U.S. patent application number 16/118393 was filed with the patent office on 2019-02-28 for sensing guidewire with integrated proximal locking feature.
The applicant listed for this patent is KONINKLIJKE PHILIPS N.V.. Invention is credited to David BURKETT, Eric HENDERSON.
Application Number | 20190059817 16/118393 |
Document ID | / |
Family ID | 63491592 |
Filed Date | 2019-02-28 |
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United States Patent
Application |
20190059817 |
Kind Code |
A1 |
HENDERSON; Eric ; et
al. |
February 28, 2019 |
SENSING GUIDEWIRE WITH INTEGRATED PROXIMAL LOCKING FEATURE
Abstract
Intravascular devices, systems and methods of fabricating the
same are provided. In one embodiment, an intravascular system
includes an intravascular guidewire that includes a flexible
elongate member having a proximal portion and a distal portion, at
least one electronic component secured to the distal portion of the
flexible elongate member, and a locking section integral with a
metal core of the flexible elongate member at the proximal portion
of the flexible elongate member. The metal core has a first
diameter. The locking section includes a first subsection and a
second subsection. The first subsection has a second of diameter
smaller than the first diameter and the second subsection
transitions between the first diameter and the second diameter.
Inventors: |
HENDERSON; Eric; (Escondido,
CA) ; BURKETT; David; (Panama City Beach,
FL) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
KONINKLIJKE PHILIPS N.V. |
Eindhoven |
|
NL |
|
|
Family ID: |
63491592 |
Appl. No.: |
16/118393 |
Filed: |
August 30, 2018 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
62552993 |
Aug 31, 2017 |
|
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61B 2562/12 20130101;
A61B 5/01 20130101; A61B 5/0066 20130101; A61B 5/02055 20130101;
A61B 5/0215 20130101; A61B 5/0205 20130101; A61B 8/12 20130101;
A61B 8/0891 20130101; A61B 5/027 20130101; A61B 5/6851 20130101;
A61B 5/6886 20130101; A61B 2562/227 20130101; A61B 2562/228
20130101; A61B 5/0035 20130101; A61B 5/055 20130101; A61B 5/02152
20130101; A61B 2562/225 20130101; A61M 2025/0002 20130101; A61B
2562/222 20130101; A61B 5/0084 20130101; A61B 5/02158 20130101;
A61M 25/09 20130101; A61M 2025/09108 20130101; A61B 2562/0247
20130101; A61M 2025/09175 20130101 |
International
Class: |
A61B 5/00 20060101
A61B005/00; A61B 5/0215 20060101 A61B005/0215; A61M 25/09 20060101
A61M025/09 |
Claims
1. An intravascular system, comprising: an intravascular guidewire,
comprising: a flexible elongate member comprising a proximal
portion and a distal portion, wherein the flexible elongate member
further comprises a metal core, the metal core having a first
diameter, at least one electronic component secured to the distal
portion of the flexible elongate member, and at the proximal
portion of the flexible elongate member, a locking section integral
with the metal core, wherein the locking section comprises a first
subsection and a second subsection, the first subsection having a
second diameter smaller than the first diameter, the second
subsection transitioning between the first diameter and the second
diameter.
2. The intravascular system of claim 1, wherein the proximal
portion terminates at a proximal end, the proximal end comprising
the first diameter.
3. The intravascular system of claim 1, wherein the flexible
elongate member further comprises a polymer layer over the metal
core and a plurality of conductive ribbons embedded within the
polymer layer.
4. The intravascular system of claim 3, wherein the proximal
portion of the flexible elongate member comprises an insulation
layer formed over a proximal portion of the plurality of conductive
ribbons, the insulation layer being distal to the locking
section.
5. The intravascular system of claim 3, wherein the proximal
portion of the flexible elongate member comprises a conductive
portion in communication with one of the plurality of conductive
ribbons.
6. The intravascular system of claim 5, wherein the conductive
portion comprises a conductive ink.
7. The intravascular system of claim 5, wherein the conductive
portion comprises a metal ring.
8. The intravascular system of claim 1, wherein the metal core
comprises an electrical ground for the electronic component.
9. The intravascular system of claim 1, wherein the locking section
further comprises a third subsection, wherein the first subsection
is between the second subsection and the third subsection, wherein
the second subsection includes a first taper, a distal end of the
first taper having the second diameter and a proximal end of the
first taper having the first diameter, and wherein the third
subsection includes a second taper, a distal end of the second
taper having the first diameter and a proximal end of the second
taper having the second diameter.
10. The intravascular system of claim 1, further comprising: a
connector for coupling to the proximal portion of the flexible
elongate member, the connector including a locking clip comprising
a slit sized and shaped to receive the locking section of the
flexible elongate member.
11. The intravascular system of claim 10, wherein the locking clip
comprises a top portion tilting proximally at a tilt angle.
12. A method of fabricating an intravascular guidewire, comprising:
providing a flexible elongate member having a proximal portion and
a distal portion, wherein the flexible elongate member comprises a
metal core and a polymer layer over the metal core, the metal core
having a first diameter; securing at least one electronic component
to the distal portion of the flexible elongate member; and forming
a locking section in the proximal portion of the flexible elongate
member by machining around a circumference of the flexible elongate
member to remove a portion of the polymer layer and a portion of
the metal core in the locking section.
13. The method of claim 12, wherein the flexible elongate member
further comprises a plurality of conductive ribbons embedded within
the polymer layer.
14. The method of claim 13, wherein forming the locking section
further comprises machining around a circumference of the flexible
elongate member to remove a portion of the plurality of conductive
ribbons in the locking section.
15. The method of claim 14, further comprising: forming an
insulation layer over a proximal portion of the plurality of
conductive ribbons, the insulation layer being distal to the
locking section.
16. The method of claim 13, further comprising: removing a portion
of the polymer layer over a conductive portion of the flexible
elongate member such that one of the plurality of conductive
ribbons is exposed, the conductive portion being adjacent to the
locking section; and forming a conductive layer over the exposed
conductive ribbon.
17. The method of claim 16, wherein the conductive layer comprises
a conductive ink.
18. The method of claim 16, wherein the conductive layer comprises
a metal ring.
19. The method of claim 12, further comprising: machining a first
subsection of the locking section until the first subsection has a
second diameter smaller than the first diameter; and machining a
second subsection such that the second subsection transitions
between the first diameter and the second diameter.
Description
TECHNICAL FIELD
[0001] The present disclosure relates to intravascular devices,
systems, and methods. In some embodiments, a guidewire includes a
metal core with an integrated locking feature.
BACKGROUND
[0002] Heart disease is very serious and often requires emergency
operations. 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.
[0003] 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.
[0004] Often intravascular guidewires are utilized to measure the
pressure within the blood vessel. For a guidewire equipped with a
pressure sensor, segments of electrical contacts are usually
arranged at the proximal portion of the guidewire. Proper alignment
between electrical contacts of a connector and the electrical
connects at the proximal portion of the guidewire are necessary to
ensure reliable electrical connection.
SUMMARY
[0005] Embodiments of the present disclosure provide an improved
intravascular system having an intravascular guidewire and a
connector. The guidewire includes a flexible elongate member with a
metal core. The flexible elongate member includes a locking section
at a proximal portion of with a reduced diameter. The locking
section is integral with the metal core and is formed by machining
a portion of the metal core. An electronic component, such as a
pressure sensor is located at the distal portion of the flexible
elongate member. The connector includes a locking clip with a slit
sized and shaped to receive the locking section at the proximal
portion of the guidewire. Advantageously, the locking section can
be received within the slit in the locking clip to ensure reliable
electrical connection between conductive portions of the flexible
elongate member and conductive contacts in the connector. In
addition, as the locking section is integral with the metal core,
it is less prone to failure, thus reducing possibility of having
undesirable relative movement between the flexible elongate member
and the connector.
[0006] In one embodiment, an intravascular system includes an
intravascular guidewire that includes a flexible elongate member
having a proximal portion and a distal portion, at least one
electronic component secured to the distal portion of the flexible
elongate member, and a locking section integral with a metal core
of the flexible elongate member at the proximal portion of the
flexible elongate member. The metal core has a first diameter. The
locking section includes a first subsection and a second
subsection. The first subsection has a second of diameter smaller
than the first diameter and the second subsection transitions
between the first diameter and the second diameter. In some
embodiments, the proximal portion terminates at a proximal end that
includes a first diameter. In some instances, the flexible elongate
member further includes a polymer layer over the metal core and a
plurality of conductive ribbons embedded within the polymer
layer.
[0007] In some implementations, the proximal portion of the
flexible elongate member includes an insulation layer formed over a
proximal portion of the plurality of conductive ribbons. The
insulation layer is distal to the locking section. In some other
implementations, the proximal portion of the flexible elongate
member includes a conductive portion in communication with one of
the plurality of conductive ribbons. In some instances, the
conductive portion includes a conductive ink. In other instances,
the conductive portion includes a metal ring. In some embodiments,
the metal core includes an electrical ground for the electronic
component. In some embodiments of the intravascular system, the
locking section further comprises a third subsection. In those
embodiments, the first subsection is between the second subsection
and the third subsection. The second subsection includes a first
taper, with a distal end of the first taper having the second
diameter and a proximal end of the first taper having the first
diameter. The third subsection includes a second taper, with a
distal end of the second taper having the first diameter and a
proximal end of the second taper having the second diameter. In
some other embodiments, the intravascular system further includes a
connector for coupling to the proximal portion of the flexible
elongate member. The connector includes a locking clip having a
slit sized and shaped to receive the locking section of the
flexible elongate member. In those embodiments, the locking clip
includes a top portion tilting proximally at a tilt angle.
[0008] In yet another embodiment, a method of fabricating an
intravascular guidewire is provided. The method includes providing
a flexible elongate member having a proximal portion and a distal
portion, wherein the flexible elongate member comprises a metal
core and a polymer layer over the metal core, the metal core having
a first diameter; securing at least one electronic component to the
distal portion of the flexible elongate member; and forming a
locking section in the proximal portion of the flexible elongate
member by machining around a circumference of the flexible elongate
member to remove a portion of the polymer layer and a portion of
the metal core in the locking section. In some instances, the
flexible elongate member further comprises a plurality of
conductive ribbons embedded within the polymer layer. In some
embodiments, forming the locking section further includes machining
around a circumference of the flexible elongate member to remove a
portion of the plurality of conductive ribbons in the locking
section. In some other embodiments, the method further includes
forming an insulation layer over a proximal portion of the
plurality of conductive ribbons, where the insulation layer is
distal to the locking section. In some implementations, the method
also includes removing a portion of the polymer layer over a
conductive portion of the flexible elongate member such that one of
the plurality of conductive ribbons is exposed, the conductive
portion being adjacent to the locking section; and forming a
conductive layer over the exposed conductive ribbon. In some
instances, the conductive layer includes a conductive ink. In other
instances, the conductive layer includes a metal ring. In some
embodiments, the method further includes machining a first
subsection of the locking section until the first subsection has a
second diameter smaller than the first diameter; and machining a
second subsection such that the second subsection transitions
between the first diameter and the second diameter.
[0009] Additional aspects, features, and advantages of the present
disclosure will become apparent from the following detailed
description.
BRIEF DESCRIPTION OF THE DRAWINGS
[0010] Illustrative embodiments of the present disclosure will be
described with reference to the accompanying drawings, of
which:
[0011] FIG. 1 is a diagrammatic perspective view of an
intravascular system, according to aspects of the present
disclosure.
[0012] FIG. 2 is a diagrammatic side view of an intravascular
device of the intravascular system of FIG. 1, according to aspects
of the present disclosure.
[0013] FIG. 3 is a diagrammatic side view of a proximal connection
portion of an intravascular device, according to aspects of the
present disclosure.
[0014] FIG. 4 is a diagrammatic side view of a proximal connection
portion and locking features of an intravascular device, according
to aspects of the present disclosure.
[0015] FIG. 5 is a diagrammatic cross-sectional view of a proximal
connection portion and locking features of an intravascular
device.
[0016] FIG. 6 is a diagrammatic top view of an intravascular
device, according to aspects of the present disclosure.
[0017] FIG. 7A is a diagrammatic perspective view of a proximal
flexible elongate member, according to aspects of the present
disclosure.
[0018] FIG. 7B is an enlarged diagrammatic perspective view of a
portion of the proximal flexible elongate member indicated in FIG.
7A, according to aspects of the present disclosure.
[0019] FIG. 8A is a picture of a locking section of an
intravascular device, according to aspects of the present
disclosure.
[0020] FIG. 8B is a picture of a locking section of an
intravascular device, according to aspects of the present
disclosure.
[0021] FIG. 8C is a picture of a locking section of an
intravascular device, according to aspects of the present
disclosure.
[0022] FIG. 8D is a picture of a locking section and a proximal
section of an intravascular device, according to aspects of the
present disclosure.
[0023] FIG. 9 is a diagrammatic top view of a connector of the
intravascular system, while the connector is in an open position,
according to aspects of the present disclosure.
[0024] FIG. 10 is a diagrammatic top cross-sectional view of a
connector, according to aspects of the present disclosure.
[0025] FIG. 11 is diagrammatic side cross-sectional view of a
connector, according to aspects of the present disclosure.
[0026] FIG. 12 is a diagrammatic enlarged view of a portion of the
connector in FIG. 11, according to aspects of the present
disclosure.
[0027] FIG. 13 is a diagrammatic top view of a locking clip,
according to aspects of the present disclosure.
[0028] FIG. 14 is a diagrammatic proximal view of a locking clip,
according to aspects of the present disclosure.
[0029] FIG. 15 is a flowchart of a method of fabricating an
intravascular device, according to aspects of the present
disclosure.
DETAILED DESCRIPTION
[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, intravascular
catheters and intravascular guidewires. In that regard,
intravascular catheters may or may not include a lumen extending
along its length for receiving and/or guiding other instruments. If
the intravascular 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, a radio frequency (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. Further, in some instances the flexible elongate member
includes multiple electronic, optical, and/or electro-optical
components (e.g., pressure sensors, temperature sensors, imaging
elements, optical fibers, ultrasound transducers, reflectors,
mirrors, prisms, ablation elements, RF electrodes, conductors,
etc.).
[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 guidewire 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) and approximately 0.018'' (0.4572 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 initially to FIG. 1, shown therein is an
intravascular system 100 according to an embodiment of the present
disclosure. In that regard, the intravascular system includes an
intravascular device 102 and a connector 104. As will be discussed
in greater detail below, a communication cable 105 extends from the
connector 104 in a direction coaxial with or parallel to the
longitudinal axis of the intravascular device 102. As a result of
the communication cable 105 extending coaxial with or parallel to
the intravascular device, the connector 104 and communication cable
105 are less likely to catch on a patient, patient's clothing,
medical equipment (including tubes, catheters, wires, leads, etc.)
and/or other structures in the procedure room when maneuvering the
intravascular device 102.
[0038] Referring now to FIG. 2, a side view of the intravascular
device 102 is provided according to an embodiment of the present
disclosure. As shown, the intravascular device 102 includes a
flexible elongate member 106 having a distal portion 107 adjacent a
distal end 108 and a proximal portion 109 adjacent a proximal end
110. A component 112 is positioned within the distal portion 107 of
the flexible elongate member 106 proximal of the distal tip 108.
Generally, the component 112 is representative of one or more
electronic, optical, or electro-optical components. In that regard,
the component 112 can include 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 112 is positioned less than 10 cm,
less than 5, or less than 3 cm from the distal tip 108. In some
instances, the component 112 is positioned within a housing of the
intravascular device 102. In that regard, the housing can be a
separate component secured to the flexible elongate member 106 in
some instances. In other instances, the housing can be integrally
formed as a part of the flexible elongate member 106.
[0039] The intravascular device 102 also includes a connection
portion 114 adjacent the proximal portion 109 of the device. In
that regard, the connection portion 114 can be spaced from the
proximal end 110 of the flexible elongate member 106 by a distance
116. Generally, the distance 116 is between 0% and 50% of the total
length of the flexible elongate member 106. 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 having a length of 1400 mm,
1900 mm, and 3000 mm. In some instances the connection portion 114
is spaced from the proximal end 110 between about 0 mm and about
1400 mm. In some specific embodiments, the connection portion 114
is spaced from the proximal end by a distance of 0 mm, 300 mm, and
1400 mm. Accordingly, in some instances the connection portion 114
is positioned at the proximal end 110. In some such embodiments,
one or more aspects of the engagement and alignment features of the
intravascular device 102 discussed below are positioned distal of
the of the connection portion 114 instead of proximal of the
connection portion 114 as shown in the embodiment of FIG. 2, or the
engagement and alignment features may be omitted entirely.
[0040] In the illustrated embodiment of FIG. 2 the intravascular
device 102 includes a locking section 118 extending proximally from
the connection portion 114 to another section 120 that extends to
proximal end 110. In the illustrated embodiment, the section 120 is
rounded to proximal end 110. In other embodiments, the section 120
has a tapered, arcuate, and/or other changing profile as it extends
proximally to proximal end 110. In that regard, in some instances
the outer profile and/or diameter of the section 120 reduces as it
extends proximally to proximal end 110 such that the reduced
profile and/or diameter of the proximal end facilitates easier
introduction of one or more other instruments over the
intravascular device. In other embodiments, the section 120 has a
constant profile as it extends proximally to proximal end 110. As
section 120 is proximal to the locking section 118, it is sometimes
referred to as the proximal section.
[0041] As shown, the connection portion 114 has a diameter 122 (or
other similar measurement for outer cross-section profiles for
non-circular cross-sectional embodiments) while locking section 118
has a diameter 124 (again, or other similar measurement for outer
cross-section profiles for non-circular cross-sectional
embodiments). The diameter 124 of locking section 118 is different
than the diameter 122 of connection portion 114. In that regard,
the different sizes of the diameters 122, 124 create a structure
that is configured to facilitate alignment and/or connection of the
intravascular device 102 to a connector, such as connector 104. In
the illustrated embodiment, the diameter 124 of locking section 118
is less than the diameter 122 of the connection portion 114. In
some embodiments, the diameter 124 of locking section 118 is
between about 40% and about 80% of diameter 122, with some
particular embodiments being about 42%, 64%, and/or other
percentage of diameter 122. In that regard, in some embodiments the
diameter 122 of connection portion 114 is between about 0.0178 mm
and about 3.0 mm, with some particular embodiments being 0.3556 mm
(0.014''), 0.4572 mm (0.018'') and 0.889 mm (0.035''). Accordingly,
in some embodiments the diameter 124 of locking section 118 is
between about 0.007 mm and about 2.4 mm, with some particular
embodiments being 0.186 mm (0.0073''), 0.23 mm, and 0.50 mm. In the
illustrated embodiment, section 120 has a diameter that is
approximately equal to diameter 122 and, therefore, greater than
diameter 124. However, in other embodiments, section 120 has a
diameter that is greater than diameter 122, less than diameter 122,
greater than diameter 124, equal to diameter 124, and/or less than
diameter 124. In some embodiments, locking section 118 is a section
of a core wire extending through the connection portion 114.
Locking section 118 and section 120 together can sometimes to be
referred to as the locking feature.
[0042] As shown in FIG. 2, the locking section 118 extends
proximally from connection portion 114 a distance 126, while
section 120 extends proximally from locking section 118 to proximal
end 110 a distance 128. Together, distances 126 and 128 equal the
distance 116 that the connection portion 114 is spaced from the
proximal end 110 of the intravascular device 102. In some
instances, the distance 126 is between about 0.508 mm (0.020'') and
about 2.54 mm (0.10''), with some particular embodiments being
0.762 mm (0.030''), 1.016 mm (0.040''), and 1.524 mm (0.060'').
Further, while the transition between connection portion 114 and
locking section 118 and the transition between locking section 118
and section 120 are shown as being stepped in the illustrated
embodiments, in other embodiments the transitions are tapered
and/or otherwise make a gradual change in outer diameter along the
length of the intravascular device. In some embodiments, use of
tapered and/or gradual transitions results in the proximal portion
of the intravascular device 102 not having any sharp edges. In some
implementations, the use of tapered and/or gradual transitions for
one or both of the transitions between locking section 118 and
either the connection portion 114 or section 120 makes cleaning the
proximal portion of the device (e.g., to remove any liquids or
other unwanted materials on the surface of the proximal portion of
the intravascular device) easier. In some embodiments, the
intravascular system 100 can include one or more features described
in U.S. patent application Ser. No. 15/374,312, titled
"SIDE-LOADING CONNECTORS FOR USE WITH INTRAVASCULAR DEVICES AND
ASSOCIATED SYSTEMS AND METHODS," filed Dec. 9, 2016, which is
hereby incorporated by reference in its entirety.
[0043] The connection portion 114 is configured to facilitate
communication between the intravascular device 102 and another
device. More specifically, in some embodiments the connection
portion 114 is configured to facilitate communication of data
obtained by the component 112 to another device, such as a
computing device or processor. Accordingly, in some embodiments,
the connection portion 114 includes one or more conductive
portions. In some implementations, the connection portion 114 can
include conductive bands, rings, coatings, coils, etc. In some
instances, the connection portion 114 includes one or more
electrical connectors, or conductive portions, as described in U.S.
patent application Ser. No. 13/931,052, titled "INTRAVASCULAR
DEVICES, SYSTEMS, AND METHODS," filed Jun. 28, 2013, which is
hereby incorporated by reference in its entirety. In other
embodiments, the connection portion 114 includes an optical
connector. In such instances, the connection portion 114 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 106 and are optically coupled to the
component 112. Further, in some embodiments the connection portion
114 provides both electrical and optical connections to both
electrical conductor(s) and optical communication pathway(s)
coupled to the component 112. In that regard, it should again be
noted that component 112 can be comprised of a plurality of
elements in some instances. In some instances, the connection
portion 114 can be configured to provide a physical connection to
another device, either directly or indirectly. In other instances,
the connection portion 114 can be configured to facilitate wireless
communication between the intravascular device 102 and another
device. Generally, any current or future developed wireless
protocol(s) may be utilized. In yet other instances, the connection
portion 114 facilitates both physical and wireless connection to
another device.
[0044] As noted above, in some instances the connection portion 114
provides a connection between the component 112 of the
intravascular device 102 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 106 between the connection
portion 114 and the component 112 to facilitate communication
between the connection portion 114 and the component 112.
Generally, any number of electrical conductors, optical pathways,
and/or combinations thereof can extend along the length of the
flexible elongate member 106 between the connection portion 114 and
the component 112. In some instances, between one and ten
electrical conductors (or conductive portions) and/or optical
pathways extend along the length of the flexible elongate member
106 between the connection portion 114 and the component 112. For
the sake of clarity and simplicity, the embodiments of the present
disclosure described below include three electrical conductors and,
therefore, the connection portion 114 is described as having three
separate conductive portions corresponding to the three electrical
conductors.
[0045] In some embodiments, the flexible elongate member 106
includes multiple core wires. For example, the flexible elongate
member 106 can include a proximal core wire (or proximal core) and
a distal core wire (or distal core) that are attached to one
another. The components associated with the proximal portion of the
intravascular device 102 (e.g., including the proximal core wire)
can be referred to a proximal subassembly, and the components
associated with the distal portion of the intravascular device 102
(e.g., including the distal core wire) can be referred to a distal
subassembly. The flexible elongate member can refer to one or more
components of the proximal subassembly and/or the distal
subassembly. In some embodiments, the flexible elongate member 106
includes features as described in U.S. patent application Ser. No.
13/931,052, titled "INTRAVASCULAR DEVICE, SYSTEMS, AND METHODS" and
filed Jun. 28, 2013, which is hereby incorporated by reference in
its entirety.
[0046] For example, as shown in FIG. 3, in some instances the
connection portion 114 includes conductive portions 132, 134, and
136 that are separated from one another and the main body of the
flexible elongate member 106 by insulating portions 138, 140, 142,
and 144. In that regard, the conductive portions 132, 134, and 136
are formed of a conductive material and are portions of a hypotube,
a coil, conductive ink, conductive coating formed over a tubular
member, and/or combinations thereof in some instances. In some
embodiments, the conductive portions 132, 134 and 136 include
features as described in U.S. patent application Ser. No.
14/143,304, titled "INTRAVASCULAR DEVICES, SYSTEMS, AND METHODS"
and filed Dec. 30, 2013, which is hereby incorporated by reference
in its entirety. It is understood that the total number of
communication pathways and/or the number of electrical conductors
and/or optical pathways is different in other embodiments and,
therefore, the number of conductive portions (or optical
connectors) included in connection portion is different as well.
More specifically, the number of communication pathways and the
number of electrical conductors and optical pathways extending
along the length of the flexible elongate member 106 can be
selected based on the desired functionality of the component 112
and the corresponding elements that define component 112 to provide
such functionality. As a result, the number and type of connections
provided by connection portion 114 are likewise determined by the
desired functionality of the component 112, the corresponding
elements that define component 112 to provide such functionality,
and the communication needs for such elements. Further still, in
some instances, one or more of the insulating portions 138, 140,
142, and 144 is omitted. For example, as shown in the exemplary
embodiment of FIG. 4, insulating portion 144 has been omitted.
[0047] Referring now to FIG. 5, shown therein is a diagrammatic
cross-sectional view of the connection portion 114, locking section
118 and section 120 of the intravascular device 102. In some
embodiments, the connection portion 114 includes three conductive
portions 132, 134, and 136 that are separated from one another and
the main body of the flexible elongate member 106 by insulating
portions 138, 140, and 142. As the conductive portions 132, 134 and
136 and the insulating portions 138, 140 and 142 are in
annular-ring shapes around a circumference of the flexible elongate
member 106, cross sections of them appear on either side of the
connection portion 114. Each of the conductive portions 132, 134
and 136 is electrically coupled to a conductive ribbon. In the
example shown in FIG. 5, conductive portion 132 is electrically
coupled to conductive wire 30, conductive portion 134 is
electrically coupled to conductive wire 40, and conductive portion
136 is electrically coupled to conductive wire 50. In some
instances, the conductive wires 30, 40 and 50 are embedded within a
polymer layer 180. Conductive wires 30, 40 and 50 are electrically
coupled to component 112 and extend proximally through the flexible
elongate member 106. The polymer layer 180 insulates the conductive
wires 30, 40 and 50 from one another and also insulates the
conductive wires 30, 40 and 50 from the metal core 150. In some
embodiments, the flexible elongate member 106 includes a metal core
150 that extends through the conductive portion 114. In some
implementations, locking section 118 and section 120 are parts of
an integral component referred to as a locking core 160. Locking
core 160 is separate from the metal core 150 and is attached by
soldering to the proximal end of the connection portion 114 at
interface 10 with conductive portion 136 and at interface 20 with a
proximal end of the metal core 150. While the soldering attachment
at interfaces 10 and 20 are generally mechanically sound, they
present possible points of failure. When the soldering attachment
at interfaces 10 and 20 fails, the flexible elongate member 106
would be movable longitudinally and conductive portions 132, 134,
and 136 would be out of alignment with corresponding electrical
contacts of the connector 104.
[0048] Referring now to FIG. 6, shown there is a diagrammatic top
view of intravascular device 102, according to aspects of the
present disclosure. The intravascular device 102 can be an
intravascular guidewire sized and shaped for positioning within a
vessel of a patient. The intravascular device 102 can include the
electronic component 112. For example, the electronic component 112
can be a pressure sensor configured to measure a pressure of blood
flow within the vessel of the patient. The intravascular device 102
includes the flexible elongate member 106. The electronic component
112 is disposed at the distal portion 107 of the flexible elongate
member 106. The electronic component 112 can be mounted at the
distal portion 107 within a housing 280 in some embodiments. A
flexible tip coil 290 extends between the housing 280 and the
distal end 108. The connection portion 114 is disposed at the
proximal portion 109 of the flexible elongate member 106. The
connection portion includes the conductive portions 132, 134, 136.
In some embodiments, the conductive portions 132, 134, 136 can be
conductive ink that is printed and/or deposited around the flexible
elongate member. In some embodiments, the conductive portions 132,
134, 136 are conductive, metallic rings that are positioned around
the flexible elongate member. The locking section 118 and section
120 are disposed at the proximal portion 109 of the flexible
elongate member 106.
[0049] The intravascular device 102 in FIG. 6 includes a distal
core 210 and a proximal core 220. The distal core 210 and the
proximal core 220 are metallic components forming part of the body
of the intravascular device 102. For example, the distal core 210
and the proximal core 220 are flexible metallic rods that provide
structure for the flexible elongate member 106. The diameter of the
distal core 210 and the proximal core 220 can vary along its
length.
[0050] In some embodiments, the intravascular device 102 comprises
a distal assembly and a proximal assembly that are electrically and
mechanically joined together, which results in electrical
communication between the electronic component 112 and the
conductive portions 132, 134, 136. For example, pressure data
obtained by the electronic component 112 (in this example,
electronic component 112 is a pressure sensor) can be transmitted
to the conductive portions 132, 134, 136. Control signals from a
computer in communication with the intravascular device 102 can be
transmitted to the electronic component 112 via the conductive
portions 132, 134, 136. The distal subassembly can include the
distal core 210. The distal subassembly can also include the
electronic component 112, the conductive members 230, and/or one or
more layers of polymer/plastic 240 surrounding the conductive
members 230 and the core 210. For example, the polymer/plastic
layer(s) can protect the conductive members 230. The proximal
subassembly can include the proximal core 220. The proximal
subassembly can also include one or more layers of polymer layer(s)
250 (hereinafter polymer layer 250) surrounding the proximal core
220 and/or conductive ribbons 260 embedded within the one or more
layers of polymer layer(s) 250. In some embodiments, the proximal
subassembly and the distal subassembly can be separately
manufactured. During the assembly process for the intravascular
device 102, the proximal subassembly and the distal subassembly can
be electrically and mechanically joined together. As used herein,
flexible elongate member can refer to one or more components along
the entire length of the intravascular device 102, one or more
components of the proximal subassembly (e.g., including the
proximal core 220, etc.), and/or one or more components the distal
subassembly 210 (e.g., including the distal core 210, etc.).
[0051] In various embodiments, the intravascular device 102 can
include one, two, three, or more core wires extending along its
length. For example, a single core wire can extend substantially
along the entire length of the flexible elongate member 106. In
such embodiments, a locking section 1180 and a section 1200 can be
integrally formed at the proximal portion of the single core wire.
The electronic component 112 can be secured at the distal portion
of the single core wire. In other embodiments, such as the
embodiment illustrated in FIG. 6, the locking section 1180 and the
section 1200 can be integrally formed at the proximal portion of
the proximal core 220. The electronic component 112 can be secured
at the distal portion of the distal core 210. The intravascular
device 102 includes one or more conductive members 230 in
communication with the electronic component 112. For example, the
conductive members 230 can be one or more electrical wires that are
directly in communication with the electronic component 112. In
some instances, the conductive members 230 are electrically and
mechanically coupled to the electronic component 112 by, e.g.,
soldering. In some instances, the conductive members 230 comprise
two or three electrical wires (e.g., a bifilar cable or a trifilar
cable). An individual electrical wire can include a bare metallic
conductor surrounded by one or more insulating layers. The
conductive members 230 can extend along the length of the distal
core 210. For example, at least a portion of the conductive members
230 can be spirally wrapped around the distal core 210.
[0052] The intravascular device 102 includes one or more conductive
ribbons 260 at the proximal portion of the flexible elongate member
106. The conductive ribbons 260 are embedded within polymer
layer(s) 250. The conductive ribbons 260 are directly in
communication with the conductive portions 132, 134, and/or 136. In
some instances, the conductive members 230 are electrically and
mechanically coupled to the electronic component 112 by, e.g.,
soldering. In some instances, the conductive portions 132, 134,
and/or 136 comprise conductive ink (e.g., metallic nano-ink, such
as silver or gold nano-ink) that is deposited or printed directed
over the conductive ribbons 260.
[0053] As described herein, electrical communication between the
conductive members 230 and the conductive ribbons 260 can be
established at the connection region 270 of the flexible elongate
member 106. By establishing electrical communication between the
conductive members 230 and the conductive ribbons 260, the
conductive portions 132, 134, 136 can be in electrically
communication with the electronic component 112.
[0054] In some embodiments represented by FIG. 6, intravascular
device 102 includes a locking section 1180 and a section 1200.
Different from the locking core 160 (including locking section 118
and section 120) in FIG. 5, which is soldered to metal core 150,
locking section 1180 and section 1200 in FIG. 6 are integral with
proximal core 220. To form locking section 1180, a machining
process is necessary to remove polymer layer 250 and conductive
ribbons 260 in locking section 1180 and to shape proximal core 220
in locking section 1180 to the desired shape. As shown in FIG. 6,
locking section 1180 includes a reduced diameter while section 1200
has a diameter substantially similar to that of proximal core 220
in the connection portion 114. In some instances, because the
machining process removes conductive ribbons in locking section
1180, proximal ends of the conductive ribbons 260 would be exposed
to moisture and/or liquids, such as blood, saline solutions,
disinfectants, and/or enzyme cleaner solutions, an insulation layer
158 is formed over the proximal end portion of the connection
portion 114 to insulate the exposed conductive ribbons.
[0055] FIGS. 7A and 7B illustrate perspective views of a proximal
subassembly of the intravascular device 102. The proximal
subassembly includes including the proximal core 220. The proximal
core 220 can be made of a metal or metal alloy in some embodiments,
such as nickel-cobalt base alloy (e.g., MP35N). The diameter of the
proximal core 220 can be between 0.0100 and 0.0110, including
values such as 0.0105'', 0.0107'', 0.0109'' in some embodiments.
The one or more polymer layers 250 surround the proximal core 220.
The layer 250 can include polyimide in some embodiments. One or
more metallic, conductive ribbons 260 are embedded within the
polymer layer(s) 250. For example, the proximal subassembly can
include two conductive ribbons 260. The polymer layer(s) 250 can
electrically isolate the conductive ribbons 260 from the proximal
core 220. Any suitable process (e.g. grinding, ablating, etc.) for
removing a portion of the polymer layer(s) 250 can be used to
expose portions of the conductive ribbons 260. Electrical
communication with the conductive ribbons 260 can be established at
the exposed portions of the conductive ribbons 260. In some
embodiments, the proximal subassembly can include features as
described in U.S. patent application Ser. No. 14/143,304, titled
"INTRAVASCULAR DEVICES, SYSTEMS, AND METHODS" and filed Dec. 30,
2013, which is hereby incorporated by reference in its
entirety.
[0056] FIG. 8A is a picture of locking section 1180 of the
intravascular device 102, according to aspects of the present
disclosure. In some embodiments, while the entire locking section
1180 is integral with proximal core 220 extending distally into the
connection portion 114, it can be machined to have different
subsections. For example, as shown in FIG. 8A, locking section 1180
includes a middle subsection 170, a distal subsection 168 and a
proximal subsection 178. In some instances, the middle subsection
170 has a uniform diameter D1 throughout its entire length. In
embodiment represented by FIG. 8A, the distal subsection 168 distal
to the middle section 170 may include a first taper that has a
diameter D2 on its distal end and a diameter D1 at its proximal
end. In some instances, the proximal subsection 178 includes a
second taper that has a diameter D1 at its distal end and a
diameter D2 at its proximal end. In some other implementations, the
distal subsection 168 may not include the first taper but
nevertheless transitions from D2 to D1 in a different fashion.
Similar, in some embodiments, the proximal subsection 178 may not
include the second taper but nevertheless transitions from D1 to D2
in a different fashion. For example, the transition between the
first and second diameter may include one or more discontinuities
or step changes. For a further example, the transition between the
first and second diameters at the distal and proximal subsections
168 and 178 may not be linear, but parabolic. In still other
embodiments, one of the distal subsection 168 and the proximal
subsection 178 may be omitted entirely. In some instances, section
1200 and insulating portion 144 include polymer layer 250 and have
a diameter D3. D3 is larger than D2, which is larger than D1. In
some embodiments, diameter D1 is between 0.0050 inch and 0.020
inch, with some particular embodiments being 0.0073 inch, while D2
is between 0.010 inch and 0.016 inch, with some particular
embodiments being 0.0107 inch and 0.013 inch. In some
implementations, the entire length L1 of the locking section 1180
is between 0.060'' and 0.200''. In some instances, the middle
section 170 has a length L2. Length L2 is between 0.020'' and
0.100''.
[0057] In some other embodiments shown in FIGS. 8B and 8C, a
thickness of polymer layer 250 around the circumference of distal
subsection 168 is machined or ground away, leaving a thinner
polymer layer 250 in distal subsection 168. In some instances, as
shown in FIG. 8B, after a thickness of the polymer layer 250 is
machined away, a length of conductive ribbon 260 (one is shown) is
exposed but remains insulated from proximal core 220. In some
implementations illustrated in FIG. 8C, the length of conductive
ribbons 260 shown in FIG. 8B is removed or shortened by machining,
grinding, or cutting. The insulation layer 158 is then formed over
the distal subsection 168 to protect residual conductive ribbons
260 in distal subsection 168, such those shown in FIGS. 8B and 8C,
from being exposed to moisture, such as blood, saline solutions,
enzyme cleaners, and/or other liquids.
[0058] In some implementations, locking section 1180 is formed by
removing polymer layer 250, conductive ribbons 260 (not shown in
FIG. 8A) embedded within the polymer layer 250, and a portion of
the proximal core 220. In those implementations, once the
conductive ribbons in locking section 1180 are removed, a proximal
end portion of the conductive ribbons 260 in the connection portion
114 would be exposed. If left un-insulated, proximal ends of the
conductive ribbons maybe exposed to moisture, such as blood, saline
solutions, enzyme cleaners, and/or other liquids, causing shorts.
Therefore, as shown in FIG. 8A, an insulation layer 158 is formed
the proximal end portion of the connection portion 114 to insulate
the exposed conductive ribbons 260 from moisture. As the insulation
layer 158 can add further thickness of the polymer layer 250, the
section where is insulation layer 158 is formed has a diameter D4.
D4 is larger than D3. In some implementations, proximal core 220 is
electrically coupled to an electrical ground and component 112 is
electrically grounded by being electrically coupled to the distal
core 210, which is electrically coupled to proximal core 220.
[0059] Reference is now made to FIG. 8D. Shown therein is a picture
of locking section 1180 and section 1200 of the intravascular
device 102. In some embodiments represented by FIG. 8D, at least a
portion of section 1200 is covered by polymer layer 250 while
polymer layer 250 is removed from another portion of section 1200
toward proximal end 110. In some other embodiments, polymer layer
250 is completely removed from section 1200 and section 1200 is
free of polymer layer 250.
[0060] Referring now to FIG. 9, shown therein is a diagrammatic top
view of the connector 104 of the intravascular system 100. In some
instances, the connector 104 of the present disclosure incorporates
one or more features of the connectors described in P.C.T.
Application No. PCT/M2016/054528, titled "SIDE-LOADING CONNECTORS
WITH INLINE CABLING FOR USE WITH INTRAVASCULAR DEVICES AND
ASSOCIATED SYSTEMS AND METHODS" and filed Jul. 28, 2016, U.S.
patent application Ser. No. 13/930,787, titled "SIDE-LOADING
CONNECTORS FOR USE WITH INTRAVASCULAR DEVICES AND ASSOCIATED
SYSTEMS AND METHODS" and filed Jun. 28, 2013, and U.S. patent
application Ser. No. 13/930,636, titled "SIDE-LOADING CONNECTORS
FOR USE WITH INTRAVASCULAR DEVICES AND ASSOCIATED SYSTEMS AND
METHODS" and filed Jun. 28, 2013, each of which is hereby
incorporated by reference in its entirety. The example connector
104 shown in FIG. 9 includes a component 204 and a component 206.
The component 204 includes a recess 208 sized and shaped to receive
the connection portion 114 of the flexible elongate member 106. The
component 206 is movable with respect to the component 204. In
particular, the component 206 is slidable with respect to the
component 204 to facilitate insertion of an intravascular device
into the connector 104 and subsequent engagement of the connector
with the received intravascular device that results in one or more
electrical connections between the intravascular device and the
connector. The sliding movement of the component 206 relative to
the component 204 can be parallel to a longitudinal axis of the
component 204 and/or the longitudinal axis of an intravascular
device received within the connector 104. Component 204 includes a
locking clip 200. The locking clip 200 includes a slit 201 sized
and shaped to receive locking section 1180 while section 1200 is
proximal to the locking clip 200.
[0061] FIG. 10 shows a diagrammatic cross-sectional view of the
connector 104. In some embodiments, component 206 includes split,
open-comb electrical contacts 232A, 232B, 234A, 234B, and 236. When
connection portion 114 is received within recess 208 and locking
section 1180 is received within slit 201, conductive portion 132 is
aligned with electrical contacts 232A and 232B along a direction of
the relative movement between component 204 and component 206.
Similarly, along the same direction of movement, conductive portion
134 is aligned with electrical contacts 234A and 234B and
conductive portion 136 is aligned with electrical contacts 236. In
some embodiments, conductive portions 132, 134 and 136 are
separated by insulating portions 138, 140, and 142. In some
instances, connection portion 114 also includes an insulating
portion 144 distal to locking section 1180. As locking section 1180
is of a reduced diameter as compared to section 1200 and insulating
portion 144 (or conductive portion 136 if insulating portion 144 is
not present), the connection portion 114 is prevented from moving
along its lengthwise direction, either distally or proximally.
[0062] Further, the open-comb electrical contacts are particularly
well-suited to facilitate proper electrical connection between the
connector 202 and an intravascular device 102 positioned within the
recess 208 of component 204 when the component 206 is translated
relative to the component 204 from the open position towards the
closed position. Further still, the open-comb configuration allows
for the intravascular device to be rotated with respect to the
connector while maintaining a proper electrical connection. Thus,
the open-comb configuration allows a user (e.g., surgeon) to keep
the connector 202 connected to the intravascular device while the
intravascular device is moved or advanced through the vasculature
with little resistance to rotational movement of the intravascular
device. In other words, the intravascular device can be moved
through the vasculature, undergoing various twists and turns,
without the connector 202 needing to move with the rotations of the
intravascular device. Also, the open-comb configuration helps
ensure good electrical contact due to the multiple fingers for each
of the contacts. In addition, the open end of the open-comb
configuration provides a good guide for ensuring that the
intravascular device is correctly positioned when the component 206
is closed. While various advantages of the open-comb configuration
have been described, it is understood that any appropriately sized
electrical contacts can be utilized, including a single contact or
a plurality of contacts.
[0063] Referring now to FIG. 11, shown therein is diagrammatic
cross-sectional side view of connector 104. FIG. 11 shows how
conductive portions engage the split, open-comb electrical contacts
232A, 232B, 234A, 234B, and 236 and how locking section 1180 is
received within slit 201 of locking clip 200. In some instances,
each of the electrical contacts has two arms that bend upward and
two arms that bend downwards. Each of the electrical contacts can
also have more or less arms bending different directions. For
example, each of the electrical contacts can have one or three arms
bending upwards and one or three arms bending downwards. In some
embodiments, the slit 201 extends halfway through the height of the
locking clip 200. To further illustrate the details of locking clip
200, the proximal portion of connector 104 is enlarged and shown in
FIG. 12. In some embodiments, locking clip 200 includes a top
portion 205 that tilts proximally at a tilt angle. The tilt angle
is defined between the plane where the top portion 205 resides and
the plane where the rest of locking clip 200 resides. In some
instances, the tilt angle is between 10 and 90 degrees. Once
locking section 1180 is received in slit 201 of locking clip 200,
the proximally tilting top portion 205 prevents locking section
1180 from slipping upwards out of the slit 201. Advantageously, the
engagement of locking section 1180 and slit 201 of locking clip 200
ensure reliable electrical connection between conductive portions
132, 134, and 136 of connection portion 114 and split, open-comb
electrical contacts 232A, 232B, 234A, 234B, and 236 in connector
104. In addition, as locking section 1180 is integral with proximal
core 220 that extends through connection portion, locking section
1180 is less prone to failure. Such failure includes locking
section 1180 detaching from connection portion 114. In the
undesirable case of such detachment, connection portion 114, along
with conductive portions 132, 134 and 136, would be allowed to move
along a longitudinal direction of flexible elongate member 106,
resulting in unreliable electrical connection between conductive
portions 132, 134 and 136 and open-comb electrical contacts 232A,
232B, 234A, 234B, and 236 in connector 104.
[0064] FIG. 13 is a diagrammatic top view of locking clip 200 from
direction T shown in FIG. 12. In some embodiments, locking section
1180 includes distal subsection 168, middle subsection 170, and
proximal subsection 178. When locking section 1180 is received
within slit 201 of locking clip 200, the movement of locking
section 1180 relative to locking clip 200 is limited to the length
of the middle subsection 170. The proximally tilting top portion
205 can engage the proximal portion 178 and section 1200 to prevent
locking section 1180 from slipping out of the slit 201. FIG. 14 is
a diagrammatic proximal view of locking clip 200 from direction P
shown in FIG. 12. In some instances, locking section 1180 is
received within slit 201 of locking clip 200. The top portion 205
tilts proximally at the tilt angle. In some embodiments, slit 201
extends half way through the height of locking clip 200.
[0065] Referring now to FIG. 15, shown therein is a flowchart of
method 300 for fabricating intravascular device 102. Method 300
includes a step 310 of: providing a flexible elongate member,
wherein the flexible elongate member includes a metal core, a
polymer layer over the metal core, and a plurality of conductive
ribbons embedded within the polymer layer; a step 320 of: securing
an electronic component to the distal portion of flexible elongate
member; a step of: machining around a circumference of the flexible
elongate member to remove a portion of the polymer layer, a portion
of the plurality of conductive ribbons, and a portion of the metal
core in a locking section; and a step 340 of: forming an insulation
layer over a proximal end of the plurality of conductive
ribbons.
[0066] At step 310, a flexible elongate member such as flexible
elongate member 106 shown in FIG. 2 is provided. In some
embodiments, flexible elongate member 106 includes a metal core
such as distal core 210 and proximal core 220 in FIG. 6. In other
embodiments, the flexible elongate member 106 includes a single
metal core along its entire length. Flexible elongate member 106
has distal portion 107 and proximal portion 109. In some instances,
the metal core is formed of stainless steel, or super-elastic
materials such as Nitinol or NiTiCo. Flexible elongate member 106
also includes a polymer layer, such as polymer layer 250 shown in
FIG. 6, over the proximal core 220. In some implementations,
polymer layer 250 is formed of polyethylene terephthalate (PET) or
other suitable insulative, flexible polymer materials. Flexible
elongate member 106 further includes a plurality of conductive
ribbons embedded in the polymer layers. For example, conductive
ribbons 260 in FIGS. 6, 7A and 7B are embedded in polymer layer
250. Polymer layer 250 surrounding conductive ribbons 260
electrically insulate conductive ribbons 260 from one another and
from proximal core 220. In some embodiments, flexible elongate
member 106 is continuously formed and is available for purchases in
rolls of hundreds or even thousands of feet. At step 310, flexible
elongate member 106 is cut to a length of 1300 mm, 1400 mm, 1900
mm, 3000 mm, 4000 mm, or other suitable length.
[0067] At step 320, an electronic component, such as component 112
shown in FIG. 2, is secured to a distal portion of the flexible
elongate member, such as distal portion 107 of flexible elongate
member 106. In some embodiments, flexible elongate member 106 has a
single metal core. In those embodiments, component 112 is mounted
in a housing secured to distal portion 107 of flexible elongate
member 106. In some other embodiments, as shown in FIG. 6, flexible
elongate member 106 includes distal core 210 and proximal core 220.
Distal core 210 is a part of a distal subassembly, and the distal
subassembly includes component 112. Generally, the component 112 is
representative of one or more electronic, optical, or
electro-optical components. In that regard, component 112 can
include a pressure sensor, a temperature sensor, an imaging
element, an optical fiber, an ultrasound transducer, a reflector, a
mirror, a prism, an ablation element, an radio frequency (RF)
electrode, a conductor, and/or combinations thereof. In some
embodiments, component 112 is electrically coupled to the plurality
of conductive ribbons, such as conductive ribbons 260 shown in
FIGS. 7A and 7B.
[0068] At step 330, in order to form a locking feature, a portion
of the polymer layer, a portion of the plurality of conductive
ribbons embedded within the polymer layer, and a portion of the
metal core is removed from a locking section by machining around a
circumference of the flexible elongate member. For example, a
portion of polymer layer 250, including any conductive ribbons 260
embedded therein, is removed from the locking section 1180 shown in
FIG. 8A by machining around the circumference of the locking
section 1180. In some embodiments, a portion of proximal core 220
is also machined away from the locking section 1180 to form the
proximal subsection 178, the middle subsection 170, and the distal
subsection 168. In some other embodiments, one of the proximal
subsection 178 and the distal subsection 168 is omitted entirely.
In the embodiments represented by FIG. 8A, the proximal subsection
178 includes the second taper that has diameter D2 at its proximal
end and diameter D1 at its distal end. In those embodiments, the
distal subsection 168 includes the first taper that has diameter D1
at its proximal end and diameter D2 at its distal end. As described
above, sometimes, the distal subsection 168 or the proximal
subsection 178 may not include a taper but nevertheless transitions
from the first diameter to the second diameter or vice versa. As
proximal core 220 remains continuous throughout section 1200,
locking section 1180 and connection portion 114, no separate
locking core has to be soldered to proximal core 220. In some
embodiments, after polymer layer 250 and conductive ribbons 260
embedded within polymer layer 250 is removed from section 1180,
proximal core 220 in section 1180 can be shaped by a one or more
machining and/or shaping processes. Such machining and/or shaping
processes include rolling, grinding, laser ablation, electrical
discharge machining (EDM), and lathing. In some instances, these
shaping processes involve locally heating section 1180. In some
implementation, the shaping process is carried out by a
computer-aid manufacturing (CAM) tool.
[0069] At step 340, an insulation layer is formed over a proximal
end portion of the plurality of the conductive ribbons. For
example, as shown in FIG. 8A, after polymer layer 250 and
conductive ribbons 260 are removed from locking section 1180,
proximal ends of the conductive ribbons 260 immediately distal to
locking section 1180 are exposed. Insulation layer 158 is then
formed over the proximal end portion of the conductive ribbons to
insulate them from moisture, blood, bodily fluids, saline
solutions, enzymatic cleaner solutions, and other
disinfectants.
[0070] Method 300 can include additional steps, such as those
relating to formation of conductive portions. In some embodiments,
method 300 further includes a step to remove a portion of polymer
layer over a section of the connection portion to expose one of the
plurality of conductive ribbons. Thereafter, method 300 includes an
additional step of forming a conductive layer over the exposed
conductive ribbon. In some instances, the conductive layer is a
coating of conductive ink. In other instances, the conductive layer
is a metal ring.
[0071] 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.
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