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Endoscopically deliverable ultrasound imaging system    
United States Patent4802487   
Link to this pagehttp://www.wikipatents.com/4802487.html
Inventor(s)Martin; Roy W. (Redmond, WA); Silverstein; Fred E. (Seattle, WA)
AbstractAn endoscopically deliverable ultrasound imaging system having an ultrasound probe mounted at the end of an endoscopically deliverable catheter. The catheter connects the probe to an ultrasound imaging system. The axial or radial position of the ultrasound probe is measured by a position transducer mounted on the endocscope adjacent the biopsy port from which the catheter extends. The output of the position measuring transducer is applied to the ultrasound imaging system so that the imaging system provides an image of the tissue depth as a function of the position of the ultrasound probe.
   














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Inventor     Martin; Roy W. (Redmond, WA); Silverstein; Fred E. (Seattle, WA)
Owner/Assignee     Washington Research Foundation (Seattle, WA)
Patent assignment
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Publication Date     February 7, 1989
Application Number     07/030,898
PAIR File History     Application Data   Transaction History
Image File Wrapper   Patent Term   Fees
Litigation
Filing Date     March 26, 1987
US Classification     600/463 600/109 600/471
Int'l Classification     A61B 010/00
Examiner     Jaworski; Francis J.
Assistant Examiner    
Attorney/Law Firm     Seed and Berry
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Priority Data    
USPTO Field of Search     128/660 128/661 128/663 128/4 128/5 128/6
Patent Tags     endoscopically deliverable ultrasound imaging
   
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4607619
Seike
600/106
Aug,1986

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Hokanson
600/472
Aug,1985

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Bechai
600/463
Nov,1983

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Leighton
600/114
Mar,1982

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Harris
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Jan,1980

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We claim:

1. A system for ultrasonically imaging internal tissues through the biopsy channel of an endoscope, comprising:

a catheter having a diameter that is sufficiently small to pass through said biopsy channel;

an ultrasound probe mounted at one end of said catheter, said ultrasound probe having a maximum transverse dimension that is sufficiently small to pass through said biopsy channel, said ultrasound probe having a transversely directed beam pattern;

position measuring means coupled to said catheter and adapted to be coupled to said endoscope for generating an ultrasound probe position signal indicative of the longitudinal position of said catheter with respect of said endoscope;

latch means actuatable to manually disengage said catheter from said position measuring means so that said catheter can move longitudinally without varying said ultrasound probe position signal; and

imaging means connected to said ultrasound probe by conductors extending through said catheter, said imaging means generating an ultrasound signal that is applied to said probe to generate an acoustic signal, said imaging means further receiving an ultrasound signal from said ultrasound probe corresponding to ultrasound acoustic signals reflected from said tissues to said ultrasound probe, said ultrasound imaging means generating said ultrasound image from said received ultrasound signal and from said ultrasound probe position signal.

2. The ultrasound imaging system of claim 1 wherein said position measuring means comprises:

a linear potentiometer having a resistance between a pair of leads that varies according to the linear position of a potentiometer wiper contact arm, said potentiometer being adapted for mounting on said endoscope adjacent the proximal end of said biopsy channel; and

a releasable fastener mounted on said wiper contact arm, said fastener releasably engaging said catheter

so that the resistance between the leads of said potentiometer varies according to the longitudinal position of said catheter when said releasable fastener is engaged with said catheter.

3. The ultrasound imaging system of claim 2 wherein said releasable fastener comprises:

a stop member secured to said catheter;

a fastener body mounted on said wiper contact arm, said fastener body having a recess adapted to receive said stop member; and

a latchpiece pivotally mounted on said fastener body, said latchpiece being movable to at least partially enclosed said recess to retain said stop member in said recess, thereby releasable securing said catheter to said potentiometer wiper contact arm.

4. The ultrasound imaging system of claim 3 wherein said latchpiece further includes an arcuate cutout to provide clearance for said catheter, thereby allowing said latchpiece to enclose substantially all of said stop member.

5. The ultrasound imaging system of claim 2 wherein the resistance between the leads of potentiometer is a linear function of the linear position of said wiper contact arm.

6. A system for ultrasonically imaging internal tissues through the biopsy channel of an endoscope, comprising:

a catheter having a diameter that is sufficiently small to pass through said biopsy channel;

an ultrasound probe mounted at one end of said catheter, said ultrasound probe having a maximum transverse dimension that is sufficiently small to pass through said biopsy channel, said ultrasound probe having a transversely directed beam pattern;

an elongated layer of resistive material covering at least a portion of said catheter along its length;

a conductor lead extending through said catheter from at least one end of said resistive material to an external location;

a conductive wiper adapted for mounting on said endoscope and making contact with said resistive material so that the resistance between said conductor lead and said wiper is indicative of the longitudinal position of said catheter with respect to said endoscope; and

imaging means connected to said ultrasound probe by conductors extending through said catheter, said imaging means generating an ultrasound signal that is applied to said probe

to generate an acoustic signal, said imaging means further receiving an ultrasound signal from said ultrasound probe corresponding to ultrasound acoustic signals reflected from said tissues to said ultrasound probe, said ultrasound imaging means generating said ultrasound image from said received ultrasound signal and from said ultrasound probe position signal.

7. The ultrasound imaging system of claim 6 wherein said conductive wiper is adapted for mounting on said endoscope adjacent the proximal end of said endoscope and said resistive material covers said catheter in an area in which said catheter enters the biopsy channel of said endoscope when the distal end of said catheter is in a position to image internal tissues.

8. A system for ultrasonically imaging internal tissues through the biopsy channel of an endoscope, comprising:

a catheter having a diameter that is sufficiently small to pass through said biopsy channel;

an ultrasound probe mounted at one end of said catheter, said ultrasound probe having a maximum transverse dimension that is sufficiently small to pass through said biopsy channel, said ultrasound probe having a transversely directed beam pattern;

a potentiometer housing adapted for mounting on said endoscope adjacent the proximal end of said biopsy channel;

a rotary potentiometer mounted in said potentiometer housing, said potentiometer having an arcuate resistance element and a rotatable wiper contact slidable along said resistance element, said wiper contact being coupled to a hollow shaft through which said catheter extends, said hollow shaft being coaxial with said arcuate resistance element;

a releasable fastener releasably securing said catheter to said hollow shaft so that said catheter and shaft rotate with each other; and

imaging means connected to said ultrasound probe by conductors extending through said catheter, said imaging means generating an ultrasound signal that is applied to said prode to generate an acoustic signal, said imaging means further receiving an ultrasound signal from said ultrasound probe corresponding to ultrasound acoustic signals reflected from said tissues to said ultrasound probe, said ultrasound imaging means generating said ultrasound image from said received ultrasound signal and from said ultrasound probe position signal.

9. The ultrasound imaging system of claim 8 wherein said releasable fastener includes a compression screw having a hollow center axis threaded into the hollow shaft of said potentiometer in coaxial alignment with said shaft so that said catheter extends through the hollow center axis of said screw, said compression screw frictionally engaging said catheter when said compression screw is threaded into said shaft to secure said catheter to said shaft.

10. A system for ultrasonically imaging internal tissues through the biopsy channel of an endoscope, comprising:

a catheter having a diameter that is sufficiently small to pass through said biopsy channel;

an ultrasound probe having a tranversely directed beam pattern mounted at one end of said catheter, said ultrasound probe having a maximum transverse dimension that is sufficiently small to pass through said biopsy channel, said ultrasound probe having a probe casing mounted at the end of said catheter, said casing having at least one acoustically transparent area , a transducer support member mounted in said casing , an ultrasound transducer mounted on said transducer support member beneath said acoustically transparent area , and actuating means for selectively moving said transducer support member longitudinally within said casing, thereby longitudinally scanning said transducer;

position measuring means coupled to said catheter and adapted to be coupled to said endoscope for generating an ultrasound probe position signal indicative of the longitudinal position of said catheter with respect to said endoscope;

imaging means connected to said ultrasound probe by conductors extending through said catheter, said imaging means generating an ultrasound signal that is applied to said transducer to generate an acoustic signal, said imaging means further receiving an ultrasound signal from said ultrasound probe corresponding to ultrasound acoustic signals reflected from said tissues to said ultrasound probe, said ultrasound imaging means generating said ultrasound image from said received ultrasound signal and from said ultrasound probe position signal.

11. The ultrasound imaging system of claim 10 wherein said catheter includes a fluid channel extending along its length and communicating with the interior of said probe casing, and wherein said transducer support member includes a piston slidably engaging the inside wall of said probe casing, and wherein said actuating means includes fluid control means for selectively applying fluid to the interior of said catheter to cause said piston to move said transducer support member longitudinally in said probe casing.

12. The ultrasound imaging system of claim 11, further including a pressure release tube extending through the catheter and piston into the interior of said probe casing to allow said fluid to flow into and out of the distal end of said casing when fluid flowing through said catheter moves said piston.

13. The ultrasound imaging system of claim 11 wherein said actuating means comprise a drive piston slidably mounted in the interior of said catheter to force said fluid toward and away from said probe, said drive piston being coupled to an electromechanical actuator and to said position measuring means.

14. The ultrasound imaging system of claim 13, further including a flexible bag positioned outside said endoscope and a pressure release tube extending from said bag through said catheter and piston into the interior of said probe casing to allow said fluid to flow into and out of the distal end of said casing when fluid flowing said catheter moves said piston.

15. A system for ultrasonically imaging internal tissues through the biopsy channel of an endoscope, comprising:

a catheter having a diameter that is sufficiently small to pass through said biopsy channel;

an ultrasound probe having a tranversely directed beam pattern mounted at one end of said catheter, said ultrasound probe having a maximum transverse dimension that is sufficiently small to pass through said biopsy channel, said ultrasound probe having a probe body having a planar transducer mounting surface and a partially spherical recess positioned above said transducer mounting surface, an ultrasound transducer mounted on said transducer mounting surface, and an impedance matching material filling said partially spherical recess;

position measuring means coupled to said catheter and adapted to be coupled to said endoscope for generating an ultrasound probe position signal indicative of the longitudinal position of said catheter with respect to said endoscope; and

imaging means connected to said ultrasound probe by conductors extending through said catheter, said imaging means generating an ultrasound signal that is applied to said transducer to generate an acoustic signal, said imaging means further receiving an ultrasound signal from said ultrasound probe corresponding to ultrasound acoustic signals reflected from said tissues to said ultrasound probe, said ultrasound imaging means generating said ultrasound image from said received ultrasound signal and from said ultrasound probe position signal.

16. The ultrasound imaging system of claim 15 wherein the probe body of said probe further includes a second partially spherical recess concentric with said first partially spherical recess, said second partially spherical recess having a radius of curvature that is smaller than the radius of curvature of said first partially spherical recess, and wherein the transducer of said probe includes outer and inner elements having respective diameters approximately equal to the diameters of said first and second partially spherical recesses, thereby allowing said probe to focus at at least two depth ranges.

17. The ultrasound imaging system of claim 16 wherein said transducer comprises a cylindrical plate of a piezoelectric material having first and second planar faces, said first planar face being plated with a metal over substantially its entire surface, said second planar face being plated with a metal in two semicircular areas having a diameter that is substantially smaller than the diameter of said cylindrical plate and in two separate arcuate areas surrounding said semicircular areas, said ultrasound imaging system being connected between the plating on said semicircular areas to focus at a relatively shallow depth and between the plating on said arcuate areas to focus at a relatively large depth, the piezoelectric material beneath the semicircular area and arcuate area on one side of said plate being polarized oppositely from the polarization of the piezoelectric material beneath the other semicircular and arcuate areas.

18. The ultrasound imaging system of claim 17 wherein said semicircular plated areas are separated from each other and said plated arcuate areas are separated from each other by a common diameter of said cylindrical plate.

19. The ultrasound imaging system of claim 15 wherein said ultrasound transducer comprises a cylindrical plate of piezoelectric material having first and second planar faces, said first planar face being plated with a metal over substantially its entire surface and said second planar face being plated with a metal in two separate semicircular areas between which said ultrasound imaging system is connected, the piezoelectric material beneath one of said semicircular areas being polarized oppositely from the polarization of the piezoelectric material beneath the other of said semicircular areas.

20. A catheter for allowing an ultrasound image to be made through the biopsy channel of an endoscope, comprising:

a tube having a diameter that is sufficiently small to pass through said biopsy channel, said tube having sufficient rigidity so that the position and orientation of the ends of the tube correspond to each other, said tube having sufficient flexibility to conform to the curved configuration of an endoscope biopsy channel;

an ultrasound probe mounted at one end of said tube, said ultrasound probe having a maximum transverse dimension that is sufficiently small to pass through said biopsy channel, said ultrasound probe having a transversely directed beam pattern;

position measuring means coupled to said tube and adapted to be coupled to siad endoscope for generating an ultrasound probe position signal indicative of the longitudinal position of said tube with respect to said endoscope; and

latch means actuated to manually disengage said tube from said position measuring means so that said tube can move longitudinally without varying said ultrasound probe position signal.

21. The catheter of claim 20 wherein said position measuring means comprises:

a linear potentiometer having a resistance between a pair of leads that varies according to the linear position of a potentiometer wiper contact arm, said potentiometer being adapted for mounting on said endoscope adjacent the proximal end of said biopsy channel; and

a releasable fastener mounted on said wiper contact arm, said fastener releasably engaging said tube as it exits from said biopsy port so that the resistance between the leads of said potentiometer varies according to the longitudinal position of said tube when said releasable fastener is engaged in said tube.

22. The catheter of claim 21 wherein said releasable fastener comprises:

a stop member secured to said tube;

a fastener body mounted on said wiper contact arm, said wiper body having a recess adapted to receive said stop member; and

a latchpiece pivotally mounted on said fastener body, said latchpiece being movable to at least partially enclose said recess to retain said stop member in said recess, thereby releasably securing said tube to said potentiometer wiper contact arm.

23. The catheter of claim 22 wherein said latchpiece further includes an arcuate cutout to provide clearance for said tube, thereby allowing said latchpiece to enclose substantially all of said stop member.

24. The catheter of claim 21 wherein the resistance between the leads of said potentiometer is a linear function of the linear position of said wiper contact arm.

25. A catheter for allowing an ultrasound image to be made through the biopsy channel of an endoscope, comprising:

a tube having a diameter that is sufficiently small to pass through said biopsy channel, said tube having sufficient rigidity so that the position and orientation of the ends of the tube correspond to each other, said tube having sufficient flexibility to conform to the curved configuration of an endoscope biopsy channel;

an ultrasound probe mounted at one end of said tube, said ultrasound probe having a maximum transverse dimension that is sufficiently small to pass through said biopsy channel, said ultrasound probe having a transversely directed beam pattern;

an elongated layer of resistive material covering at least a portion of said tube along its length;

a conductor lead extending through said tube from at least one end of said resistive material to an external location; and

a conductive wiper adapted for mounting on said endoscope at a location that allows said wiper to make contact with said resistive material when the distal end of said tube is in a position to image internal tissues so that the resistance between said conductor lead and said wiper is indicative of the longitudinal position of said tube with respect to said endoscope.

26. The catheter of claim 25 wherein said conductive wiper is adapted for mounting on said endoscope adjacent the proximal end of the biopsy channel of said endoscope, and said resistive material covers said tube in an area in which said tube enters the biopsy channel of said endoscope when the distal end of sid tube is in a position to image internal tissues.

27. A catheter for allowing an ultrasound image to be made through the biopsy channel of an endoscope, comprising:

a tube having a diameter that is sufficiently small to pass through said biopsy channel, said tube having sufficient rigidity so that the position and orientation of the ends of the tube correspond to each other, said tube having sufficient flexibility to conform to the curved configuration of an endoscope biopsy channel;

an ultrasound probe mounted at one end of said tube, said ultrasound probe having a maximum transverse dimension that is sufficiently small to pass through said biopsy channel, said ultrasound probe having a transversely directed beam pattern;

a potentiometer housing adapted for mounting on said endoscope adjacent the proximal end of said biopsy channel;

a rotary potentiometer mounted in said potentiometer housing, said potentiometer having an arcuate resistance element and a rotatable wiper contact slidable along said resistance element, said wiper contact being coupled to a hollow shaft through which said tube extends, said hollow shaft being coaxial with said arcuate resistance element; and

a releasable fastener releasably securing said tube to said hollow shaft so that said tube and shaft rotate with each other.

28. The catheter of claim 27 wherein said releasable fastener includes a compression screw having a hollow center axis threaded into the hollow shaft of said potentiometer in coaxial alignment with said shaft so that tube extends through the hollow center axis of said screw, said compression screw frictionally engaging said tube when said compression screw is threaded into said shaft to secure said tube to said shaft.

29. A catheter for allowing an ultrasound image to be made through the biopsy channel of an endoscope, comprising:

a tube having a diameter that is sufficiently small to pass through said biopsy channel, said tube having sufficient rigidity so that the position and orientation of the ends of the tube correspond to each other, said tube having sufficient flexibility to conform to the curved configuration of an endoscope biopsy channel;

an ultrasound probe having a transversely directed beam pattern mounted at one end of said tube, said ultrasound probe having a maximum transverse dimension that is sufficiently small to pass through said biopsy channel, said ultrasound probe having

a probe casing mounted at the end of said tube, said casing having at least one acoustically transparent area , a transducer support member mounted in said tube, an ultrasound transducer mounted on said transducer support member beneath said acoustically transparent area , and actuating means for selectively moving said transducer support member longitudinally within said tube, thereby longitudinally scanning said transducer; and

position measuring means coupled to said tube and adapted to be coupled to said endoscope for generating an ultrasound probe position signal indicative of the position of said tube with respect to said endoscope.

30. The catheter of claim 29, further including a fluid channel extending along the length of said catheter and communicating with the interior of said probe casing, and wherein said transducer support member includes a piston slidably engaging the inside wall of said probe casing, and wherein said actuating means includes fluid control means for selectively applying fluid to the interior of said catheter to cause said piston to move said transducer support member longitudinally in said probe casing.

31. The catheter of claim 30, further including a pressure release tube extending through said catheter and piston into the interior of said probe casing to allow said fluid to flow into and out of the distal end of said casing when fluid flowing through said catheter moves said piston.

32. The catheter of claim 30 wherein said actuating means comprise a drive piston slidably mounted in the interior of said catheter to force said fluid toward and away from said probe, said drive piston being coupled to an electromechanical actuator and to said position measuring means.

33. A catheter for allowing an ultrasound image to be made through the biopsy channel of an endoscope, comprising:

a tube having a diameter that is sufficiently small to pass through said biopsy channel, said tube having sufficient rigidity so that the position and orientation of the ends of the tube correspond to each other, said tube having sufficient flexibility to conform to the curved configuration of an endoscope biopsy channel;

an ultrasound probe having a transversely directed beam pattern mounted at one end of said tube, said ultrasound probe having a maximum transverse dimension that is sufficiently small to pass through said biopsy channel, said ultrasound probe having a probe body having a planar transducer mounting surface and a partially spherical recess positioned above said transducer mounting surface , an ultrasound transducer mounted on said transducer mounting surface , and an impedance matching material filling said partially spherical recess; and

position measuring means coupled to said tube and adapted to be coupled to said endoscope for generating an ultrasound probe position signal indicative of the position of said tube with respect to said endoscope.

34. The catheter of claim 33 wherein the probe body of said probe further includes a second partially spherical recess, said second partially spherical recess having a radius of curvature that is smaller than the radius of curvature of said first partially spherical recess, and wherein the transducer of said probe includes outer and inner elements having respective diameters approximately equal to the diameters of said first and second partially spherical recesses, thereby allowing said probe to focus at at least two depth ranges.

35. The catheter of claim 34 wherein said transducer comprises a cylindrical plate of a piezoelectric material having first and second planar faces, said first planar face being plated with a metal over substantially its entire surface, said second planar face being plated with a metal in two separate semicircular areas having a diameter that is substantially smaller than the diameter of said cylindrical plate and in two separate arcuate areas surrounding said semicircular areas, each of said plated areas being connected to leads extending from said probe through said tube so that an ultrasound signal applied between the plating on said semicircular areas causes said probe to focus at a relatively shallow depth and an ultrasound signal applied between the plating on said arcuate areas causes said probe to focus at a relatively large depth, the piezoelectric material beneath the semicircular area and arcuate area on one side of said plate being polarized oppositely from the polarization of the piezoelectric material beneath the other semicircular and arcuate areas.

36. The catheter of claim 35 wherein said semicircular plated areas are separated from each other and said plated arcuate areas are separated from each other by a common diameter of said cylindrical plate.

37. The catheter of claim 33 wherein said ultrasound transducer comprises a cylindrical plate of piezoelectric material having first and second planar faces, said first planar face being plated with a metal over substantially its entire surface, and said second planar face being plated with a metal in two separate semicircular areas, the piezoelectric material beneath one of said semicircular areas being polarized oppositely from the polarization of the piezoelectric material beneath the other of said semicircular areas, said catheter further including a pair of leads extending between respective semicircular plated areas of said probe through said tube.

38. An ultrasound probe for generating an ultrasound acoustic signal and receiving reflected ultrasound acoustic signals, comprising:

a probe body having a planar transducer mounting surface and first and second partially spherical recesses positioned above said transducer mounting surface, said second partially spherical recess having a radius of curvature that is smaller than the radius of curvature of said first partially spherical recess;

an ultrasound transducer mounted on said transducer mounting surface, said transducer having outer and inner elements having respective diameters approximately equal to the diameter of said first and second partially spherical recesses ; and

an impedance matching material filling said partially spherical recess.

39. The ultrasound probe of claim 38 wherein said transducer comprises a cylindrical plate of a piezoelectric material having first and second planar faces, said first planar face being plated with a metal over substantially its entire surface, said second planar face being plated with a metal in two separated semicircular areas having a diameter that is substantially smaller than the diameter of said cylindrical plate and in two arcuate areas surrounding said semicircular areas, said semicircular areas causing said probe to focus at a relatively shallow depth when an ultrasound signal is applied between said semicircular areas, and said arcuate plated areas causing said probe to focus at a relatively large depth when an ultrasound signal is applied between said arcuate plated areas, the piezoelectric material beneath the semicircular area and arcuate area on one side of said plate being polarized oppositely from the polarization of the piezoelectric material beneath the other semicircular and arcuate areas.

40. The ultrasound probe of claim 39 wherein said semicircular plated areas are separated from each other and said plated arcuate areas are separated from each other by a common diameter of said cylindrical plate.

41. An ultrasound probe for generating an ultrasound acoustic signal and receiving reflected ultrasound acoustic signals, comprising:

a probe body having a planar transducer mounting surface and a partially spherical recess positioned above said transducer mounting surface;

an ultrasound transducer mounted on said transducer mounting surface, said ultrasound transducer including a cylindrical plate of piezoelectric material having first and second planar faces, said first planar face being plated with a metal over substantially its entire surface, and said second planar face being plated with a metal with two separate semicircular areas, the piezoelectric material beneath one of said semicircular areas being polarized oppositely from the polarization of the piezoelectric material beneath the other of said semicircular areas; and an impedance matching material filling said semicircular areas partially spherical recess.

42. An ultrasound transducer for generating an ultrasound acoustic signal from an ultrasound electric signal and for generating an ultrasound electric signal from a received ultrasound acoustic signal, said transducer comprising a cylindrical plate of piezoelectric material having first and second planar faces, said first planar face being plated with a metal over substantially its entire surface, and said second planar face being plated with a metal in two separate semicircular areas between which said ultrasound electric signal is applied or generated, the piezoelectric material between said first planar face and one semicircular area of said second planar face being polarized opposite to the polarization of the piezoelectric material between said first planar face and the other semicircular area of said second planar face.

43. The ultrasound transducer of claim 42 wherein said semicircular areas have a diameter that is substantially smaller than the diameter of said cylindrical plate, said transducer further including two separate arcuate areas surrounding said semicircular areas, thereby allowing said transducer to focus at a relatively shallow depth when said electrical signal is applied to or generated between said semicircular plated areas and allowing said transducer to focus at a relatively large depth when said ultrasound electric signal is applied to or generated between said arcuate areas.

44. The transducer of claim 43 wherein said semicircular plated areas are separated from each other and said plated arcuate areas are separated from each other by a common diameter of said cylindrical plate.
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TECHNICAL FIELD

This invention relates to ultrasound imaging, and more particularly, to a system for ultrasonically imaging internal body tissues using an endoscopically deliverable imaging probe.

BACKGROUND ART

A wide variety of ultrasound systems have long been used for medical diagnostic purposes. One of these ultrasound devices is the Doppler probe, in which ultrasound energy is transmitted into the body and the change in frequency of the return signal is detected to provide an indication of blood flowing in veins and arteries. The characteristics of the frequency-shifted Doppler signal indicate the presence of an adjacent blood vessel and identify whether the vessel is a vein or an artery. Recently, an endoscopically deliverable ultrasound Doppler probe has been proposed and is described in U.S. Pat. No. 4,582,067, to Silverstein et al. The endoscopically deliverable Doppler probe can be passed through the biopsy channel of standard endoscopes and placed, under direct vision, against the tissue to be examined. The system has been found to be useful for evaluating the papilla of Vater to determine whether an abnormal blood vessel is present which might cause life-threatening hemorrhage. The system has also been used for locating arteries in ulcers that are responsible for massive upper gastrointestinal hemorrhage before and after the application of endoscopically delivered hemostatic therapy.

Another conventional, commonly used ultrasound system allows subcutaneous tissues to be visualized. In ultrasound imaging, an ultrasound transducer is generally placed in contact with the skin of the patient and pulses of ultrasound energy are transmitted from the transducer into the tissues of interest. Return echoes from the tissues are localized to a specific depth by conventional range gating and used to modulate the intensity of a cathode-ray tube display as the probe is either electrically or mechanically scanned across the tissues. The scan of the probe modulates one axis of the CRT, while the other axis of the CRT is modulated by the range gate. The CRT thus displays a cross section of tissue. The internal organs are visible primarily as a result of the changes in the acoustic impedance of such organs in comparison to the surrounding tissues.

Ultrasound imaging has also been combined with the Doppler principle to image blood flowing veins and arteries. In ultrasound Doppler imaging, returns from non-moving tissues and organs are either ignored or processed separately to display return echoes from moving blood.

Although tissues and internal organs, particularly those close to the surface, can be imaged externally, the walls of the gastrointestinal track cannot be externally imaged with any degree of accuracy for several reasons. First, the wall of the gastrointestinal tract moves toward and away from the transducer, thus making it extremely difficult to isolate the relatively small thickness of the GI track as the depth of interest. Furthermore, deep ultrasound imaging can be effectively accomplished only by utilizing relatively low frequencies. However, the high resolution required to usefully image the walls of the GI track require a substantially higher ultrasound frequency. Yet this higher ultrasound frequency is quickly attenuated in the body and never reaches the walls of the GI track of interest.

In order to allow the walls of the gastrointestinal track to be ultrasonically imaged without the many problems of external imaging, attempts have been made to endoscopically image such tissues. Internal ultrasound imaging offers several advantages over percutaneous ultrasound and other imaging techniques. With internal ultrasound imaging, penetration is less of a problem when the transducer is placed immediately adjacent to the tissue target. The anterior abdominal wall and other intervening structures do not have to be penetrated. Intervening structures, especially air, can severely limit the percutaneous ultrasound in certain clinical situations. The reduced penetration requirement allows for the use of highfrequency ultrasound, which is capable of producing images of high resolution. High-resolution ultrasound may reduce exposure to ionizing radiation from other diagnostic procedures by eliminating other less specific tests. Although ultrasound does have biological effects, for use at diagnostic levels no significant effects have been reported.

There is a critical need to be able to obtain during routine endoscopy information about wall structure. This data may be useful to guide the next diagnostic or therapeutic steps while the endoscope is still in place. The earlier diagnosis which internal ultrasound imaging would allow could have highly desirable effects upon the treatment of the patient in terms of directing appropriate effective therapy and avoiding inappropriate therapy. The advantages of an early, specific, inexpensive, and noninvasive diagnosis are well recognized. For example, if the exact extent of wall involvement by a sessile tumor could be determined, tumors that could be ablated endoscopically without causing perforation could be easily identified. Given the decision that the disease is localized to the mucosa without deep invasion, laser or electrocautery could be applied. If, however, the ultrasound image indicated that the tumor had spread to adjacent structures, then palliative therapy would be appropriate.

Internal ultrasound imaging is particularly appropriate for diseases which have certain common characteristics. Diseases which involve the gastrointestinal wall, diseases which can be reached endoscopically, diseases that are frequent, disabling, and currently not readily diagnosed, and diseases that are now poorly treated because they are diagnosed too late are all prime candidates.

One disease that could be advantageously diagnosed by internal ultrasound imaging is Crohn's inflammatory bowel disease. Crohn's disease is a disabling inflammatory disease of the gastrointestinal track which affects the small and large bowel. The cause is unknown. It is one of the most frequently encountered types of inflammatory bowel disease, the other being mucosal ulcerative colitis. However, Crohn's disease involves the entire thickness of the bowel wall (transmural disease), whereas ulcerative colitis is limited to the mucosa of the colon. It has been estimated that between one million and two million Americans have inflammatory bowel diseases, and the frequency of these diseases is increasing. Most of the new cases are diagnosed before the age of thirty. Crohn's disease is difficult to diagnose and treat. When the patient first presents, the work-up may include history, physical exam, sigmoidoscopy, barium enema and small intestine X-rays, colonoscopy, and rectal biopsy. Even with this evaluation, diagnosis may be uncertain. Symptoms and complications are variable. By rapidly examining the wall of the rectum and colon with internal ultrasound imaging, an early specific diagnosis may be made. When following such patients, internal ultrasound imaging may also provide an essential parameter to evaluate whether the disease to adjacent structures or formed an abscess.

Gastric malignancies, including adenocarcinoma and lymphoma, may also be diagnosed using internal ultrasound imaging. Tumors of the upper gastrointestinal tract are frequent. Currently, gastroenterologists use endoscopy to evaluate the patient with epigastric symptoms suggesting an ulcer or tumor. After visually inspecting an abnormal area, biopsies and brush cytologies are taken. However, it is impossible for an endoscopist to evaluate the area of the submucosa. There may be a lump, but the biopsies will often contain only normal surface mucosa from over the mass. If a cancer is suspected, the endoscopist cannot assess the degree of extension of the tumor. Internal ultrasound imaging could be used routinely during diagnostic endoscopy. Once an abnormal area was visualized, an ultrasound probe could determine the nature of the underlying wall. It could also answer such questions as whether there is a mass present, whether the mass is abnormally thick, whether there are abnormal lymph nodes adjacent to the stomach, or whether there are other diagnostic features. This information might allow an earlier diagnosis, expedite correct therapy, and avoid unnecessary intervention.

Internal ultrasound imaging may also be applicable to esophageal carcinoma. Tumors of the esophagus have posed a significant problem for the clinician for years. When a patient presents with symptoms caused by cancer, the tumor is usually too expensive to be surgically resectable. The result is that only 39% of esophageal cancers are considered resectable and the five-year survival rate is only about 5%-10%. Since internal ultrasound imaging would allow the endoscopist to evaluate an area which is equivocal, the image might reveal diagnostic thickening of the mucosa consistent with carcinoma. It can evaluate an obvious cancer to determine whether the cancer has extended into the mediastinum, which would make the patient inoperable. Internal ultrasound imaging may also be especially helpful in the patient with a premalignant condition of the esophagus, such as Barrett's epithelium, by early detection of possibly treatable adenocarcinomas.

Tumors of the colon and rectum are one of the most common visceral tumors in the Western Hemisphere. The instance of colon and rectal cancer has increased over the past several years, and these tumors are now among the three most frequent tumors in the United States. Colon and rectal cancers account for approximately 15% of all newly diagnosed cancers in both men and women in the United States. Significant progress in early detection of these lesions has been made by screening stools for blood and by using sigmoidoscopy and colonoscopy. However, it is usually difficult to stage carcinomas of the colon and rectum preoperatively, despite CT scans and other methods. But staging can be very important for patient management. The extent of the tumor may dictate whether or not it is appropriate to use preoperative radiation therapy. Internal ultrasound imaging could be used to provide staging.

Finally, there is increasing interest in the motility of the gastrointestinal tract since many diseases which trouble patients seem related to motility. Such diseases include esophageal spasm, achalasia, abnormal gastric emptying, functional bowel disease, and other motility disfunctions.

Attempts have been made to provide internal ultrasound imaging through endoscopes using linear arrays, phased arrays, and mechanical sector scanners. The mechanical sector scanner endoscope, as described in Hisanaga, "A New Trans-Digestive-Tract Scanner with a Gastro-Fiber-Scope," Proc. 23 AIUM 1978, uses a specially designed, side-viewing endoscope having a transducer mounted on the end of a wire. The transducer has a transversely directed beam pattern, and it is rotated ab