[0014] FIG. 3 is a side view of the catheter of FIG. 1 within the
coronary sinus with the anchor in a deployed position;
[0015] FIG. 4 is a side view of an electrophysiology catheter
(e.g., a coronary sinus catheter) with an anchor mechanism
according to a second exemplary embodiment of the present
invention;
[0016] FIG. 5 is a side view of an electrophysiology catheter
(e.g., a coronary sinus catheter) with an anchor mechanism
according to a third exemplary embodiment of the present
invention;
[0017] FIG. 6 is a local side view of the catheter shaft of the
catheter of FIG. 5 showing blood flow when the distal anchor is
deployed;
[0018] FIG. 7 is a side view of an electrophysiology catheter
(e.g., a coronary sinus catheter) with an anchor mechanism
according to a fourth exemplary embodiment of the present
invention;
[0019] FIG. 8 is a side view of the catheter of FIG. 7 in the
coronary sinus with the distal anchor deployed;
[0020] FIG. 9 is an end and side view of the catheter of FIG. 7
showing windows through which anchor elements are deployed;
[0021] FIG. 10 is side view showing the two dimensions of the
anchor;
[0022] FIG. 11 shows methods of increasing the projection of the
anchor elements;
[0023] FIG. 12 is a side view of an electrophysiology catheter
(e.g., a coronary sinus catheter) with an anchor mechanism
according to a fifth exemplary embodiment of the present
invention;
[0024] FIG. 13 illustrates side and end views of an
electrophysiology catheter (e.g., a coronary sinus catheter)
catheter with an anchor mechanism according to a sixth exemplary
embodiment of the present invention;
[0025] FIG. 14 is a side view of an electrophysiology catheter
(e.g., a coronary sinus catheter) with a tapered shaft according to
an exemplary embodiment of the present invention;
[0026] FIG. 15 is a side view of the catheter of FIG. 14 inserted
into the coronary sinus;
[0027] FIG. 16 shows a tapered tipstock used in combination with a
conventional proximal shaft;
[0028] FIG. 17 is a side view of an electrophysiology catheter
(e.g., a coronary sinus catheter) with an anchor mechanism
according to another embodiment of the present invention;
[0029] FIG. 18 is a cross-sectional view of an anchor mechanism in
a collapsed state;
[0030] FIG. 19 is a cross-sectional view of an anchor mechanism in
a deployed state;
[0031] FIG. 20 is side view of the anchor mechanism in the deployed
state; and
[0032] FIG. 21 is a perspective view of the catheter of FIG.
18.
DETAILED DESCRIPTION OF CERTAIN EMBODIMENTS OF THE INVENTION
[0033] In accordance with a first embodiment of the present
invention, shown in FIGS. 1-3, a coronary sinus (CS) catheter 100
is provided. The catheter 100 has a shaft portion 110, a control
handle 120 and a connector portion 130. The catheter 100 is
preferably part of a catheter system and when the catheter 100 is
used in a mapping application, the catheter 100 can be operatively
coupled to a recording device 140 via a cable 150 or the like.
Signals coming from the catheter 100 can be processed and delivered
to the recording device 140. In addition, the catheter system can
include and be connected to a 3D mapping system 160.
[0034] It will also be understood that the catheter 100 can be part
of a catheter system that can include an energy source that is
operatively connected to the connector portion 130, as by cable
150, for selectively delivering energy to one more portions of the
catheter. It will be appreciated that the energy source and the
recording device 140 can be incorporated into a single unit.
[0035] As illustrated, the catheter shaft portion 110 includes a
distal end 112 and an opposite proximal end 114 that joins the
control handle 120. The shaft portion 110 is a hollow structure
that includes at least one lumen to allow routing of different
members, such as wires, etc., along the length of the shaft portion
110. The catheter shaft portion 110 includes an outer surface 116.
As shown in FIG. 1, the distal end 112 includes a distal tip that
can have a rounded shape.
[0036] Similarly, the control handle 120 includes a first end 122
and an opposing second end 124 with the first end 122 being the end
of the control handle 120 that is joined to the shaft portion 110.
The second end 124 is the end that joins to the connector portion
130. The control handle 120 can have any number of different shapes
and is designed to be held by the operator during the procedure and
further can provide accessible control features that permit control
and/or operation of the catheter 100.
[0037] For example, the catheter 100 can be a steerable device. For
example, a distal tip portion 115 of the catheter shaft portion 110
can be deflected by a mechanism that is incorporated within the
control handle 120. The control handle 120 can include a rotatable
thumbwheel and/or a slide actuator which can be used by a user to
deflect the distal end of the catheter. In FIG. 1, a steering
mechanism is generally indicated at 125. The thumbwheel (or any
other suitable actuating device) is connected to one or more pull
or push wires which extend through shaft portion 110 and are
connected to the distal end of the catheter at an off-axis
location, whereby tension applied to one or more of the pull wires
causes the distal portion of the catheter to curve in a
predetermined direction or directions. U.S. Pat. Nos. 5,383,852;
5,462,527 and 5,611,777, which are hereby incorporated by reference
in their entirety, illustrate various embodiments of control handle
that can be used for steering the catheter 100.
[0038] The catheter 100 includes one or more electrodes and
preferably includes a plurality of electrodes 210 that are disposed
along the length of the shaft portion 110. The electrodes 210 can
be in the form of recording electrodes when the catheter 100 is
used as part of a mapping application. In the illustrated
embodiment, the electrodes 210 are divided into two groups and in
particular, the electrodes 210 are divided into a first set 212 of
electrodes and a second set 214 of electrodes. The second set 214
of the electrodes are located in the distal tip portion 115 and one
of the electrodes in the second set 214 is located at the distal
end 112 (a tip electrode). The number of electrodes in the first
set 212 can be the same or different than the number of electrodes
in the second set 214. When the catheter 100 is used in a mapping
application, the electrodes 210 are operably connected to the
recording device 140 and/or 3D mapping system 160. As previously
mentioned, it is also within the scope of the present invention
that the catheter 100 can be used in an ablation application in
which case the electrodes 210 are operatively connected to an
energy source to allow energy to be delivered to selected
electrodes. The electrodes 210 can be in the form of electrode
bands.
[0039] In accordance with the present invention, the catheter 100
includes a mechanism for anchoring the shaft portion 110 in a
desired location (coronary sinus) during the electrophysiology
procedure by deployment of an anchor 300. In particular, the
mechanism is a user actuatable mechanism that causes the anchor 300
to be either deployed or to be collapsed (return the anchor to a
normal operating position). The mechanism includes an actuator 205
that is accessible to the user and is designed so that upon
manipulation of the actuator 205, the anchor 300 is either moved to
a deployed position or is withdrawn and moved to a collapsed
position. The actuator 205 is preferably disposed within the
control handle 120; however, other locations are possible for
placement of the actuator 205. It will also be appreciated that any
number of different types of actuator designs can be used including
a slide actuator, a thumbwheel, etc.
[0040] In the illustrated embodiment, the actuator 205 is a slide
actuator that is slid linearly to cause the anchor 300 to change
its position and in particular, to cause the anchor 300 to either
deploy or to be placed back into a collapsed position. The slide
actuator 205 is operatively coupled to the anchor 300 such that the
sliding action of the actuator 205 is translated into a change in
the position (condition) of the anchor 300 (e.g., anchor 300
deploys and radially expands so as to provide a structure that
anchors the catheter 100 in place, or conversely, anchor 300
radially contracts and is returned to a collapsed state. FIG. 1
shows the anchor 300 in its deployed position and FIG. 2 shows the
anchor 300 in its collapsed position.
[0041] Any number of different techniques and mechanisms can be
used to mechanically couple the actuator 205 to the anchor 300 to
cause a translation of the movement of the actuator 205 into the
desired radial expansion and radial contraction of the anchor 300.
In one embodiment, a mechanical attachment member or link member in
the form of a mandrel 250 is coupled to both the anchor 300 and the
actuator 205 and is constructed so that it can withstand the normal
movements of the catheter 100 including the selected bending of a
portion of the catheter shaft 110. For example, the anchor 300 can
have a proximal end 302 and an opposing distal end 304 that is
closer to the distal end 112 of the catheter shaft 110. The
proximal end 302 of the anchor 300 is fixed relative to the
catheter shaft 110, while the distal end 304 is an adjustable end
in that it can move relative to the catheter shaft 110 or vice
versa.
[0042] Any number of different members can be used to couple the
mandrel 250 to the distal end 304 of the anchor 300 to allow
controlled movement of the distal end 304 both relative to the
catheter shaft 110 and the proximal end 302. For example, a
coupling member 310, such as a slide ring or collar can be used and
disposed about the outer surface of the catheter shaft 110. The
coupling member 310 is movable relative to the catheter shaft 110
and is coupled to the distal end 304 of the anchor 300 such that
movement of the coupling member 310 (due to movement of the mandrel
250) is translated into movement of the anchor 300 in the desired
direction.
[0043] The coupling member 310 can even travel in one or more
channels formed in the outer surface of the catheter shaft 110 to
control the movement of the coupling member 310. For example, a pin
and groove mechanism can be employed between the coupling member
310 and the catheter shaft 110.
[0044] The mandrel 250 can be constructed using methods that are
identical or similar to those previously disclosed by the current
assignee for a mesh or sliding electrode catheter. For example, see
U.S. Pat. No. 7,727,229 and U.S. patent application publication No.
2007/0129717, each of which is hereby incorporated by reference in
its entirety. The mandrel 250 can thus be an elongate structure
that has one end that is coupled to the coupling member 310 and
another end that is coupled to the actuator 205. Alternatively, the
catheter shaft 110 can include a dedicated lumen formed therein
along at least a length thereof for containing the mandrel 250. In
this manner, the mandrel 250 can be both mechanically and
electrically isolated from the recording wires and other electrical
components that are in communication with the electrodes 210.
[0045] In yet another embodiment, the mandrel 250 can be used
intentionally as a conductor to carry electrical signals from
selected areas of the anchor 300 which in this case can function as
a recording electrode. It will further be appreciated that separate
electrical wires can be routed to select sections (e.g., wires) of
the anchor 300 (e.g., a wire mesh) to facilitate recording
signals
[0046] In the illustrated embodiment, the anchor 300 is located
between the first set of electrodes 212 and the second set of
electrodes 214; however, this is merely one exemplary location for
the anchor 300 and the anchor 300 can thus be located anywhere
along the catheter shaft 110 that allows the anchor 300 to perform
the intended function. Typically, the anchor 300 will be located
adjacent or proximate electrodes since anchoring of the catheter
shaft 110 is desirable in the region where electrodes are present
to permit the electrodes to perform their intended function. In the
case of a coronary sinus catheter, the electrodes are recording
electrodes. However, in other catheter designs, the electrodes 210
can be constructed specially as mapping or ablation electrodes.
Depending upon the application, electrodes 210 are optimally placed
relative to the location of the anchor 300 and typically, as
previously mentioned, electrodes are located both proximal and
distal to the anchor 300.
[0047] The anchor 300 can take any number of different forms so
long as the structure can be deployed and collapsed relative to the
catheter shaft and permits conventional catheter functions and
operations to be performed. In particular, since the anchor 300 is
designed to hold the catheter shaft 110 in placed within a vessel
(e.g., coronary sinus), the anchor arrangement cannot obstruct
fluid flow (e.g., blood flow) within the vessel. In one embodiment,
the anchor 300 is in the form of a mesh structure, such as a
braided mesh structure, that is disposed about the outer surface of
the catheter shaft 110 and can be moved between both collapsed and
deployed positions, as previously described. It will also be
appreciated that the anchor 300 can be locked in positions that are
between the fully collapsed position and the fully deployed
position.
[0048] The anchor 300 can thus be in the form of a plurality of
interlaced filaments 320, such as wires that form a braided wire
mesh. The filaments are flexible and capable of being expanded
radially outwardly from catheter shaft 110. The filaments 320 can
be formed of metallic elements having relatively small cross
sectional diameters, such that the filaments can be expanded
radially outwardly. The filaments may be round, having a dimension
on the order of about 0.001-0.030 inches in diameter.
Alternatively, the filaments may be flat, having a thickness on the
order of about 0.001-0.030 inches, and a width on the order of
about 0.001-0.030 inches. The filaments can be formed of Nitinol
type wire. Alternatively, the filaments may include non-metallic
elements, or non-metallic elements woven with metallic elements,
with the non-metallic elements providing support to or separation
of the metallic elements. A multiplicity of individual filaments
320 can be provided in braided mesh structure 300, for example up
to 300 or more filaments 320. It will be appreciated that the
aforementioned dimensions and description is merely exemplary for a
mesh structure according to one embodiment and other structures and
other dimensions are equally possible so long as the intended
catheter functions and operations can be performed.
[0049] As mentioned herein, in some embodiments, the anchor 300 can
be formed of wire filaments (wires) and the filaments 320 can be
electrically isolated from each other by an insulation coating.
This insulation coating may be, for example, a polyimide type
material. A portion of the insulation on the outer circumferential
surface of the braided conductive member is removed. This allows
each of the filaments to facilitate recording signals.
Alternatively, specific filaments 320 can be permitted to contact
each other to form a preselected grouping of filaments 320.
[0050] Each of the filaments 320 can be helically wound under
compression about the catheter shaft 110. As a result of this
helical construction, select movement of the anchor 300 causes
radial expansion of the anchor 300 and in particular, the radial
expansion of the portions of filaments 320 that results in the
deployment of the anchor 300.
[0051] As mentioned herein, proximal end 302 of the braided wire
mesh 300 can be fixed relative to the catheter shaft 110 while the
distal end 304 of the braided wire mesh 300 is attached to the
sliding coupling member 310. When the coupling member 310 is moved
in a proximal direction, the distal end 304 of the wire mesh 300 is
drawn towards the proximal end 302 and this results in a radial
expansion of the wire mesh 300. The coupling member 310 is moved
proximally due to proximal movement of the mandrel 250 within the
catheter shaft 110. (The converse arrangement can have the mesh
expand by moving the coupling member in a distal direction).
[0052] When the anchor 300 is positioned between two sets of
electrodes, the sets of electrodes are placed to allow for movement
of the anchor 300 between the collapsed and deployed positions. In
the collapsed position, the distal end 304 of the anchor 300 is
closest to the more distally located electrodes (e.g., the second
set 214 of electrodes) and when the anchor 300 is deployed, the
spacing between the distal end 304 of the anchor 300 and the
electrode set is greater. The wire mesh structure of the anchor 300
permits fluid to flow therethrough and thus, when the catheter 100
is placed in a vessel (e.g., the coronary sinus), fluid (e.g.,
blood) can flow through the wire mesh and its flow is not
obstructed as it flows about the catheter 100.
[0053] Now referring to FIGS. 1-3, a method of using the catheter
100 as a coronary sinus catheter and for advancing the catheter 100
within the coronary sinus are described. The catheter 100 is
advanced by inserting the distal end 112 of the catheter shaft 110
into the coronary sinus (vessel) while the anchor 300 is in the
collapsed position as shown in FIG. 2. Once the catheter 100 is in
an optimal location within the coronary sinus, the anchor 300 is
deployed by manipulating the actuator 205 to cause the mandrel 250
to move in a proximal direction, thereby causing the coupling
member 310 to likewise move in a proximal direction. This movement
of the mandrel 250 and the coupling member 310 is directly
translated into the radial expansion of the anchor 300. FIG. 3
shows the anchor 300 in a deployed position within the coronary
sinus.
[0054] As discussed herein, the anchor 300 is designed to locate
and hold the catheter 100 in its desired location within the
coronary sinus by applying outward radial pressure to the vessel
wall. Blood flows past the deployed wire mesh 300 due to its open
wire construction. The deployment mechanism can be reversed in the
design to optimize contact and safe deployment and collapse. This
can be achieved by reversing the anchor point from the proximal end
302 to the distal end 304 and attaching the mandrel actuation
mechanism to the proximal end 302. In this configuration, a push on
the mandrel 250 deploys the wire mesh 300 (anchor) and collapse the
wire mesh 300 against the catheter shaft 110.
[0055] The actuator 205 also preferably includes a lock mechanism
that permits the actuator 205 to be locked in place and prevent
inadvertent movement of the anchor 300. For example, when the
anchor 300 is fully deployed to position and retain the catheter
100 in its desired position, the actuator 205 can be locked to
prevent inadvertent movement of the catheter 100 due to a change in
the deployment status of the anchor 300. Similarly, the actuator
205 can be placed into a locked position when the anchor 300 is not
deployed (collapsed state).
[0056] In one other embodiment, the catheter shaft 110 can be
constructed such that when the coupling member 310 is moved to
cause the radial expansion of the anchor 300, an electrode (e.g., a
ring electrode, etc.) is exposed.
[0057] In yet another embodiment that is illustrated in FIG. 4, a
telescoping catheter shaft design can be used for deploying and
collapsing the anchor 300. In this embodiment, the catheter shaft
110 includes a first main section 115 and a second sliding section
117 that is coupled to the main section 115 and slidable relative
thereto. The second sliding section 117 represents the distal end
section of the catheter 100 and is disposed relative to the main
section 115 so that the sliding section 117 can be moved relative
to the main section 115 in both proximal and distal directions.
[0058] In FIG. 4, the sliding section 117 is disposed about a
portion of the outer surface of the main section 115. The sliding
section 117 is coupled to the mandrel 250 (not shown) so that
movement of the mandrel 250 in the proximal and distal directions
is translated into proximal and distal movement of the sliding
section 117.
[0059] The proximal end 302 of the anchor 300 (e.g., a wire mesh)
is fixedly attached to the first main section 115 of the catheter
shaft 110, while the distal end 304 of the anchor 300 is fixedly
attached to the sliding section 117. When the sliding catheter
section 117 is moved in a proximal direction, the anchor 300 is
deployed (expands radially outward). Conversely, when the sliding
catheter section 117 is moved in a distal direction, the anchor 300
is collapsed due to the flattening out of the anchor 300 along the
catheter shaft 110.
[0060] In this embodiment, the catheter shaft 110 is thus formed of
two sections with one movable relative to the other one to cause a
change in the position of the anchor 300.
[0061] Now referring to FIGS. 5 and 6, another mechanism for
temporarily anchoring or fixing a catheter 400 within a vessel,
such as a coronary sinus, is shown. The catheter 400 is similar to
catheter 100 and therefore like elements are numbered alike. The
catheter shaft 100 includes a distal tip at the distal end 112. The
distal tip can be in the form of a recording electrode or the
distal tip can be free of a recording electrode. Proximal to the
distal tip 112 is an anchor in the form of an inflatable balloon
410, such as an inflation balloon, that can be inflated so as to
extend radially outward from the catheter shaft 110. As described
herein the inflation balloon 410 can have any number of different
shapes and can have any number of different sizes. One preferred
shape is ovoid. The inflation balloon 410 can be inflated using
conventional techniques including delivering a fluid, including a
liquid or gas, to the inflation balloon 410 using a fluid conduit
(e.g., a lumen formed in the catheter shaft) or the like that is
routed internally through the catheter shaft and is in
communication with the interior of the balloon 410. The inflation
of the balloon 410 can be preferably accomplished using controls
that are part of the control handle 120 or alternatively, an
actuator that is either a part of or separate from the catheter can
be used. For example, a syringe or the like or other type of device
that holds a fluid can be used to inject fluid into the balloon 410
as by injecting the fluid within one or more inflation lumens that
are formed in the catheter shaft and in fluid communication with
the interior of the balloon 410. The actuator of the present
invention can thus be thought of as any mechanism that is
configured to cause the anchor to deploy and/or collapse.
[0062] Proximal to the inflation balloon 410, a first port hub 420
is formed in the catheter shaft 110 and in addition, proximal to
the inflation balloon 410, recording electrodes 210 are disposed
along the length of the catheter shaft 110. The catheter shaft 110
includes an entrance port 430 at the distal tip 112 of the catheter
shaft 110 from which a conduit 440, such as a shunt tube, runs
through the center of the inflation balloon 410, within the
catheter shaft, to the proximal port hub 420. In the proximal port
hub 420, there are 1 or more exit ports 422 that are in
communication with the entrance port 430 via the shunt tube 430. It
will further be appreciated that in some embodiments, the shunt
tube 430 can be eliminated due to the construction of the balloon
itself, such as when an ovoid shaped balloon is used or a balloon
with a non-occluding shape is used.
[0063] As with the previous embodiments, the catheter 400 typically
includes a steering mechanism and in particular, the catheter 400
can include one or more catheter steering cables (not shown) that
can or cannot be anchored to the port hub 420, or the steering
cables can pass through the hub 420 to anchor at the distal tip
112.
[0064] As with the other embodiments and in contrast to
conventional designs, the catheter 400 of the present invention
includes a mechanism for temporarily anchoring itself within the
vessel (e.g., coronary sinus). The catheter 400 can thus be used as
a common coronary sinus diagnostic catheter. Once inserted into the
coronary sinus, the inflation balloon 410 is inflated using
conventional techniques such as filling the balloon 410 with a
fluid or air. The inflation of the balloon 410 results in the
catheter 400 being anchored within the coronary sinus in a desired
position for added stability and to help prevent the catheter 400
from popping out or otherwise moving within the coronary sinus.
[0065] Since blood flows through the coronary sinus, the catheter
400 is designed to accommodate such blood flow. More specifically,
blood is allowed to bypass the inflation balloon 410 by first
flowing through the entrance port 430 and flowing through the shunt
tube 440 to the one or more exit ports 422 through which the blood
exits the catheter shaft 110. FIG. 6 shows the flow of blood within
the catheter shaft 110. Since the shunt tube 440 runs through the
inflation balloon 410, within the shaft, blood can flow in an
unimpeded manner even when the inflation balloon 410 is fully
inflated and in contact with the walls of the coronary sinus.
[0066] Now referring to FIGS. 7-11, another embodiment of the
present invention is illustrated for temporarily securing a
catheter 500 within a vessel, such as the coronary sinus. The
catheter 500 is similar to the other catheters disclosed herein and
therefore, like elements are numbered alike. The catheter 500
includes an elongated catheter shaft 510. As with the other
embodiments, the catheter 500 has both a deployed state for
temporarily securing and holding the catheter 500 in a desired
position and location within the vessel (e.g., coronary sinus) and
a collapsed state. In this embodiment, the catheter 500 includes a
plurality of deployable splines 520. As shown in the figures, when
the splines 520 are deployed, the splines 520 move radially outward
from the catheter shaft 510 for intimately contacting the walls of
the vessel.
[0067] In one embodiment, each spline 520 is disposed within a
lumen 525 that extends along a length of the catheter shaft 510. In
the illustrated embodiment, there are four lumens 525 that contain
four splines 520 (e.g., the lumens and splines can be oriented 90
degrees relative to one another). A length of each lumen 525 is
exposed along the outer surface of the catheter shaft 110. In other
words, the splines 520 are accessible within these exposed lumen
sections which can be thought of as being windows 522 formed along
the catheter shaft 510. These openings or windows 522 formed within
and along the catheter shaft 510 permit the radial expansion
(outward radial movement) of the splines 520 and this translates
into the splines 520 being moved into contact with the vessel wall
(i.e., wall of the coronary sinus).
[0068] The location of the splines 520 can vary to coincide with
the vessel dimensions and it will be appreciated that the use of
splines 520 allows for blood flow to only be minimally restricted
(an important consideration in typical coronary sinus
applications). The amount of the projection (radial outward
movement--diameters) of the spline 520 can be varied by lengthening
the degree of exposure of the splines 520 (e.g., increase the
length of the window formed within the catheter shaft 510) and/or
lengthening the stroke of the exposed splines 520. This is
generally shown in FIGS. 10-11, where x is equal to the length of
the exposed spline 520 (variable radius or the catheter) and y is
equal to the stroke of the spline 520 (e.g., the amount of
projection). By altering one or more of these parameters, the
overall diameter of the catheter shaft 510 can be varied.
[0069] Varying the "y" dimension can be achieved using a number of
different mechanisms including a push/pull deployment mechanism to
control the spline deployment or spline retraction (collapse).
[0070] The splines 520 can be actuated using any number of
different techniques where movement of one member, such as an
actuator in the handle control section, is translated into the
splines 520 either being deployed by expanding radially outward
from the catheter shaft or collapsing as by laying flat within the
lumens 525. For example, a handle mechanism can be used and include
a control in which the splines 520 can be moved forward and
rearward within the catheter shaft 510 to cause the deployment
and/or collapse of the splines 520. The handle mechanism thus can
drive the movement of the splines 520. A dual control handle can be
provided if steering is needed as previously described herein.
[0071] The splines 520 can be in form of an elongated filament,
such as an elongated wire, that is disposed within the lumen 525.
However, other materials can be used so long as the splines 520 can
be deployed and placed into a collapsed position.
[0072] FIG. 12 shows an alternative embodiment where the catheter
shaft 510 includes a distal end section 512 that is slidable
relative to a main shaft section 514. In this embodiment, one end
of the spline 520 is attached to the slidable end section 512,
while the other end of the spline 520 is attached to the main
section 514. As a result, movement of the end section 512 relative
to the main section 514 causes a change in the position of the
spines 520. For example, the proximal movement of the end section
512 relative to the main section 514 can cause the splines 520 to
project radially outward and into contact with the vessel wall for
locally anchoring the catheter 500 within the vessel (e.g.,
coronary sinus). Alternatively, a pushing (movement of the main
section 512 relative to the end section 514) can cause deployment
of the splines 520. The actuation (deployment) of the splines 520
can be controlled at the control handle portion of the catheter
500. In this embodiment, the catheter shaft 510 can be thought of
as being of a telescoping type.
[0073] The splines 520 can be actuated using any number of
different techniques where movement of one member, such as an
actuator in the handle control section, is translated into the
splines 520 either being deployed by expanding radially outward
from the catheter shaft or collapsing as by laying flat within the
lumens 525.
[0074] The splines 520 can be in form of an elongated filament,
such as an elongated wire, that is disposed within the lumen
525.
[0075] In yet another embodiment, as shown in FIG. 13, a catheter
600 is provided and is similar to the other embodiments disclosed
herein with the exception that each spline 520 is covered with a
membrane 610 that can readily flex and contract as a result of the
movement of the underlying spline 520. The flexible membrane 610 is
disposed over a respective spline 520 and is deployed by the spline
520 as shown in the end view of FIG. 13. FIG. 13 shows blood flow
around the catheter 600 and shows how the splines 520 anchor and
hold the catheter 600 in place within the vessel (e.g., coronary
sinus).
[0076] The advantages of this embodiment are that this design
prevents exposed splines 520 and thus avoids any issues that are
attributable to having exposed splines 520 present. At the same
time, blood flow is still permitted in the embodiment where the
splines 520 lie in a single plane as is the case when the splines
520 are oriented 180 degrees apart. The splines 520 can be a metal,
a plastic, etc., and can be flat wire, round wire, etc.
[0077] Now referring to FIGS. 14-15, a catheter 700 according to
another embodiment is shown.
[0078] The catheter 700 is of a tapered design in that a shaft 710
of the catheter 700 has a tapered construction. In the illustrated
embodiment, the catheter shaft 710 has three distinct regions,
namely, a first region 720, a second region 730, and a third region
740. The first region 720 represents a distal end (distal tip) of
the catheter shaft 710 and the third region 740 is the most
proximal region with the second region 730 being located between
the first and third regions 720, 740. A first taper 725 is formed
between the first and second regions 720, 730 and a second taper
735 is formed between the second and third regions 730, 740. The
dimensions of the catheter shaft 700 decrease along its length from
the proximal end to the distal end and in particular, the first
region 720 has the smallest diameter, the third region 740 has the
largest diameter and the second region 730 has diameter between the
first and third regions 720, 740.
[0079] A tapered tip (e.g., two or more tapered regions)
facilitates a closer geometry match to the coronary sinus
morphology as the surgeon spans the right to left side of the heart
during the procedure. In other words, the coronary sinus is
typically not of a constant diameter and is better described as
having a tapered construction itself. The catheter shaft 710 thus
provides the benefit of deeper coronary sinus penetration. A
tapered profile can also provide a means to secure the device
within the vessel (e.g., coronary sinus). More specifically, the
larger diameter portion (e.g., third region 740) of the catheter
shaft 710 can become slightly wedged in the coronary sinus as the
larger diameter region of the catheter shaft meets a narrower
transition within the coronary sinus (vessel).
[0080] A tapered transition allows for the ability to maintain an
existing transition relationship with a shaft that mates with the
larger proximal end, which aides in processing and mechanical
properties for traversing the coronary sinus with a strengthened
proximal segment. Proximal support of the curve is better for
advancement into the coronary sinus versus a device that fails to
include the tapered section. FIG. 16 shows a tapered tip stock in
the form of the tapered tip of the present invention used in
combination with a conventional catheter shaft that has a uniform
diameter.
[0081] It will be appreciated that the coronary sinus catheter
shaft can include a combination of the above described features,
including but not limited to the inclusion of an anchor in a distal
region of a catheter shaft that has a tapered construction as
described herein. In some applications the inclusion of an anchor
(e.g., deployable mesh, deployably splines, inflatable balloon,
etc.) along a tapered catheter shaft can provide improved results
in that the tapered shaft permits the catheter to be disposed
further within the coronary sinus and allow deployment of the
anchor at an optimal location to anchor the entire catheter. It
will also be appreciated that it is also within the scope of the
invention that two different anchors (of same type or different
types) can be utilized.
[0082] FIGS. 17-21 illustrate an electrophysiology catheter (e.g.,
coronary sinus catheter) 800 according to another embodiment. The
catheter 800 includes an elongated shaft 810 similar to the other
catheters disclosed herein. It will be understood that the catheter
800 can include the same features of the catheter 100 shown in FIG.
1 including one or more control mechanisms that are part of a
handle, etc. and can be operatively connected to other equipment,
such as the recording device 140 and/or the 3D mapping system 160.
For ease of illustration, FIGS. 17-21 only show a portion of the
catheter shaft 810. The catheter shaft 810 can be of a single lumen
type or of a multi lumen type. FIGS. 17-21 illustrate a multi lumen
type. In accordance with the invention, the catheter shaft 810 has
one or more (preferably two or more) windows 820 formed in the
catheter shaft 810. The windows 820 can be elongated slots formed
in the shaft 810. FIG. 18 shows four windows 820 and FIG. 19 shows
two windows 820. The windows 820 are preferably formed opposite
(180 degrees one another since this permits the anchor to contact
the vessel in two opposite points (locations); however, they can be
located in positions that are not directly opposite one
another.
[0083] Each window 820 of the catheter shaft 810 is in fluid
communication with at least one lumen 825 that is formed in the
shaft 810. Each window 820 can have its on respective lumen 825
formed in the catheter shaft in which case each window 820 is in
fluid communication with a respective lumen 825 or one lumen 825
can be in communication with two or more windows 820.
[0084] An inflatable member 830 is disposed about the catheter
shaft 810 in covering relation to the windows 820. In other words,
the inflatable member 830 covers the windows 820. In one
embodiment, the inflatable member 830 is a balloon, such as an
ovoid shaped balloon that is disposed about the shaft 810. In this
embodiment, the balloon is a continuous structure about the outer
surface of the catheter shaft. However, it will also be appreciated
that the inflatable member 830 can be formed of one or more
sections of flexible material that expands when a fluid force is
applied thereto and collapses when the fluid force is removed. In
other words, each window 820 can be covered with a single piece or
section of a material that has inflatable characteristics (e.g.,
balloon like material) and the regions between the windows 820 can
be entirely free of the expandable material. In this embodiment,
the pieces of expandable material are bonded or otherwise attached
to the outer surface of the catheter shaft along the periphery of
the respective window 820.
[0085] When an inflation fluid, such as a gas (air) or liquid,
flows through the lumen(s) 825, the fluid flows through the
window(s) that is fluidly connected to the lumen and into the
inflatable member 830 for inflation thereof. Alternatively, in the
embodiment where sections or pieces of material are individually
disposed over each window or the embodiment where the balloon is
bonded to the catheter shaft in regions between the catheter shaft,
the fluid force of the fluid flowing through the window against the
piece of material causes the radial expansion of the material
locally above the window. For example, the inflatable member 830 is
at least locally inflated in the areas of the windows 820. This is
shown in FIGS. 18 and 19. As shown in FIG. 21, the inflatable
member 830 can be bonded or otherwise secured to the catheter shaft
810 in areas surrounding the windows 820 so as to prevent inflation
of the member 830 in areas that are not overlying a window 820. As
a result, the inflation characteristics are influenced and
controlled by the shape of the window 820 and in the case of two or
four windows, the resulting inflated structure can be thought of as
being two or four elongated inflated sections (i.e., balloon
splines) that overlie the window 820.
[0086] It will be understood that the fluid (e.g., blood) can flow
around the balloon splines and thus, fluid flow (e.g., blood flow)
is not occluded. In other words, in regions where the inflatable
member 830 is bonded to the catheter shaft 810 or in regions of the
shaft 810 where the inflatable member 830 is absent , fluid flows
freely along the catheter shaft 810 since the balloon splines are
absent in these regions.
[0087] As with the other embodiments, the catheter 800 can be a
coronary sinus catheter that is used in the coronary sinus.
[0088] In addition, it will be appreciated that the catheters
described herein are configured so that the anchor element can be
partially deployed in that it can be deployed in a position between
the fully collapsed position and the fully deployed position.
Partial deployment may be desired in a narrower coronary sinus,
etc. Partial deployment is possible in both the mechanically
actuated anchor structures, such as the mesh, splines, etc., as
well as the embodiments where the anchor is an inflatable member,
such as a balloon in which case the balloon is only partially
inflated.
Example
[0089] In accordance with the present invention, a catheter
according to one of the embodiments is inserted into the coronary
sinus by first inserting a distal end of the catheter into the
coronary sinus. The catheter is inserted with the anchor being in a
collapsed position or state. The catheter is continually advanced
within the coronary sinus and the position of the catheter can be
monitored until the catheter is in a target area of the coronary
sinus. When the catheter is being used as part of a mapping
application, the target area can be a location where the mapping
electrodes of the catheter are in locations where mapping signals
are to be detected. Once the catheter is in a desired location
within the coronary sinus where a mapping application is to be
performed, the anchor is then deployed. In its deployed position,
the anchor locally anchors the catheter within the coronary vessel
by applying a radially outward force against the vessel wall.
However, as discussed herein, the embodiments of the present
invention do not occlude blood flow and therefore, blood flows
around the deployed anchor. Once the mapping application is
completed, the anchor can then be collapsed and the catheter is
moved in the opposite direction resulting in the catheter shaft
being removed from the coronary sinus.
[0090] While the invention has been described in connection with
certain embodiments thereof, the invention is capable of being
practiced in other forms and using other materials and structures.
In particular, features of different embodiments can be combined,
for example, to have splines or covered splines on a taper-tipped
catheter, and so on. Accordingly, the invention is defined by the
recitations in the claims appended hereto and equivalents
thereof
* * * * *