U.S. patent application number 16/525117 was filed with the patent office on 2019-11-21 for intravascular devices, systems, and methods having an adhesive filled flexible element.
The applicant listed for this patent is VOLCANO CORPORATION. Invention is credited to David H. BURKETT, Eric HENDERSON, Ramiro REYES, Chris SZUNYOG.
Application Number | 20190350528 16/525117 |
Document ID | / |
Family ID | 54288838 |
Filed Date | 2019-11-21 |
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United States Patent
Application |
20190350528 |
Kind Code |
A1 |
BURKETT; David H. ; et
al. |
November 21, 2019 |
INTRAVASCULAR DEVICES, SYSTEMS, AND METHODS HAVING AN ADHESIVE
FILLED FLEXIBLE ELEMENT
Abstract
Intravascular devices are disclosed, comprising a core member
and a radiopaque marker element formed of a single length of
material wound in a coil, wherein a first pitch of a first portion
of the coil differs from a second pitch of a second portion of the
coil.
Inventors: |
BURKETT; David H.;
(TEMECULA, CA) ; HENDERSON; Eric; (TEMECULA,
CA) ; SZUNYOG; Chris; (MURRIETA, CA) ; REYES;
Ramiro; (OCEANSIDE, CA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
VOLCANO CORPORATION |
San Diego |
CA |
US |
|
|
Family ID: |
54288838 |
Appl. No.: |
16/525117 |
Filed: |
July 29, 2019 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
14837611 |
Aug 27, 2015 |
10413243 |
|
|
16525117 |
|
|
|
|
62043115 |
Aug 28, 2014 |
|
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61B 5/026 20130101;
A61M 2205/3334 20130101; A61B 5/6851 20130101; A61M 2025/09108
20130101; A61M 2025/09133 20130101; A61M 2025/09166 20130101; A61B
2090/064 20160201; A61B 2090/3966 20160201; A61B 6/12 20130101;
A61B 8/12 20130101; A61B 5/0215 20130101; A61M 2205/3344 20130101;
A61B 6/487 20130101; A61M 2025/09083 20130101; A61B 2562/12
20130101; A61B 8/0891 20130101; A61B 2018/00791 20130101; A61M
2210/12 20130101; A61B 18/1492 20130101 |
International
Class: |
A61B 5/00 20060101
A61B005/00; A61B 5/0215 20060101 A61B005/0215; A61B 5/026 20060101
A61B005/026; A61B 18/14 20060101 A61B018/14 |
Claims
1. A guidewire comprising: a core member; a radiopaque marker
element formed of a single length of material wound in a coil,
wherein the core member extends within a lumen of the coil, wherein
a first pitch of a first portion of the coil differs from a second
pitch of a second portion of the coil; and the core member is
coupled to the radiopaque marker element.
2. The guidewire of claim 1, comprising multiple portions of the
coil having the first pitch and multiple portions of the coil
having the second pitch, wherein the portions with different
pitches alternate along the length of the core member.
3. The guidewire of claim 2, wherein a distance between consecutive
portions of the coil having the first pitch is in the range of 0.5
to 5 cm.
4. The guidewire of claim 1, wherein a width of the first portion
of the coil is in the range of 1.0 to 5 mm.
5. The guidewire of claim 4, wherein the first portion of the coil
has closed pitch of tightly compressed turns and the second portion
of the coil has an open pitch in the range of 1.1938 to 1.3462
mm.
6. The guidewire according to claim 1, wherein the material wound
in coil is coated with a radiopaque material.
7. The guidewire of claim 1, wherein the radiopaque marker element
is positioned within a polymer tube and is embedded in flexible
adhesive.
8. The guidewire of claim 7, further comprising a sensing element
coupled to the polymer tube.
9. The guide wire of claim 8, wherein the sensing element includes
a pressure sensor and/or a flow sensor.
Description
CROSS REFERENCE TO RELATED APPLICATIONS
[0001] The present application is a Continuation of application
Ser. No. 14/837,611, filed Aug. 27, 2015, which claims priority to
and the benefit of the U.S. Provisional Patent Application No.
62/043,115, filed Aug. 28, 2014, which are hereby incorporated by
reference it its entirety.
TECHNICAL FIELD OF THE INVENTION
[0002] The present disclosure relates to intravascular devices,
systems, and methods. In some embodiments, the intravascular
devices are guide wires that include a distal coil filled with a
flexible adhesive.
BACKGROUND OF THE INVENTION
[0003] Heart disease is very serious and often requires emergency
operations to save lives. A main cause of heart disease is the
accumulation of plaque inside the blood vessels, which eventually
occludes the blood vessels. Common treatment options available to
open up the occluded vessel include balloon angioplasty, rotational
atherectomy, and intravascular stents. Traditionally, surgeons have
relied on X-ray fluoroscopic images that are planar images showing
the external shape of the silhouette of the lumen of blood vessels
to guide treatment. Unfortunately, with X-ray fluoroscopic images,
there is a great deal of uncertainty about the exact extent and
orientation of the stenosis responsible for the occlusion, making
it difficult to find the exact location of the stenosis. In
addition, though it is known that restenosis can occur at the same
place, it is difficult to check the condition inside the vessels
after surgery with X-ray.
[0004] A currently accepted technique for assessing the severity of
a stenosis in a blood vessel, including ischemia causing lesions,
is fractional flow reserve (FFR). FFR is a calculation of the ratio
of a distal pressure measurement (taken on the distal side of the
stenosis) relative to a proximal pressure measurement (taken on the
proximal side of the stenosis). FFR provides an index of stenosis
severity that allows determination as to whether the blockage
limits blood flow within the vessel to an extent that treatment is
required. The normal value of FFR in a healthy vessel is 1.00,
while values less than about 0.80 are generally deemed significant
and require treatment.
[0005] Often intravascular catheters and guide wires are utilized
to measure the pressure within the blood vessel, visualize the
inner lumen of the blood vessel, and/or otherwise obtain data
related to the blood vessel. To date, guide wires containing
pressure sensors, imaging elements, and/or other electronic,
optical, or electro-optical components have suffered from reduced
performance characteristics compared to standard guide wires that
do not contain such components. For example, the handling
performance of previous guide wires containing electronic
components have been hampered, in some instances, by the limited
space available for the core wire after accounting for the space
needed for the conductors or communication lines of the electronic
component(s), the stiffness of the rigid housing containing the
electronic component(s), and/or other limitations associated with
providing the functionality of the electronic components in the
limited space available within a guide wire.
[0006] Further, a problem with existing pressure and flow guide
wires is that the coil(s) defining the distal tip of the device can
be fragile and prone to unwanted bending or kinking. In that
regard, the small diameter and high flexibility of the coil(s)
limits the structural integrity that can be provided. Further, the
rigid nature of the sensor housing adjacent to the coil(s) causes
additional stress to be applied to the coil(s) during use,
especially when traversing complex vasculature with many curves and
turns. As a result, the handling and performance of the guide wires
can be reduced because of the limitations of the coil(s).
[0007] Guide wires are designed to be steered through vascular
anatomy to suspected lesion sites to allow for treatment of those
lesions. There are many desired performance characteristics that
have to be considered for the guide wire design: torqueability,
support level, tip stiffness, lubricity, smooth transitions, and
device compatibility. Regardless of the design needs, good
torqueability of the wire tip remains the most important
performance output of the wire. Without good torque control of the
tip of the wire, physicians have difficulty steering the tip into
the appropriate branches to reach the desired lesion.
[0008] In order to make a guide wire that meets the desired output
requirement, a flexible section of the guide wire (typically the
distal most 20 to 40 cm of the wire that will be inserted into the
vasculature) can be created via grinding of the core wire to create
the desired support and transition conditions. To improve
compatibility with other devices that will be advanced over the
guide wire, a covering is often placed over the ground section of
the core wire and coated with a lubricious coating to improve
lubricity. Flexible coverings can include one or more coils, tubes,
and/or tubes with integrated spiral coil support. The flexible
coverings can be aligned to adjacent components of the guide wire
and locked into place at each end via adhesive or solder. These
types of flexible coverings are typically attached to the core wire
in only two places, at the proximal and distal ends of the flexible
covering. In that regard, a rigid adhesive is often used to fixedly
secure the ends of the flexible covering to the core wire. The
lubricious coatings that are applied to these coverings provide
excellent movement in an axial direction within the vasculature and
also help devices move smoothly over the wire. However, the
traditional use of flexible coverings has a significant deficiency
relating to torqueing the tip of the guide wire when the distal
section of the guide wire, including the flexible covering, is in
tortuosity. In that regard, the more tortuosity that the flexible
covering is pushed into and/or the more acute the tortuosity
becomes, the more the torqueability of the guide wire tip is
degraded.
[0009] This degradation in torqueability of the distal section of
the guide wire relative to the proximal section of the guide wire
occurs because the flexible coverings have very poor torqueability
characteristics. For example, when the distal section of the guide
wire is in significant tortuosity, as the proximal end of the wire
is rotated, the torque is poorly transmitted to the from the core
wire to the flexible covering because the flexible covering is
typically only attached at each end. This results in the guide wire
building up torque with the tip rotation lagging behind the
proximal rotation. When the flexible covering is only locked at its
ends, the core wire is rotating against a non-lubricious inner
surface of the flexible covering and, therefore, not getting the
benefit of the lubricity of the outer coating of the flexible
covering. At some point, the torque builds up enough to overcome
the tortuosity effect on the flexible covering and the flexible
covering suddenly spins causing the distal tip of the guide wire to
whip through a large angle quickly. This whipping of the distal tip
worsens with severe tortuosity and/or increased length of
tortuosity. The unwanted whipping of the distal tip can cause
problems with placing the guide wire in the desired location within
the patient's anatomy and, in severe cases, can even cause damage
to the patient's anatomy. Accordingly, there remains a need for
intravascular devices, systems, and methods that include one or
more electronic, optical, or electro-optical components and have
improved handling characteristics.
SUMMARY OF THE INVENTION
[0010] The present disclosure is directed to intravascular devices
defined by the claims.
[0011] For example, in some instances, a flexible covering is
secured to the core member with a low durometer adhesive within a
distal section of the guide wire and along the full length, or at
least a majority of the length, of the flexible covering. This
approach provides a significant improvement in torqueability when
the guide wire is in significant tortuosity. In that regard, by
applying the adhesive along the full length, at least a majority of
the length, and/or at spaced intervals along the length of the
flexible covering, the torque transmission from the core member to
the flexible covering is provided along the full length of the
flexible covering and allows the lubricity of the outer surface of
the flexible covering to improve torqueability of the guide wire
within the vessel of the patient. Suitable flexible adhesives
include those with a low to medium durometer (for example, between
25A and 60D, including 90A in some instances), good flexibility,
reasonable shear strength, and low to medium viscosity prior to
curing for ease of application within the flexible covering.
Examples of suitable adhesives include, but are not limited to
urethane adhesives and silicon adhesives, such as Dymax 1901-M,
Dymax 9001, etc.
[0012] Beyond the advantage in torqueability improvement of the
guide wire, there are a number of other benefits of using a
flexible adhesive to secure the flexible cover to the core member
along the entire length, or a majority of the length, of the
flexible covering. For example, as the core tapers toward the tip,
the impact of a harder adhesive would then begin to impact bending
stiffness and thus potentially create other undesirable performance
issues, such as kinking when the hard adhesive fractures in tight
tortuosity. Also, when the guide wire is a pressure, flow, or other
type of sensor-based guide wire with fragile electrical conductor
wires, harder adhesives could damage the conductors when the
adhesive fractures in tortuosity. Further locking the conductors of
a sensor-based guide wire between the core and covering with a
flexible adhesive can eliminate or greatly minimize potential
conductor failure as the conductors can be stressed during the
whipping effect. Further still, filling the flexible covering with
adhesive may minimize damage to the flexible covering by providing
internal support to the structure of the flexible covering that can
minimize kinking of the flexible covering, minimize potential for
stretching or bunching up (like a sock) of the flexible covering,
and minimize potential for overlap of adjacent portions of the
flexible covering (e.g., windings of a coil) to occur in very tight
tortuosity.
[0013] In addition, flexible adhesives can also provide benefit in
the use of radiopaque marker coils. For example, the flexible
adhesive can be used to lock a marker coil that has been wound into
a desired marker pattern in the desired orientation. For example,
the pattern can alternate between stacked lengths and high-pitch
windings to provide a radiopaque pattern for visualization of the
distal tip of the guide wire under fluoroscopy. These markers can
be useful in co-registration of a sensor-based guide wire to the
x-ray images and can also have use for estimating lesion or other
anatomical measurements. A single component coil wound into a
desired pattern also has a major benefit in that it is easy to
create desired variations in the marker pattern when winding the
coil.
[0014] The use of flexible adhesives within the flexible elements
of the distal portion of the guide wire can also be used for
transition support in the distal portion of the wire. This can be
important in sensor-based guide wires where stiff sensor housings
may be used to mount and/or protect the sensors. Often such
housings are placed at approximately 3 cm from the distal tip of
the guide wire, with a radiopaque tip coil extending the 3 cm from
the housing to the distal tip. Stiff sensor housings can cause
kinking of the flexible core member just distal to the housing as
the guide wire is being pushed into a tight vessel takeoff. In
order to minimize adverse effects of the rigid sensor housing on
the distal tip of the guide wire, the flexible adhesive can be
applied to the proximal 1-2 cm of the tip coil, leaving the distal
1-2 cm free of adhesive and, thereby, providing a more gradual
transition in support from the relatively rigid housing to the
highly flexible radiopaque tip coil. This can allow a physician to
shape the tip of the wire in a more traditional manner (i.e., as
with a frontline guide wire that does not include a sensor) and
does not require the tip to be designed even more flexible to
compensate for the effect of the adhesive on the atraumatic
tip.
[0015] Additional aspects, features, and advantages of the present
disclosure will become apparent from the following detailed
description.
BRIEF DESCRIPTION OF THE DRAWINGS
[0016] Illustrative embodiments of the present disclosure will be
described with reference to the accompanying drawings, of
which:
[0017] FIG. 1 is a diagrammatic, schematic side view of an
intravascular device according to an embodiment of the present
disclosure.
[0018] FIG. 2 is a diagrammatic, schematic side view of a distal
portion of the intravascular device of FIG. 1 according to an
embodiment of the present disclosure.
[0019] FIG. 3 is a cross-sectional side view of the distal portion
of the intravascular device of FIGS. 1 and 2 taken along section
line 3-3 of FIG. 2 according to an embodiment of the present
disclosure.
[0020] FIG. 4 is a magnified cross-sectional side view of a section
of the distal portion of the intravascular device of FIGS. 1-3
according to an embodiment of the present disclosure.
[0021] FIG. 5 is a magnified cross-sectional side view of a section
of the distal portion of the intravascular device of FIGS. 1-3
according to another embodiment of the present disclosure.
[0022] FIG. 6 is a magnified cross-sectional side view of a section
of the distal portion of the intravascular device of FIGS. 1-3
according to yet another embodiment of the present disclosure.
[0023] FIG. 7 a diagrammatic, schematic side view of a distal
portion of an intravascular device according to another embodiment
of the present disclosure.
[0024] FIG. 8 is a cross-sectional side view of the distal portion
of the intravascular device of FIG. 7 taken along section line 8-8
of FIG. 7 according to an embodiment of the present disclosure.
[0025] FIG. 9 is a cross-sectional side view of a distal portion of
an intravascular device according to another embodiment of the
present disclosure.
[0026] FIG. 10 is a side view of a variable pitch marker coil
according to an embodiment of the present disclosure.
[0027] FIG. 11 is a side view of part of a distal portion of an
intravascular device incorporating a variable pitch marker coil
according to an embodiment of the present disclosure.
[0028] FIG. 12 is a side view of part of a distal portion of an
intravascular device incorporating a varying radiopacity coils
according to an embodiment of the present disclosure.
[0029] FIG. 13 is a fluoroscopic image of an intravascular device
incorporating a variable radiopacity element according to an
embodiment of the present disclosure.
DETAILED DESCRIPTION OF THE DRAWINGS
[0030] For the purposes of promoting an understanding of the
principles of the present disclosure, reference will now be made to
the embodiments illustrated in the drawings, and specific language
will be used to describe the same. It is nevertheless understood
that no limitation to the scope of the disclosure is intended. Any
alterations and further modifications to the described devices,
systems, and methods, and any further application of the principles
of the present disclosure are fully contemplated and included
within the present disclosure as would normally occur to one
skilled in the art to which the disclosure relates. In particular,
it is fully contemplated that the features, components, and/or
steps described with respect to one embodiment may be combined with
the features, components, and/or steps described with respect to
other embodiments of the present disclosure. For the sake of
brevity, however, the numerous iterations of these combinations
will not be described separately.
[0031] As used herein, "flexible elongate member" or "elongate
flexible member" includes at least any thin, long, flexible
structure that can be inserted into the vasculature of a patient.
While the illustrated embodiments of the "flexible elongate
members" of the present disclosure have a cylindrical profile with
a circular cross-sectional profile that defines an outer diameter
of the flexible elongate member, in other instances all or a
portion of the flexible elongate members may have other geometric
cross-sectional profiles (e.g., oval, rectangular, square,
elliptical, etc.) or non-geometric cross-sectional profiles.
Flexible elongate members include, for example, guide wires and
catheters. In that regard, catheters may or may not include a lumen
extending along its length for receiving and/or guiding other
instruments. If the catheter includes a lumen, the lumen may be
centered or offset with respect to the cross-sectional profile of
the device.
[0032] In most embodiments, the flexible elongate members of the
present disclosure include one or more electronic, optical, or
electro-optical components. For example, without limitation, a
flexible elongate member may include one or more of the following
types of components: a pressure sensor, a flow sensor, a
temperature sensor, an imaging element, an optical fiber, an
ultrasound transducer, a reflector, a mirror, a prism, an ablation
element, an RF electrode, a conductor, and/or combinations thereof.
Generally, these components are configured to obtain data related
to a vessel or other portion of the anatomy in which the flexible
elongate member is disposed. Often the components are also
configured to communicate the data to an external device for
processing and/or display. In some aspects, embodiments of the
present disclosure include imaging devices for imaging within the
lumen of a vessel, including both medical and non-medical
applications. However, some embodiments of the present disclosure
are particularly suited for use in the context of human
vasculature. Imaging of the intravascular space, particularly the
interior walls of human vasculature can be accomplished by a number
of different techniques, including ultrasound (often referred to as
intravascular ultrasound ("IVUS") and intracardiac echocardiography
("ICE")) and optical coherence tomography ("OCT"). In other
instances, infrared, thermal, or other imaging modalities are
utilized.
[0033] The electronic, optical, and/or electro-optical components
of the present disclosure are often disposed within a distal
portion of the flexible elongate member. As used herein, "distal
portion" of the flexible elongate member includes any portion of
the flexible elongate member from the mid-point to the distal tip.
As flexible elongate members can be solid, some embodiments of the
present disclosure will include a housing portion at the distal
portion for receiving the electronic components. Such housing
portions can be tubular structures attached to the distal portion
of the elongate member. Some flexible elongate members are tubular
and have one or more lumens in which the electronic components can
be positioned within the distal portion.
[0034] The electronic, optical, and/or electro-optical components
and the associated communication lines are sized and shaped to
allow for the diameter of the flexible elongate member to be very
small. For example, the outside diameter of the elongate member,
such as a guide wire or catheter, containing one or more
electronic, optical, and/or electro-optical components as described
herein are between about 0.0007'' (0.0178 mm) and about 0.118''
(3.0 mm), with some particular embodiments having outer diameters
of approximately 0.014'' (0.3556 mm), approximately 0.018'' (0.4572
mm), and approximately 0.035'' (0.889 mm). As such, the flexible
elongate members incorporating the electronic, optical, and/or
electro-optical component(s) of the present application are
suitable for use in a wide variety of lumens within a human patient
besides those that are part or immediately surround the heart,
including veins and arteries of the extremities, renal arteries,
blood vessels in and around the brain, and other lumens.
[0035] "Connected" and variations thereof as used herein includes
direct connections, such as being glued or otherwise fastened
directly to, on, within, etc. another element, as well as indirect
connections where one or more elements are disposed between the
connected elements.
[0036] "Secured" and variations thereof as used herein includes
methods by which an element is directly secured to another element,
such as being glued or otherwise fastened directly to, on, within,
etc. another element, as well as indirect techniques of securing
two elements together where one or more elements are disposed
between the secured elements.
[0037] Referring now to FIG. 1, shown therein is a portion of an
intravascular device 100 according to an embodiment of the present
disclosure. In that regard, the intravascular device 100 includes a
flexible elongate member 102 having a distal portion 104 adjacent a
distal tip 105 and a proximal portion 106 adjacent a proximal end
107. A component 108 is positioned within the distal portion 104 of
the flexible elongate member 102 proximal of the distal tip 105.
Generally, the component 108 is representative of one or more
electronic, optical, or electro-optical components. In that regard,
the component 108 is a pressure sensor, a flow sensor, a
temperature sensor, an imaging element, an optical fiber, an
ultrasound transducer, a reflector, a mirror, a prism, an ablation
element, an RF electrode, a conductor, and/or combinations thereof.
The specific type of component or combination of components can be
selected based on an intended use of the intravascular device. In
some instances, the component 108 is positioned less than 10 cm,
less than 5, or less than 3 cm from the distal tip 105. In some
instances, the component 108 is positioned within a housing of the
flexible elongate member 102. In that regard, the housing is a
separate component secured to the flexible elongate member 102 in
some instances. In other instances, the housing is integrally
formed as a part of the flexible elongate member 102.
[0038] The intravascular device 100 also includes a connector 110
adjacent the proximal portion 106 of the device. In that regard,
the connector 110 is spaced from the proximal end 107 of the
flexible elongate member 102 by a distance 112. Generally, the
distance 112 is between 0% and 50% of the total length of the
flexible elongate member 102. While the total length of the
flexible elongate member can be any length, in some embodiments the
total length is between about 1300 mm and about 4000 mm, with some
specific embodiments have a length of 1400 mm, 1900 mm, and 3000
mm. Accordingly, in some instances the connector 110 is positioned
at the proximal end 107. In other instances, the connector 110 is
spaced from the proximal end 107. For example, in some instances
the connector 110 is spaced from the proximal end 107 between about
0 mm and about 1400 mm. In some specific embodiments, the connector
110 is spaced from the proximal end by a distance of 0 mm, 300 mm,
and 1400 mm.
[0039] The connector 110 is configured to facilitate communication
between the intravascular device 100 and another device. More
specifically, in some embodiments the connector 110 is configured
to facilitate communication of data obtained by the component 108
to another device, such as a computing device or processor.
Accordingly, in some embodiments the connector 110 is an electrical
connector. In such instances, the connector 110 provides an
electrical connection to one or more electrical conductors that
extend along the length of the flexible elongate member 102 and are
electrically coupled to the component 108. In some embodiments the
electrical conductors are embedded within a core of the flexible
elongate member. In other embodiments, the connector 110 is an
optical connector. In such instances, the connector 110 provides an
optical connection to one or more optical communication pathways
(e.g., fiber optic cable) that extend along the length of the
flexible elongate member 102 and are optically coupled to the
component 108. Similarly, in some embodiments the optical fibers
are embedded within a core of the flexible elongate member.
Further, in some embodiments the connector 110 provides both
electrical and optical connections to both electrical conductor(s)
and optical communication pathway(s) coupled to the component 108.
In that regard, it should be noted that component 108 is comprised
of a plurality of elements in some instances. The connector 110 is
configured to provide a physical connection to another device,
either directly or indirectly. In some instances, the connector 110
is configured to facilitate wireless communication between the
intravascular device 100 and another device. Generally, any current
or future developed wireless protocol(s) may be utilized. In yet
other instances, the connector 110 facilitates both physical and
wireless connection to another device.
[0040] As noted above, in some instances the connector 110 provides
a connection between the component 108 of the intravascular device
100 and an external device. Accordingly, in some embodiments one or
more electrical conductors, one or more optical pathways, and/or
combinations thereof extend along the length of the flexible
elongate member 102 between the connector 110 and the component 108
to facilitate communication between the connector 110 and the
component 108. In some instances, at least one of the electrical
conductors and/or optical pathways is embedded within the core of
the flexible elongate member 102, as described in U.S. Provisional
Patent Application No. 61/935,113, filed Feb. 3, 2014. Generally,
any number of electrical conductors, optical pathways, and/or
combinations thereof can extend along the length of the flexible
elongate member 102 between the connector 110 and the component
108, embedded in the core or not. In some instances, between one
and ten electrical conductors and/or optical pathways extend along
the length of the flexible elongate member 102 between the
connector 110 and the component 108. The number of communication
pathways and the number of electrical conductors and optical
pathways extending along the length of the flexible elongate member
102 is determined by the desired functionality of the component 108
and the corresponding elements that define component 108 to provide
such functionality.
[0041] Referring now to FIGS. 2-6, shown therein are aspects of the
intravascular devices of the present disclosure that include one or
more flexible elements filled with a flexible adhesive. In that
regard, one of the major issues associated with existing functional
guide wires is poor mechanical performance as compared to frontline
guide wires. The use of an adhesive filled coil at the distal tip
of the intravascular device and/or an adhesive filled flexible
element proximal of the sensing element in accordance with the
present disclosure has been found to significantly improve the
mechanical performance of the guide wires, including the durability
of the distal assembly.
[0042] Referring now to FIG. 2, shown therein is a diagrammatic,
schematic side view of the distal portion 104 of the intravascular
device 100 according to an embodiment of the present disclosure. As
shown, the distal portion 104 includes a proximal flexible element
120 and a distal flexible element 122 on each side of a housing 124
containing component 108. A core member 126 extends through the
proximal flexible element 120. Similarly, a core member 128 extends
through the distal flexible element 122. In some implementations,
the core members 126 and 128 are an integral component (i.e., the
core member 126 extends through the housing 124 and to define core
member 128). Generally, the core members 126, 128 are sized,
shaped, and/or formed out of particular material(s) to create a
desired mechanical performance for the distal portion 104 of the
intravascular device 100. In that regard, in some instances the
core member 128 is coupled to a shaping ribbon. For example, in
some particular implementations the core member 128 is coupled to a
shaping ribbon utilizing a multi-flat transition as described in
U.S. Provisional Patent Application No. 62/027,556, filed Jul. 22,
2014.
[0043] The proximal and distal flexible elements 120, 122 can be
any suitable flexible element, including coils, polymer tubes,
and/or coil-embedded polymer tubes. In the illustrated embodiment
the proximal flexible element 120 is a coil-embedded polymer tube
and the distal flexible element 122 is a coil. As discussed in
greater detail below, the proximal and/or distal flexible elements
120, 122 are at least partially filled with one or more flexible
adhesives to improve the mechanical performance and durability of
the intravascular device 100. In that regard, in some instances
adhesives with varying degrees of durometer are utilized to provide
a desired transition in bending stiffness along the length of the
intravascular device 100. A solder ball 130 or other suitable
element is secured to the distal end of the distal flexible element
122. As shown, the solder ball 130 defines the distal tip 105 of
the intravascular device 100 with an atraumatic tip suitable for
advancement through patient vessels, such as vasculature. In some
embodiments, a flow sensor is positioned at the distal tip 105
instead of the solder ball 130.
[0044] The distal portion 104 of the intravascular device 100--as
well as the proximal portion 106 and the flexible elongate member
102--may be formed using any suitable approach so long as the
distal flexible element 122 is filled with a flexible adhesive in
accordance with the present disclosure. Accordingly, in some
implementations the intravascular device 100 includes features
similar to the distal, intermediate, and/or proximal sections
described in one or more of U.S. Pat. No. 5,125,137, U.S. Pat. No.
5,873,835, U.S. Pat. No. 6,106,476, U.S. Pat. No. 6,551,250, U.S.
patent application Ser. No. 13/931,052, filed Jun. 28, 2013, U.S.
patent application Ser. No. 14/135,117, filed Dec. 19, 2013, U.S.
patent application Ser. No. 14/137,364, filed Dec. 20, 2013, U.S.
patent application Ser. No. 14/139,543, filed Dec. 23, 2013, U.S.
patent application Ser. No. 14/143,304, filed Dec. 30, 2013, and
U.S. Provisional Patent Application No. 61/935,113, filed Feb. 3,
2014.
[0045] Referring now to FIG. 3, shown therein is a cross-sectional
side view of the distal portion 104 of the intravascular device 100
taken along section line 3-3 of FIG. 2 according to an embodiment
of the present disclosure. As shown, the proximal and distal
flexible elements 120, 122 are filled, or partially filled, with
one or more flexible materials. In that regard, the material(s)
filling, or partially filling, the flexible elements is (are)
configured to improve the mechanical integrity of the proximal and
distal flexible elements 120,122, while maintaining sufficient
flexibility for use of the intravascular device in tortuous
vessels. In some instances, the materials include one or more
flexible adhesives, such as Dymax 1901-M, Dymax 9001, etc. In that
regard, in some implementations the flexible adhesives have a
minimum durometer of shore hardness 25A to a maximum durometer of
shore hardness 60D.
[0046] As shown, in the illustrated embodiment a flexible adhesive
132 fills substantially all of the open space within the lumen of
the flexible element 120. However, as will be discussed below, in
other instances multiple flexible adhesives are utilized to fill,
or partially fill, the interior of the flexible element 120. In
that regard, the one or more flexible adhesives generally fill the
space within the flexible element along the full length, or at
least a majority of the length of the flexible element 120,
including at least fifty percent, at least sixty percent, at least
seventy percent, at least eighty percent, at least ninety percent,
and at least ninety-nine percent of the length of the flexible
element in some implementations. In some implementations, the
flexible adhesive is introduced at spaced intervals, with fixed
and/or variable spacing, along the length of the flexible covering.
For example, openings can be created in the flexible element 120 at
the spaced intervals to allow introduction of the flexible adhesive
at different points along the length of the flexible element. The
flexible adhesive(s) secure the flexible element 120 to the
proximal core 126 along a majority of the length of the flexible
element 120. Accordingly, the flexible element 120 is much less
likely to slip or twist relative to the proximal core 126 compared
to a typical design where the flexible element 120 is secured to
the proximal core 126 only at the proximal and distal ends of the
flexible element 120. As a result of the use of the flexible
adhesive(s) along a majority of the length of the flexible element
120, the distal portion of the intravascular device 100 is more
responsive to movements imparted at the proximal end of the
intravascular device 100, providing improved handling and control
to a user.
[0047] In the context of a coil distal flexible element 122, the
flexible adhesive can secure the windings in place relative to one
another, which helps protect the distal portion 104 of the
intravascular device 100 from damage during subsequent
manufacturing steps, transport, and/or use. In that regard, the
adhesive(s) will lock the coil position relative to itself and the
distal core 128. This can greatly minimize potential for damage to
the tip due to stretching of the coils during handling or use. All
tip coils need to have some initial stretch because a stacked coil
would have significantly high column strength and could overlap
coils when put into tortuosity. However, the more stretch in the
coil, the more easily the coil can be damaged. Embodiments of the
present disclosure help prevent this from happening.
[0048] Referring now to FIGS. 4-6, shown therein are magnified
cross-sectional side views of the distal portion 104 of the
intravascular device 100 according to various exemplary embodiments
of the present disclosure. Referring initially to FIG. 4, a
flexible adhesive 132 partially fills a central lumen of the distal
flexible element 122. As shown, the flexible adhesive 132 at least
partially fills spaces 134 between adjacent windings of the distal
flexible element 122. In that regard, in some instances the
flexible adhesive 132 is introduced into the central lumen of the
distal flexible element 122 through the spaces 134 (e.g. by
wicking, injecting, flowing, and/or combinations thereof). In some
instances, the flexible adhesive 132 is introduced into the central
lumen of the distal flexible element 122 through an opening in one
of the ends of the flexible element 122 and filled until the
material at least partially fills the spaces 134. In that regard,
the flexible adhesive 132 is spaced from the outer most surface(s)
136 of the distal flexible element 122 in some embodiments.
[0049] As shown, the outer most surface(s) 136 of the distal
flexible element 122 have a diameter 138. Generally, the diameter
138 is approximately equal to the maximum desired outer diameter of
the intravascular device 100. Accordingly, in some particular
implementations the diameter 138 is about 0.014'', 0.018'', or
0.035''. The outer boundary 140 of the flexible adhesive 132 has a
diameter 142 that is smaller than the diameter 138 of the distal
flexible element 122 such that the material is spaced from the
outer most surface(s) 136 of the distal flexible element. In some
instances, the diameter 142 is less than the diameter 138 by
between about 0.0001'' and about 0.005'', or other suitable range.
Accordingly, in some instances, the diameter 142 is about 0.013'',
0.017'', or 0.034''. In some implementations the diameter 142 is
equal to the diameter 138 of the distal flexible element or reduced
by up to two times the diameter of the tip coil wire utilized to
form the coil. Accordingly, for a 0.014'' outer diameter tip coil
using 0.0025'' diameter wire material, the diameter 142 may range
from 0.009'' to 0.014''. Similarly, in some implementations, the
diameter 142 is less than the diameter 138 by a percentage of the
diameter of the wire material used to form the coil, such as ten
percent, twenty percent, twenty-five percent, fifty percent or more
the wire diameter.
[0050] By spacing the flexible adhesive 132 from the outer most
surface(s) 136 of the distal flexible element 122, the tactile
response to a user associated with the distal flexible element 122
contacting anatomical structures is maintained. On the other hand,
if the flexible adhesive 132 completely covers the outer surface(s)
of the distal flexible element 122, then a continuous surface of
flexible adhesive 132 may be formed that can affect the tactile
response of the intravascular device 100 when in use.
[0051] In the embodiment of FIG. 4, the flexible adhesive 132
extends along only a portion of the length of the distal flexible
element 122. In particular, the flexible adhesive 132 is positioned
only within a proximal section of the distal flexible element 122
such that a distal section of the distal flexible element 122 does
not include the flexible adhesive. In that regard, the flexible
adhesive 132 extends along the distal flexible element 122 between
about 1 percent and about 100 percent of the length of the distal
flexible element 122. In some instances, the distal flexible
element 122 has a length of approximately 3 cm and the flexible
adhesive 132 extends from a proximal end of the distal flexible
element a distance between about 1 mm and about 20 mm. FIG. 5
illustrates another embodiment where the flexible adhesive 132
substantially fills the entire central lumen of the distal flexible
element 122.
[0052] Referring now to FIG. 6, shown therein is another embodiment
where multiple flexible adhesives are utilized within the distal
flexible element 122. In particular, the flexible adhesive 132
fills a portion of the distal flexible element 122 and a flexible
adhesive 133 fills another portion of the distal flexible element
122. In the illustrated embodiment, the flexible adhesive 133 is
positioned distal of the flexible adhesive 132. In that regard, the
relative material properties of the adhesives 132, 133 can be
selected to provide a desired transition in stiffness along the
length of the distal flexible element 122. For example, where the
distal flexible element 122 extends from a rigid housing, it can be
desirable to provide a gradual transition in stiffness from the
housing to the distal flexible element 122. Accordingly, in some
implementations the flexible adhesive 132 has an increased
stiffness or durometer relative to the flexible adhesive 133 to
facilitate a gradual transition in stiffness. The relative amounts
of each adhesive 132, 133 utilized can be selected to achieve the
desired stiffness transition along the length of the distal
flexible element 122. Further, in some instances three or more
adhesives having varying stiffness properties can be utilized.
[0053] Referring now to FIGS. 7 and 8, shown therein is a
diagrammatic, schematic side view of the distal portion 104 of the
intravascular device 100 according to another embodiment of the
present disclosure. As shown, the distal portion 104 includes a
proximal flexible element 120 and a distal flexible element 122 on
each side of a housing 124 containing component 108. Again, the
proximal and distal flexible elements 120, 122 can be any suitable
flexible element, including coils, polymer tubes, and/or
coil-embedded polymer tubes. In the illustrated embodiment the
proximal flexible element 120 is a coil and the distal flexible
element 122 is a coil.
[0054] Referring now to FIG. 8, shown therein is a cross-sectional
side view of the distal portion 104 of the intravascular device 100
taken along section line 8-8 of FIG. 7 according to an embodiment
of the present disclosure. As shown, the proximal and distal
flexible elements 120, 122 are filled, or partially filled, with
one or more flexible materials. In that regard, the material(s)
filling, or partially filling, the flexible elements is (are)
configured to improve the mechanical integrity of the proximal and
distal flexible elements 120,122, while maintaining sufficient
flexibility for use of the intravascular device in tortuous
vessels. In some instances, the materials include one or more
flexible adhesives, such as Dymax 1901-M, Dymax 9001, etc. In that
regard, in some implementations the flexible adhesives have a
minimum durometer of shore hardness 25A to a maximum durometer of
shore hardness 60D.
[0055] In the illustrated embodiment, the proximal flexible element
120 is filled with multiple types of flexible adhesives along its
length. In particular, a flexible adhesive 132 fills a first
portion of the proximal flexible element 120 and a flexible
adhesive 133 fills a second portion of the proximal flexible
element 120. In the illustrated embodiment, the flexible adhesive
132 fills a proximal section of the proximal flexible element 120
and the flexible adhesive 133 fills a distal section of the
proximal flexible element 120 leading to the housing 124 and
coinciding with a taper in the proximal core member 126. In that
regard, the relative material properties and/or amounts of the
adhesives 132, 133 can be selected to provide a desired transition
in stiffness along the length of the proximal flexible element 122.
Accordingly, in some implementations the flexible adhesive 132 has
an increased stiffness or durometer relative to the flexible
adhesive 133. Further, in some instances three or more adhesives
having varying stiffness properties can be utilized along the
length of the proximal flexible element 122.
[0056] In some instances, a method of forming or manufacturing a
sensing guide wire in accordance with the present disclosure
includes providing the requisite components and coupling them
together in a manner to form the intravascular device 100. In that
regard, the flexible element(s) can be filled, or partially filled,
with the flexible adhesive(s) before and/or after coupling other
components together. In that regard, the flexible adhesive(s) can
be inserted into the flexible element(s) using any suitable
techniques, including wicking, injecting, flowing, and/or
combinations thereof. In that regard, in some instances the
flexible adhesive(s) have a starting viscosity in the range of 10
CPS to 30,000 CPS, with some implementations being between about
200 CPS and 20,000 CPS. In some instances, the flexible adhesive(s)
are UV cured with a secondary heat or moisture cure due to ensure
any hidden sections are cured. However, the adhesive(s) can be heat
and/or moisture cure only adhesives in some instances.
[0057] Referring now to FIGS. 9 and 10, shown therein are aspects
of the distal portion of an intravascular device according to
another embodiment of the present disclosure. In that regard, FIG.
9 shows a cross-sectional side view of the distal portion of an
intravascular device similar to those of FIGS. 3 and 8 described
above, but illustrating another embodiment. In particular, the
distal portion 104 shown in FIG. 9 includes a proximal flexible
element 120, a distal flexible element 122, and a housing 124
containing component 108. In the illustrated embodiment of FIG. 9,
the proximal flexible element 120 includes a coil-embedded tube and
the distal flexible element 122 is a coil. A core member 126
extends through the proximal flexible element 120 and the housing
124 such that a distal section of the core member 126 defines a
core member 128 that extends through a portion of the distal
flexible element 122. In that regard, the core member 128 is shown
coupled to a shaping ribbon 129. In some implementations, the core
member 128 is coupled to the shaping ribbon 129 utilizing a
multi-flat transition as described in U.S. Provisional Patent
Application No. 62/027,556, filed Jul. 22, 2014. In some
embodiments where the distal flexible element 122 has a length of
approximately 3 cm, the core member 128 extends along the length of
the distal flexible element 122 approximately 2 cm such that only
the shaping ribbon 129 extends the last 1 cm of the distal flexible
element 122.
[0058] The distal portion 104 of the intravascular device 100 shown
in FIG. 9 also includes a radiopaque marker element 150. In that
regard, the radiopaque marker element 150 is formed of a variable
pitch coil. For example, FIG. 10 illustrates an exemplary
radiopaque marker element 150 having a variable pitch coil. In this
embodiment, the radiopaque marker element 150 defines radiopaque
markers in the form of tightly wound sections 155 separated by the
loosely wound sections 162. The radiopaque marker element 150 may
be formed of a single length of material that has been wound into
areas of varying pitch and coated with a radiopaque material.
Alternatively, the portions of the radiopaque marker element 150
that are to define the radiopaque markers can be formed of and/or
coated with a radiopaque material. The radiopaque material may be
one or more radiopaque metals including, but not limited to, gold,
tungsten, iridium, rhodium, platinum, barium, bismuth, and
combinations and/or alloys thereof. In some embodiments, the
radiopaque material is a radiopaque polymer, which may comprise a
matrix of a polymeric material in combination with a radiopaque
metal. Any material with a high enough radiodensity when shaped
into a tightly wound section 155 can be used. For example, the
radiopaque marker element 150 may be formed of lower cost
alternatives to precious metals with equivalent radiodensity.
[0059] The tightly wound sections 155 are tightly wound areas of
the radiopaque marker element 150 that form blocks of greater
radiopacity or radiodensity with respect to the loosely wound
sections 162. As such, the tightly wound sections of the radiopaque
element are ultrasonically recognizable to the imaging device. In
some embodiments, the tightly wound sections 155 have a width (W)
ranging from 1.0 mm to 5.0 mm. Both the tightly wound sections 155
and the loosely wound sections 162 retain the ability to flex. As a
result, the tightly wound sections 155 may have greater widths W
(and greater resultant visibility) than rigid, metallic marker
bands without adversely affecting the flexibility of the
intravascular device. Thus, the tightly wound sections 155 form
flexible radiopaque markers that are capable of curving/bending
with the intravascular device 100 as it traverses through tortuous
anatomy without causing the inadvertent catheter kinking and/or
trauma that can be caused by rigid marker bands. The coil winding
process provides good control, allowing the creation of accurate
marker configurations. In some instances, the tightly wound
sections 155 are defined by a stack of coils. In that regard, the
stack of coils may have slight spacing between each winding for
improved bending performance through tortuous vessels.
[0060] The tightly wound sections 155 have a closed pitch while the
loosely wound sections 162 have an open pitch. In other words, the
tightly wound sections 155 are formed of tightly compressed
individual coils having little to no space between them, while the
loosely wound sections 162 are formed by coils having greater space
between centers of adjacent coils 154. In some embodiments, the
pitch of the coils in the loosely wound sections 162 may range from
1.1938 mm (0.047 inches) to 1.3462 mm (0.053 inches). In the
pictured embodiment, the loosely wound sections 162 are formed by
four loosely wound turns or coils. However, the loosely wound
sections may be formed by any number of turns or coils.
[0061] In one embodiment, the radiopaque marker element 150 is
manufactured by stretching a tightly compressed coil at constant
intervals past the recovery point of the coil material, thereby
creating alternating areas of tightly wound coil and loosely wound
coil. Stretching the coil past its recovery point "sets" the
intervals between the individual coils and creates constant
intervals between the tightly wound sections 155 and the loosely
wound sections 162. For example, in the pictured embodiment in FIG.
10, the tightly wound sections 155 are separated from one another
by a constant interval I1, which reflects a fixed distance between
adjacent tightly wound sections 155. The individual coils of the
loosely wound sections 162 are separated from one another by a
constant interval I2, which reflects a fixed distance between
adjacent loosely wound coils 154 in the loosely wound sections. The
interval I1 may vary in different embodiments depending upon the
particular application desired. For example, in various
embodiments, the interval I1 may range from 0.5 cm to 5 cm.
[0062] In the illustrated embodiment of FIG. 9, the radiopaque
marker element 150 is positioned within a polymer tube 152 and
embedded in flexible adhesive 133 that serves to maintain the
radiopaque marker element 150 in the desired spacing, while
maintaining flexibility. In that regard, the flexible adhesive 133
serves to lock the coil configuration in the desired pattern and
can eliminate the potential for movement of the coils during
subsequent steps of the intravascular device manufacturing process,
shipping, and use. In some embodiments, flexible adhesive 133 has
an increased flexibility (i.e., lower durometer) than a flexible
adhesive 132 filling a proximal section of the proximal flexible
element 120. In some implementations, the flexible adhesive 133 is
also used within a distal section of the proximal flexible element
120 such that there is continuity in the flexible adhesive across
the boundary between the proximal flexible element 120 and the
polymer tube 152.
[0063] The radiopaque marker element 150 allows co-registration of
the location of the intravascular device 100 with other diagnostic
techniques, such as external and internal imaging. For example, in
some instances the radiopaque marker element 150 is utilized in
combination with the housing 124 to define a pattern of radiopaque
marker elements. For example, using the housing 124 and the tightly
wound sections 155 of the radiopaque marker element 150 as markers
and the loosely wound section 162 of the radiopaque marker element
150 as spacers, a repeating pattern of radiopaque markers with
known spacings can be provided. The pattern of loosely and tightly
wound sections of the radiopaque marker element 150 can be locked
into place by use of the low durometer adhesive(s). Benefits of
utilizing such an approach include: pressure wires having this
patterned tip will be pushed past the lesion of interest and not
get in the way of stent markers; can be utilized to identify the
exact location of the sensor based on the location of the
radiopaque housing; and use of various adhesive durometers can
provide smooth transition to the housing even with use of the
radiopaque marker element 150.
[0064] Referring now to FIG. 11, shown therein is another
implementation of an intravascular device incorporating a
radiopaque marker element. In particular, a section of a distal
portion of the intravascular device is shown having a variable
pitch radiopaque marker coil, including tightly wound sections 155
spaced by a loosely wound section 162. A flexible adhesive 133 is
utilized to fill the loosely wound section 162. In that regard, in
contrast to the embodiment of FIG. 9, in the embodiment of FIG. 11
the variable pitch radiopaque marker coil and/or the flexible
adhesive 133 define the outer surface of the intravascular device.
In other words, the radiopaque marker element is not positioned
within polymer tube 152, or other surrounding structure. In such
embodiments, the adhesive serves to lock the coils in the desired
configuration to prevent unwanted movement during subsequent steps
of the intravascular device manufacturing process, shipping, and
use.
[0065] Referring now to FIG. 12, shown therein is another
implementation of an intravascular device incorporating a
radiopaque marker element. In particular, a section of a distal
portion of the intravascular device is shown having radiopaque
sections 170 spaced by a non-radiopaque (or at least less
radiopaque) section 172. In the illustrated embodiment, the
radiopaque sections 170 are defined by a stack of coils formed by
and/or coated with a radiopaque material, while the non-radiopaque
section 172 is formed by a non-radiopaque material (or at least a
material less radiopaque than that forming sections 170). The
radiopaque sections 170 are coupled to the non-radiopaque section
172 at weld points 174. In that regard, it is understood that
additional welds beyond the end-to-end type weld shown in FIG. 12
may be used to achieve a desired coil alignment and/or tensile. In
that regard, the separate coils can be assembled such that they
perform similar to a coil wound as a single unit. Using such an
approach, any pattern radiopaque and non-radiopaque sections is
possible by choosing coils of desired lengths, though more markers
require more welds. Further, such an approach provides a very
distinct transition between the radiopaque and non-radiopaque
sections. Further still, this multi-section approach can be used
for the distal tip of the intravascular device that extends
distally from a sensing element. In that regard, the need for
markers proximal to a sensing element, which are often not desired
by physicians, can be eliminated while still providing sufficient
marker data to allow co-registration of the location of the
intravascular device and, in particular, the sensing element.
Further, a flexible adhesive may or may not be utilized to fill the
radiopaque and/or non-radiopaque sections 170, 172.
[0066] Referring now to FIG. 13, shown therein is a fluoroscopic
image 200 of an intravascular device incorporating a variable
radiopacity element according to an embodiment of the present
disclosure. The image 200 shows radiopaque sections 202 spaced by a
non-radiopaque sections 204. In that regard, the radiopaque
sections 202 are representative of the tightly wound sections 155
and/or the radiopaque sections 170 of FIGS. 9-12, while the
non-radiopaque sections 204 are representative of the loosely wound
sections 162 and/or the non-radiopaque sections 172 of FIGS.
9-12.
[0067] Guide wires of the present disclosure can be connected to an
instrument, such as a computing device (e.g. a laptop, desktop, or
tablet computer) or a physiology monitor, that converts the signals
received by the sensors into pressure and velocity readings. The
instrument can further calculate Coronary Flow Reserve (CFR) and
Fractional Flow Reserve (FFR) and provide the readings and
calculations to a user via a user interface. In some embodiments, a
user interacts with a visual interface to view images associated
with the data obtained by the intravascular devices of the present
disclosure. Input from a user (e.g., parameters or a selection) are
received by a processor in an electronic device. The selection can
be rendered into a visible display.
[0068] Persons skilled in the art will also recognize that the
apparatus, systems, and methods described above can be modified in
various ways. Accordingly, persons of ordinary skill in the art
will appreciate that the embodiments encompassed by the present
disclosure are not limited to the particular exemplary embodiments
described above. In that regard, although illustrative embodiments
have been shown and described, a wide range of modification,
change, and substitution is contemplated in the foregoing
disclosure. It is understood that such variations may be made to
the foregoing without departing from the scope of the present
disclosure. Accordingly, it is appropriate that the appended claims
be construed broadly and in a manner consistent with the present
disclosure.
* * * * *