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Method and apparatus for analyzing material properties using ultrasound    
United States Patent5197475   
Link to this pagehttp://www.wikipatents.com/5197475.html
Inventor(s)Antich; Peter P. (Richardson, TX); Dowdey; James E. (Arlington, TX); Murry, Jr.; Robert C. (Irving, TX)
AbstractApparatus is disclosed for investigating the mechanical properties of a solid material such as bone, including means for positioning the apparatus in proximity to a surface of the material, at least one emitting ultrasound transducer, at least one receiving ultrasound transducer positioned to received ultrasound waves that have been emitted and have contacted the surface of the material, means for varying the angle of incidence of the emitted ultrasound wave towards the material, means for determining the alignment of the surface of the material with respect to the emitting and receiving ultrasound transdsucers, and signal analyzer means coupled to the receiving transducer for determining at least one characteristic of the received ultrasound wave which is indicative of a mechanical property of the material. A method is also disclosed of using such apparatus. The present invention permits the quick and efficient evaluation of treatment for osteoporosis, and whether that treatment has in fact reduced the tendency of a patient's bones to fracture.



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Drawing from US Patent 5197475
Method and apparatus for analyzing material properties using ultrasound - US Patent 5197475 Drawing
Method and apparatus for analyzing material properties using ultrasound
Inventor     Antich; Peter P. (Richardson, TX); Dowdey; James E. (Arlington, TX); Murry, Jr.; Robert C. (Irving, TX)
Owner/Assignee     The Board of Regents, The University of Texas System (Austin, TX)
Patent assignment
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Publication Date     * March 30, 1993
Application Number     07/717,025
PAIR File History     Application Data   Transaction History
Image File Wrapper   Patent Term   Fees
Litigation
Filing Date     June 18, 1991
US Classification     600/437 73/602 600/444
Int'l Classification     A61B 008/00
Examiner     Jaworski; Francis
Assistant Examiner    
Attorney/Law Firm     Arnold, White & Durkee
Address
Parent Case     This application is a continuation-in-part of U.S. Ser. No. 230,845, filed on Aug. 10, 1988, and now U.S. Pat. No. 5,038,787. That application is incorporated here by reference.
Priority Data    
USPTO Field of Search     128/660.01 128/660.08 73/602
Patent Tags     analyzing material properties ultrasound
   
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ReferenceRelevancyCommentsReferenceRelevancyComments
5038787
Antich
600/437
Aug,1991

[0 after 0 votes]
4682497
Sasaki
73/602
Jul,1987

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4476873
Sorenson
600/447
Oct,1984

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4458689
Sorenson
600/447
Jul,1984

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4457311
Sorenson
600/447
Jul,1984

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4437468
Sorenson
600/459
Mar,1984

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4421119
Pratt, Jr.
600/437
Dec,1983

[0 after 0 votes]
4364273
Redding
73/614
Dec,1982

[0 after 0 votes]
4361154
Pratt, Jr.
600/437
Nov,1982

[0 after 0 votes]
4098129
Deblaere
73/599
Jul,1978

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4094304
Wright, Jr.

Jun,1978

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We claim:

1. Apparatus for investigating the mechanical properties of a solid material, including:

means for positioning the apparatus in proximity to a surface of a solid material;

at least one emitting ultrasound transducer positioned for emitting an ultrasound wave towards a surface of the material;

at least one receiving ultrasound transducer positioned for receiving an ultrasound wave that has been emitted and has contacted the surface of the material;

means for varying the angle of incidence of the emitted ultrasound wave towards the surface of the material;

means responsive to the received ultrasound wave for determining the alignment of the surface of the material with respect to the emitting and receiving ultrasound transducers; and

signal analyzer means coupled to the at least one receiving ultrasound transducer for determining at least one characteristic of the received ultrasound wave which is indicative of a mechanical property of the material.

2. The apparatus of claim 1, further comprising means for varying the emitting plane which is defined by the emitted ultrasound wave and the normal to the surface of the material at the location where the ultrasound wave has contacted the surface of the material.

3. The apparatus of claim 2, where the means for varying the emitting plane include a stepper mechanism coupled to the transducers, which stepper mechanism comprises means for moving and positioning the transducers in relation to the material.

4. The apparatus of claim 1, where the at least one receiving ultrasound transducer is positioned to receive an ultrasound wave that has been reflected from the surface of the material.

5. The apparatus of claim 4, where the signal analyzer means is operable to determine the amplitude of the reflected ultrasound wave as a function of the angle of incidence.

6. The apparatus of claim 5, where the signal analyzer means comprises means for determining at least one edge in which the amplitude of the reflected ultrasound wave decreases rapidly as a function of the angle of incidence between two regions of slower variability.

7. The apparatus of claim 4, where the signal analyzer means comprises means for determining the phase of the reflected ultrasound wave as a function of angle of incidence.

8. The apparatus of claim 7, where the signal analyzer means is also operable to determine at least one angle of incidence at which the phase of the reflected ultrasound wave first appreciably deviates from zero as that angle increases from 0.degree..

9. The apparatus of claim 1, where the at least one receiving ultrasound transducer is positioned to receive an ultrasound wave that has been transmitted through the material.

10. The apparatus of claim 9, where the signal analyzer means comprises means for determining the amplitude of the transmitted ultrasound wave as a function of the angle of incidence.

11. The apparatus of claim 10, where the signal analyzer means comprises means for determining maxima and minima in the amplitude of the transmitted ultrasound wave as a function of the angle of incidence.

12. The apparatus of claim 1, where the signal analyzer means comprises means for determining at least one characteristic of the received ultrasound wave selected from the group consisting of amplitude and phase.

13. The apparatus of claim 1, where the means for varying the angle of incidence include a stepper mechanism coupled to the transducers, which stepper mechanism comprises means for moving and positioning the transducers in relation to the material.

14. The apparatus of claim 1, where the apparatus includes an array of transducers, said array comprising the at least one emitting ultrasound transducer and the at least one receiving ultrasound transducer.

15. The apparatus of claim 14, where the array of transducers is in the form of a semicircular array.

16. The apparatus of claim 14, where the array of transducers is in the form of a hemispherical array.

17. The apparatus of claim 14, where the means for varying the angle of incidence include a switching circuit for selectably operating at least one transducer in the array as an emitting transducer.

18. The apparatus of claim 14, where the means for varying the angle of incidence include a switching circuit for selectably operating at least one transducer in the array as a receiving transducer.

19. The apparatus of claim 1, where the material is bone.

20. The apparatus of claim 19, where the signal analyzer means comprises means for approximating the velocity of a pressure wave in the bone based on a first critical angle corresponding to a first maxima in amplitude encountered as the angle of incidence increases in the range of 0.degree.-90.degree..

21. The apparatus of claim 20, where the signal analyzer means comprises means for approximating the velocity of a shear wave in the bone based on a second critical angle corresponding either to a second maxima in amplitude followed by a deep minimum or to an inflection point in amplitude following a deep minimum and encountered after the first maxima as the angle of incidence increases in the range of 0.degree.-90.degree..

22. The apparatus of claim 19, where the apparatus includes a liquid-filled bag which has at least one surface that is flexible and which can be positioned on the surface of a patient's body in proximity to a bone, and where the ultrasound transducers are in acoustic contact with the liquid in the bag.

23. Apparatus for investigating the mechanical properties of bone, including:

a liquid-filled bag which has at least one surface that is flexible;

an array of ultrasound transducers which are in acoustic contact with the liquid in the bag, and which include switching means for selectably operating at least one transducer in the array as an emitting ultrasound transducer positioned for transmitting an ultrasound wave towards a surface of the bone, and for selectably operating at least one ultrasound transducer in the array as a receiving ultrasound transducer positioned for receiving ultrasound waves reflected by the surface of the bone;

means for varying the angle of incidence of the emitted ultrasound wave towards the surface of the bone;

means for varying the emitting plane which is defined by the emitted ultrasound wave and the normal to the surface of the bone; and

signal analyzer means coupled to the array of ultrasound transducers, which receive the reflected ultrasound wave and are operable to determine at least one characteristic of the reflected ultrasound wave as a function of the angle of incidence, and from that to estimate the strength of the bone.

24. The apparatus of claim 23, where the signal analyzer means comprises means for determining the phase of the reflected ultrasound wave as a function of the angle of incidence.

25. A method of investigating the mechanical properties of a material, including the steps of:

a. emitting an ultrasound wave to impinge a surface of a material at an angle of incidence;

b. receiving the ultrasound wave after it has contacted the material;

c. determining the normal to the surface of the material by analyzing the received ultrasound waves generated when the emitted ultrasound wave impinges the material from each of a plurality of varying directions; and

d. determining a characteristic of the received ultrasound wave at each of a plurality of varying angles of incidence in the range of 0.degree.-90.degree., and in a plurality of varying emitting planes defined by the emitted ultrasound wave and the normal to the surface of the material, and using that characteristic to estimate a mechanical property of the material.

26. The method of claim 25, where the characteristic in step d is selected from the group consisting of amplitude and phase of the received ultrasound wave.

27. The method of claim 25, where the ultrasound wave is received after reflecting from the surface of the material.

28. The method of claim 27, where step d includes determining the amplitude of the reflected ultrasound wave as a function of the angle of incidence.

29. The method of claim 28, where step d also includes determining at least one edge in which the amplitude of the reflected ultrasound wave decreases rapidly as a function of the angle of incidence between two regions of slower variability.

30. The method of claim 27, where step d includes determining the phase of the reflected ultrasound wave as a function of angle of incidence.

31. The method of claim 30, where step d also includes determining at least one angle of incidence at which the phase of the reflected ultrasound wave first appreciable deviates from zero as the angle is increased from 0.degree..

32. The method of claim 25, where the ultrasound wave is received after being transmitted through the material.

33. The method of claim 32, where step d includes determining the amplitude of the transmitted ultrasound wave as a function of the angle of incidence, and determining maxima and minima in the amplitude.

34. The method of claim 25, where the material is bone.

35. The method of claim 34, where step d includes approximating the velocity of a pressure wave in the bone based on a first critical angle corresponding to a first maxima in amplitude encountered as the angle of incidence increases in the range of 0.degree.-90.degree..

36. The method of claim 35, where step also includes approximating the velocity of a shear wave in the bone based on a second critical angle corresponding either to a second maxima in amplitude followed by a deep minimum or to an inflection point in amplitude following a deep minimum and encountered after the first maxima as the angle of incidence increases in the range of 0.degree.-90.degree..

37. The method of claim 36, where step d includes computing the shear wave velocity (v.sub.s) using the relationship: ##EQU14## where c is the velocity of the transmitted ultrasound wave (I) in the medium adjacent the bone and .phi..sub.2 is the angle of incidence at the second critical angle.

38. The method of claim 35, where step d includes computing the pressure wave velocity (v.sub.p) using the relationship: ##EQU15## where c is the velocity of the transmitted ultrasound wave in the medium adjacent the bone and .phi..sub.1 is the angle of incidence at the first critical angle.
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BACKGROUND OF THE INVENTION

This invention relates to a method and apparatus for determining the mechanical properties of a material, such as bone.

A number of situations arise where it is important to assess the mechanical properties of a material without destroying or damaging the material. In some cases, this can be done using simplified techniques as a result of the homogeneity of the material. However, in other cases, the material is not homogenous and therefore simplified techniques do not give accurate results.

For instance, in medical applications, it is frequently desirable to determine the mechanical properties of a material such as bone, but destructive tests of course cannot be used in a living patient. Further, invasive tests are undesirable, and the bone is nonhomogeneous and nonisotropic. These complications present a particular problem in the case of patients suffering from osteoporosis, who are more susceptible to fractures as a result of decreased bone strength. Standard radiographic properties of bone, such as bone mineral density, do not correlate well with bone strength, and therefore are of relatively little use in diagnosing osteoporosis or evaluating the results of treatment for that condition.

Although some treatments for osteoporosis are available that can increase the strength of a patient's bones, the utility of those treatments would be enhanced by a noninvasive method of assessing their effect on the patient's bones. In the past, various methods have been investigated for this purpose, but have failed to solve the problem. For example, radiologic methods such as quantitative computed tomography, single or dual photon absorptiometry, and dual energy X-ray absorptiometry measure the amount and distribution of minerals in bone, but do not directly assess its mechanical qualities. These problems of the prior art are minimized or solved by the method and apparatus of the present invention.

SUMMARY OF THE INVENTION

The present invention relates to apparatus for investigating the mechanical properties of a solid material, such as bone. The apparatus can include means for positioning the apparatus in proximity to a surface of a solid material, at least one emitting ultrasound transducer positioned for emitting an ultrasound wave towards the surface of the material, at least one receiving ultrasound transducer positioned for receiving ultrasound waves that have been emitted and have contacted the surface of the material, means for varying the angle of incidence of the emitted ultrasound wave towards the surface of the material, means responsive to the received ultrasound wave for determining the alignment of the surface of the material with respect to the emitting and receiving ultrasound transducers, and signal analyzer means coupled to the receiving ultrasound transducer for determining at least one characteristic of the received ultrasound wave which is indicative of a mechanical property of the material.

"Emitting" and "receiving" are intended to cover both embodiments in which the ultrasound wave is reflected from the material, and embodiments in which the ultrasound is transmitted through the material. In either case, the receiving ultrasound transducer receives the wave after it has contacted the material (i.e., reflected from the material or transmitted through it).

The apparatus preferably also includes means for varying the emitting plane which is defined by the emitted ultrasound wave and the normal to the surface of the material. The means for varying the emitting plane, as well as the means for varying the angle of incidence, can constitute a stepper mechanism which is coupled to the transducers, or, if the apparatus includes an array of transducers, can constitute a switching circuit for selectably operating at least one transducer in the array as an emitting transducer and at least one transducer in the array as a receiving transducer.

The signal analyzer means is preferably operable to determine at least one characteristic of the received ultrasound wave, selected from the group consisting of amplitude and phase of the received ultrasound wave. With respect to the amplitude of the received ultrasound wave, parameters such as maxima, minima (collectively referred to as "extrema"), and edges can be used to determine various velocities, and from that to estimate mechanical properties of the material. With respect to phase, parameters such as the angle of incidence at which phase first appreciably deviates from zero can likewise be used to estimate mechanical properties of the material.

The present invention also relates to a method of investigating the mechanical properties of a material, such as bone. The method includes the steps of emitting an ultrasound wave to impinge a surface of a material at an angle of incidence, receiving ultrasound waves after they have contacted the material, determining the normal to the surface of the material by analyzing the received ultrasound waves generated when the emitted ultrasound wave impinges the material from each of a plurality of varying directions, and determining a characteristic of the received ultrasound wave at each of a plurality of varying angles of incidence in the range of 0.degree. to 90.degree., and in a plurality of varying emitting planes defined by the emitted ultrasound wave and the normal to the surface of the material, and using the characteristic to estimate a mechanical property of the material. The characteristic of the received ultrasound wave that is determined is preferably selected from the group consisting of amplitude and phase. Again, the received ultrasound wave can either be reflected from the material or transmitted through it.

The present invention provides the capability of determining the normal to the surface of the bone, which permits the use of a rational set of measurements to align the detectors and the bone. This is important because the normal defines the zero angle as well as the emitting plane (or plane of scattering), which must contain the normal and the incident wave (I). If the plane and zero were chosen incorrectly, the measurements obtained would be of little value as the angles would not be well measured. No known prior art procedure has this same capability.

In determining the normal, measurements could be taken in scattering planes some angle less than 90 degrees apart, such as 30 degrees apart; the smaller the incremental angle, the higher the accuracy and the precision of the method. Critical angles would be obtained for each plane. In an ex vivo use of the present invention, the bone sample would be rotated, while in clinical use with living patients, the applicator device (which would include the transducers) would be rotated while the patient remains stationary.

The advantages of the present invention are believed to be quite significant in evaluating the results of treatment for osteoporosis. Treatment of that condition can cause small variations in the material properties of bone (e.g., 2-5 percent change as a consequence of treatment over two years in representative experiments), and yet those small variations can correlate to clinically significant improvements in the resistance of the bone to fracture. Therefore, the present invention provides a much more accurate and useful means of evaluating the effect of osteoporosis treatment than any known prior art ultrasound apparatus.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a schematic view of the propagation patterns of the ultrasound waves in the method of the present invention.

FIG. 2 is a schematic view of an apparatus in accordance with the present invention.

FIG. 3 is a schematic view showing in block diagram the components of an embodiment of the apparatus of the present invention.

FIG. 4 is a schematic view showing in block diagram an alternative embodiment of the apparatus of the present invention.

FIG. 5 is a flow chart of the application software for the computer of FIGS. 3 and 4, where:

FIG. 5A describes the "Distance to Bone" subroutine,

FIG. 5B describes the "Find Flat Spot" subroutine,

FIG. 5C shows the "Locate Surfaces" subroutine,

FIG. 5D illustrates the "Scan Bone" subroutine,

FIG. 5E describes the "Signal Analysis" subroutine, and

FIG. 5F illustrates the "Cross Comparison" subroutine.

FIG. 6 is a graph of the amplitude of a reflected ultrasound wave in the method of the present invention as a function of angle of incidence of the emitted wave.

FIG. 7 is a graph of the phase of a reflected ultrasound wave in the method of the present invention as a function of the angle of incidence of the emitted wave.

FIG. 8 is a simplified block diagram of the apparatus used in the tests of Example 2.

FIG. 9 is a graph of reflected ultrasound wave amplitude vs. angle of incidence in samples that are and are not saturated with MMA plastic.

FIG. 10 is a histogram of the distribution of ultrasound velocities in bone biopsy specimens (A) before and (B) following two years of intermittent slow-release fluoride therapy.

FIG. 11 is a comparison of pre- versus post-treatment ultrasound velocities in bone biopsy specimens from 16 patients before and after two years of intermittent slow-release fluoride therapy. Measurements for each angle of specimen orientation are plotted. The solid line represents the line of identity whereby points above and below the line represent negative and positive responses respectively.

FIG. 12 is a histogram of the change in ultrasound velocity in bone biopsy specimens following two years of intermittent slow-release fluoride therapy.

FIG. 13 shows the mean and 95% confidence levels for ultrasound velocity in cancellous bone in five groups of subjects.

FIG. 14 shows the mean values and standard errors of velocity (solid dots) and vertebral bone mineral density (open dots) (BMD) in five patient groups.

DESCRIPTION OF THE PREFERRED EMBODIMENTS

The method and apparatus of the present invention are useful in determining the physical properties of a variety of materials. Because the present invention relies on ultrasound waves, the only material requirements are that the material under investigation reflect and/or transmit a significant ultrasound component, and that the velocity of sound in it be greater than that of the first medium (e.g. water or soft tissue).

FIGS. 1 and 2 illustrate the general critical angle of reflection method of the present invention and are useful in understanding the specific embodiments of FIGS. 3-5. FIG. 1 illustrates an ultrasound transducer 10 functioning as an emitter or transmitter and an ultrasound transducer 12 functioning as a receiver. An ultrasound wave (I) impinges upon a plane separating the material under investigation 14 (such as bone) from a separating medium 16 (such as soft tissue). For convenience, the plane defined by the direction of propagation of the transmitted wave and the normal to the surface of the material 14 is defined as the XY plane in FIG. 1. The incoming or transmitted wave (I) upon arrival at the interface of the material 14 and medium 16 (YZ plane with X=0) gives rise to a reflected wave (R) redirected through the medium 16 to the receiving transducer 12. For illustrative purposes, particle motion in FIG. 1 is seen to be constrained to the XY plane, so that the transmitted wave (I) gives rise to a pressure wave T.sub.p and shear wave T.sub.s. The angle of refraction of the pressure wave T.sub.p is denoted as .beta., while the angle of refraction of the shear wave T.sub.s is .gamma.. In FIG. 1, the angle of incidence of the transmitted wave (I) is .phi., and in a preferred embodiment the angle of reflection of the reflected wave (R) is about equal to the angle of incidence .phi..

In an alternate embodiment, the transmitted wave (I) contacts the material 14 and is transmitted through the material, with the receiving transducer 12 located on the opposite side of the material.

The amplitudes of the displacement velocities corresponding to the pressure wave T.sub.p and shear wave T.sub.s are determined by conservation laws, which take into account the properties of material 14 and medium 16 as follows:

(1) continuity of normal components of the displacement (displacements along the normal are equal on each side of the interface);

(2) continuity of normal components of the stresses;

(3) continuity of the normal components of the intensity vector (absence of energy absorption at the interface); and

(4) constant phase relationship between waves along the entire wave front.

Obeying such conservation laws, from FIG. 1 the angles are related by the following condition: ##EQU1## where c is the velocity of the transmitted wave (I) in the medium 16, v.sub.p is the velocity of the pressure wave T.sub.p, and v.sub.s is the velocity of the shear wave T.sub.s in the material 14.

At a certain angle of incidence .phi., T.sub.p =T.sub.s =0, and therefore all the wave energy is reflected (reflection is a maxima, R=1). This angle of incidence is referred to as the first critical angle .phi..sub.1, and is useful in the method of the present invention.

A second critical angle (.phi..sub.2) occurs when the transmitted shear wave vanishes (T.sub.s =0) and the absolute value of the reflected wave (R) is at or near a maximum. This second critical angle is greater than the first critical angle .phi..sub.1, but is still less than 90.degree.. At this angle, the amplitude T.sub.p represents a surface wave traveling parallel to the surface of the medium 16. .phi..sub.2 occurs either at a maximum (R.sub.2 positive) or at an inflection point (R.sub.2 negative). In this latter case, .phi..sub.2 falls between a zero (minimum) and a maximum.

Turning to FIG. 2 the schematic of an apparatus 20 in accordance with the present invention is illustrated. Broadly speaking, the apparatus 20 includes a means for emitting or transmitting an ultrasound wave (transducer 10) and a means for receiving the reflected ultrasound wave (transducer 12). (In an embodiment where the system uses transmitted ultrasound rather than reflected ultrasound waves, the receiving transducer 12 would be positioned on the opposite side of the material 14 from the transmitting transducer 10.) A holding mechanism 22 positions the material under examination, while the separating medium 16 is interposed between the material 14 and transmitter and receivers 10 and 12. In FIG. 2, the material 14 under examination is a bone, while the separating medium 16 includes water and soft tissue.

A stepping motor 24 is coupled to transmitter 10 and receiver 12 respectively, and is coupled to the holding mechanism 22 by a toothed circular rail (not shown). The stepping motors are operable through motor controls 30 to move the transmitter 10 and receiver 12 through an arc about the material 14.

The signal analyzer 26 is preferably a microcomputer, which periodically triggers the signal generator 28. Upon receiving the trigger, the signal generator 28 generates a pulse which is amplified and passed to the transmitter 10. The transmitter 10 upon receiving the pulse transmits the ultrasound wave (I) through the medium 16 towards the material 14. The receiver 12 receives the ultrasound wave (R) reflected by the material 14 (or transmitted through the material 14 in an alternate embodiment). Preferably the transmitter 10 and receiver 12 are tuned to the same frequency.

During examination, the transmitter 10 and receiver 12 are initially positioned close to the normal to the material 14 (adjacent the Y axis as shown in FIG. 1). The transmitter 10 and receiver 12 are simultaneously stepped about the holding mechanism 22 so that the angle of incidence of the transmitted wave (I) is equal to the angle of reflection of the reflected wave (R). As shown in FIG. 1, this angle is denoted .phi. and preferably increases in the range from 0.degree.-90.degree., but useful investigations may be conducted using a more restricted range, e.g. to include only the first critical angle. As can be appreciated from FIG. 2, after each ultrasound transmitted wave (I), the motor controls 30 simultaneously step the transmitter 10 and receiver 12 to a new position. Depending upon the number of measurements desired (i.e. resolution), the transmitter 10 and receiver 12 are preferably stepped in increments of a fraction of a degree. Thus, the receiver 12 generates a signal at each increment which is recorded by the signal analyzer means 26 and represents the amplitude of the reflected wave (R) for a corresponding angle .phi.. The result of this examination is a plot of reflected amplitude (ordinate) versus the angle of incidence .phi. (abscissa).

Turning now to FIG. 3, an embodiment of the apparatus 20 of the present invention is illustrated in more detail. In the embodiment of FIG. 3, the transmitting transducer 10 is used as a signal transceiver, while the receiving transducer 12 is used as a receiver only. The microcomputer 26 periodically generates a trigger signal through the timer and pulse generator 32. The timer 32 generates a trigger to the signal generator 28 as shown in the drawing, and additionally generates a signal which is simultaneously passed to the analog-to-digital converters 34. The signal generator 28 generates a signal which is amplified by RF power amplifier 36, with the amplified signal passing through transmit switch 38 to the impedance matching network 40.

As can be appreciated from FIG. 1, the ultrasonic wave pressure from the transmitted wave (I) is reflected from the material surface 14 as reflected wave (R) and received by the receiver 12. The receiver 12 transforms the reflected wave (R) into a return signal which is passed through an impedance matching network 42, amplified at power amp 44, and presented to the A to D converters 34 as a return (retarded) pulse. The A to D converters 34 generate a digital signal which is representative of the analog return signal from transducer 12. As can be appreciated, if the transducer 10 is operated as a receiver, the switch 38 is toggled and the return signal amplified by the power amp 46 and presented to the A to D converters 34 in a similar fashion.

Digital oscilloscope 50 is used as needed and can be coupled as shown to the various circuits to verify, quantify and test signals in these circuits. Thus, the digital oscilloscope can monitor the amplified signal from the power amplifier 36, the return signals from the amplifiers 44 and 46, as well as the timing pulse from the timer 32. The signals monitored by the digital oscilloscope 50 may be graphically presented through the IEEE-488 interface 52 on the graphic display of the computer 26. A printer/plotter 54 is provided as an output option from the computer 26.

The stepper motor controls 30 receive inputs from the computer 26 as shown to incrementally step the transducers 10 and 12 about the material 14. As can be seen, the motor drivers 56 sense the input from the motor control 30 to synchronously, but independently, actuate the respective stepping motors 24 to move the transducers 10 and 12. The transducers 10 and 12 are preferably moved in incremental steps of fixed value and are at the approximately identical angle of incidence .phi. for each increment.

The holding mechanism 22 is adaptable for different uses, primarily dependent upon its size. For example, in the preferred embodiment of FIG. 3 a small, laboratory size system has been used for holding a single sample of polished bone or other material 14 in the water medium 16. This holding mechanism 22 has been found useful not only for experimental verification, but also for ex vivo analysis of samples and biopsies. Alternatively, a clinical system of the holding mechanism 22 has been devised in which the holding mechanism 22 is sufficiently large to receive portions of the human skeletal structure. This clinical system may be used for in vivo or in situ analysis and diagnosis of the tendency of bone to fracture, of bone healing, etc. Of course, different types of holding mechanisms 22 may be devised for holding different types of materials 14 other than bone.

Turning to FIG. 4, a block diagram of an alternative embodiment is illustrated in which the transducers are fixed and the transmission and reception are controlled electronically rather than mechanically as illustrated in FIG. 3. In FIG. 4, in situ analysis of a material 14 (bone) is illustrated. A transceiver system 60 includes an applicator head 62 which is capable of three dimensional adjustment motion (as shown by the direction arrows in FIG. 4). Although the applicator head 62 of FIG. 4 is manually adjustable, computer adjustment control is a desirable alternative. As can be seen, a pressurized, temperature controlled water bag or water bolus 64 is interposed between the applicator head 62 and patient, assuring good contact and match with the surface of the body of the patient. The water bag 64 has at least one surface that is flexible and can be positioned on the surface of a human body in proximity to a bone. The ultrasound transducers are in acoustic contact with the water bag. For example, the transducers can be immersed in the bag, or can be external to the bag but contacting it such that the ultrasound is conducted through the bag to or from the transducers. The applicator head 62 is positioned so that its focal point on the bone surface and its axis is aligned with the axis of the normal to the bone surface 14 at the point of interest as illustrated in FIG. 4.

The transceiver system 60 incorporates a circular transducer array comprising eighty small (1/2 inch by 1/4 inch) transducers 66. As can be appreciated, with the transceiver system 60 positioned in a desired location adjacent the patient, the transducers 66 can be electronically activated alternatively as transmitters or receivers as desired. Preferably, the transducers 66 are sequentially activated one at a time as a transmitter, or may be activated in a small group to give better definition of sound wave as it intersects with the bone 14. After a transducer 66 pulse, the transducers will be switched to act as receivers for the reflected sound energy of the reflected wave (R).

Sequence and timing mechanism 70 is provided which upon receiving a trigger signal from the computer 26 selects which transducer 66 (or group of transducers) will be pulsed and the duration of the pulse. The timing signal at the beginning of the pulse is also supplied to the A/D converter section 34. The pulse generator and switcher 72 generates and amplifies the signal which is directed through a specific lead line and switch 38 and impedance matching network 40, to a specific transducer 66 (or group of transducers). As soon as the transmitted wave (I) is generated from the activated transducer 66, the pulse generator and switcher 72 toggles the switches 38 to convert the transducers 66 to receive operation. Thus, all eighty transducers are acting as receivers for the reflected wave (R). The return signals indicative of the reflected wave (R) will pass through the A/D convertors 34, digitized, and presented to the computer 26 for processing and presentation.

FIG. 5 represents the flow charts for the operating software of the computer 26 of FIG. 3. FIG. 5 illustrates the main program or program overview, while FIGS. 5A-5F illustrate the subroutines as indicated. As can be seen from FIGS. 5 and 5A, the first subroutine is designed to determine the distance from the transducer 10 (or transducer "A") to the bone 14. This is easily accomplished using the apparatus 20 of FIG. 3, by operating the transducer 10 alternately in the transmit and receive mode. As can be seen from FIG. 5A, the patient or bone 14 is first manually positioned in the holding mechanism 22 and the transducer 10 manually positioned in a direct vertical orientation to the bone as viewed in FIG. 3. The transducer 10 is then pulsed and the echoes received with the lapsed time determinative of the distance to the bone 14. Distance to the bone can be calculated for each incremental increase in the angle of incidence .phi. (transducer 10 positioned in the arc about bone 14 as in FIG. 2 or by moving the applicator head 62 as in FIG. 4).

After the completion of subroutine 5A, the program proceeds to subroutine "Find Flat Spot" as illustrated in FIG. 5B. The distance to the bone calculated at various increments from the subroutine "Distance To Bone" are graphically displayed as an image on the computer 26 and correlated to find a relatively smooth, flat spot for evaluation. Once such a relatively flat spot is located, patient movement is prohibited and the transducers are positioned for evaluation of the flat spot, i.e. at a distance such that this spot is at the center of rotation and taking the normal to the flat spot as the axis of symmetry of transducer motion in a given plane (direction). The direction of the plane can be varied.

The program's next step is the subroutine "Locate Surfaces" illustrated in FIG. 5C, which is designed to locate the surfaces separating various media (tissues) which intervene between the transducers and bone surface. The transducer 10 is first positioned at a relatively small angle of incidence .phi. and the transmitted signal (I) initiated (pulsed). The reflected signal (R) is received, digitized, and stored on computer 26 before stepping the transducer 10 in the arc about the bone 14. Note from FIG. 5C that after the arc is completed and the digitized amplitude of the echo return signals stored, the various patient tissues are identified. That is, the patient surface, bone surface, and other intervening tissue boundaries (muscle, fat) are located, attenuation and scatter coefficients are assigned for each respective tissue, and the angle dependent attenuation thicknesses and beam path calculated. Thus, the "Locate Surfaces" subroutine primarily identifies the intervening tissue boundaries so that tissue attenuation and the ray path followed by the incident and reflected waves can be identified.

The next subroutine is illustrated in FIG. 5D and performs the "Scan Bone" routine to generate the primary raw data. As can be seen in FIG. 5D, the transmitted wave (I) is generated and the reflected wave (R) is received for each increment in angle of incidence .phi.. The distance from transducer 10 to the patient surface and bone surface is retrieved and the time of flight calculated for both the transmitted wave (I) and reflected wave (R). These are compared to the information obtained in the previous routine to check for patient movements. If no movement occurred, the "Scan Bone" subroutine then calculates bone echo amplitude corrected for attenuation in the intervening tissues and stores the digitized echo amplitude. The "Scan Bone" subroutine loops until the scan is complete. If more scans at the same site but along different directions are desired, the program loops back to "Locate Surfaces" until all desired scan directions are completed. Once all selected scan sites and