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| United States Patent | 4841977 |
| Link to this page | http://www.wikipatents.com/4841977.html |
| Inventor(s) | Griffith; James M. (Idaho Falls, ID);
Maciel; Mario (Phelan, CA);
Henry; Walter L. (South Laguna, CA);
Zalesky; Paul J. (Huntington Beach, CA) |
| Abstract | An array of miniature ultrasound crystals mounted on preassembled
subassembly which is, in turn, mounted on a small lumen catheter provides
dimensional and other quantitative information relating to arterial wall
geometry and character at disease or obstruction sites. Balloons also
mounted to the catheter make it possible to use the catheter for the
angioplasty (PCTA) procedure while actually imaging, in real time, the
artery being dilatated and unblocked by the procedure. Efficient, highly
miniature transducers are presented along with several different
configurations for catheter structure containing fluid lumen,
through-lumen, and electrical microcable assemblies for conducting
electrical signals to and from the transducers. |
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Title Information  |
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Drawing from US Patent 4841977 |
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Ultra-thin acoustic transducer and balloon catheter using same in
imaging array subassembly |
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| Publication Date |
June 27, 1989 |
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Title Information  |
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References  |
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| *references marked with an asterisk below are user-added references |
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U.S. References |
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| | Reference | Relevancy | Comments | Reference | Relevancy | Comments | 3542014
|      Your vote accepted [0 after 0 votes] | | 4672963 Barken 606/12 Jun,1987 |      Your vote accepted [0 after 0 votes] | | 4665925 Millar 600/585 May,1987 |      Your vote accepted [0 after 0 votes] | | 4589419 Laughlin 600/439 May,1986 |      Your vote accepted [0 after 0 votes] | | 4576177 Webster, Jr. 600/439 Mar,1986 |      Your vote accepted [0 after 0 votes] | | 4567898 Plugge 600/443 Feb,1986 |      Your vote accepted [0 after 0 votes] | | 4543960 Harui 600/462 Oct,1985 |      Your vote accepted [0 after 0 votes] | | 4466443 Utsugi 600/463 Aug,1984 |      Your vote accepted [0 after 0 votes] | | 4462408 Silverstein 600/146 Jul,1984 |      Your vote accepted [0 after 0 votes] | | 4446395 Hadjicostis 310/327 May,1984 |      Your vote accepted [0 after 0 votes] | | 4442842 Baba 600/463 Apr,1984 |      Your vote accepted [0 after 0 votes] | | 4433692 Baba 600/470 Feb,1984 |      Your vote accepted [0 after 0 votes] | | 4408612 Utsugi 600/463 Oct,1983 |      Your vote accepted [0 after 0 votes] | | 4391282 Ando 600/463 Jul,1983 |      Your vote accepted [0 after 0 votes] | | 4375818 Suwaki 600/463 Mar,1983 |      Your vote accepted [0 after 0 votes] | | 4349032 Koyata 600/139 Sep,1982 |      Your vote accepted [0 after 0 votes] | | 4327738 Green 600/109 May,1982 |      Your vote accepted [0 after 0 votes] | | 4319580 Colley 600/453 Mar,1982 |      Your vote accepted [0 after 0 votes] | | 4176662 Frazer 600/114 Dec,1979 |      Your vote accepted [0 after 0 votes] | | 4146019 Bass 600/108 Mar,1979 |      Your vote accepted [0 after 0 votes] | | 3938502 Bom 600/463 Feb,1976 |      Your vote accepted [0 after 0 votes] | | 3817089 Eggleton 73/623 Jun,1974 |      Your vote accepted [0 after 0 votes] | | 3779234 Eggleton 600/466 Dec,1973 |      Your vote accepted [0 after 0 votes] | | 4354501
600/469 Dec,1969 |      Your vote accepted [0 after 0 votes] | | |
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| Market Size |
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Market Review  |
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Technical Review  |
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Claims  |
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What is claimed is:
1. An ultra-thin electroacoustic transducer having an overall thickness
less than 0.0075 inch and comprising:
an active piezoelectric layer having a thickness of approximately
one-fourth wavelength at its acoustic operating frequency and having an
acoustic impedance Z.sub.1 ;
a backing layer affixed to a first face of said piezoelectric layer, said
backing layer having an acoustic impedance Z.sub.2 which is greater than
Z.sub.1 ;
a faceplate layer affixed to a second, opposite, face of said piezoelectric
layer, said faceplate layer having a thickness of approximately one-fourth
wavelength at said operating frequency and having an acoustic impedance
Z.sub.3 which is approximately the geometric mean of Z.sub.1 and an
ambient acoustic impedance during use; and
electrical lead means for making electrical connections to said first and
second faces of the piezoelectric layer.
2. An ultra-thin electroacoustic transducer as in claim 1 wherein Z.sub.1
is about 27.times.10.sup.6 Kg/(M.sup.2 sec) and Z.sub.2 is about
30.times.10.sup.6 to 40.times.10.sup.6 Kg/(M.sup.2 sec).
3. An ultra-thin electroacoustic transducer as in claim 1 wherein said
electrical lead means includes metallic surfaces applied to said first and
second faces of the piezoelectric layer and wherein said backing and
faceplate layers each comprise an in situ cured layer of powders mixed
with epoxy on respectively associated faces of the piezoelectric layer.
4. An ultra-thin electroacoustic transducer as in claim 1 wherein said
backing and faceplate layers each comprise an in situ cured layer of an
epoxy material respectively associated faces of the piezoelectric layer.
5. An ultra-thin electroacoustic transducer as in claim 1 wherein said
backing layer comprises Tungsten powder mixed with epoxy.
6. An ultra-thin electroacoustic transducer as in claim 1 wherein said
faceplate layer comprises Al.sub.2 O.sub.3 powder mixed with epoxy.
7. An array subassembly of ultra-thin electroacoustic transducers
comprising:
a cylindrical carriage which includes means for defining (i) a plurality of
circumferentially arranged wall apertures, and (ii) a through aperture
along its axis; and
a corresponding plurality of transducers adhesively mounted in respective
said wall apertures and thereby disposed in a circumferentially extending
array so as to provide an array subassembly of plural said transducers
disposed within the wall apertures of said cylindrical carriage; and
wherein
at least one of said transducers has an overall thickness of less than
0.0075 inch and includes,
(a) an active piezoelectric layer having a thickness of approximately
one-fourth wavelength at its acoustic operating frequency and having an
acoustic impedance Z1;
(b) a backing layer affixed to a first face of said piezoelectric layer,
said backing layer having an acoustic impedance Z2 which is greater than
Z1;
(c) a faceplate layer affixed to a second, opposite, face of said
piezoelectric layer, said faceplate layer having a thickness of
approximately one-fourth wavelength at said operating frequency and having
an acoustic impedance Z3 which is approximately the geometric mean of Z1
and an ambient acoustic impedance during use; and
(d) electrical lead means for making electrical connections to said first
and second faces of the piezoelectric layer.
8. An array subassembly of ultra-thin electroacoustic transducers as in
claim 7 further comprising a catheter tube adhesively affixed within said
through aperture of the cylindrical carriage.
9. An array subassembly of ultra-thin electroacoustic transducers as in
claim 8 wherein said catheter tube includes a through-lumen for slidably
passing a guidewire therethrough.
10. An electroacoustic transducer array subassembly for mounting about a
catheter sized to pass through human blood vessels, said subassembly
comprising:
a carriage structure having a generally cylindrical configuration and
including means defining (i) a plurality of circumferentially spaced-apart
wall apertures and (ii) an axially extending through aperture which is
sized and configured to fit over at least a portion of said catheter; and
plural electroacoustic transducers each of which includes a backing layer
having a portion which extends into a respective said defined wall
aperture and is affixed therewithin by means of a cured adhesive material,
wherein
said cylindrical carriage structure includes means which facilitate folding
of an initially flat form of said carriage structure into said generally
cylindrical configuration thereof, said fold-facilitating means including
a number of axially extending regions of reduced material thickness which
establish a corresponding number of axially extending fold lines, whereby
said generally cylindrical configuration of said carriage structure is
polygonal in cross-section.
11. An electroacoustic transducer array subassembly as in claim 10 wherein
said cylindrical carriage is a solid body of material.
12. An electroacoustic transducer array subassembly as in claim 10 wherein
said cylindrical carriage is made of a conductive metallic material.
13. An electroacoustic transducer array subassembly as in claim 10 wherein
said cylindrical carriage includes wall apertures without transducers
therein to facilitate subsequent adhesive affixation of the carriage to
said catheter.
14. An electroacoustic transducer array subassembly as in claim 10 wherein
said transducers include insulated lead wires connected therewith and said
cylindrical carriage includes lead wire clamp means for relieving
mechanical loads from connections to said transducers.
15. An electroacoustic transducer array subassembly for mounting about a
catheter sized to pass through human blood vessels, said subassembly
comprising:
a carriage structure having a generally cylindrical configuration and
including means defining (i) a plurality of circumferentially spaced-apart
wall apertures and (ii) an axially extending through aperture which is
sized and configured to fit over at least a portion of said catheter; and
plural electroacoustic transducers each of which includes a backing layer
having a portion which extends into a respective said defined wall
aperture and is affixed therewithin by means of a cured adhesive material,
wherein
each said electroacoustic transducer is an ultra-thin transducer having an
overall thickness less than 0.0075 inch and comprises:
(a) an active piezoelectric layer having a thickness of approximately
one-forth wavelength at an intended acoustic operating frequency and
having an acoustic impedance Z.sub.1 ;
(b) a backing layer affixed to a first face of said piezoelectric layer,
said backing layer having an acoustic impedance Z.sub.2 which is greater
than Z.sub.1 ;
(c) a faceplate layer affixed to a second, opposite, face of said
piezoelectric layer, said faceplate layer having a thickness of
approximately one-fourth wavelength at said operating frequency and having
an acoustic impedance Z.sub.3 which is approximately the geometric mean of
Z.sub.1 and an ambient acoustic impedance during use; and
(d) electrical lead means for making electrical connections to said first
and second faces of the piezoelectric layer.
16. An electroacoustic transducer array subassembly as in claim 16 wherein
Z.sub.1 is about 27.times.10.sup.6 Kg/(M.sup.2 sec) and Z.sub.2 is about
30.times.10.sup.6 to 40.times.10.sup.6 Kg/(M.sup.2 sec).
17. An electroacoustic transducer array subassembly as in claim 16 wherein
said electrical lead means includes metallic surfaces applied to said
first and second faces of the piezoelectric layer and wherein said backing
and faceplate layers each comprise are in situ cured layer of powders
mixed with epoxy on respectively associated faces of the piezoelectric
layer.
18. An electroacoustic transducer array subassembly as in claim 16 wherein
said backing and faceplate layers each comprise an in situ cured epoxy
material on respectively associated faces of the piezoelectric layer.
19. An electroacoustic transducer array subassembly as in claim 16 wherein
said backing layer comprises Tungsten powder mixed with epoxy.
20. An electroacoustic transducer array subassembly as in claim 16 wherein
said faceplate layer comprises Al.sub.2 O.sub.3 powder mixed with epoxy.
21. An electroacoustic transducer array subassembly as in claim 10 where
said through aperture of said carriage is adhesively affixed to a catheter
tube.
22. An electroacoustic transducer array subassembly as in claim 22 wherein
said catheter tube has a through-lumen for slidably passing over a
guidewire.
23. A dilatation angioplasty catheter of the type which is insertable into
a blood vessel, said catheter comprising:
a hollow, elongated tubular body of sufficiently small size so as to be
insertable into a blood vessel and defining a central lumen therethrough
and a fluid passageway;
inflatable balloon means, fixedly disposed on an exterior portion of said
body and fluid-connected to said fluid passageway, said balloon means
varying in outside dimensions in response to fluid pressure with said
fluid passageway; and
ultrasonic transducer means dispoed within said central lumen of said body
and surrounded by said balloon means, for producing acoustical signals and
for sensing echoes of said produced signals, said transducer means
including means (i) providing a substantially cylindrical array of
individual ultrasonic transducers and (ii) defining a through aperture
substantially coaxially disposed with respect to said central lumen.
24. An angioplasty imaging system including:
a hollow, elongated tubular body defining a central lumen and a fluid
passage therethrough, said body being of sufficiently small size and
thereby adapted for insertion into a blood vessel;
inflatable balloon means, fixedly disposed on an exterior portion of said
body and fluid-connected to said fluid passage, said balloon means varying
in outside dimensions in response to fluid pressure within said fluid
passage;
ultrasonic transducer means disposed within said central lumen of said body
and surrounded by said balloon means, said transducer means including a
number of individual ultrasonic transducers arranged in a substantially
cylindrical configuration so as to establish a through aperture in axial
communication with said central lumen, each said ultrasonic transducers
for producing acoustical signals in response to electrical excitation
signals and for generating electrical signals responsive to echoes of said
produced acoustical signals;
driver/imaging means for alternately (a) producing said excitation signals,
and (b) generating an image of said blood vessel in response to said
transducer means-generated electrical signals; and
means disposed within said body for establishing a signal path between said
drive/imaging means and said transducer means.
25. A system as in claim 25 wherein said driver/imaging means includes
means for producing acoustic signals from said transducer means at a
frequency of approximately 20 megahertz.
26. A miniature ultrasonic transducer small enough to be disposed within a
vascular catheter body, said transducer comprising:
piezoelectric chip means for resonating at an operating frequency of
approximately 20 MHz, said chip means having first and second opposing
surfaces which establish therebetween a thickness of said chip means of
approximately one-fourth wavelength at said operating frequency and having
an acoustic impedance Z1;
backing means, disposed on said chip means first surface, and having an
acoustic impedance Z2 which is greater than the acoustic impedance Z1 of
said chip means for attenuating acoustical energy passing therethrough;
a layer of conductive material disposed on said chip means second surface
and having a thickness of approximately one-fourth wavelength at said
operating frequency and having an acoustic impedance Z3 which is
approximately the geometric mean of Z1 and an ambient acoustic impedance
during use;
a flattened electrical terminal electrically connected to said conductive
material layer; and
matching layer means, disposed on said conductive material layer and over
said electrical terminal, said matching layer means defining a dimension
which is an odd multiple of a quarter wavelength of said operating
frequency, said matching layer means for increasing the efficiency of
acoustical energy transfer to and from said chip means.
27. A miniature transducer array subassembly comprising:
cylindrical sleeve defining plural substantially planar outer surfaces;
a miniature ultrasonic transducer disposed on one of said plural outer
surfaces, said transducer having at least one electrical connection;
lead wire means including a flattened electrically conductive distal end
attached to said electrical connection of said transducer for electrically
connecting said transducer; and
means carried by said sleeve for affixation to said lead wire means for
relieving stress from said connection, wherein said stree relieving means
includes a longitudinal depression defined by means of said sleeve
proximally of said one outer surface for receiving at least that portion
of said lead wire means which is proximal to said flattened distal end
thereof, and wire clamp means operatively associated with said defined
depression for positionally retaining said proximal portion of said lead
wire means within said defined depression.
28. A dilatation angioplasty cathether of the type which is insertable into
a blood vessel, said catheter comprising:
a hollow, elongated tubular body defining a fluid passage therethrough;
inflatable balloon means, fixedly disposed on the exterior of said body and
coupled to said fluid passage, said balloon means varying in outside
dimensions in response to fluid pressure within said fluid passage;
piezoelectric chip means for resonating at an operating frequency of
approximately 20 MHz, said chip means having first and second opposing
surfaces which establish therebetween a thickness of said chip means of
approximately one-fourth wavelength at said operating frequency and having
an acoustic impedance Z1;
backing means, disposed on said chip means first surface, and having an
acoustic impedance Z2 which is greater than the acoustic impedance Z1 of
said chip means for attenuating acoustic energy passing therethrough;
a layer of conductive material disposed on said chip means second surface
and having a thickness of approximately one-fourth wavelength at said
operating frequency and having an acoustic impedance 23 which is
approximately the geometric mean of Z1 and an ambient acoustic impedance
during use;
a flattened electrical terminal electrically connected to said conductive
material layer; and
matching layer means, disposed on said conductive material layer and over
said electrical terminal, said matching layer means defining a dimension
which is an odd multiple of a quarter wavelength of said operating
frequency, said matching layer means for increasing the efficiency of
acoustical energy transfer to and from said chip means; and
electrical cable means, disposed within said tubular body and electrically
connected to said flattened electrical terminal, for conducting electrical
signals to and from said terminal.
29. A dilatation angioplasty catheter of the type which is insertable into
a blood vessel, said cathether comprising:
a hollow, elongated tubular body defining a fluid passage therethrough;
inflatable balloon means, fixedly disposed on the exterior of said body and
coupled to said fluid passage, said balloon means varying in outside
dimensions in response to fluid pressure within said fluid passage;
an electrically conductive cylindrical sleeve defining plural substantially
planar outer surfaces, said sleeve enclosing at least a segment of said
guide wire retaining passage;
a miniature ultrasonic transducer disposed on one of said sleeve plural
outer surfaces, said transducer having first and second electrical
connections;
lead wire means for electrically connecting to said transducer connections;
and
stress relieving means, carried by said sleeve for affixation to said lead
wire means for relieving stress from said connections, said stress
relieving means including a longitudinal depression for receifing at least
a portion of said lead wire means, and clamp means operatively associated
with said depression for positionally retaining said lead wire means
within said depression.
30. A carriage structure for supporting a plurality of electroacoustic
transducers, said carriage structure being foldable into a generally
cylindrical configuration and thereby being adapted to surround an
exterior portion of a catheter for electroacoustic imaging of human blood
vessels and the like, said carriage structure comprising:
a substantially planar sheet member having upper and lower surfaces which
define therebetween a thickness dimension;
means for defining a number of individual apertures in said sheet member
which are sized and configured to accept a discrete electroacoustic
transducer therein; and
means for establishing a number of axially extending regions of said sheet
member having a reduced thickness dimension as compared to the thickness
dimension of said sheet member defined between said upper and lower
surfaces thereof, to thereby define a number of fold lines which subdivide
said planar sheet member into several planar regions having at least one
of said apertures defined therein, wherein
said established axially extending regions and said defined fold lines
collectively provide means which facilitate folding of said carriage
structure into said generally cylindrical configuration by allowing
adjacent ones of said several planar regions to be angularly disposed
relative to one another along a respective said fold line.
31. A carriage structure as in claim 31, wherein said means for
establishing includes a number of axially extending grooves which are each
defined in said lower surface.
32. A carriage structure as in claim 31, further comprising means for
defining a number of second apertures for facilitating adhesive connection
of said carriage structure to said catheter portion.
33. A carriage structure as in claim 33, wherein said second apertures are
located at a distal end of said carriage structure as compared to said
first-mentioned apertures. |
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Claims  |
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Description  |
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This invention generally relates to ultrasound imaging of blood vessel
geometry and associated tissue character. More particularly, the present
invention relates to an ultra-thin acoustic transducer and to an
angioplasty balloon catheter using an array subassembly of same for
providing an ultrasound imaging capability (e.g. for guiding the
inflation, positioning and end point of the dilatation procedure). The
catheter provides a coronary or peripheral angioplasty balloon device
incorporating ultrasound technology for real-time intravascular imaging of
blood vessels and arteries before, during and after an interventional
angioplasty procedure.
Intravascular catheters which include ultrasound imaging crystal arrays
have been proposed in the past. It is known to mount a piezoelectric
crystal element on or within a catheter of the type which can be inserted
into a blood vessel. Once the catheter has been inserted into a blood
vessel, the crystal element is electrically excited to cause it to emit
ultrasonic energy into the surrounding tissue. While much of the emitted
energy is absorbed by the tissue, some of the energy is reflected back
toward the crystal element (with reflection occurring principally at
interfaces between different types of materials, e.g., the interface
between blood and the vascular wall, the interface between blood and
lesions adhered to the vascular wall, etc.). The crystal element produces
weak electrical signals in response to mechanical excitation by the
returning reflected ("echo") ultrasonic energy. These weak electrical
signals can be used to determine the geometry and other characteristics of
the blood vessel and lesions within the vessel.
Below is a non-exhaustive list of references which are generally relevant
in disclosing intravascular catheters (and other) ultrasound imaging
systems:
"High Speed Solution of 2nd Order Curves With Special Application to Planar
Sections of Blood Vessels", Roy W. Martin, Computer Programs in
Biomedicine, Vol. 13, (1981), pp. 45-60, Elsevier/North-Holland Biomedical
Press.
"Applicability of Ultrasonic Tissue Characterization for Longitudinal
Assessment and Differentiation of Calcification and Fibrosis in
Cardiomyopathy", Julio E. Perez, MD. et al, Journal of the American
College of Cardiology, Vol. 4, No. 1, (July 1984), pp. 88-95.
"In Vitro and In Vivo Studies using a 4F Pulsed Doppler Velocimeter
Catheter System, W. F. Voyles et al, Lovelace Medical Foundation,
University of New Mexico School of Medicine and Baylor College of
Medicine, ISA (1984), pp. 17-23.
"High Frequency Ultrasound Guidance of Laser Angioplasty", H. J. Geschwind
et al, Abstract #1866, Circulation, Vol. 74, Supp II, (Oct. 1986).
"Ultrasonic Instrumentation for Cardiovascular Studies", C. J. Hartley et
al; Baylor College of Medicine, Grant #2, RO1 HL 22512-09, Devices and
Technology Branch Contractor Meeting, (Dec. 8-10, 1986), pp. 65.
"Stroke Volume Measurement With an Ultrasonic Catheter Ty System", R. W.
Martin et al Ultrasound in Medicine, Vol. 3, New York, (1977), pp. 23-29.
"Signal Enhancement For Automatic Application of Arterial Wall Echos From
Cardiovascular Scanner", R. W. Martin et al, Ultrasound in Medicine, Vol.
4, (New York, 1978), p. 431.
Anatomical and Pathological Aspects in Ultrasonic Endoscopy For GI Tract",
Y. Panaha et al, Scandinavian Journal Gastroenterol, Vol. 19, Supp. 94,
(1984), pp. 43-50.
"Coronary Atherosclerosis Causes Remodeling of Arterial Geometry:
Demonstration by High-Frequency Epicardial Echocardiography", David D.
McPherson et al, Abstract #1864, Circulation, Vol 74, Supp. II, (Oct.
1986).
N. Bom et al, An Ultrasonic Intercardiac Scanner, Ultrasonico (March 1972),
pp. 72-76.
LanCee et al, "Construction of a Circular Ultrasonic Array With Miniature
Elements for Cardiac Application", Proceedings of the 2d European Congress
on Ultrasonics in Medicine, Munich, Germany (May 1, 1985), pp. 49-53.
U.S. Pat. No. 3,542,014--Peronneau (1970)
U.S. Pat. No. 3,938,502--Bom (1976)
U.S. Pat. No. 4,319,580--Colley et al (1982)
U.S. Pat. No. 4,327,738--Green et al (1982)
U.S. Pat. No. 4,462,408--Silverstein et al (1984)
U.S. Pat. No. 4,576,177--Webster Jr.
U.S. Pat. No. 4,432,692--
U.S. Pat. No. 4,567,898--
The Geschwind et al paper describes a non-invasive (i.e., extra vascular)
ultrasound system used to monitor echoes from bubbles caused by tissue
vaporization under the influence of laser angioplasty.
Hartley et al describes the use of a focused, unbacked (i.e., air-backed)
submillimeter (e.g., 0.5.times.1.0 millimeter) crystal operating at a
frequency of about 20 MHz to produce close-range, high-resolution vascular
imaging during the laser angioplasty procedure. This paper teaches
mounting the air-backed crystal to the side of a rigid 17-gauge needle,
and rotating the needle manually to obtain a 360.degree. image with a
resolution approaching 0.2 millimeters.
The Martin article appearing in Computer Programs in Biomedicine discloses
a computer program which determines blood vessel areas rapidly in response
to signals produced by an intravascular ultrasonic catheter.
Perez et al teach generating images of hamster hearts using broadb | | |