U.S. patent application number 17/575723 was filed with the patent office on 2022-06-30 for conductive support member for intravascular imaging device and associated devices, systems, and methods.
The applicant listed for this patent is PHILIPS IMAGE GUIDED THERAPY CORPORATION. Invention is credited to Maritess Minas, Princeton Saroha, Jeremy Stigall, David Kenneth Wrolstad.
Application Number | 20220202391 17/575723 |
Document ID | / |
Family ID | |
Filed Date | 2022-06-30 |
United States Patent
Application |
20220202391 |
Kind Code |
A1 |
Wrolstad; David Kenneth ; et
al. |
June 30, 2022 |
CONDUCTIVE SUPPORT MEMBER FOR INTRAVASCULAR IMAGING DEVICE AND
ASSOCIATED DEVICES, SYSTEMS, AND METHODS
Abstract
An intravascular imaging device is provided. In one embodiment,
the intravascular imaging device includes a flexible elongate
member sized and shaped for insertion into a vessel of a patient,
the flexible elongate member having a proximal portion and a distal
portion; an imaging assembly disposed at the distal portion of the
flexible elongate member, the imaging assembly including: a flex
circuit; a conductor extending along the flexible elongate member
and in electrical communication with the flex circuit; and a
support member around which the flex circuit is positioned, the
support member including a conductive portion electrically coupled
to the support member.
Inventors: |
Wrolstad; David Kenneth;
(FALLBROOK, CA) ; Minas; Maritess; (SAN DIEGO,
CA) ; Saroha; Princeton; (LADERA RANCH, CA) ;
Stigall; Jeremy; (CARLSBAD, CA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
PHILIPS IMAGE GUIDED THERAPY CORPORATION |
SAN DIEGO |
CA |
US |
|
|
Appl. No.: |
17/575723 |
Filed: |
January 14, 2022 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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16088250 |
Sep 25, 2018 |
11224407 |
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PCT/EP2017/057558 |
Mar 30, 2017 |
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17575723 |
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62315421 |
Mar 30, 2016 |
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International
Class: |
A61B 8/00 20060101
A61B008/00; A61B 8/08 20060101 A61B008/08 |
Claims
1. An intravascular imaging device comprising: a flexible elongate
member sized and shaped for insertion into a vessel of a patient,
wherein the flexible elongate member comprises a proximal portion
and a distal portion; and an imaging assembly disposed at the
distal portion of the flexible elongate member, wherein the imaging
assembly comprises: a support member comprising a first conductive
portion with a first end and a second end; a flexible substrate
comprising a second conductive portion, wherein the flexible
substrate is wrapped around the support member such that the second
conductive portion contacts the second end of the first conductive
portion and establishes electrical communication with first
conductive portion; and a conductor extending along the flexible
elongate member, wherein the conductor is in electrical
communication with the first conductive portion at a location
proximate to the first end of the first conductive portion such
that an electrical signal is transmitted between the conductor and
the flexible substrate via the first conductive portion and the
second conductive portion.
2. The device of claim 1, wherein the support member comprises a
proximal flange, and wherein the proximal flange comprises the
first conductive portion.
3. The device of claim 2, wherein the first conductive portion is
disposed on a surface of the proximal flange.
4. The device of claim 2, wherein the first conductive portion is
disposed within a wall of the proximal flange.
5. The device of claim 1, wherein the first conductive portion
extends through a channel formed in the support member.
6. The device of claim 1, wherein the flexible substrate includes a
first section comprising a plurality of transducers, a second
section comprising a plurality of controllers, and a third section
comprising a plurality of conductive traces facilitating
communication between the plurality of the transducers and the
plurality of controllers.
7. The device of claim 6, wherein the first conductive portion is
in electrical communication with at least one of the plurality of
controllers.
8. The device of claim 1, wherein the imaging assembly further
comprises a plurality of conductors, wherein the support member
includes a plurality of first conductive portions, wherein each one
of the plurality of conductors is in communication with a
respective one of the plurality of first conductive portions.
9. The device of claim 8, wherein the plurality of conductors
comprises four conductors and the plurality of first conductive
portions comprises four conductive portions.
10. The device of claim 9, wherein the plurality of first
conductive portions are spaced around a circumference of the
proximal flange.
11. The device of claim 9, wherein the plurality of first
conductive portions are adjacent to one another.
12. The device of claim 1, wherein the imaging assembly further
comprises a conductive pad in electrical communication with the
first conductive portion, and wherein the conductor is in
electrical communication with the conductive pad.
13. The device of claim 12, wherein the conductor is soldered to
the conductive pad.
Description
[0001] CROSS-REFERENCE TO PRIOR APPLICATIONS
[0002] This application is a continuation of U.S. application Ser.
No. 16/088,250, filed Sep. 25, 2018, now U.S. Pat. No. 11,224,407,
which is the U.S. National Phase application under 35 U.S.C. .sctn.
371 of International Application No. PCT/EP2017/057558, filed on
Mar. 30, 2017, which claims the benefit of Provisional Application
Ser. No. 62/315,421, filed Mar. 30, 2016. These applications are
hereby incorporated by reference herein.
TECHNICAL FIELD
[0003] The present disclosure relates generally to intravascular
ultrasound (IVUS) imaging and, in particular, to the structure of
an intravascular imaging device. For example, the structure can
include a distal support member having a conductive portion that
facilitates communication of electrical signals between a conductor
and a flex circuit of the intravascular imaging device.
BACKGROUND
[0004] Intravascular ultrasound (IVUS) imaging is widely used in
interventional cardiology as a diagnostic tool for assessing a
diseased vessel, such as an artery, within the human body to
determine the need for treatment, to guide the intervention, and/or
to assess its effectiveness. An IVUS device including one or more
ultrasound transducers is passed into the vessel and guided to the
area to be imaged. The transducers emit ultrasonic energy in order
to create an image of the vessel of interest. Ultrasonic waves are
partially reflected by discontinuities arising from tissue
structures (such as the various layers of the vessel wall), red
blood cells, and other features of interest. Echoes from the
reflected waves are received by the transducer and passed along to
an IVUS imaging system. The imaging system processes the received
ultrasound echoes to produce a cross-sectional image of the vessel
where the device is placed.
[0005] Solid-state (also known as synthetic-aperture) IVUS
catheters are one of the two types of IVUS devices commonly used
today, the other type being the rotational IVUS catheter.
Solid-state IVUS catheters carry a scanner assembly that includes
an array of ultrasound transducers distributed around its
circumference along with one or more integrated circuit controller
chips mounted adjacent to the transducer array. The controllers
select individual transducer elements (or groups of elements) for
transmitting an ultrasound pulse and for receiving the ultrasound
echo signal. By stepping through a sequence of transmit-receive
pairs, the solid-state IVUS system can synthesize the effect of a
mechanically scanned ultrasound transducer but without moving parts
(hence the solid-state designation). Since there is no rotating
mechanical element, the transducer array can be placed in direct
contact with the blood and vessel tissue with minimal risk of
vessel trauma. Furthermore, because there is no rotating element,
the electrical interface is simplified. The solid-state scanner can
be wired directly to the imaging system with a simple electrical
cable and a standard detachable electrical connector, rather than
the complex rotating electrical interface required for a rotational
IVUS device.
[0006] Manufacturing an intravascular imaging device that can
efficiently traverse physiology within the human body is
challenging. In that regard, components at the distal portion of
the imaging device can be assembled in a manner that excessively
enlarges an outer diameter, which makes navigation through smaller
diameter vessels difficult.
[0007] Thus, there remains a need for intravascular ultrasound
imaging system that overcomes the limitations of a large diameter
imaging assembly while achieving efficient assembly and
operation.
SUMMARY
[0008] Embodiments of the present disclosure provide an improved
intravascular ultrasound imaging system for generating images of a
blood vessel. A distal portion of an intravascular imaging device
can include a flex circuit and a support member around which the
flex circuit is positioned. The support member can include
conductive portions that are respectively coupled conductors or
wires that extend along the length of the intravascular imaging
device. For example, conductive material can be positioned on a
surface of the support member or within a wall of the support
member. The conductive portions of the support member can be
electrically connected to a conductive portion of the flex circuit
so that the conductors can communicate electrical signals to the
flex circuit via the support member. Coupling the conductors to the
conductive portion of the support member advantageously allows for
the imaging assembly to be assembled with a relatively smaller
outer diameter.
[0009] In one embodiment, an intravascular imaging device is
provided. The intravascular imaging device includes a flexible
elongate member sized and shaped for insertion into a vessel of a
patient, the flexible elongate member having a proximal portion and
a distal portion; an imaging assembly disposed at the distal
portion of the flexible elongate member, the imaging assembly
including: a flex circuit; a conductor extending along the flexible
elongate member and in electrical communication with the flex
circuit; and a support member around which the flex circuit is
positioned, the support member including a conductive portion
electrically coupled to the support member.
[0010] In some embodiments, the conductive portion is disposed on a
proximal flange of the support member. In some embodiments, the
conductive portion extends through a channel formed in the support
member. In some embodiments, the flex circuit is in electrical
communication with the conductive portion of the support member. In
some embodiments, the flex circuit includes a first section having
a plurality of transducers, a second section having a plurality of
controllers, and a third section having a plurality of conductive
traces facilitating communication between the plurality of the
transducers and the plurality of controllers. In some embodiments,
the conductive portion is in electrical communication with at least
one of the plurality of controllers. In some embodiments, the
conductive portion is disposed on a surface of the proximal flange.
In some embodiments, the conductive portion is disposed within a
wall of the proximal flange. In some embodiments, the imaging
assembly further comprises a plurality of conductors and wherein
the support member includes a plurality of conductive portions. In
some embodiments, the plurality of conductors comprises four
conductors and the plurality of conductive portions comprises four
conductive portions, wherein each one of the plurality of
conductors is in communication with a respective one of the
plurality of conductive portions. In some embodiments, the
plurality of conductive portions are spaced around a circumference
of the proximal flange. In some embodiments, the plurality of
conductive portions are adjacent to one another. In some
embodiments, the device further includes a conductive pad in
electrical communication with conductive portion, wherein the
conductor is electrically coupled to the conductive pad. In some
embodiments, the conductor is soldered to the conductive pad.
[0011] In one embodiment, a method of assembling an intravascular
imaging device is provided. The method includes obtaining a support
member having a conductive portion; positioning a flex circuit
around the support member such that the flex circuit is in
electrical communication with the conductive portion of the support
member; electrically coupling a conductor to the conductive portion
of support member such that the conductor is in electrical
communication with the flex circuit; and coupling a flexible
elongate member to at least one of the flex circuit or the support
member such that the flex circuit and the support member are
disposed at a distal portion of the flexible elongate member.
[0012] In some embodiments, the obtaining includes filling a
channel of the support member with a conductive material. In some
embodiments, the electrically coupling includes electrically
coupling the conductor to a conductive pad disposed on a proximal
flange of the support member. In some embodiments, the electrically
coupling includes soldering the conductor to the conductive portion
of the support member. In some embodiments, the method further
includes positioning the conductor within the flexible elongate
member. In some embodiments, the support member includes a
plurality of conductive portions and wherein the electrically
coupling includes electrically coupling each one a plurality of
conductors to a respective one of the plurality of conductive
portions.
[0013] Additional aspects, features, and advantages of the present
disclosure will become apparent from the following detailed
description.
BRIEF DESCRIPTION OF THE DRAWINGS
[0014] Illustrative embodiments of the present disclosure will be
described with reference to the accompanying drawings, of
which:
[0015] FIG. 1 is a diagrammatic schematic view of an imaging
system, according to aspects of the present disclosure.
[0016] FIG. 2 is a diagrammatic top view of a scanner assembly in a
flat configuration, according to aspects of the present
disclosure.
[0017] FIG. 3 is a diagrammatic side view of a scanner assembly in
a rolled configuration around a support member, according to
aspects of the present disclosure.
[0018] FIG. 4 is a diagrammatic cross-sectional side view of a
distal portion of an intravascular device, according to aspects of
the present disclosure.
[0019] FIG. 5 is a diagrammatic cross-sectional side view of a
proximal portion of an imaging assembly of an intravascular device,
according to aspects of the present disclosure.
[0020] FIG. 6 is a diagrammatic end view of a proximal portion of a
support member, according to aspects of the present disclosure.
[0021] FIG. 7 is a diagrammatic cross-sectional side view of a
proximal portion of an imaging assembly of the intravascular device
of, according to aspects of the present disclosure.
[0022] FIG. 8 is a diagrammatic end view of a proximal portion of a
support member, according to aspects of the present disclosure.
[0023] FIG. 9 is a flow diagram of a method of assembling an
intravascular device, according to aspects of the present
disclosure.
DETAILED DESCRIPTION
[0024] 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. For example,
while the focusing system is described in terms of cardiovascular
imaging, it is understood that it is not intended to be limited to
this application. The system is equally well suited to any
application requiring imaging within a confined cavity. 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.
[0025] FIG. 1 is a diagrammatic schematic view of an intravascular
ultrasound (IVUS) imaging system 100, according to aspects of the
present disclosure. The IVUS imaging system 100 may include a
solid-state IVUS device 102 such as a catheter, guide wire, or
guide catheter, a patient interface module (PIM) 104, an IVUS
processing system or console 106, and a monitor 108.
[0026] At a high level, the IVUS device 102 emits ultrasonic energy
from a transducer array 124 included in scanner assembly 110
mounted near a distal end of the catheter device. The ultrasonic
energy is reflected by tissue structures in the medium, such as a
vessel 120, surrounding the scanner assembly 110, and the
ultrasound echo signals are received by the transducer array 124.
The PIM 104 transfers the received echo signals to the console or
computer 106 where the ultrasound image (including the flow
information) is reconstructed and displayed on the monitor 108. The
console or computer 106 can include a processor and a memory. The
computer or computing device 106 can be operable to facilitate the
features of the IVUS imaging system 100 described herein. For
example, the processor can execute computer readable instructions
stored on the non-transitory tangible computer readable medium.
[0027] The PIM 104 facilitates communication of signals between the
IVUS console 106 and the scanner assembly 110 included in the IVUS
device 102. This communication includes the steps of: (1) providing
commands to integrated circuit controller chip(s) 206A, 206B,
illustrated in FIG. 2, included in the scanner assembly 110 to
select the particular transducer array element(s) to be used for
transmit and receive, (2) providing the transmit trigger signals to
the integrated circuit controller chip(s) 206A, 206B included in
the scanner assembly 110 to activate the transmitter circuitry to
generate an electrical pulse to excite the selected transducer
array element(s), and/or (3) accepting amplified echo signals
received from the selected transducer array element(s) via
amplifiers included on the integrated circuit controller chip(s)126
of the scanner assembly 110. In some embodiments, the PIM 104
performs preliminary processing of the echo data prior to relaying
the data to the console 106. In examples of such embodiments, the
PIM 104 performs amplification, filtering, and/or aggregating of
the data. In an embodiment, the PIM 104 also supplies high- and
low-voltage DC power to support operation of the device 102
including circuitry within the scanner assembly 110.
[0028] The IVUS console 106 receives the echo data from the scanner
assembly 110 by way of the PIM 104 and processes the data to
reconstruct an image of the tissue structures in the medium
surrounding the scanner assembly 110. The console 106 outputs image
data such that an image of the vessel 120, such as a
cross-sectional image of the vessel 120, is displayed on the
monitor 108. Vessel 120 may represent fluid filled or surrounded
structures, both natural and man-made. The vessel 120 may be within
a body of a patient. The vessel 120 may be a blood vessel, as an
artery or a vein of a patient's vascular system, including cardiac
vasculature, peripheral vasculature, neural vasculature, renal
vasculature, and/or or any other suitable lumen inside the body.
For example, the device 102 may be used to examine any number of
anatomical locations and tissue types, including without
limitation, organs including the liver, heart, kidneys, gall
bladder, pancreas, lungs; ducts; intestines; nervous system
structures including the brain, dural sac, spinal cord and
peripheral nerves; the urinary tract; as well as valves within the
blood, chambers or other parts of the heart, and/or other systems
of the body. In addition to natural structures, the device 102 may
be may be used to examine man-made structures such as, but without
limitation, heart valves, stents, shunts, filters and other
devices.
[0029] In some embodiments, the IVUS device includes some features
similar to traditional solid-state IVUS catheters, such as the
EagleEye.RTM. catheter available from Volcano Corporation and those
disclosed in U.S. Pat. No. 7,846,101 hereby incorporated by
reference in its entirety. For example, the IVUS device 102
includes the scanner assembly 110 near a distal end of the device
102 and a transmission line bundle 112 extending along the
longitudinal body of the device 102. The transmission line bundle
or cable 112 can include a plurality of conductors, including one,
two, three, four, five, six, seven, or more conductors 218 (FIG.
2). It is understood that any suitable gauge wire can be used for
the conductors 218. In an embodiment, the cable 112 can include a
four-conductor transmission line arrangement with, e.g., 41 AWG
gauge wires. In an embodiment, the cable 112 can include a
seven-conductor transmission line arrangement utilizing, e.g., 44
AWG gauge wires. In some embodiments, 43 AWG gauge wires can be
used.
[0030] The transmission line bundle 112 terminates in a PIM
connector 114 at a proximal end of the device 102. The PIM
connector 114 electrically couples the transmission line bundle 112
to the PIM 104 and physically couples the IVUS device 102 to the
PIM 104. In an embodiment, the IVUS device 102 further includes a
guide wire exit port 116. Accordingly, in some instances the IVUS
device is a rapid-exchange catheter. The guide wire exit port 116
allows a guide wire 118 to be inserted towards the distal end in
order to direct the device 102 through the vessel 120.
[0031] FIG. 2 is a top view of a portion of an ultrasound scanner
assembly 110 according to an embodiment of the present disclosure.
The assembly 110 includes a transducer array 124 formed in a
transducer region 204 and transducer control logic dies 206
(including dies 206A and 206B) formed in a control region 208, with
a transition region 210 disposed therebetween. The transducer
control logic dies 206 and the transducers 212 are mounted on a
flex circuit 214 that is shown in a flat configuration in FIG. 2.
FIG. 3 illustrates a rolled configuration of the flex circuit 214.
The transducer array 202 is a non-limiting example of a medical
sensor element and/or a medical sensor element array. The
transducer control logic dies 206 is a non-limiting example of a
control circuit. The transducer region 204 is disposed adjacent a
distal portion 220 of the flex circuit 214. The control region 208
is disposed adjacent the proximal portion 222 of the flex circuit
214. The transition region 210 is disposed between the control
region 208 and the transducer region 204. Dimensions of the
transducer region 204, the control region 208, and the transition
region 210 (e.g., lengths 225, 227, 229) can vary in different
embodiments. In some embodiments, the lengths 225, 227, 229 can be
substantially similar or a length 227 of the transition region 210
can be greater than lengths 225, 229 of the transducer region and
controller region, respectively. While the imaging assembly 110 is
described as including a flex circuit, it is understood that the
transducers and/or controllers may be arranged to form the imaging
assembly 110 in other configurations, including those omitting a
flex circuit.
[0032] The transducer array 124 may include any number and type of
ultrasound transducers 212, although for clarity only a limited
number of ultrasound transducers are illustrated in FIG. 2. In an
embodiment, the transducer array 124 includes 64 individual
ultrasound transducers 212. In a further embodiment, the transducer
array 124 includes 32 ultrasound transducers 212. Other numbers are
both contemplated and provided for. With respect to the types of
transducers, in an embodiment, the ultrasound transducers 124 are
piezoelectric micromachined ultrasound transducers (PMUTs)
fabricated on a microelectromechanical system (MEMS) substrate
using a polymer piezoelectric material, for example as disclosed in
U.S. Patent 6,641,540, which is hereby incorporated by reference in
its entirety. In alternate embodiments, the transducer array
includes piezoelectric zirconate transducers (PZT) transducers such
as bulk PZT transducers, capacitive micromachined ultrasound
transducers (cMUTs), single crystal piezoelectric materials, other
suitable ultrasound transmitters and receivers, and/or combinations
thereof
[0033] The scanner assembly 110 may include various transducer
control logic, which in the illustrated embodiment is divided into
discrete control logic dies 206. In various examples, the control
logic of the scanner assembly 110 performs: decoding control
signals sent by the PIM 104 across the cable 112, driving one or
more transducers 212 to emit an ultrasonic signal, selecting one or
more transducers 212 to receive a reflected echo of the ultrasonic
signal, amplifying a signal representing the received echo, and/or
transmitting the signal to the PIM across the cable 112. In the
illustrated embodiment, a scanner assembly 110 having 64 ultrasound
transducers 212 divides the control logic across nine control logic
dies 206, of which five are shown in FIG. 2. Designs incorporating
other numbers of control logic dies 206 including 8, 9, 16, 17 and
more are utilized in other embodiments. In general, the control
logic dies 206 are characterized by the number of transducers they
are capable of driving, and exemplary control logic dies 206 drive
4, 8, and/or 16 transducers.
[0034] The control logic dies are not necessarily homogenous. In
some embodiments, a single controller is designated a master
control logic die 206A and contains the communication interface for
the cable 112. Accordingly, the master control circuit may include
control logic that decodes control signals received over the cable
112, transmits control responses over the cable 112, amplifies echo
signals, and/or transmits the echo signals over the cable 112. The
remaining controllers are slave controllers 206B. The slave
controllers 206B may include control logic that drives a transducer
212 to emit an ultrasonic signal and selects a transducer 212 to
receive an echo. In the depicted embodiment, the master controller
206A does not directly control any transducers 212. In other
embodiments, the master controller 206A drives the same number of
transducers 212 as the slave controllers 206B or drives a reduced
set of transducers 212 as compared to the slave controllers 206B.
In an exemplary embodiment, a single master controller 206A and
eight slave controllers 206B are provided with eight transducers
assigned to each slave controller 206B.
[0035] The flex circuit 214, on which the transducer control logic
dies 206 and the transducers 212 are mounted, provides structural
support and interconnects for electrical coupling. The flex circuit
214 may be constructed to include a film layer of a flexible
polyimide material such as KAPTON.TM. (trademark of DuPont). Other
suitable materials include polyester films, polyimide films,
polyethylene napthalate films, or polyetherimide films, other
flexible printed semiconductor substrates as well as products such
as Upilex.RTM. (registered trademark of Ube Industries) and
TEFLON.RTM. (registered trademark of E.I. du Pont). In the flat
configuration illustrated in FIG. 2, the flex circuit 214 has a
generally rectangular shape. As shown and described herein, the
flex circuit 214 is configured to be wrapped around a support
member 230 (FIG. 3) to form a cylindrical toroid in some instances.
Therefore, the thickness of the film layer of the flex circuit 214
is generally related to the degree of curvature in the final
assembled scanner assembly 110. In some embodiments, the film layer
is between 5 .mu.m and 100 .mu.m, with some particular embodiments
being between 12.7 .mu.m and 25.1 .mu.m.
[0036] To electrically interconnect the control logic dies 206 and
the transducers 212, in an embodiment, the flex circuit 214 further
includes conductive traces 216 formed on the film layer that carry
signals between the control logic dies 206 and the transducers 212.
In particular, the conductive traces 216 providing communication
between the control logic dies 206 and the transducers 212 extend
along the flex circuit 214 within the transition region 210. In
some instances, the conductive traces 216 can also facilitate
electrical communication between the master controller 206A and the
slave controllers 206B. The conductive traces 216 can also provide
a set of conductive pads that contact the conductors 218 of cable
112 when the conductors 218 of the cable 112 are mechanically and
electrically coupled to the flex circuit 214. Suitable materials
for the conductive traces 216 include copper, gold, aluminum,
silver, tantalum, nickel, and tin, and may be deposited on the flex
circuit 214 by processes such as sputtering, plating, and etching.
In an embodiment, the flex circuit 214 includes a chromium adhesion
layer. The width and thickness of the conductive traces 216 are
selected to provide proper conductivity and resilience when the
flex circuit 214 is rolled. In that regard, an exemplary range for
the thickness of a conductive trace 216 and/or conductive pad is
between 10-50 .mu.m. For example, in an embodiment, 20 .mu.m
conductive traces 216 are separated by 20 .mu.m of space. The width
of a conductive trace 216 on the flex circuit 214 may be further
determined by the width of the conductor 218 to be coupled to the
trace/pad.
[0037] The flex circuit 214 can include a conductor interface 220
in some embodiments. The conductor interface 220 can be a location
of the flex circuit 214 where the conductors 218 of the cable 114
are coupled to the flex circuit 214. For example, the bare
conductors of the cable 114 are electrically coupled to the flex
circuit 214 at the conductor interface 220. The conductor interface
220 can be tab extending from the main body of flex circuit 214. In
that regard, the main body of the flex circuit 214 can refer
collectively to the transducer region 204, controller region 208,
and the transition region 210. In the illustrated embodiment, the
conductor interface 220 extends from the proximal portion 222 of
the flex circuit 214. In other embodiments, the conductor interface
220 is positioned at other parts of the flex circuit 214, such as
the distal portion 220, or the flex circuit 214 omits the conductor
interface 220. A value of a dimension of the tab or conductor
interface 220, such as a width 224, can be less than the value of a
dimension of the main body of the flex circuit 214, such as a width
226. In some embodiments, the substrate forming the conductor
interface 220 is made of the same material(s) and/or is similarly
flexible as the flex circuit 214. In other embodiments, the
conductor interface 220 is made of different materials and/or is
comparatively more rigid than the flex circuit 214. For example,
the conductor interface 220 can be made of a plastic,
thermoplastic, polymer, hard polymer, etc., including
polyoxymethylene (e.g., DELRIN.RTM.), polyether ether ketone
(PEEK), nylon, and/or other suitable materials. As described in
greater detail herein, the support member 230, the flex circuit
214, the conductor interface 220 and/or the conductor(s) 218 can be
variously configured to facilitate efficient manufacturing and
operation of the scanner assembly 110.
[0038] In some instances, the scanner assembly 110 is transitioned
from a flat configuration (FIG. 2) to a rolled or more cylindrical
configuration (FIGS. 3 and 4). For example, in some embodiments,
techniques are utilized as disclosed in one or more of U.S. Pat.
No. 6,776,763, titled "ULTRASONIC TRANSDUCER ARRAY AND METHOD OF
MANUFACTURING THE SAME" and U.S. Pat. No. 7,226,417, titled "HIGH
RESOLUTION INTRAVASCULAR ULTRASOUND TRANSDUCER ASSEMBLY HAVING A
FLEXIBLE SUBSTRATE," each of which is hereby incorporated by
reference in its entirety.
[0039] As shown in FIGS. 3 and 4, the flex circuit 214 is
positioned around the support member 230 in the rolled
configuration. FIG. 3 is a diagrammatic side view with the flex
circuit 214 in the rolled configuration around the support member
230, according to aspects of the present disclosure. FIG. 4 is a
diagrammatic cross-sectional side view of a distal portion of the
intravascular device 110, including the flex circuit 214 and the
support member 230, according to aspects of the present
disclosure.
[0040] The support member 230 can be referenced as a unibody in
some instances. The support member 230 can be composed of a
metallic material, such as stainless steel, or non-metallic
material, such as a plastic or polymer as described in U.S.
Provisional Application No. 61/985,220, "Pre-Doped Solid Substrate
for Intravascular Devices," filed Apr. 28, 2014, the entirety of
which is hereby incorporated by reference herein. The support
member 230 can be ferrule having a distal portion 262 and a
proximal portion 264. The support member 230 can define a lumen 236
extending longitudinally therethrough. The lumen 236 is in
communication with the exit port 116 and is sized and shaped to
receive the guide wire 118 (FIG. 1). The support member 230 can be
manufactured accordingly to any suitable process. For example, the
support member 230 can be machined, such as by removing material
from a blank to shape the support member 230, or molded, such as by
an injection molding process. In some embodiments, the support
member 230 may be integrally formed as a unitary structure, while
in other embodiments the support member 230 may be formed of
different components, such as a ferrule and stands 242, 244, that
are fixedly coupled to one another.
[0041] Stands 242, 244 that extend vertically are provided at the
distal and proximal portions 262, 264, respectively, of the support
member 230. The stands 242, 244 elevate and support the distal and
proximal portions of the flex circuit 214. In that regard, portions
of the flex circuit 214, such as the transducer portion 204, can be
spaced from a central body portion of the support member 230
extending between the stands 242, 244. The stands 242, 244 can have
the same outer diameter or different outer diameters. For example,
the distal stand 242 can have a larger or smaller outer diameter
than the proximal stand 244. To improve acoustic performance, any
cavities between the flex circuit 214 and the surface of the
support member 230 are filled with a backing material 246. The
liquid backing material 246 can be introduced between the flex
circuit 214 and the support member 230 via passageways 235 in the
stands 242, 244. In some embodiments, suction can be applied via
the passageways 235 of one of the stands 242, 244, while the liquid
backing material 246 is fed between the flex circuit 214 and the
support member 230 via the passageways 235 of the other of the
stands 242, 244. The backing material can be cured to allow it to
solidify and set. In various embodiments, the support member 230
includes more than two stands 242, 244, only one of the stands 242,
244, or neither of the stands. In that regard the support member
230 can have an increased diameter distal portion 262 and/or
increased diameter proximal portion 264 that is sized and shaped to
elevate and support the distal and/or proximal portions of the flex
circuit 214.
[0042] The support member 230 can be substantially cylindrical in
some embodiments. Other shapes of the support member 230 are also
contemplated including geometrical, non-geometrical, symmetrical,
non-symmetrical, cross-sectional profiles. Different portions the
support member 230 can be variously shaped in other embodiments.
For example, the proximal portion 264 can have a larger outer
diameter than the outer diameters of the distal portion 262 or a
central portion extending between the distal and proximal portions
262, 264. In some embodiments, an inner diameter of the support
member 230 (e.g., the diameter of the lumen 236) can
correspondingly increase or decrease as the outer diameter changes.
In other embodiments, the inner diameter of the support member 230
remains the same despite variations in the outer diameter.
[0043] A proximal inner member 256 and a proximal outer member 254
are coupled to the proximal portion 264 of the support member 230.
The proximal inner member 256 and/or the proximal outer member 254
can be flexible elongate member that extend from proximal portion
of the intravascular 102, such as the proximal connector 114, to
the imaging assembly 110. For example, the proximal inner member
256 can be received within a proximal flange 234. The proximal
outer member 254 abuts and is in contact with the flex circuit 214.
A distal member 252 is coupled to the distal portion 262 of the
support member 230. The distal member 252 can be a flexible
component that defines a distal most portion of the intravascular
device 102. For example, the distal member 252 is positioned around
the distal flange 232. The distal member 252 can abut and be in
contact with the flex circuit 214 and the stand 242. The distal
member 252 can be the distal-most component of the intravascular
device 102.
[0044] One or more adhesives can be disposed between various
components at the distal portion of the intravascular device 102.
For example, one or more of the flex circuit 214, the support
member 230, the distal member 252, the proximal inner member 256,
and/or the proximal outer member 254 can be coupled to one another
via an adhesive.
[0045] FIG. 5 is diagrammatic cross-sectional side view of a
proximal portion of the imaging assembly 110 of an intravascular
device. FIG. 5 is illustrates an embodiment of a support member 330
including one or more conductive portions 304, 306. The support
member 330 can be similar to the support member 230 in some
aspects. The support member 330 additionally includes the
conductive portion(s) 304, 306 facilitate electrical communication
between the conductors 218 of the cable 112 (FIGS. 1 and 2) and the
flex circuit 214. In that regard, the conductors 214 may be
electrically and/or mechanically coupled to conductive portion(s)
304, 306 of the support member 230, rather than electrically and/or
mechanically coupled to the interface 220 of the flex circuit 214
(FIG. 2).
[0046] Electrically coupling the conductive member 218 to the
support member 330, rather than the flex circuit 214, can
advantageously minimize the outer diameter of the imaging assembly
110. In some instances, the outer diameter of the imaging assembly
can undesirably bulge in the area where the conductors 218 are
coupled to the conductor interface 220 (FIG. 2). Aspects of the
present disclosure address this difficulty by establishing
electrical communication between the flex circuit 214 and the
conductors 218 within an interior of the imaging assembly 110, at
the support member 330. The outer diameter of the imaging assembly
can also be undesirably large if the conductors 218 extend along an
exterior surface of the outer member 254 after being coupled to the
conductor interface 220. Because the conductors 218 are coupled to
the support member 230 within the interior of the imaging assembly
110, according to aspects of the present disclosure, the conductors
218 can extend along a length of the intravascular device within,
e.g., the outer member 254. A more robust electrical and/or
mechanical connection can also be established between the
conductors 218 and the support member 330, which is relatively more
rigid than the flex circuit 214.
[0047] A conductive portion 304 of the support member 330 is a
channel 302 filled with a conductive material 304. In the
embodiment of FIG. 5, the channel 302 extends within a wall of the
stand 244 and along a surface of the proximal flange 234. It is
understood that the conductive portion 304 can positioned anywhere
within and/or along a surface of the support member 330. The
channel 302 can be formed according to any suitable process,
including machining the support member 330 to form the channel 302
and/or molding along support member 330 with the channel 302 formed
therein. Similarly, the channel 302 can be filled according to any
suitable process, such as a physical vapor deposition, chemical
vapor deposition, chemical adsorption, physical adsorption, dip
coating, solvent evaporation, among others. In some embodiments,
the conductive material is a metal, such as gold, silver, copper,
aluminum, steel, and/or other suitable materials.
[0048] The conductive portion 304 is in electrical contact with the
flex circuit 208. For example, the conductive portion 304 may be
communication with electronic components of the flex circuit 214,
such as the controllers 206A, 206B, transducers 212, and/or
conductive traces 215. An inferior or bottom side of the flex
circuit 214 (e.g., the side of the flex circuit 214 in contact with
the support member 330) can have a conductive portion that
physically contacts the conductive portion 304 within the stand 244
of the support member 330 when the flex circuit 214 is positioned
around the support member 330. In that regard, the flex circuit 214
and the support member 330 may be aligned such that the conductive
portion of the flex circuit 214 and the conductive portion 304 are
in contact. An adhesive may be used to affix the flex circuit 214
and the support member 330.
[0049] The conductive portion 304 may extend along a surface of the
proximal flange 234. In some embodiments, the conductor 218 is
electrically coupled directly to the conductive portion 304. In
other embodiments, as illustrated in FIG. 5, the conductor 218 is
electrically coupled directly to a conductive pad 306. For example,
as shown, solder 308 may be used to electrically and/or
mechanically The conductive pad 306 may be conductive region of the
support member 330 that is configured to allow the conductors the
be efficiently coupled thereto. For example, the conductive pad 306
may be sized and shaped to so that a user, during manufacturing,
can quickly and easily solder the conductor 218 to the support
member 330. For example, the length, width, and/or height of the
conductive pad 306 may be larger than corresponding dimensions of
the conductive portion 304. The conductive portion 304 may be in
contact with and electrically coupled to the conductive pad 306.
The conductor 218 may be in electrical communication with the
conductive portion 304 via the conductive pad 306.
[0050] The conductors 218 extend between the proximal connector 114
and the imaging assembly 110 along the length of and within an
interior of the intravascular device 102 (FIG. 1). For example, the
conductors can be disposed within a lumen of the outer member 254,
such as between the inner member 256 and the outer member 254.
[0051] Any suitable number of conductors 218 can be electrically
coupled the support member 330. The support member 330 can include
a corresponding number of conductive portions 304, 306 based on the
number of conductors 218. For example, one, two, three, four, five,
six, seven, or more conductors 218 can extend along the length of
the intravascular device. The support member can correspondingly
include one, two, three, four, five, six, seven, or more conductive
portions 304, 306. Two sets of conductive portions 304, 306 are
shown in the cross-sectional illustration of FIG. 5. FIG. 6 is a
diagrammatic end view of the proximal portion 264 of the support
member 330 that includes four conductive portions 306 disposed on
the proximal flange 234. Each one of four conductors 218 can be
electrically and/or mechanically coupled to a respective one of the
four conductive pads 306 of the support member 330.
[0052] FIGS. 7 and 8 illustrate an embodiment of the support member
330 that includes the conductive portion 304 extending within a
wall of the proximal flange 234. FIG. 7 diagrammatic
cross-sectional side view of the proximal portion 264 of the
support member 330, including the proximal flange 234. FIG. 8 is a
diagrammatic end view of the proximal portion 264 of the support
member 330, including the proximal flange 234. The conductive
portion 304 is disposed within the proximal flange 234 in a similar
manner as the conductive portion 304 is disposed within the stand
244 (FIG. 5). Accordingly, the conductive portion 304 can extend
entirely through the structure of the support member 330, rather
than along a surface of the support member 330, in some
embodiments. The conductor 218 can be electrically and/or
mechanically coupled to the conductive portion 304 at a proximal
end 310. In some embodiments, the proximal flange 234 can include a
recess at the distal end 310 that receives the conductor 218. For
example, the conductor 218 can be positioned within and coupled to
the conductive portion 304 within a wall of the proximal flange
234. While the conductor 218 is directly coupled to the conductive
portion 304 in the illustrated embodiment, other embodiments of the
support member 330 can include a conductive pad 306 (FIGS. 5 and 6)
in communication with the conductive portion 304 and directly
coupled to the conductor 218.
[0053] As shown in FIGS. 6 and 8, the conductive portions 304, 306
can be variously positioned around circumference of the proximal
flange 234. FIG. 6 illustrates the conductive pads 306 spaced
around the circumstance of the proximal flange 234. In that regard,
the conductive pads 306 are equally spaced around circumference of
the proximal flange 234, within each conductive pad 306 positioned
in a quadrant of the circumference. Equally spacing the conductive
pads 306 may allow a user to individually couple the conductor 218
to the respective conductive pad 306 such that the electrical
and/or mechanical connection is effectively established. Spacing
between the conductive pads 306 may also ensure the conductors 218
remain electrically isolated. Distributing the conductive pads 306
around the circumference of the proximal flange 234 may also result
in the positioning conductive portions 304 around the circumference
of the support member 330. For example, as shown in FIG. 5, the
conductive portions 304 are shown on both the superior/top and
inferior/bottom portions of the stand 244 and the proximal flange
234.
[0054] FIG. 8 illustrates the conductive portions 304 are
positioned adjacent to one another. In that regard, the grouping of
the multiple conductive portions 304 can be disposed anywhere along
the circumference of the proximal flange 234, including in the
superior or top section shown in FIG. 8. Positioning the multiple
conductive portions 304 in a relatively small area may allow for
the conductors 218 to be coupled to support member 330 in an
efficient manner while ensuring the conductors 218 are electrically
isolated. Relatively less spacing between the conductive portions
304 may also result in conductive portions 304 being positioned in
fewer areas around the support member 330. For example, as shown in
FIG. 7, the conductive portions 304 are shown only on the
superior/top portion of the proximal flange 234.
[0055] FIG. 9 is a flow diagram of a method 400 of assembling an
intravascular imaging device, including an imaging assembly with a
support member described herein. It is understood that the steps of
method 400 may be performed in a different order than shown in FIG.
9, additional steps can be provided before, during, and after the
steps, and/or some of the steps described can be replaced or
eliminated in other embodiments. The steps of the method 400 can be
carried out by a manufacturer of the intravascular imaging
device.
[0056] At step 410, the method 410 includes obtaining a support
member. The support member includes a conductive portion. For
example, the conductive portion may extend along a surface or a
within a wall of the support member. In some embodiments, a
proximal portion of the support member, such as a proximal flange,
includes the conductive portion. In some embodiments, step 410 can
include filling a channel of the support member with a conductive
material.
[0057] At step 420, the method 400 includes positioning a flex
circuit around a support member to form an imaging assembly of the
intravascular device. The flex circuit can include a conductive
portion that contacts and establishes electrical communication with
the conductive portion of the support member when the flex circuit
is positioned around the support member. Step 420 can include
aligning the flex circuit and the support member such that the
respective conductive portions contact when the flex circuit is
positioned around the support member.
[0058] At step 430, the method 400 includes electrically coupling a
conductor to the conductive portion of the support member. As a
result, the conductor is in electrical communication with the flex
circuit. For example, the flex circuit can include a first section
having a plurality of transducers, a second section having a
plurality of controllers, and a third section having a plurality of
conductive traces facilitating communication between the plurality
of the transducers and the plurality of controllers. At step 430,
the conductor establishes electrical communication with the
controller(s), transducer(s), and/or conductive traces of flex
circuit. Electrical signals representative of control signals to
the controller(s), imaging data from the transducer(s), and/or
other suitable data are transmitted to/from the conductors to the
flex circuit via the conductive portion of the support member. In
some embodiments, step 430 can include electrically coupling the
conductor to a conductive pad disposed on a proximal flange of the
support member. In some embodiments, step 430 can include soldering
the conductor to the conductive portion of the support member. In
some embodiments, the support member includes a plurality of
conductive portions. The intravascular device can include a
plurality of conductors. In such embodiments, step 430 includes
electrically coupling each one a plurality of conductors to a
respective one of the plurality of conductive portions.
[0059] At step 440, the method 400 includes positioning the one or
more conductors within a flexible elongate member. At step 440, the
method 400 can include coupling the flex circuit and/or the support
member to one or more flexible elongate members. For example, one
or more proximal flexible elongate members (e.g., an inner member
and/or an outer member) are coupled to the flex circuit and/or the
support member. In that regard, the flex circuit and/or the support
member are positioned at the distal portion of the flexible
elongate member. The conductor(s) can extend along a length of the
intravascular device. The conductor(s) can be threaded through the
flex elongate member such that, e.g., the conductor(s) are
positioned with a lumen of an outer member and/or disposed between
an inner member and an outer member.
[0060] The method 400 can also include coupling the flex circuit
and/or the support member to a distal component that defines a
distal-most end of the intravascular imaging device. The method 400
can include introducing adhesive to affix the flex circuit and the
support member and/or other components of the intravascular imaging
device. The method 400 can also include introducing a liquid
acoustic backing material between the flex circuit and the support
member. A mandrel can be temporarily positioned around the support
member to allow positioning of the flex circuit around the support
member. The method 400 can also include removing the mandrel after
the liquid acoustic backing material has cured.
[0061] Various embodiments of an intravascular device and/or
imaging assembly can include features described in U.S. Provisional
App. No. 62/315,395, filed Mar. 30, 2016, U.S. Provisional App. No.
62/315,406, filed Mar. 30, 2016, U.S. Provisional App. No.
62/315,428, filed Mar. 30, 2016, and U.S. Provisional App. No.
62/315,416, filed Mar. 30, 2016, the entireties of which are hereby
incorporated by reference herein.
[0062] Persons skilled in the art will 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.
* * * * *