U.S. patent application number 13/209110 was filed with the patent office on 2011-12-08 for electrophysiology/ablation catheter having second passage.
Invention is credited to Rassoll Rashidi.
Application Number | 20110301536 13/209110 |
Document ID | / |
Family ID | 46327620 |
Filed Date | 2011-12-08 |
United States Patent
Application |
20110301536 |
Kind Code |
A1 |
Rashidi; Rassoll |
December 8, 2011 |
Electrophysiology/ablation catheter having second passage
Abstract
A deflectable tip cardiac electrophysiology/ablation lumen
catheter includes first and second passages, one of which
communicates with an inflatable member or balloon. The second
passage terminates in an opening or port downstream of the
inflatable member. The second passage is adapted to introduce a
liquid during an electrophysiology study while the inflatable
member prevents backflow of an injected liquid or dye and blood, or
is adapted to alternatively receive a guide wire or other medical
device therethrough.
Inventors: |
Rashidi; Rassoll; (Lakewood,
OH) |
Family ID: |
46327620 |
Appl. No.: |
13/209110 |
Filed: |
August 12, 2011 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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11730160 |
Mar 29, 2007 |
8000764 |
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13209110 |
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10784512 |
Feb 23, 2004 |
7218958 |
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11730160 |
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10260242 |
Sep 30, 2002 |
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10784512 |
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09232866 |
Jan 15, 1999 |
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10260242 |
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08880080 |
Jun 20, 1997 |
5861024 |
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09232866 |
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Current U.S.
Class: |
604/95.01 |
Current CPC
Class: |
A61B 2018/1472 20130101;
A61B 2017/22067 20130101; A61B 2018/1467 20130101; A61B 2018/00285
20130101; A61B 2018/00839 20130101; A61B 2218/002 20130101; A61B
18/1492 20130101; A61B 5/287 20210101; A61B 2017/003 20130101 |
Class at
Publication: |
604/95.01 |
International
Class: |
A61M 25/092 20060101
A61M025/092 |
Claims
1. A medical device, comprising: an elongated body comprising a
distal portion and a proximal portion, the distal portion
comprising a deflectable portion and a distal end portion; a
deflection member disposed within the elongated body and movable
relative to the proximal portion, wherein the deflection member is
operably fixed to the distal end portion such that pushing on the
deflection member causes the deflectable portion to deflect in a
first direction; and a handle coupled to the proximal portion of
the elongated body, the handle comprising a housing and an actuator
assembly comprising an actuator, wherein the actuator assembly is
operably coupled to the deflection member such that rotation of the
actuator in a first rotational direction relative to the housing
causes the actuator assembly to push on the deflection member,
thereby causing the deflection member to move within the proximal
portion of the elongate body and the deflectable portion of the
elongate body to deflect in the first direction.
2. The medical device of claim 1, wherein the deflection member is
operably fixed to the distal portion such that pulling on the
deflection member causes the distal portion to deflect in a second
direction.
3. The medical device of claim 1, wherein the elongated body
comprises a lumen sized and configured to pass a medical device
therethrough.
4. The medical device of claim 1, wherein the deflection member
comprises a circular cross-section.
5. The medical device of claim 1, wherein the elongated body
comprises a tubular shape.
6. The medical device of claim 1, wherein the actuator assembly is
operably coupled to the deflection member such that rotation of the
actuator in a second rotational direction relative to the housing
causes the actuator assembly to pull on the deflection member,
thereby causing the deflection member to move within the proximal
portion of the elongate body and the deflectable portion of the
elongate body to deflect in a second direction.
7. The medical device of claim 1, wherein the actuator is sized and
configured to be manually rotated by a user.
8. The medical device of claim 1, further comprising a reinforcing
member disposed within the elongate body.
9. The medical device of claim 8, wherein the reinforcing member
varies in stiffness from the proximal portion to the deflectable
portion of the elongate body.
10. The medical device of claim 9, wherein the reinforcing member
is stiffer within the proximal portion than within the deflectable
portion of the elongate body.
11. The medical device of claim 10, wherein the reinforcing member
comprises an opening within the deflectable portion.
12. The medical device of claim 8, wherein the reinforcing member
comprises a braided tube.
13. The medical device of claim 1, further comprising an electrode
disposed on the distal portion of the elongated body.
14. The medical device of claim 1, wherein the distal portion of
the elongated body is configured to contact blood.
15. The medical device of claim 1, wherein the elongated body
defines a longitudinal axis and wherein the first direction is not
parallel to the longitudinal axis.
16. A catheter, comprising: an elongated body comprising a distal
portion and a proximal portion, the distal portion comprising a
steerable portion and a distal end portion; a steering member
disposed within the elongated body and movable relative to the
proximal portion, wherein the steering member is operably fixed to
the distal end portion such that placing a compressive force on the
steering member steers the steerable portion in a first direction;
and a handle coupled to the proximal portion of the elongated body,
the handle comprising a housing and an actuator assembly comprising
an actuator, wherein the actuator assembly is operably coupled to
the steering member such that rotation of the actuator in a first
rotational direction relative to the housing causes the actuator
assembly to place a compressive force on the steering member,
thereby causing the steering member to move within the proximal
portion of the elongate body and the steerable portion of the
elongate body to steer in the first direction.
17. The catheter of claim 16, wherein the steering member is
operably fixed to the distal portion such that placing a tensile
force on the steering member steers the steerable portion in a
second direction.
18. The catheter of claim 16, wherein the elongated body comprises
a lumen sized and configured to pass a medical device
therethrough.
19. The catheter of claim 16, wherein the actuator assembly is
operably coupled to the steering member such that rotation of the
actuator in a second rotational direction relative to the housing
causes the actuator assembly to place a tensile force on the
steering member, thereby causing the steering member to move within
the proximal portion of the elongate body and the steerable portion
of the elongate body to steer in a second direction.
20. The catheter of claim 16, further comprising a reinforcing
member disposed within the elongate body, wherein the reinforcing
member varies in stiffness from the proximal portion to the
deflectable portion, and wherein the reinforcing member is stiffer
within the proximal portion than within the deflectable portion.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application is a division of U.S. application Ser. No.
11/730,160, filed 29 Mar. 2007, now pending (the '160 application),
which is a continuation-in-part of U.S. application Ser. No.
10/784,512, filed 23 Feb. 2004, now U.S. Pat. No. 7,218,958 (the
512 application). The '160 application is also a
continuation-in-part of U.S. application Ser. No. 10/260,242, filed
30 Sep. 2002, now abandoned (the '242 application), which is a
division of U.S. application Ser. No. 09/232,866, filed 15 Jan.
1999, now abandoned (the '866 application), which is a
continuation-in-part of U.S. application Ser. No. 08/880,080, filed
20 Jun. 1997, now U.S. Pat. No. 5,861,024 (the '080 application).
The '160 application, the 512 application, the '242 application,
the '866 application, and the '080 application are all hereby
incorporated by reference in their entirety as though fully set
forth herein.
BACKGROUND OF THE INVENTION
[0002] a. Field of the Invention
[0003] The present invention relates to catheters employed for
diagnostic and/or therapeutic procedures in medicine, more
specifically in minimally invasive cardiac electrophysiology
studies and/or cardiac ablation procedures.
[0004] b. Background Art
[0005] It is known from the inventors' prior patents and pending
applications to provide a pair of tension and compression members
(such as push/pull wires) that cooperate to selectively actuate a
distal end of a catheter. The distal end typically carries
axially-spaced electrodes which, when located in the body passage
such as the heart, monitor and record intra-cardiac electrical
signals during desired studies or intra-cardiac mapping procedure.
As is known, the electrodes conduct the cardiac electrical signals
to monitoring and recording devices. In addition, the electrodes
may be used to deliver electrical energy to selectively destroy a
site of cardiac tissue that causes an arrhythmia or abnormality in
the heart rhythm.
[0006] It is important for these types of procedures that wires
extending through the catheter for connection with the electrode be
of sufficient size to carry desired electrical energy levels to
perform these procedures. It is also important that a distal
portion of the catheter be able to deflect into a variety of
configurations, typically curved configurations having selective
radii of curvature in response to actuation from a catheter handle.
U.S. Pat. Nos. 5,552,713 and 5,861,024 are commonly owned by the
assignee of the present application and show and describe in detail
preferred catheter embodiments of this type. The disclosure and
details of these patents are expressly incorporated herein by
reference. The actuating mechanism described in the patents is
ergonomic, easy to operate, requires a relatively low force to form
a desired curvature of the catheter distal portion, allows a
comfortable range of displacement of the actuator to provide a full
range of curvature formation of the catheter distal portion, and
permits for curvature formation and curvature retention by a single
action of the physician's hand. These desired features are all
achieved through side-by-side longitudinal reciprocation of
tension/compression members that cooperate to provide simultaneous
tension in one member or wire, and compression in the other member
or wire. The tension/compression members preferably have a
generally circular cross-section throughout a major portion of
their length and a generally flattened, ribbon-like configurations
adjacent the distal portion of the catheter. A kinematic junction
is provided on the ribbon-like portions of the tension/compression
members. Bi-directional curvature or lateral deflection is thus
provided by employing tension/compression members without the need
of a compression strut in the distal portion. Typical dimensions of
a catheter casing, electrodes, and diametrical curvature upon
actuation are set forth in greater detail in commonly owned U.S.
patent application Ser. No. 09/726,235, (Publication No.
US2002-0065514-A1, published May 30, 2002), the details of which
are also incorporated herein by reference.
[0007] It is known from U.S. Pat. No. 6,325,797 to use an
inflatable balloon that is selectively pressurized from an
associated liquid source. A lumen is formed within the catheter and
carries the liquid, such as saline, to the balloon. In this manner,
the balloon is selectively inflated to engage the inner wall of an
intra-cardiac vessel, for example the pulmonary vein wall.
[0008] However, a need exists for an electrophysiology lumen
catheter that provides effective minimally invasive cardiac
diagnostic electrophysiology and/or cardiac ablation procedures,
that also provides a flexible liquid delivery tube within the shaft
of the catheter, and still maintains all of the benefits of
bidirectional deflection and curvature configurations.
BRIEF SUMMARY OF THE INVENTION
[0009] According to one embodiment of the invention, an
electrophysiology/ablation lumen catheter includes: an elongated
flexible body having a proximal end and a series of spaced
electrodes disposed adjacent a distal end thereof; a pair of
tension/compression members extending through the body for
selectively deflecting at least the distal end of the body; an
electrical lead connected to each of the electrodes and extending
through the body to adjacent the proximal end thereof, the leads
adapted for external connection thereof; an actuator operatively
connected to the tension/compression members and operable upon
movement to effect lateral displacement of the distal end; an
inflatable member operatively extending from an outer surface of
the body when inflated; a first passage extending through the body
adapted to supply an associated liquid therethrough to the
inflatable member; and a second passage that communicates with an
opening in the body located on the distal end side of the
inflatable member. In some embodiments of the invention, the
opening is located at a terminus or tip of the distal end, while in
other embodiments of the invention, the opening is located inwardly
therefrom, between the distal end and the inflatable member. The
second passage may be used to deliver liquid or a medical device to
a body cavity on the distal side of the inflatable member. Further,
it is contemplated that the catheter may be advanced along a
guidewire passing through the second passage.
[0010] In another embodiment of the invention, an
electrophysiology/ablation lumen catheter includes: an elongated
flexible body having a proximal end and at least one electrode
disposed adjacent a distal end thereof; a catheter deflection
assembly disposed in the body, wherein the catheter deflection
assembly includes a pair of flexible members disposed substantially
side-by-side within the body; an electrical lead connected to each
of the electrodes and extending through the body to adjacent the
proximal end thereof, the lead adapted for external connection
thereof; an actuator connected adjacent the proximal end of the
catheter deflection assembly and operable upon movement to effect
lateral displacement of the distal end; an inflatable member
operatively extending from an outer surface of the body when
inflated; a first passage extending through the body adapted to
supply an associated liquid therethrough to the inflatable member;
and a second passage that communicates with an opening in the body
located on the distal end side of the inflatable member. The
flexible members may extend through the body from a point of
attachment adjacent the distal end to the proximal end such that
the deflection assembly may move the distal end in a plane
substantially normal to a longitudinal extend of the catheter.
Typically, tensioning of one of the pair of flexible members will
deflect the distal end of the catheter; optionally, this may also
compress another of the pair of flexible members. The flexible
members may have a portion adjacent the distal end with a flattened
transverse section, while the balance of the flexible members is
circular. A transversely resilient spacer, such as a wave spring,
may be disposed between the pair of flexible members.
[0011] In yet another embodiment, an electrophysiology/ablation
lumen catheter includes: an elongated flexible body having a
proximal end and a distal end; at least one electrode disposed
adjacent the distal end; a pair of flexible deflection members
disposed substantially side-by-side within the body and extending
from a point of attachment adjacent the distal end to the proximal
end; an inflatable member operatively extending from an outer
surface of the body when inflated; a first passage in fluid
communication with the inflatable member; a second passage that
communicates with an opening in the body, wherein the opening is
located distally of the inflatable member; and a handle including
an actuator movable in opposite directions and coupled to the pair
of flexible deflection members for effecting, upon actuation,
longitudinal tensioning of one of the flexible deflection members
with respect to the body, thereby effecting lateral displacement of
the distal end of the body. A spacer may be provided between the
pair of deflection members in order to maintain lateral spacing
therebetween, and at least one end of the spacer may be
free-floating between the deflection members. The second passage
may be dimensioned to receive a medical device, such as a needle or
other puncture device, therethrough for introduction into a
patient. The opening of the second passage may be located in a
sidewall of the body between the tip of the catheter and the
inflatable member, or, alternatively, may be located at the
tip.
[0012] In still another embodiment, an electrophysiology/ablation
catheter includes: an elongated flexible body having a proximal end
and a distal end; at least one electrode disposed adjacent the
distal end; at least one deflection member disposed within the body
and extending from a point of attachment adjacent the distal end to
the proximal end; an inflatable member operatively extending from
an outer surface of the body when inflated; a first passage in
fluid communication with the inflatable member; a second passage
that communicates with an opening in the body, wherein the opening
is located distally of the inflatable member; and a handle
including an actuator coupled to the at least one deflection member
for effecting, upon actuation, lateral displacement of the distal
end of the body.
[0013] A primary advantage of the present invention is the ability
to combine these various features into a single catheter
assembly.
[0014] Yet another advantage is the capability of incorporating the
inflatable balloon functions in conjunction with a secondary
passage for liquid delivery and without impacting the deflection
capabilities of the electrophysiology catheter.
[0015] A further advantage of the invention relates to alternative
use of the liquid delivery passage for placement of a guide wire
into a desired heart cavity site.
[0016] Still other advantages and benefits of the invention will
become apparent to those skilled in the art upon reading and
understanding the following detailed description.
BRIEF DESCRIPTION OF THE DRAWINGS
[0017] FIG. 1 is a view of the cardiac catheter of the present
invention.
[0018] FIG. 2 is an enlarged cross-sectional view of a distal end
of a first embodiment of the catheter with an inflatable member in
a deflated state.
[0019] FIG. 3 is a view similar to FIG. 2 with the inflatable
member shown in an inflated state.
[0020] FIG. 4 is an enlarged detail cross-sectional view of a
second embodiment of a distal end of the catheter with the
inflatable member in a deflated state.
[0021] FIG. 5 is a view of the distal portion of the catheter of
FIG. 4 with the inflatable member in an inflated state.
[0022] FIG. 6 is a schematic view of the distal portion of the
lumen catheter with the inflatable member in an inflated state and
liquid being discharged from a port located in the distal end.
DETAILED DESCRIPTION OF THE INVENTION
[0023] FIG. 1 illustrates an electrophysiology lumen catheter LC,
and the drawings thereof are not intended to limit the invention.
The lumen catheter assembly LC includes an elongated flexible main
casing or body 20 that includes an actuator assembly 22 at one end
and a distal portion 24 at the other end. Although the details are
not shown in FIG. 1, it is also contemplated that the catheter
assembly can include two main components, a blood-contacting
portion and a subassembly that includes the actuator mechanism as
shown and described in commonly owned U.S. Pat. No. 5,861,024. The
actuator mechanism 22 preferably includes a handle 26 and a
delta-shaped (.DELTA.-shaped) actuating member 28 that is
selectively manipulated by the user to cause desired deflection or
curvature of the distal portion 24 of the catheter assembly. Again,
although this particular arrangement of the actuator mechanism and
deflectable distal portion are shown and described in the commonly
owned prior patents, it will also be appreciated that selective
modifications can be made without departing from the scope and
intent of the present invention.
[0024] With continued reference to FIG. 1, and additional reference
to FIGS. 2 and 3, a first embodiment of the lumen catheter assembly
LC will be described in greater detail. Particularly, the distal
portion 24 includes an outer body 30, typically a tubular outer
body, that is secured to or receives a distal electrode 32 which is
shown as a generally mushroom-shaped configuration. That is, the
distal electrode 32 has a hemispherical dome portion 34 that closes
the end of the body. In addition, axially spaced electrodes 36a-f
are provided along the body 30 and are each connected to a separate
electrical wire (not shown for ease of illustration) that conducts
electrical energy to the respective electrode in a manner generally
well-known in the art for diagnostic and therapeutic
procedures.
[0025] The distal portion of the catheter is selectively deflected
by a catheter deflection assembly. The deflection assembly includes
a pair of tension and compression members 40 which acts in concert
to selectively deflect the distal end, preferably in a curved
configuration (FIG. 1). As particularly illustrated in FIG. 2, the
tension/compression member pair 40 includes a first member 42 and a
second member 44 disposed in side-by-side relation. The
tension/compression members are disposed in side-by-side relation
within an inner tube 50 which extends to the proximal end of the
catheter (not shown). Additionally, a thin wall polymer tube 52 is
received over the flattened ribbon-like portions of the
tension/compression members in order to prevent lateral separation
of these components during actuation and/or curvature formation.
Accordingly, the tube 52 terminates at the location shown in FIG. 2
and does not extend to the proximal end like the inner tube 50. The
tension/compression members are typically arranged to provide
curved deflection in either direction as represented in phantom in
FIG. 1. The tension/compression members are preferably thin wires
(e.g., stainless steel wires) received in the tube 50, and include
the flattened or ribbon-like portions 46, 48. Optionally, a spacer
51, such as a wave spring, may be disposed between the flattened
ends of the tension/compression members 40. Again, particular
details of the deflection assembly are shown and described in the
commonly assigned patents and applications noted above.
[0026] An annular inflatable member such as balloon 60 communicates
through a first passage 62 with a source of liquid such as saline.
It will be understood that the passage 62 extends through the
length of the catheter body and is in operative communication with
a liquid source (not shown). As shown in FIG. 2, the annular
balloon is disposed on the outer surface of the body 30 and is
shown in a deflated condition. Upon introduction of a liquid into
the balloon, the balloon inflates to an expanded state or condition
(FIG. 3) thereby engaging an inner wall of the body passage and
providing a sealed arrangement therewith. The inflatable member is
preferably disposed at a predetermined dimension from the terminal
end of the distal portion and likewise at a location where the
electrodes are interposed between the balloon and the distal tip of
the catheter. As will be appreciated, the particular location of
the balloon may be varied as desired for particular
electrophysiology studies.
[0027] Also extending through the body 20 of FIG. 1 is a second
lumen or passage 70. The second passage is dimensioned to serve as
a liquid or dye delivery tube and also advantageously is
dimensioned to alternatively receive a guide wire therethrough for
reasons which will be described in greater detail below. The second
passage or lumen 70, for example, may have an inner diameter of
approximately 0.037 inches, adapting it to receive a guide wire on
the order of 0.035 inches. These dimensions are merely for
exemplary purposes and should not be deemed limiting, since other
dimensions can be used with equal success. The second passage 70
extends the length of the catheter body 20 and preferably
terminates at the distal end. As shown in FIGS. 2 and 3, the
terminal end or port 72 of this passage is located at the distal
tip within the hemispherical dome portion 32. That is, a guide
wire, represented herein by dotted line 74, can proceed through the
second lumen and facilitates guiding of the distal end of the
catheter to a desired location within the body cavity. Thus, it is
desirable in this instance that the lumen 70 terminate at the
distal tip.
[0028] This arrangement of the second lumen may be compared to that
shown in FIGS. 4 and 5 where like reference numerals with a primed
suffix refer to like elements, and new reference numerals refer to
new elements. The primary distinction is the location of the
terminal end or port of the second passage 70'. Here, the terminal
end 74 is located at or extends through a sidewall of the outer
body 30. As will be appreciated from FIGS. 4 and 5, the terminal
location 74 of the second passage is preferably located between the
distal tip and the inflatable member. In this manner, when the
balloon is inflated as shown in FIG. 5, the second passage delivers
a liquid or dye to a location disposed between the inflated balloon
and the distal tip of the catheter. Even though the terminal end of
the second passage is not located at the distal tip of the
catheter, and may not be as desirable for use as a through passage
that receives a guide wire, the embodiment of FIGS. 4 and 5 still
provides the advantageous function of a delivery tube through which
a liquid or dye can be introduced downstream of the sealed area
provided by the inflated balloon (and that is selectively inflated
via the first passage 62).
[0029] As shown in FIG. 6, the distal end of the catheter of FIG. 1
is shown inserted into a cardiac cavity, for example, the coronary
sinus. The opening in the coronary sinus is illustrated as a
generally conically tapered arrangement. The balloon is inflated
into engagement with an interior wall of the coronary sinus passage
via a liquid provided through the first passage and fluid is able
to be discharged from an end port, whether at the distal end or at
another location downstream of the inflated balloon via the second
passage, so that the lumen catheter introduces an injected liquid
or dye during an electrophysiology study.
[0030] In summary, the actuator is still able to alter the
configuration of the catheter and the arrangement provides a
flexible liquid delivery tube disposed within the catheter shaft.
The tip steering mechanism within the catheter handle and distal
portion steerability and configuration, along with the electrical
features are still retained, while adding the ability to deliver
liquid to the cavity of, for example, the heart during cardiac
electrophysiology studies. The same second tube may be
advantageously used as a passage for placement of a guide wire into
a desired site within, for example, the heart cavity. The distal,
open end of the secondary passage either exits or terminates at the
distal tip of the catheter or at the proximity of the distal
tip.
[0031] Provision of an inflatable balloon disposed externally and
circumferentially in an axi-symmetric configuration on the outer
surface of the catheter shaft is provided proximal to the last
electrode. Saline or other appropriate liquid may be used to
inflate the balloon. The balloon, upon inflation, assumes a
preferred annular or donut-shaped configuration. A second flexible
tube disposed within the shaft of the catheter has its distal end
exiting the catheter outer body and terminating for communication
with the interior of the balloon. This allows a second liquid to be
introduced into the cavity or to receive a guidewire
therethrough.
[0032] When the distal portion of the catheter is placed into a
typical cardiac vessel for example the coronary sinus, the balloon
is inflated in order to prevent backflow of the injected liquid or
dye and blood during the electrophysiology study.
[0033] Both of the elongated flexible tubes or lumens described
above are terminated at the proximal end of the catheter handle
with appropriate inlet openings. The openings are used to deliver
liquid into each of the tubes as required. When the liquid delivery
tube is alternatively used as a passage for guide wire placement,
the guide wire can be introduced into this tube via its inlet
opening, positioned at the proximal end of the catheter. Once the
catheter distal end is positioned in place, the guidewire is then
removed and the lumen can be used to introduce a liquid into the
body cavity.
[0034] Although several embodiments of this invention have been
described above with a certain degree of particularity, those
skilled in the art could make numerous alterations to the disclosed
embodiments without departing from the spirit or scope of this
invention. For example, one of ordinary skill in the art will
appreciate that, in addition to introducing a guide wire through
second passage 70, one may introduce another medical device, such
as a needle or other puncture device, therethrough.
[0035] All directional references (e.g., upper, lower, upward,
downward, left, right, leftward, rightward, top, bottom, above,
below, vertical, horizontal, clockwise, and counterclockwise) are
only used for identification purposes to aid the reader's
understanding of the present invention, and do not create
limitations, particularly as to the position, orientation, or use
of the invention. Joinder references (e.g., attached, coupled,
connected, and the like) are to be construed broadly and may
include intermediate members between a connection of elements and
relative movement between elements. As such, joinder references do
not necessarily infer that two elements are directly connected and
in fixed relation to each other.
[0036] It is intended that all matter contained in the above
description or shown in the accompanying drawings shall be
interpreted as illustrative only and not limiting. Changes in
detail or structure may be made without departing from the spirit
of the invention as defined in the appended claims.
* * * * *