US5785656A — Ultrasonic bone assessment method and apparatus

Claim 1

Independent Claim 325 words

A method of non-invasive and quantitative assessment of the status of bone tissue in vivo for one or more of the quantities, bone-mineral density, bone strength, bone fracture risk, bone architecture and bone quality, comprising the steps of: (a) acoustically coupling a pair of multi-element, array transducers to nearby skin on opposite sides of said bone tissue; (b) generating an ultrasound signal and directing said ultrasound signal from an element of one array transducer of said pair of transducers to an element of another array transducer of said pair of transducers through said bone tissue thereby producing a bone oriented electrical output signal of the form z s (t)=p s (t)+n s (t), where p s (t) is said bone-oriented output signal per se and n s (t) is an additive, uncorrelated Gaussian measurement noise associated with said bone-oriented signal, said ultrasound signal being a finite-duration signal repeated substantially in a range from 1 to 1000 Hz and consisting of plural frequencies spaced in an ultrasonic spectral region up to about 2 MHz; (c) independently directing said ultrasound signal from said element of said one array transducer to said element of said another array transducer through a medium with known acoustic properties and path length and free of said bone tissue, thereby producing a reference electrical output signal of the form of z r (t)=p r (t)+n r (t), where p r (t) is said reference output signal per se and n r (t) is an additive, uncorrelated Gaussian measurement noise associated with said reference signal; (d) parametric modeling said bone-oriented signal and said reference signal, by obtaining two parametric models thereof, p s (t) and p r (t), respectively, to thereby establish a set ⊖ s of bone-oriented parameters and a set ⊖ r of reference parameters correspondingly associated with said models; and, (e) subjecting said two sets of parameters to comparative analysis, whereby an estimate of said one or more quantities is obtained.

Claim 2

Independent Claim 325 words

A method of non-invasive and quantitative assessment of the status of bone tissue in vivo for one or more of the quantities, bone-mineral density, bone strength, bone fracture risk, bone architecture and bone quality, comprising the steps of: (a) acoustically coupling a pair of multi-element, array transducers to nearby skin on opposite sides of said bone tissue; (b) generating an ultrasound signal and directing said ultrasound signal from an element of one array transducer of said pair of transducers to an element of another array transducer of said pair of transducers through said bone tissue thereby producing a bone oriented electrical output signal of the form z s (t)=p s (t)+n s (t), where p s (t) is said bone-oriented output signal per se and n s (t) is an additive, uncorrelated Gaussian measurement noise associated with said bone-oriented signal, said ultrasound signal being a finite-duration signal repeated substantially in a range from 1 to 1000 Hz and consisting of plural frequencies spaced in an ultrasonic spectral region up to about 2 MHz; (c) independently directing said ultrasound signal from said element of said one array transducer to said element of said another array transducer through a medium with known acoustic properties and path length and free of said bone tissue, thereby producing a reference electrical output signal of the form of z r (t)=p r (t)+n r (t), where p r (t) is said reference output signal per se and n r (t) is an additive, uncorrelated Gaussian measurement noise associated with said reference signal; (d) parametric modeling said bone-oriented signal and said reference signal, by obtaining two parametric models thereof, p s (t) and p r (t), respectively, to thereby establish a set ⊖ s of bone-oriented parameters and a set ⊖ r of reference parameters correspondingly associated with said models; and, (e) subjecting said two sets of parameters to comparative analysis, whereby an estimate of said one or more quantities is obtained.

Claim 3

Independent Claim 333 words

A method of non-invasive and quantitative assessment of the status of bone tissue in vivo for one or more of the quantities, bone-mineral density, bone strength, bone fracture risk, bone architecture and bone quality, comprising the steps of: (a) acoustically coupling a pair of multi-element, array transducers to nearby skin on opposite sides of said bone tissue; (b) generating an ultrasound signal and directing said ultrasound signal from a plurality of elements of one array transducer of said pair of transducers to a plurality of elements of another array transducer of said pair of transducers through said bone tissue thereby producing a bone oriented electrical output signal of the form z s (t)=p s (t)+n s (t), where p s (t) is said bone-oriented output signal per se and n s (t) is an additive, uncorrelated Gaussian measurement noise associated with said bone-oriented signal, said ultrasound signal being a finite-duration signal repeated substantially in a range from 1 to 1000 Hz and consisting of plural frequencies spaced in an ultrasonic spectral region up to about 2 MHz; (c) independently directing said ultrasound signal from said plurality of elements of said one array transducer to said plurality of elements of said another array transducer through a medium with known acoustic properties and path length and free of said bone tissue, thereby producing a reference electrical output signal of the form of z r (t)=p r (t)+n r (t), where p r (t) is said reference output signal per se and n r (t) is an additive, uncorrelated Gaussian measurement noise associated with said reference signal; (d) parametric modeling said bone-oriented signal and said reference signal, by obtaining two parametric models thereof, p s (t) and p r (t), respectively, to thereby establish a set ⊖ s of bone-oriented parameters and a set ⊖ r of reference parameters correspondingly associated with said models; and, (e) subjecting said two sets of parameters to comparative analysis, whereby an estimate of said one or more quantities is obtained.

Claim 4

Independent Claim 333 words

A method of non-invasive and quantitative assessment of the status of bone tissue in vivo for one or more of the quantities, bone-mineral density, bone strength, bone fracture risk, bone architecture and bone quality, comprising the steps of: (a) acoustically coupling a pair of multi-element, array transducers to nearby skin on opposite sides of said bone tissue; (b) generating an ultrasound signal and directing said ultrasound signal from a plurality of elements of one array transducer of said pair of transducers to a plurality of elements of another array transducer of said pair of transducers through said bone tissue thereby producing a bone oriented electrical output signal of the form z s (t)=p s (t)+n s (t), where p s (t) is said bone-oriented output signal per se and n s (t) is an additive, uncorrelated Gaussian measurement noise associated with said bone-oriented signal, said ultrasound signal being a finite-duration signal repeated substantially in a range from 1 to 1000 Hz and consisting of plural frequencies spaced in an ultrasonic spectral region up to about 2 MHz; (c) independently directing said ultrasound signal from said plurality of elements of said one array transducer to said plurality of elements of said another array transducer through a medium with known acoustic properties and path length and free of said bone tissue, thereby producing a reference electrical output signal of the form of z r (t)=p r (t)+n r (t), where p r (t) is said reference output signal per se and n r (t) is an additive, uncorrelated Gaussian measurement noise associated with said reference signal; (d) parametric modeling said bone-oriented signal and said reference signal, by obtaining two parametric models thereof, p s (t) and p r (t), respectively, to thereby establish a set ⊖ s of bone-oriented parameters and a set ⊖ r of reference parameters correspondingly associated with said models; and, (e) subjecting said two sets of parameters to comparative analysis, whereby an estimate of said one or more quantities is obtained.

Claim 5

Dependent Claim 61 words

A method as described in claim 2, further comprising the step of: (f) repeating said step (b), said step (c), said step (d), and said step (e) wherein said ultrasound signal is directed in said step (b) and said step (c) from a second plurality of elements of said one transducer to a second plurality of elements of said another transducer.

Claim 6

Dependent Claim 58 words

A method according to claim 1, further comprising the step of: (f) repeating said step (b), said step (c), said step (d) and said step (e), wherein said ultrasound signal is directed in said step (b) and said step (c) from a second element of said one array transducer to a second element of said another array transducer.

Claim 7

Independent Claim 268 words

A method of non-invasive and quantitative assessment of the status of bone tissue in vivo for at least one of the quantities, bone-mineral density, bone strength, bone fracture risk, bone architecture and bone quality comprising, the steps of: (a) acoustically coupling a pair of multi-element, array transducers to nearby skin on opposite sides of said bone tissue; (b) generating an ultrasound signal and directing said ultrasound signal from an element of one array transducer of said pair of transducers to an element of another array transducer of said pair of transducers through said bone tissue, to produce a bone-oriented electrical output signal z s (t), said ultrasound signal being a finite-duration signal repeated substantially in a range of from about 1 to about 1000 Hz and having plural frequencies spaced in an ultrasonic spectral region up to about 2 MHz; (c) independently directing said ultrasound signal from said element of said one array transducer to said element of said another array transducer through a medium with known acoustic properties and path length and free of said bone tissue to produce a reference electrical output signal z r (t); (d) establishing a set ⊖ s of bone-oriented parameters associated with said bone-oriented output signal z s (t) and a set ⊖ r of reference parameters associated with said reference signal z r (t); and (e) subjecting said set ⊖ s of bone-oriented parameters and said set ⊖ r of reference parameters to comparative analysis, whereby an estimate of said at least one of the quantities, bonemineral density, bone strength, bone fracture risk, bone architecture and bone quality is obtained.

Claim 8

Independent Claim 268 words

A method of non-invasive and quantitative assessment of the status of bone tissue in vivo for at least one of the quantities, bone-mineral density, bone strength, bone fracture risk, bone architecture and bone quality comprising, the steps of: (a) acoustically coupling a pair of multi-element, array transducers to nearby skin on opposite sides of said bone tissue; (b) generating an ultrasound signal and directing said ultrasound signal from an element of one array transducer of said pair of transducers to an element of another array transducer of said pair of transducers through said bone tissue, to produce a bone-oriented electrical output signal z s (t), said ultrasound signal being a finite-duration signal repeated substantially in a range of from about 1 to about 1000 Hz and having plural frequencies spaced in an ultrasonic spectral region up to about 2 MHz; (c) independently directing said ultrasound signal from said element of said one array transducer to said element of said another array transducer through a medium with known acoustic properties and path length and free of said bone tissue to produce a reference electrical output signal z r (t); (d) establishing a set ⊖ s of bone-oriented parameters associated with said bone-oriented output signal z s (t) and a set ⊖ r of reference parameters associated with said reference signal z r (t); and (e) subjecting said set ⊖ s of bone-oriented parameters and said set ⊖ r of reference parameters to comparative analysis, whereby an estimate of said at least one of the quantities, bonemineral density, bone strength, bone fracture risk, bone architecture and bone quality is obtained.

Claim 9

Dependent Claim 49 words

The method according to claim 5, wherein said set ⊖ s of bone-oriented parameters includes a mean instantaneous frequency associated with said bone-oriented output signal z s (t) and said set ⊖ r of reference parameters includes a mean instantaneous frequency associated with said reference signal z r (t).

Claim 10

Dependent Claim 169 words

The method according to claim 6, wherein said step (d) includes the steps of: processing said bone-oriented output signal z s (t) to obtain a corresponding Hilbert transform, z SH (t); obtaining a complex analytic signal z sA (t) associated with said bone-oriented output signal z s (t) wherein said complex analytic signal z sA (t) is defined as z sA (t)=z s (t)+jz sH (t), where j=(-1) 1/2 ; processing said complex analytic signal z sA (t) to obtain said mean instantaneous frequency associated with said bone-oriented output signal z s (t); processing said reference signal z r (t) to obtain a corresponding Hilbert transform, z rH (t); obtaining a complex analytic signal z rA (t) associated with said reference signal z r (t) wherein said complex analytic signal z rA (t) is defined as z rA (t)=z r (t)+jz rH (t), where j=(-1).sup. 1/2; and processing said complex analytic signal z rA (t) to obtain said mean instantaneous frequency associated with said reference signal z r (t).

Claim 11

Dependent Claim 82 words

The method according to claim 6, wherein said step (e) includes the step of evaluating a quantitative ultrasonic feature parameter β wherein β=1-(MIF/MIF ref ) where MIF is said mean instantaneous frequency associated with said bone-oriented output signal z s (t) and MIF ref is said mean instantaneous frequency associated with said reference signal z r (t), to thereby obtain an estimate of said at least one of the quantities, bone-mineral density, bone strength, bone fracture risk, bone architecture, and bone quality.

Claim 12

Dependent Claim 47 words

The method according to claim 5, wherein said set ⊖ s of bone-oriented parameters includes an average frequency content of said bone-oriented output signal z s (t) and said set ⊖ r of reference parameters includes an average frequency content of said reference signal z r (t).

Claim 13

Dependent Claim 48 words

The method according to claim 9, wherein said step (d) includes the steps of: using zero-crossing analysis to define said average frequency content of said bone-oriented output signal z s (t); and using zero-crossing analysis to define said average frequency content of said reference signal z r (t).

Claim 14

Dependent Claim 49 words

The method according to claim 5, wherein said set ⊖ s of bone-oriented parameters includes an envelope time duration parameter of said bone-oriented output signal z s (t) and said set ⊖ r of reference parameters includes an envelope time duration parameter of said reference signal z r (t).

Claim 15

Dependent Claim 170 words

The method according to claim 11, wherein said step (d) includes the steps of: processing said bone-oriented output signal z s (t) to obtain a corresponding Hilbert transform z sH (t); obtaining a complex analytic signal z sA (t) associated with said bone-oriented output signal z s (t) wherein said complex analytic signal z sA (t) is defined as z sA (t)=z s (t)+jz sH t), where j=(-1) 1/2 ; processing said complex analytic signal z sA (t) to obtain said envelope time duration parameter of said bone-oriented output signal z s (t); processing said reference signal z r (t) to obtain a corresponding Hilbert transform z rH (t); obtaining a complex analytic signal z rA (t) associated with said reference signal z r (t) wherein said complex analytic signal z rA (t) is defined as z rA (t)=z r (t)+jz rH (t), where j=(-1) 1/2 ; and processing said complex analytic signal z rA (t) to obtain said envelope time duration parameter of said reference signal z r (t).

Claim 16

Dependent Claim 53 words

The method according to claim 11, wherein said (d) includes the steps of: using an envelope detection method to obtain said envelope time duration parameter of said bone-oriented output signal z s (t); and using an envelope detection method to obtain said envelope time duration parameter of said reference signal z r (t).

Claim 17

Dependent Claim 47 words

The method according to claim 5, wherein said set ⊖ s of bone-oriented parameters includes an overall energy content of said bone-oriented output signal z s (t) and said set ⊖ r of reference parameters includes an overall energy content of said reference signal z r (t).

Claim 18

Dependent Claim 49 words

The method according to claim 5, wherein said set ⊖ s of bone-oriented parameters includes an envelope time delay parameter of said bone-oriented output signal z z (t) and said set ⊖ r of reference parameters includes an envelope time delay parameter of said reference signal z r (t).

Claim 19

Dependent Claim 102 words

The method according to claim 5 further comprising a first step, prior to said step (e), of obtaining a differential phase estimate τ g (f) associated with the phase difference between said bone-oriented output signal z s (t) and said reference signal z r (t); and wherein said step (e) includes subjecting said set ⊖ s of bone-oriented parameters, said set ⊖ r of reference parameters and said differential phase estimate τ g (f) to comparative analysis, whereby an estimate of said at least one of the quantities, bone-mineral density, bone strength, bone fracture risk, bone architecture and bone quality is obtained.

Claim 20

Dependent Claim 81 words

The method according to claim 16, wherein said first step prior to said step (e) includes: processing said bone-oriented output signal z s (t) to obtain a corresponding Fourier transform Z s (f); processing said reference signal z r (t) to obtain a corresponding Fourier transform Z r (f); and generating said differential phase estimate τ g (f) wherein τ g (f)=(-L/2π)*(dβ(f)/df), where β(f)=arg H(f)!/L and where H(f)=Z s (f)/Z r (f) and L is a thickness of a bony member.

Claim 21

Dependent Claim 15 words

The method according to claim 17, wherein L is a thickness of said bone tissue.

Claim 22

Dependent Claim 91 words

The method according to claim 16, further comprising a second step, prior to said step (e), of processing said differential phase estimate τ g (f) to obtain a group velocity estimate v g (f); and wherein said step (e) includes subjecting said set ⊖ s of bone-oriented parameters, said set ⊖ r of reference parameters, and said group velocity estimate v g (f) to comparative analysis, whereby an estimate of said at least one of the quantities, bone-mineral density, bone strength, bone fracture risk, bone architecture and bone quality is obtained.

Claim 23

Dependent Claim 87 words

The method according to claim 19, further comprising a third step, prior to said step (e), of processing said group velocity estimate v g (f) to obtain a set of polynomial coefficients; and wherein said step (e) includes subjecting said set ⊖ s of bone-oriented parameters, said set ⊖ r of reference parameters, and said set of polynomial coefficients to comparative analysis, whereby an estimate of said at least one of the quantities, bone-mineral density, bone strength, bone fracture risk, bone architecture and bone quality is obtained.

Claim 24

Dependent Claim 90 words

The method according to claim 5 wherein said step (e) includes subjecting said set ⊖ s of bone-oriented parameters, said set ⊖ r of reference parameters and at least one value selected from the group consisting of a patient's age, a patient's sex, a patient's height, a patient's weight, a thickness of said bone tissue, and a thickness of a bony member to comparative analysis, whereby an estimate of said at least one of the quantities, bonemineral density, bone strength, bone fracture risk, bone architecture and bone quality is obtained.

Claim 25

Dependent Claim 19 words

The method according to claim 5, wherein said comparative analysis is performed with the use of a neural network.

Claim 26

Dependent Claim 18 words

The method according to claim 5, wherein said comparative analysis is performed with the use of multivariate regressions.

Claim 27

Dependent Claim 21 words

The method according to claim 5, wherein said comparative analysis is performed with the use of a statistical hypothesis testing algorithm.

Claim 28

Dependent Claim 58 words

The method according to claim 5, further comprising the step of: (f) repeating said step (b), said step (c), said step (d), and said step (e), wherein said ultrasound signal is directed in said step (b) and said step (c) from a second element of said one array transducer to a second element of said another array transducer.

Claim 29

Dependent Claim 40 words

The method according to claim 5, wherein said ultrasound signal is directed in said step (b) and said step (c) from a plurality of elements of said one array transducer to a plurality of elements of said another array transducer.

Claim 30

Dependent Claim 62 words

The method according to claim 26, further comprising the step of: (f) repeating said step (b), said step (c), said step (d) and said step (e), wherein said ultrasound signal is directed in said step (b) and said step (c) from a second plurality of elements of said one array transducer to a second plurality of elements of said another array transducer.

Claim 31

Independent Claim 303 words

A method of non-invasive and quantitative assessment of the status of bone tissue in vivo for at least one of the quantities, bone-mineral density, bone strength, bone fracture risk, bone architecture and bone quality, comprising the steps of: (a) acoustically coupling a pair of multi-element, array transducers to nearby skin on opposite sides of said bone tissue; (b) generating an ultrasound signal and directing said ultrasound signal from an element of one array transducer of said pair of transducers to an element of another array transducer of said pair of transducers through said bone tissue, to produce a bone-oriented electrical output signal, said ultrasound signal being a finite-duration signal having plural frequencies spaced in an ultrasonic spectral region up to about 2 MHz; (c) repeating step (b) a plurality of times to obtain a plurality of bone-oriented output signals; (d) averaging said plurality of bone-oriented output signals to obtain an averaged bone-oriented output signal; (e) independently directing said ultrasound signal from said element of said one array transducer to said element of said another array transducer through a medium with known acoustic properties and path length and free of said bone tissue to produce a reference electrical output signal; (f) repeating step (e) a plurality of times to obtain a plurality of reference signals; (g) averaging said plurality of reference signals to obtain an averaged reference signal; (h) establishing a set ⊖ s of bone-oriented parameters associated with said averaged bone-oriented output signal and a set ⊖ r of reference parameters associated with said averaged reference signal; and (i) subjecting said set ⊖ s of bone-oriented parameters and said set ⊖ r of reference parameters to comparative analysis whereby an estimate of said at least one of the quantities, bonemineral density, bone strength, bone fracture risk, bone architecture and bone quality is obtained.

Claim 32

Independent Claim 303 words

A method of non-invasive and quantitative assessment of the status of bone tissue in vivo for at least one of the quantities, bone-mineral density, bone strength, bone fracture risk, bone architecture and bone quality, comprising the steps of: (a) acoustically coupling a pair of multi-element, array transducers to nearby skin on opposite sides of said bone tissue; (b) generating an ultrasound signal and directing said ultrasound signal from an element of one array transducer of said pair of transducers to an element of another array transducer of said pair of transducers through said bone tissue, to produce a bone-oriented electrical output signal, said ultrasound signal being a finite-duration signal having plural frequencies spaced in an ultrasonic spectral region up to about 2 MHz; (c) repeating step (b) a plurality of times to obtain a plurality of bone-oriented output signals; (d) averaging said plurality of bone-oriented output signals to obtain an averaged bone-oriented output signal; (e) independently directing said ultrasound signal from said element of said one array transducer to said element of said another array transducer through a medium with known acoustic properties and path length and free of said bone tissue to produce a reference electrical output signal; (f) repeating step (e) a plurality of times to obtain a plurality of reference signals; (g) averaging said plurality of reference signals to obtain an averaged reference signal; (h) establishing a set ⊖ s of bone-oriented parameters associated with said averaged bone-oriented output signal and a set ⊖ r of reference parameters associated with said averaged reference signal; and (i) subjecting said set ⊖ s of bone-oriented parameters and said set ⊖ r of reference parameters to comparative analysis whereby an estimate of said at least one of the quantities, bonemineral density, bone strength, bone fracture risk, bone architecture and bone quality is obtained.

Claim 33

Dependent Claim 19 words

The method according to claim 28, wherein said comparative analysis is performed with the use of a neural network.

Claim 34

Dependent Claim 18 words

The method according to claim 28, wherein said comparative analysis is performed with the use of multivariate regressions.

Claim 35

Dependent Claim 21 words

The method according to claim 28, wherein said comparative analysis is performed with the use of a statistical hypothesis testing algorithm.

Claim 36

Independent Claim 258 words

An apparatus for non-invasive and quantitative assessment of the status of bone tissue in vivo for at least one of the quantities, bone-mineral density, bone strength, bone fracture risk, bone architecture, and bone quality, comprising a pair of multi-element, array ultrasonic transducers; means for generating an ultrasound signal, said ultrasound signal being a finite-duration signal repeated substantially in a range of from about 1 to about 1000 Hz and having plural frequencies spaced in an ultrasonic spectral region up to about 2 MHz; means for directing said ultrasound signal from an element of one array transducer of said pair of transducers to an element of another array transducer of said pair of transducers through said bone tissue to produce a bone-oriented electrical output signal z s (t); means for independently directing said ultrasound signal from said element of said one array transducer to said element of said another array transducer through a medium of known acoustic properties and path length and free of said bone tissue to produce a reference electrical output signal z r (t); means for establishing a set ⊖ s of bone-oriented parameters associated with said bone-oriented output signal z s (t) and a set ⊖ r of reference parameters associated with said reference signal z r (t); and means for performing comparative analysis of said set of bone-oriented parameters ⊖ s and said set of reference parameters ⊖ r to thereby obtain an estimate of said at least one of the quantities, bone-mineral density, bone strength, bone fracture risk, bone architecture and bone quality.

Claim 37

Independent Claim 258 words

An apparatus for non-invasive and quantitative assessment of the status of bone tissue in vivo for at least one of the quantities, bone-mineral density, bone strength, bone fracture risk, bone architecture, and bone quality, comprising a pair of multi-element, array ultrasonic transducers; means for generating an ultrasound signal, said ultrasound signal being a finite-duration signal repeated substantially in a range of from about 1 to about 1000 Hz and having plural frequencies spaced in an ultrasonic spectral region up to about 2 MHz; means for directing said ultrasound signal from an element of one array transducer of said pair of transducers to an element of another array transducer of said pair of transducers through said bone tissue to produce a bone-oriented electrical output signal z s (t); means for independently directing said ultrasound signal from said element of said one array transducer to said element of said another array transducer through a medium of known acoustic properties and path length and free of said bone tissue to produce a reference electrical output signal z r (t); means for establishing a set ⊖ s of bone-oriented parameters associated with said bone-oriented output signal z s (t) and a set ⊖ r of reference parameters associated with said reference signal z r (t); and means for performing comparative analysis of said set of bone-oriented parameters ⊖ s and said set of reference parameters ⊖ r to thereby obtain an estimate of said at least one of the quantities, bone-mineral density, bone strength, bone fracture risk, bone architecture and bone quality.

Claim 38

Dependent Claim 96 words

The apparatus of claim 32, further comprising means for preprocessing said set of bone-oriented parameters ⊖ s and said set of reference parameters ⊖ r prior to performing said comparative analysis in order to obtain a reduced set of bone-oriented parameters and a reduced set of reference parameters; and wherein said performing means performs said comparative analysis of said reduced set of bone-oriented parameters and said reduced set of reference parameters to thereby obtain an estimate of said at least one of the quantities, bone-mineral density, bone strength, bone fracture risk, bone architecture and bone quality.

Claim 39

Dependent Claim 76 words

The apparatus of claim 32, further comprising: means for averaging a plurality of bone-oriented output signals z s (t) to produce an averaged bone-oriented output signal; means for averaging a plurality of reference signals z r (t)to produce an averaged reference signal; and wherein said establishing means produces a set ⊖ s of bone-oriented parameters associated with said averaged bone-oriented output signal and a set ⊖ r of reference parameters associated with said averaged reference signal.

Claim 40

Independent Claim 382 words

A method of non-invasive and quantitative assessment of the status of bone tissue in vivo for at least one of the quantities, bone-mineral density, bone strength, bone fracture risk, bone architecture and bone quality comprising, the steps of: (a) acoustically coupling a pair of multi-element, array transducers to nearby skin on opposite sides of said bone tissue; (b) generating an ultrasound signal and directing said ultrasound signal from an element of one array transducer of said pair of transducers to an element of another array transducer of said pair of transducers through said bone tissue, to produce a bone-oriented electrical output signal z s (t), said ultrasound signal being a finite-duration signal repeated substantially in a range of from about 1 to about 1000 Hz and having plural frequencies spaced in an ultrasonic spectral region up to about 2 MHz; (c) independently directing said ultrasound signal from said element of said one array transducer to said element of said another array transducer through a medium with known acoustic properties and path length and free of said bone tissue to produce a reference electrical output signal z r (t); (d) establishing a set ⊖ s of bone-oriented parameters associated with said bone-oriented output signal z s (t) and a set ⊖ r of reference parameters associated with said reference signal z r (t); (e) repeating said step (b), said step (c), and said step (d) at least one time wherein said ultrasound signal is directed in said step (b) and said step (c) from a previously unselected element of said one array transducer to a previously unselected element of said another array transducer to thereby create a plurality of sets ⊖ s of bone-oriented parameters and a plurality of sets ⊖ r of reference parameters; (f) evaluating said plurality of sets es of boneoriented parameters to locate an anatomical region; (g) subjecting at least one set ⊖ s of said plurality of sets ⊖ s of bone-oriented parameters, said one set ⊖ s corresponding to said anatomical region, and at least one set ⊖ r of said plurality of sets ⊖ r of reference parameters to comparative analysis, whereby an estimate of said at least one of the quantities, bone-mineral density, bone strength, bone fracture risk, bone architecture and bone quality is obtained.

Claim 41

Independent Claim 382 words

A method of non-invasive and quantitative assessment of the status of bone tissue in vivo for at least one of the quantities, bone-mineral density, bone strength, bone fracture risk, bone architecture and bone quality comprising, the steps of: (a) acoustically coupling a pair of multi-element, array transducers to nearby skin on opposite sides of said bone tissue; (b) generating an ultrasound signal and directing said ultrasound signal from an element of one array transducer of said pair of transducers to an element of another array transducer of said pair of transducers through said bone tissue, to produce a bone-oriented electrical output signal z s (t), said ultrasound signal being a finite-duration signal repeated substantially in a range of from about 1 to about 1000 Hz and having plural frequencies spaced in an ultrasonic spectral region up to about 2 MHz; (c) independently directing said ultrasound signal from said element of said one array transducer to said element of said another array transducer through a medium with known acoustic properties and path length and free of said bone tissue to produce a reference electrical output signal z r (t); (d) establishing a set ⊖ s of bone-oriented parameters associated with said bone-oriented output signal z s (t) and a set ⊖ r of reference parameters associated with said reference signal z r (t); (e) repeating said step (b), said step (c), and said step (d) at least one time wherein said ultrasound signal is directed in said step (b) and said step (c) from a previously unselected element of said one array transducer to a previously unselected element of said another array transducer to thereby create a plurality of sets ⊖ s of bone-oriented parameters and a plurality of sets ⊖ r of reference parameters; (f) evaluating said plurality of sets es of boneoriented parameters to locate an anatomical region; (g) subjecting at least one set ⊖ s of said plurality of sets ⊖ s of bone-oriented parameters, said one set ⊖ s corresponding to said anatomical region, and at least one set ⊖ r of said plurality of sets ⊖ r of reference parameters to comparative analysis, whereby an estimate of said at least one of the quantities, bone-mineral density, bone strength, bone fracture risk, bone architecture and bone quality is obtained.

Claim 42

Dependent Claim 25 words

The method according to claim 35, wherein said step (f) includes using at least one edge of said bone tissue to locate said anatomical region.

Claim 43

Dependent Claim 19 words

The method according to claim 36, wherein said at least one edge is identified using an edge detection algorithm.

Claim 44

Dependent Claim 19 words

The method according to claim 35, wherein said step (f) includes using template matching to locate said anatomical region.

Claim 45

Dependent Claim 19 words

The method according to claim 35, wherein said step (f) includes using correlative techniques to locate said anatomical region.

Claim 46

Independent Claim 317 words

A method of non-invasive and quantitative assessment of the status of bone tissue in vivo for one or more of the quantities, bone-mineral density, bone strength, bone fracture risk, bone architecture and bone quality, comprising the steps of: (a) acoustically coupling a pair of multi-element, array transducers to nearby skin on opposite sides of bone tissue; (b) generating an ultrasound signal and directing said ultrasound signal from an element of one array transducer of said pair of transducers to an element of another array transducer of said pair of transducers through said bone tissue thereby producing a bone oriented electrical output signal of the form z s (t)=p s (t)+n s (t), where p s (t) is said bone-oriented output signal per se and n s (t) is an additive, uncorrelated Gaussian measurement noise associated with said bone-oriented signal, said ultrasound signal being a finite-duration signal repeated substantially in a range from 1 to 1000 Hz and consisting of plural frequencies spaced in an ultrasonic spectral region up to about 2 MHz; (c) independently directing said ultrasound signal from said element of said one array transducer to said element of said another array transducer through a medium with known acoustic properties and path length and free of said bone tissue, thereby producing a reference electrical output signal of the form of z r (t)=p r (t)+n r (t), where p r (t) is said reference output signal per se and n r (t) is an additive, uncorrelated Gaussian measurement noise associated with said reference signal; (d) parametric modeling said bone-oriented signal and said reference signal, by obtaining two parametric models thereof, p s (t) and p r (t), respectively, to thereby establish a set ⊖ s of bone-oriented parameters and a set ⊖ r of reference parameters correspondingly associated with said models; and, (e) subjecting said two sets of parameters to comparative analysis to assess bone status.

Claim 47

Independent Claim 317 words

A method of non-invasive and quantitative assessment of the status of bone tissue in vivo for one or more of the quantities, bone-mineral density, bone strength, bone fracture risk, bone architecture and bone quality, comprising the steps of: (a) acoustically coupling a pair of multi-element, array transducers to nearby skin on opposite sides of bone tissue; (b) generating an ultrasound signal and directing said ultrasound signal from an element of one array transducer of said pair of transducers to an element of another array transducer of said pair of transducers through said bone tissue thereby producing a bone oriented electrical output signal of the form z s (t)=p s (t)+n s (t), where p s (t) is said bone-oriented output signal per se and n s (t) is an additive, uncorrelated Gaussian measurement noise associated with said bone-oriented signal, said ultrasound signal being a finite-duration signal repeated substantially in a range from 1 to 1000 Hz and consisting of plural frequencies spaced in an ultrasonic spectral region up to about 2 MHz; (c) independently directing said ultrasound signal from said element of said one array transducer to said element of said another array transducer through a medium with known acoustic properties and path length and free of said bone tissue, thereby producing a reference electrical output signal of the form of z r (t)=p r (t)+n r (t), where p r (t) is said reference output signal per se and n r (t) is an additive, uncorrelated Gaussian measurement noise associated with said reference signal; (d) parametric modeling said bone-oriented signal and said reference signal, by obtaining two parametric models thereof, p s (t) and p r (t), respectively, to thereby establish a set ⊖ s of bone-oriented parameters and a set ⊖ r of reference parameters correspondingly associated with said models; and, (e) subjecting said two sets of parameters to comparative analysis to assess bone status.

Annuity Stage	Window Opens	Payment Deadline	Surcharge Period Until	Estimated Fee	Status
3.5 Years (Year 4)	2001-07-27	2002-01-26	2002-07-28	$2000.00	Window Closed / Lapsed
7.5 Years (Year 8)	2005-07-27	2006-01-26	2006-07-28	$3760.00	Window Closed / Lapsed
11.5 Years (Year 12)	2009-07-27	2010-01-26	2010-07-28	$7700.00	Window Closed / Lapsed

Ultrasonic bone assessment method and apparatus

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