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Ultra-thin acoustic transducer and balloon catheter using same in imaging array subassembly    
United States Patent4841977   
Link to this pagehttp://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)
AbstractAn 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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Drawing from US Patent 4841977
Ultra-thin acoustic transducer and balloon catheter using same in

     imaging array subassembly - US Patent 4841977 Drawing
Ultra-thin acoustic transducer and balloon catheter using same in imaging array subassembly
Inventor     Griffith; James M. (Idaho Falls, ID); Maciel; Mario (Phelan, CA); Henry; Walter L. (South Laguna, CA); Zalesky; Paul J. (Huntington Beach, CA)
Owner/Assignee     Inter Therapy, Inc. (Costa Mesa, CA)
Patent assignment
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Publication Date     June 27, 1989
Application Number     07/053,692
PAIR File History     Application Data   Transaction History
Image File Wrapper   Patent Term   Fees
Litigation
Filing Date     May 26, 1987
US Classification     600/439 29/25.35 600/470
Int'l Classification     A61B 008/12
Examiner     Jaworski; Francis
Assistant Examiner    
Attorney/Law Firm     Nixon & Vanderhye
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Parent Case    
Priority Data    
USPTO Field of Search     128/344 128/348.1 128/772 128/660 128/661 128/663 128/642 128/692 128/660.03 128/660.06 29/25.35
Patent Tags     ultra-thin acoustic transducer balloon catheter in imaging array subassembly
   
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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.
 Description Submit all comments and votes
 


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