U.S. patent application number 16/165422 was filed with the patent office on 2020-04-23 for systems, catheters, drive units, and methods for automatic catheter identification.
The applicant listed for this patent is Boston Scientific SciMed, Inc.. Invention is credited to Joe Corrigan, Peter Thornton, JR..
Application Number | 20200121286 16/165422 |
Document ID | / |
Family ID | 70281092 |
Filed Date | 2020-04-23 |
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United States Patent
Application |
20200121286 |
Kind Code |
A1 |
Corrigan; Joe ; et
al. |
April 23, 2020 |
SYSTEMS, CATHETERS, DRIVE UNITS, AND METHODS FOR AUTOMATIC CATHETER
IDENTIFICATION
Abstract
A catheter for an ultrasound system can a marker disposed on the
hub. The marker is optically or magnetically readable and, when
read, identifies the catheter. A drive unit can include an optical
or magnetic marker reader. Alternatively or additionally, a
catheter may include an active memory arrangement that can be read
by an appropriate reader on the drive unit.
Inventors: |
Corrigan; Joe; (Cambridge,
GB) ; Thornton, JR.; Peter; (Los Altos, CA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Boston Scientific SciMed, Inc. |
Maple Grove |
MN |
US |
|
|
Family ID: |
70281092 |
Appl. No.: |
16/165422 |
Filed: |
October 19, 2018 |
Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61B 90/96 20160201;
A61B 8/12 20130101; A61B 8/445 20130101; A61B 8/4461 20130101; A61B
90/94 20160201; A61B 8/56 20130101; A61B 8/54 20130101; A61B 8/4438
20130101; A61B 90/90 20160201 |
International
Class: |
A61B 8/00 20060101
A61B008/00; A61B 8/12 20060101 A61B008/12; A61B 90/96 20060101
A61B090/96; A61B 90/94 20060101 A61B090/94; A61B 90/90 20060101
A61B090/90 |
Claims
1. A catheter for an ultrasound system, the catheter comprising: a
catheter sheath defining a lumen; a hub coupled to the catheter
sheath and configured for attachment to a motor drive; an
elongated, rotatable driveshaft disposed within the lumen of the
catheter sheath and extending into the hub, the driveshaft having a
proximal end and a distal end, wherein the proximal end is
configured and arranged for coupling to the motor drive for
rotating the driveshaft; an imaging device coupled to the distal
end of the driveshaft with rotation of the driveshaft causing a
corresponding rotation of the imaging device, the imaging device
comprising at least one transducer configured and arranged for
transforming applied electrical signals to acoustic signals and
also for transforming received echo signals to electrical signals;
at least one conductor extending from the hub through the lumen of
the catheter sheath and coupled to the imaging device for carrying
the electrical signals; and a marker disposed on the hub, wherein
the marker is optically or magnetically readable and, when read,
identifies the catheter.
2. The catheter of claim 1, wherein the marker is optically
readable.
3. The catheter of claim 1, wherein the marker comprises a one- or
two-dimensional code.
4. The catheter of claim 1, wherein the marker comprises a barcode
or QR code.
5. The catheter of claim 1, wherein the marker is magnetically
readable.
6. The catheter of claim 1, wherein the marker comprises a strip
with information magnetically encoded thereon.
7. The catheter of claim 1, wherein the marker is printed onto the
hub.
8. The catheter of claim 1, wherein the marker is disposed on a
rotating portion of the hub.
9. The catheter of claim 1, wherein the marker, when read,
identifies a type of the catheter.
10. The catheter of claim 1, wherein the marker, when read,
identifies a serial number of the catheter.
11. The catheter of claim 1, wherein the marker, when read,
identifies an expiration date of the catheter.
12. The catheter of claim 1, wherein the marker is disposed on
non-curved surface of the hub.
13. An ultrasound system, comprising: the catheter of claim 1; and
a drive unit coupleable to the catheter, the drive unit comprising:
a drive hub configured for attachment to the hub of the catheter; a
rotation mechanism configured for rotating the driveshaft of the
catheter; and a marker reader configured to optically or
magnetically read the marker on the catheter to identify the
catheter.
14. The ultrasound system of claim 13, further comprising a
processor coupleable to the drive unit and configured for
identifying the catheter from the marker when read by the marker
reader.
15. The ultrasound system of claim 14, wherein the processor is
further configured for altering or setting one or more settings of
the ultrasound system in response to the identification of the
catheter.
16. A drive unit for an ultrasound system, the drive unit
comprising: a drive hub configured for attachment to a catheter; a
rotation mechanism configured for rotating a driveshaft of the
catheter; and a reader configured to optically or magnetically read
a marker on the catheter to identify the catheter.
17. The drive unit of claim 16, wherein the reader is an optical
reader.
18. The drive unit of claim 16, wherein the reader is a magnetic
reader.
19. A catheter for an ultrasound system, the catheter comprising: a
catheter sheath defining a lumen; a hub coupled to the catheter
sheath and configured for attachment to a motor drive; an
elongated, rotatable driveshaft disposed within the lumen of the
catheter sheath and extending into the hub, the driveshaft having a
proximal end and a distal end, wherein the proximal end is
configured and arranged for coupling to the motor drive for
rotating the driveshaft; an imaging device coupled to the distal
end of the driveshaft with rotation of the driveshaft causing a
corresponding rotation of the imaging device, the imaging device
comprising at least one transducer configured and arranged for
transforming applied electrical signals to acoustic signals and
also for transforming received echo signals to electrical signals;
at least one conductor extending from the hub through the lumen of
the catheter sheath and coupled to the imaging device for carrying
the electrical signals; and an active memory arrangement disposed
on the hub, wherein the active memory arrangement is configured for
transferring information using a single conductor and is configured
to store information that identifies the catheter.
20. An ultrasound system, comprising: the catheter of claim 19; and
a drive unit coupleable to the catheter, the drive unit comprising:
a drive hub configured for attachment to the hub of the catheter; a
rotation mechanism configured for rotating the driveshaft of the
catheter; and a reader configured to obtain the information from
the active memory arrangement on the catheter to identify the
catheter.
Description
TECHNICAL FIELD
[0001] The present disclosure is directed to the area of
intravascular ultrasound imaging systems and methods of making and
using the systems. The present disclosure is also directed to
intravascular ultrasound imaging systems that include arrangements
for automatic catheter identification when the catheter is attached
to a drive unit.
BACKGROUND
[0002] Intravascular ultrasound ("IVUS") imaging systems have
proven diagnostic capabilities for a variety of diseases and
disorders. For example, IVUS imaging systems have been used as an
imaging modality for diagnosing blocked blood vessels and providing
information to aid medical practitioners in selecting and placing
stents and other devices to restore or increase blood flow. IVUS
imaging systems have been used to diagnose atheromatous plaque
build-up at particular locations within blood vessels. IVUS imaging
systems can be used to determine the existence of an intravascular
obstruction or stenosis, as well as the nature and degree of the
obstruction or stenosis. IVUS imaging systems can be used to
visualize segments of a vascular system that may be difficult to
visualize using other intravascular imaging techniques, such as
angiography, due to, for example, movement (e.g., a beating heart)
or obstruction by one or more structures (e.g., one or more blood
vessels not desired to be imaged). IVUS imaging systems can be used
to monitor or assess ongoing intravascular treatments, such as
angiography and stent placement in real (or almost real) time.
Moreover, IVUS imaging systems can be used to monitor one or more
heart chambers.
[0003] IVUS imaging systems have been developed to provide a
diagnostic tool for visualizing a variety of diseases or disorders.
An IVUS imaging system can include a control module (with a pulse
generator, an image processor, and a monitor), a drive unit, a
catheter, and one or more transducers disposed in the catheter. The
transducer-containing catheter can be positioned in a lumen or
cavity within, or in proximity to, a region to be imaged, such as a
blood vessel wall or patient tissue in proximity to a blood vessel
wall. The pulse generator in the control module generates
electrical pulses that are delivered to the one or more transducers
and transformed to acoustic signals that are transmitted through
patient tissue. Reflected pulses of the transmitted acoustic
signals are absorbed by the one or more transducers and transformed
to electric pulses. The transformed electric pulses are delivered
to the image processor and converted to an image displayable on the
monitor.
BRIEF SUMMARY
[0004] One aspect is a catheter for an ultrasound system that
includes a catheter sheath defining a lumen; a hub coupled to the
catheter sheath and configured for attachment to a motor drive; an
elongated, rotatable driveshaft disposed within the lumen of the
catheter sheath and extending into the hub, the driveshaft having a
proximal end and a distal end, wherein the proximal end is
configured and arranged for coupling to the motor drive for
rotating the driveshaft; an imaging device coupled to the distal
end of the driveshaft with rotation of the driveshaft causing a
corresponding rotation of the imaging device, the imaging device
including at least one transducer configured and arranged for
transforming applied electrical signals to acoustic signals and
also for transforming received echo signals to electrical signals;
at least one conductor extending from the hub through the lumen of
the catheter sheath and coupled to the imaging device for carrying
the electrical signals; and a marker disposed on the hub, wherein
the marker is optically or magnetically readable and, when read,
identifies the catheter.
[0005] In at least some aspects, the marker is optically readable.
In at least some aspects, the marker includes a one- or
two-dimensional code. In at least some aspects, the marker includes
a barcode or QR code.
[0006] In at least some aspects, the marker is magnetically
readable. In at least some aspects, the marker includes a strip
with information magnetically encoded thereon.
[0007] In at least some aspects, the marker is printed onto the
hub. In at least some aspects, the marker is adhered to the
catheter with an adhesive. In at least some aspects, the marker is
disposed on a rotating portion of the hub.
[0008] In at least some aspects, the marker, when read, identifies
a type of the catheter. In at least some aspects, the marker, when
read, identifies a serial number of the catheter. In at least some
aspects, the marker, when read, identifies an expiration date of
the catheter.
[0009] In at least some aspects, the marker extends around a full
circumference of the hub. In at least some aspects, the marker is
disposed on non-curved surface of the hub.
[0010] Another aspect is an ultrasound system that includes any of
the catheters described above; and a drive unit coupleable to the
catheter. The drive unit includes a drive hub configured for
attachment to the hub of the catheter; a rotation mechanism
configured for rotating the driveshaft of the catheter; and a
marker reader configured to optically or magnetically read the
marker on the catheter to identify the catheter.
[0011] In at least some aspects, the ultrasound system further
includes a processor coupleable to the drive unit and configured
for identifying the catheter from the marker when read by the
marker reader. In at least some aspects, the processor is further
configured for altering or setting one or more settings of the
ultrasound system in response to the identification of the
catheter.
[0012] Another aspect is a drive unit for an ultrasound system that
includes a drive hub configured for attachment to a catheter; a
rotation mechanism configured for rotating a driveshaft of the
catheter; and a reader configured to optically or magnetically read
a marker on the catheter to identify the catheter.
[0013] In at least some aspects, the reader is an optical reader.
In at least some aspects, the reader is a magnetic reader.
[0014] Yet another aspect is a catheter for an ultrasound system
that includes a catheter sheath defining a lumen; a hub coupled to
the catheter sheath and configured for attachment to a motor drive;
an elongated, rotatable driveshaft disposed within the lumen of the
catheter sheath and extending into the hub, the driveshaft having a
proximal end and a distal end, wherein the proximal end is
configured and arranged for coupling to the motor drive for
rotating the driveshaft; an imaging device coupled to the distal
end of the driveshaft with rotation of the driveshaft causing a
corresponding rotation of the imaging device, the imaging device
including at least one transducer configured and arranged for
transforming applied electrical signals to acoustic signals and
also for transforming received echo signals to electrical signals;
at least one conductor extending from the hub through the lumen of
the catheter sheath and coupled to the imaging device for carrying
the electrical signals; and an active memory arrangement disposed
on the hub, wherein the active memory arrangement is configured for
transferring information using a single conductor and is configured
to store information that identifies the catheter.
[0015] Another aspect is an ultrasound system that includes any of
the catheters described above; and a drive unit coupleable to the
catheter. The drive unit includes a drive hub configured for
attachment to the hub of the catheter; a rotation mechanism
configured for rotating the driveshaft of the catheter; and a
reader configured to obtain the information from the active memory
arrangement on the catheter to identify the catheter.
BRIEF DESCRIPTION OF THE DRAWINGS
[0016] Non-limiting and non-exhaustive embodiments of the present
invention are described with reference to the following drawings.
In the drawings, like reference numerals refer to like parts
throughout the various figures unless otherwise specified.
[0017] For a better understanding of the present invention,
reference will be made to the following Detailed Description, which
is to be read in association with the accompanying drawings,
wherein:
[0018] FIG. 1 is a schematic view of one embodiment of an
intravascular ultrasound imaging system;
[0019] FIG. 2 is a schematic side view of one embodiment of a
catheter of an intravascular ultrasound imaging system;
[0020] FIG. 3 is a schematic perspective view of one embodiment of
a distal end of the catheter shown in FIG. 2 with an imaging core
disposed in a lumen defined in the catheter;
[0021] FIG. 4A is a schematic perspective view of one embodiment of
a catheter coupled to a drive unit of an intravascular ultrasound
imaging system;
[0022] FIG. 4B is a schematic block diagram of one embodiment of a
drive unit;
[0023] FIG. 5 is a schematic side view of one embodiment of a
portion of a catheter with a marker on the hub of the catheter;
[0024] FIG. 6 is a schematic side view of another embodiment of a
portion of a catheter with a marker on the hub of the catheter;
[0025] FIG. 7 is a schematic perspective view of a third embodiment
of a portion of a catheter with a marker on the hub of the
catheter;
[0026] FIG. 8 is a schematic side view of one embodiment of a
portion of a drive unit with a marker reader; and
[0027] FIG. 9 is a schematic perspective view of a fourth
embodiment of a portion of a catheter with a marker on a rotating
portion of the hub of the catheter, the housing of the hub in FIG.
9 is partially transparent to illustrate components of the hub
within the housing including the rotating portion of the hub and
the marker.
DETAILED DESCRIPTION
[0028] The present disclosure is directed to the area of
intravascular ultrasound imaging systems and methods of making and
using the systems. The present disclosure is also directed to
intravascular ultrasound imaging systems that include arrangements
for automatic catheter identification when the catheter is attached
to a drive unit.
[0029] Suitable intravascular ultrasound ("IVUS") imaging systems
include, but are not limited to, one or more transducers disposed
on a distal portion of a catheter configured and arranged for
percutaneous insertion into a patient. Examples of IVUS imaging
systems with catheters are found in, for example, U.S. Pat. Nos.
7,306,561; and 6,945,938; as well as U.S. Patent Application
Publication Nos. 20060253028; 20070016054; 20070038111;
20060173350; and 20060100522, all of which are incorporated herein
by reference.
[0030] FIG. 1 schematically shows one embodiment of an IVUS imaging
system 100. The IVUS imaging system 100 includes a catheter 102
that is coupleable to a control module 104. The control module 104
may include, for example, a processor 106, a pulse generator 108, a
drive unit 110, and one or more displays 112. In at least some
embodiments, the pulse generator 108 forms electric signals that
are input to one or more transducers (312 in FIG. 3) disposed in
the catheter 102. In at least some embodiments, electric signals
transmitted from the one or more transducers (312 in FIG. 3) is
input to the processor 106 for processing. The processed electric
signals from the one or more transducers (312 in FIG. 3) may be
displayed as one or more images on the one or more displays 112. In
at least some embodiments, mechanical energy from the drive unit
110 is used to drive an imaging core (306 in FIG. 3) disposed in
the catheter 102. For example, the drive unit 110 can be used to
rotate the imaging core or to pullback the imaging core along
vasculature of the patient or any combination thereof. In at least
some embodiments, the drive unit 110 is spatially separated from
the other components of the control module 104 and may be coupled
to the processor using a cord or other wired arrangement or by
wireless connection.
[0031] The processor 106 may also be used to control the
functioning of one or more of the other components of the control
module 104. For example, the processor 106 may be used to control
at least one of the frequency or duration of the electrical signals
transmitted from the pulse generator 108, the rotation rate of the
imaging core (306 in FIG. 3) by the drive unit 110, the velocity or
length of the pullback of the imaging core (306 in FIG. 3) by the
drive unit 110, or one or more properties of one or more images
formed on the one or more displays 112.
[0032] FIG. 2 shows, in schematic side view, one embodiment of the
catheter 102 of the IVUS imaging system (100 in FIG. 1). The
catheter 102 includes an elongated member 203 and a hub 204. The
elongated member 203 includes a proximal portion 206 and a distal
portion 208. In FIG. 2, the proximal portion 206 of the elongated
member 203 is coupled to the catheter hub 204 and the distal
portion 208 of the elongated member is configured and arranged for
percutaneous insertion into a patient. In at least some
embodiments, the catheter 102 defines at least one flush port, such
as flush port 210. In at least some embodiments, the flush port 210
is defined in the hub 204. In at least some embodiments, the hub
204 is configured and arranged to couple to the drive unit (110 in
FIG. 1). In some embodiments, the elongated member 203 and the hub
204 are formed as a unitary body. In other embodiments, the
elongated member 203 and the hub 204 are formed separately and
subsequently assembled together. In addition, as described in more
detail below, the catheter 102 can also include a marker 211 which,
when read, can identify the catheter. For example, the marker 211
can identify the type of the catheter (using, for example, an
identification code or a name or any other suitable identification
information) or can include a serial number for the catheter or any
other catheter identification information or any combination
thereof.
[0033] FIG. 3 shows, in schematic perspective view, one embodiment
of the distal portion 208 of the elongated member 203 of the
catheter 102. The elongated member 203 includes a sheath 302 and a
lumen 304. An imaging core 306 is disposed in the lumen 304. The
imaging core 306 includes an imaging device housing 308 coupled to
a distal end of a transducer connection system, such as a drive
cable or driveshaft 309.
[0034] The sheath 302 may be formed from any flexible,
biocompatible material suitable for insertion into a patient.
Examples of suitable materials include, for example, polyethylene,
polyurethane, plastic, spiral-cut stainless steel, nitinol
hypotube, and the like or combinations thereof.
[0035] One or more transducers 312 may be mounted to the imaging
device housing 308 and employed to transmit and receive acoustic
signals. In a preferred embodiment (as shown in FIG. 3), an array
of transducers 312 are mounted to the imaging device housing 308.
In other embodiments, a single transducer may be employed. In yet
other embodiments, multiple transducers in an irregular-array may
be employed. Any number of transducers 312 can be used. For
example, there can be one, two, three, four, five, six, seven,
eight, nine, ten, twelve, fifteen, sixteen, twenty, twenty-five,
fifty, one hundred, five hundred, one thousand, or more
transducers. As will be recognized, other numbers of transducers
may also be used.
[0036] The one or more transducers 312 may be formed from one or
more known materials capable of transforming applied electrical
signals to pressure distortions on the surface of the one or more
transducers 312, and vice versa. Examples of suitable materials
include piezoelectric ceramic materials, piezocomposite materials,
piezoelectric plastics, barium titanates, lead zirconate titanates,
lead metaniobates, polyvinylidenefluorides, and the like.
[0037] The pressure distortions on the surface of the one or more
transducers 312 form acoustic signals of a frequency based on the
resonant frequencies of the one or more transducers 312. The
resonant frequencies of the one or more transducers 312 may be
affected by the size, shape, and material used to form the one or
more transducers 312. The one or more transducers 312 may be formed
in any shape suitable for positioning within the catheter 102 and
for propagating acoustic signals of a desired frequency in one or
more selected directions. For example, transducers may be
disc-shaped, block-shaped, rectangular-shaped, oval-shaped, and the
like. The one or more transducers may be formed in the desired
shape by any process including, for example, dicing, dice and fill,
machining, microfabrication, and the like.
[0038] As an example, each of the one or more transducers 312 may
include a layer of piezoelectric material sandwiched between a
conductive acoustic lens and a conductive backing material formed
from an acoustically absorbent material (e.g., an epoxy substrate
with tungsten particles). During operation, the piezoelectric layer
may be electrically excited by both the backing material and the
acoustic lens to cause the emission of acoustic signals.
[0039] In at least some embodiments, the one or more transducers
312 can be used to form a radial cross-sectional image of a
surrounding space. Thus, for example, when the one or more
transducers 312 are disposed in the catheter 102 and inserted into
a blood vessel of a patient, the one more transducers 312 may be
used to form an image of the walls of the blood vessel and tissue
surrounding the blood vessel.
[0040] In at least some embodiments, the imaging core 306 is
rotated about a longitudinal axis of the catheter 102. As the
imaging core 306 rotates, the one or more transducers 312 emit
acoustic signals in different radial directions. When an emitted
acoustic signal with sufficient energy encounters one or more
medium boundaries, such as one or more tissue boundaries, a portion
of the emitted acoustic signal is reflected back to the emitting
transducer as an echo signal. Each echo signal that reaches a
transducer with sufficient energy to be detected is transformed to
an electrical signal in the receiving transducer. The one or more
transformed electrical signals are transmitted to the control
module (104 in FIG. 1) where the processor 106 processes the
electrical-signal characteristics to form a displayable image of
the imaged region based, at least in part, on a collection of
information from each of the acoustic signals transmitted and the
echo signals received. In at least some embodiments, the rotation
of the imaging core 306 is driven by the drive unit 110 (FIG.
1).
[0041] As the one or more transducers 312 rotate about the
longitudinal axis of the catheter 102 emitting acoustic signals,
multiple images are formed that collectively form a radial
cross-sectional image of a portion of the region surrounding the
one or more transducers 312, such as the walls of a blood vessel of
interest and the tissue surrounding the blood vessel. In at least
some embodiments, the radial cross-sectional image can be displayed
on one or more displays 112.
[0042] In at least some embodiments, the imaging core 306 may also
move axially along the blood vessel within which the catheter 102
is inserted so that a plurality of cross-sectional images may be
formed along an axial length of the blood vessel. In at least some
embodiments, during an imaging procedure the one or more
transducers 312 are retracted (i.e., pulled back) along the
longitudinal length of the catheter 102. In at least some
embodiments, the catheter 102 includes at least one telescoping
section that can be retracted during pullback of the one or more
transducers 312. In at least some embodiments, the drive unit 110
drives the pullback of the imaging core 306 within the catheter
102. In at least some embodiments, the drive unit 110 pullback
distance of the imaging core is at least 5 cm. In at least some
embodiments, the drive unit 110 pullback distance of the imaging
core is at least 10 cm. In at least some embodiments, the drive
unit 110 pullback distance of the imaging core is at least 15 cm.
In at least some embodiments, the drive unit 110 pullback distance
of the imaging core is at least 20 cm. In at least some
embodiments, the drive unit 110 pullback distance of the imaging
core is at least 25 cm.
[0043] The quality of an image produced at different depths from
the one or more transducers 312 may be affected by one or more
factors including, for example, bandwidth, transducer focus, beam
pattern, as well as the frequency of the acoustic signal. The
frequency of the acoustic signal output from the one or more
transducers 312 may also affect the penetration depth of the
acoustic signal output from the one or more transducers 312. In
general, as the frequency of an acoustic signal is lowered, the
depth of the penetration of the acoustic signal within patient
tissue increases. In at least some embodiments, the IVUS imaging
system 100 transmits acoustic signals centered at an operational
frequency. The operational frequency is typically within a range of
5 MHz to 60 MHz. The acoustic signals may be transmitted within a
frequency bandwidth that includes the operational frequency.
[0044] In at least some embodiments, the one or more transducers
312 may be mounted to the distal portion 208 of the imaging core
306. The imaging core 306 may be inserted in the lumen of the
catheter 102. In at least some embodiments, the catheter 102 (and
imaging core 306) are inserted percutaneously into a patient via an
accessible blood vessel, such as the femoral artery, at a site
remote from a target imaging location. The catheter 102 may then be
advanced through patient vasculature to the target imaging
location, such as a portion of a selected blood vessel.
[0045] As discussed above, the driveshaft 309 couples the imaging
device housing 308 to the drive unit (110 in FIG. 1). In at least
some embodiments, one or more transducer conductors 314
electrically couple the one or more transducers 312 to the control
module (104 in FIG. 1).
[0046] FIG. 4A shows, in perspective view, one embodiment of a
catheter 102 coupled to a drive unit 110. The catheter 102 includes
an elongated member 203 (e.g., catheter sheath) and a hub 204. As
shown in FIG. 4A, the hub 204 of the catheter 102 is coupled to the
drive unit 110 with the elongated member 203 extending outward from
the drive unit 110. As described above, the drive unit 110 can be
coupled to one or more other components of an IVUS imaging system,
such as a pulse generator, a processor, a display, or the like.
[0047] Any suitable drive unit can be used. FIG. 4B is a block
diagram illustrating one example of components that can be part of
a drive unit 110. It will be recognized that a drive unit may
include more or fewer components and may include one or more
additional components. In the embodiment of FIG. 4B, the drive unit
110 includes a hub 416 for coupling to the catheter, a rotation
mechanism 418 for rotating the driveshaft of the catheter, a
pullback mechanism 420 for pulling back the driveshaft of the
catheter during the imaging procedure, and a signal transmission
unit 422 that conveys signals (drive signals or ultrasound response
signals) between the catheter and a pulse generator or processor of
the IVUS imaging system. In addition, as described in more detail
below, the drive unit 110 can include a reader 424, such as an
optical or magnetic reader.
[0048] Drive units are typically reusable and can be compatible
with a variety of different catheters 102. The different catheters
that are compatible with a drive unit may house transducers having
different operational frequencies at which the transducers operate
or other different operational settings or differences. It is
useful if the drive unit 110, and associated processor 106 (FIG.
1), can automatically determine which type of catheter 102 is
attached to the drive unit 110.
[0049] In one commercial embodiment, the identification of the
catheter type includes the catheter having a small printed circuit
(PC) board with short, opens, or diodes between three pads on the
board. The PC board is connected to the motor drive 102 through
spring pins on the PC board (and part of the catheter) that connect
it through the motor drive 102 to the processor 106 (FIG. 1) which
"reads" the code, identifies the catheter 102, and adjusts settings
appropriate to the catheter type. This arrangement, however, may be
prone to error arising from contamination of the spring pins or
motor drive connector, insufficient travel in the spring pins, or
saline contamination of the PC board or motor drive connector
creating shorts between the pads that can misinterpreted as the
wrong catheter ID code.
[0050] Instead of this pin/PC board combination, a marker 211 can
be applied to the exterior of the catheter hub, as illustrated in
FIG. 2, and can be read or scanned by the system (for example, the
drive unit) as the catheter hub 204 is coupled to the drive unit.
In at least some embodiments, it may be possible to retrofit
existing catheters or drive units to include the marker and reader,
respectively. The marker 211 can be used to identify the catheter.
For example, the marker 211 can identify the type of the catheter
(using, for example, an identification code or a name or any other
suitable identification information) or can include a serial number
for the catheter or any other catheter identification information
or any combination thereof. In at least some embodiments, the
ultrasound system can use this identification information for
settings for the system or to limit or provide system features
based on the identification of the catheter or otherwise use the
identification to facilitate operation or use of the catheter.
[0051] In at least some embodiments, the marker 211 may also
include an expiration date or other shelf-life or expiration
information. In at least some embodiments, the system may prevent
or limit use or reuse of the catheter or provide a warning to the
user regarding the expiration, or any combination of these actions
if the expiration date has passed when the catheter is coupled to
the drive unit.
[0052] FIG. 5 illustrates one embodiment of a marker 211 attached
to the hub 204 of a catheter 102. The marker 211 can be, for
example, a one-dimension or two-dimensional code that can be
optically or magnetically read. For example, the marker 211 can be
a barcode, a QR code, or any other suitable code that can be
optically read. For example, such a marker 211 could be
laser-printed, pad-printed, heat stamped, adhesively adhered, or
otherwise attached, inscribed, or positioned onto the hub 204.
[0053] FIG. 6 illustrates another embodiment of a marker 211 in the
form of multiple circumferential rings (or portions of rings) that
can be optically or magnetically read. For example, such a marker
211 could be laser-printed, pad-printed, heat stamped, adhesively
adhered, or otherwise attached or inscribed onto the hub 204.
[0054] The marker 211 could be a magnetic stripe or any other
suitable magnetic marker which can be read magnetically. The
magnetic strip can be adhered or otherwise attached to the hub
using an adhesive or any other suitable method.
[0055] The marker 211 can be a 1-Wire.TM. memory arrangement (such
as those available from Maxim Integrated, San Jose, Calif.) or
other active memory arrangement on which the identification of the
catheter is stored. The 1-Wire.TM. memory arrangement provides for
low-speed data transfer over a single conductor using a
communication protocol. The corresponding reader in this embodiment
would be a reader capable of obtaining information from the
1-Wire.TM. or other active memory arrangement.
[0056] FIG. 7 illustrates another embodiment in which the marker
211 is positioned on a flat (e.g., non-curved) surface of the hub
204 of the catheter 102 instead of a cylindrical or curved surface,
as illustrated in FIGS. 5 and 6.
[0057] FIG. 8 illustrates the drive unit 110 with a corresponding
reader 424. The reader can be any suitable optical or magnetic
reader including, but not limited to, a camera, a CCD
(charge-coupled device) array, magnetic stripe reader, 1-Wire.TM.
or other active memory, or any other suitable reader. In at least
some embodiments, the reader 424 of the drive unit 110 may have a
processor or memory that can identify the catheter by reading the
marker 211 and provide that identification to the processor 106
(FIG. 1) of the control module 104 (FIG. 1). In at least some
embodiments, the reader 424 of the drive unit 110 produces signals
as the reader 424 reads these markers and these signals are
delivered to the processor 106 (FIG. 1) of the control module 104
(FIG. 1) which then identifies the catheter. In at least some
embodiments, upon identification of the catheter the processor 106
or other components of the system automatically sets one or more
system settings based on the identification of the catheter. In at
least some embodiments, the system may limit or provide access to
system functions or features based on the identification of the
catheter.
[0058] In at least some embodiments, fully attaching the hub 204 of
the catheter 102 with the drive unit 110 (for example, engaging the
drive unit and rotating the hub to a final, locked position) aligns
the marker 211 with the reader 424. In at least some embodiments,
the hub 204 of the catheter 102 can be inserted or otherwise
attached to the drive unit 110 in any orientation and the reader
424 of the drive unit can be arranged to read the marker 211 as the
hub of the catheter or drive unit rotates to fully engage. In at
least some embodiments, the rotation of the hub 204 of the catheter
102 or drive unit 110 can facilitate reading of the marker 211,
such as, for example, reading a bar code.
[0059] In at least some embodiments, the reader 424 may be arranged
to read the marker 211 regardless of the orientation of the marker
relative to the drive unit 110. For example, a barcode or
circumferential rings (see, for example, the embodiment illustrated
in FIG. 6) may be positioned entirely around a circumference (or at
least 50%, 66%, 75%, 80%, 90%, 95% or more of the circumference) to
facilitate reading the marker regardless of the orientation of the
marker relative to the drive unit. In at least some embodiments,
there may be one or more gaps in the barcode or circumferential
rings so that the barcode or circumferential rings do not extend
entirely around the circumference, but rather includes one or more
interruptions (i.e., gaps) around the ring. In at least some
embodiments, properly engaging the hub 204 of the catheter 102 with
the drive unit 110 (for example, as illustrated in the embodiments
illustrated in FIGS. 7 and 8) aligns the marker 211 with the reader
424.
[0060] In at least some embodiments, if the marker 211 cannot be
read or does not provide the expected information or produces an
error, the system may direct the user to disengage and recouple the
catheter 102 to the drive unit 110 so that the marker 211 can be
reread. The system may alert the user if there are multiples read
failures and the user may be requested to manually enter the
catheter information.
[0061] In at least some embodiments, the marker 211 can be attached
to a rotating portion of the catheter so that the rotational motion
can facilitate reading of the marker. FIG. 9 illustrates one
embodiment of a hub 204 of a catheter 102 with a housing 930
(which, FIG. 9, is partially transparent in order to view
components in the interior of the housing) and a rotating hub
portion 932 that couples to the driveshaft 309 (FIG. 3) of the
catheter and, when the catheter is coupled to the drive unit 110
(FIG. 4), couples to the rotation mechanism 418 (FIG. 4) of the
drive unit. In this embodiment, the reader 424 (FIG. 4) of the
drive unit 110 (FIG. 4) is positioned within the drive unit so that
the reader 424 can read the marker when the catheter is coupled to
the drive unit. In at least some embodiments, the rotation of the
rotating hub portion 932 of the catheter 102 during operation or
testing of the system can facilitate reading of the marker 211,
such as, for example, reading a bar code. For example, the marker
211 can be a one-dimensional bar code that can be read as the
rotating hub portion 932 is rotated by the rotation mechanism 418
(FIG. 4) of the drive unit 110 (FIG. 4)
[0062] The above specification and examples provide a description
of the invention and the manufacture and use of the invention.
Since many embodiments of the invention can be made without
departing from the spirit and scope of the invention, the invention
also resides in the claims hereinafter appended.
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