Systems and methods for minimally-invasive optical-acoustic imaging

FIELD OF THE INVENTION

This document relates generally to imaging, and particularly, but not by way of limitation, to systems and methods for minimally-invasive optical-acoustic imaging.

BACKGROUND

Vardi et al. PCT Patent Application No. <patcit id="pcit0001" dnum="US9904913W"><text>PCT/US99/04913, which published on 18 November 1999</text></patcit> as International Publication No. <patcit id="pcit0002" dnum="WO9958059A"><text>WO 99/58059</text></patcit>, discusses an optical-acoustic imaging device. In that document, which is incorporated herein by reference in its entirety, including its disclosure of a guidewire optical-acoustic imaging device, an elongated imaging guidewire includes an elongated optical fiber driven by light from a laser. A distal end of the guidewire includes a polyvinyldiene fluoride (PVDF) film piezoelectric ultrasound transducer. The ultrasound transducer transmits ultrasound to an imaging region of interest about the distal tip of the guidewire, and also receives the returned ultrasound energy. The received ultrasound energy deforms a Fiber Bragg Grating (FBG or "Bragg grating") at the distal end of the guide wire, which, in turn, modulates the optical signal through the optical fiber. Imaging information about the region of interest is then obtained at the proximal end of the guidewire from the modulated optical signal.

Among other things, the present applicant has recognized that a piezoelectric ultrasound transducer may be difficult to integrate with a minimally-invasive guidewire because of electrical signal losses in ultrafine electrical conductors extending longitudinally through the guidewire assembly. Moreover, the present applicant has recognized that the field of view of the Vardi et al. device may be limited by the size of aperatures around the PVDF ultrasound transducers and/or the spacing between FBGs. Furthermore, the present applicant has recognized that the sensitivity of the Vardi et al. device may limit its usefulness in an imaging application. For these and other reasons, the present applicant has recognized that there is an unmet need in the art for improved systems and methods for performing optical-acoustic imaging.

<patcit id="pcit0003" dnum="WO9958059A"><text>WO 99/58059</text></patcit> discloses a guide wire imaging device for vascular or non-vascular imaging utilizing optic acoustical methods, which device has a profile of less than 1 mm in diameter. The ultrasound imaging device of the invention comprises a single mode optical fiber with at least one Bragg grating, and a piezoelectric or piezo-ceramic jacket, which device may achieve omnidirectional (360°) imaging. The imaging guide wire of the invention can function as the guide wire for vascular interventions, can enable real time imaging during balloon inflation, and stent deployment, thus will provide clinical information that is not available when catheter based imaging systems are used. The device of the invention may enable shortened total procedure times, including the fluoroscopy time, will also reduce radiation exposure to the patient, and the operator.

In <patcit id="pcit0004" dnum="GB2270159A"><text>GB2270159</text></patcit> an optically controlled ultrasonic array comprises method and means of optically addressing and activating a slab of a suitable material which can be pixelated or continuous and which acts as a remotely controlled ultrasonic array. The slab is addressed and activated by a scanning optical beam or by an optical array, and replaces hard wired ultrasonic arrays reducing or eliminating transducer wiring and solid state switching. The scanned addressing and activation into acoustic oscillation of areas on the slab, effective pixel elements, is remote and faster than can be achieved by electronic switching of individual transducer elements on a conventional piezoelectric transducer array, e.g. by optically switching electrical parts of the elements or by optically activating photo-sensitive cells which will generate the electrical signals necessary to energise the elements. The optical control can make use of a photo-thermal or photo-acoustic transduction process to generate acoustic waves. The system can be used for medical diagnosis or treatment as well as non-destructive testing or ultrasonic treatment, including plastic welding.

<patcit id="pcit0005" dnum="WO03057061A"><text>WO 03/057061</text></patcit> discloses an acoustic generator, comprising: a source of electro-magnetic radiation; a waveguide coupled to said source; and at least one absorbing region defined in said waveguide, said region being selectively absorbing for portions of said radiation meeting at least one certain criterion and having significantly different absorbing characteristics for radiation not meeting said criterion, both of said radiation portions being suitable for conveyance through said waveguide, wherein said absorbing region converts said radiation into an ultrasonic acoustic field. Optionally, said region comprises a volumetric absorber. Alternatively or additionally, said region comprises a plurality of regions.

SUMMARY

The invention is defined by claims 1, 22 and 37.

BRIEF DESCRIPTION OF THE DRAWINGS

In the drawings, which are not necessarily drawn to scale, like numerals describe substantially similar components throughout the several views. Like numerals having different letter suffixes represent different instances of substantially similar components. The drawings illustrate generally, by way of example, but not by way of limitation, various embodiments discussed in the present document. <ul id="ul0001" list-style="none" compact="compact"><li><figref idref="f0001">Figure 1</figref> is a cross-sectional side view illustrating generally, by way of example, but not by way of limitation, one example of an FBG strain sensor in an optical fiber.</li><li><figref idref="f0001">Figure 2</figref> is a cross-sectional side view illustrating generally, by way of example, but not by way of limitation, an example of an FBG grating interferometer sensor.</li><li><figref idref="f0002">Figure 3A</figref> is a cross-sectional schematic diagram illustrating generally one example of a distal portion of an imaging guidewire that combines an acousto-optic FBG sensor with an photoacoustic transducer.</li><li><figref idref="f0002">Figure 3B</figref> is a cross-sectional schematic diagram illustrating generally one example of a distal portion of an imaging guidewire that combines an acousto-optic FBG sensor with an photoacoustic transducer.</li><li><figref idref="f0003">Figure 4</figref> is a cross-sectional schematic diagram illustrating generally one example of the operation of a blazed grating FBG photoacoustic transducer.</li><li><figref idref="f0003">Figure 5</figref> is a schematic diagram comparing an expected angular sensitivity pattern of an exemplary blazed FBG optical-to-acoustic and acoustic-to-optical combined device to that of a piezoelectric sensor.</li><li><figref idref="f0004">Figure 6</figref> is a schematic diagram illustrating generally one technique of generating an image by rotating the blazed FBG optical-to-acoustic and acoustic-to-optical combined transducer and displaying the resultant series of radial image lines to create a radial image.</li><li><figref idref="f0004">Figure 7</figref> is a schematic diagram that illustrates generally one such phased array example, in which the signal to/from each array transducer is combined with the signals from the other transducers to synthesize a radial image line.</li><li><figref idref="f0005">Figure 8</figref> is a schematic diagram that illustrates generally an example of a side view of a distal portion of a guidewire.</li><li><figref idref="f0005">Figure 9</figref> is a schematic diagram that illustrates generally one example of a cross-sectional side view of a distal portion of a guidewire.</li><li><figref idref="f0006">Figure 10</figref> is a schematic diagram that illustrates generally one example of a cross-sectional end view of a proximal portion of a guidewire.</li><li><figref idref="f0006">Figure 11</figref> is a schematic diagram that illustrates generally one example of a cross-sectional end view of a distal portion of a guidewire.</li><li><figref idref="f0007">Figure 12</figref> is a schematic diagram that illustrates generally one example of a cross-sectional side view of a distal portion of a guidewire.</li><li><figref idref="f0007">Figure 13A</figref> is a cross-sectional schematic diagram illustrating generally one example of a proximal portion of a guidewire, which is communicatively coupled to an instrumentation/control interface via an optical coupler.</li><li><figref idref="f0008">Figure 13B</figref> is a cross-sectional schematic diagram illustrating generally a further example of a proximal portion of a guidewire that is communicatively coupled to an instrumentation/control interface using an optical coupler.</li><li><figref idref="f0009">Figure 14A</figref> is a block diagram illustrating generally one example of the imaging guidewire and associated interface components.</li><li><figref idref="f0010">Figure 14B</figref> is a block diagram illustrating generally another example of the imaging guidewire and associated interface components, including tissue characterization and image enhancement modules.</li><li><figref idref="f0011">Figure 15</figref> is a cross-sectional schematic diagram illustrating generally one example of an alternate acoustic-to-optical transducer.</li><li><figref idref="f0012">Figure 16</figref> is a cross-sectional schematic diagram illustrating generally one example of operation of the acoustic-to-optical transducer of <figref idref="f0011">Figure 15</figref>.</li></ul>

DETAILED DESCRIPTION

In the following detailed description, reference is made to the accompanying drawings that form a part hereof, and in which is shown by way of illustration specific embodiments in which the invention may be practiced. These embodiments are described in sufficient detail to enable those skilled in the art to practice the invention, and it is to be understood that the embodiments may be combined, or that other embodiments may be utilized and that structural, logical and electrical changes may be made without departing from the scope of the present invention. The following detailed description is, therefore, not to be taken in a limiting sense, and the scope of the present invention is defined by the appended claims.

In this document, the terms "a" or "an" are used, as is common in patent documents, to include one or more than one. Furthermore, all publications, patents, and patent documents referred to in this document are incorporated by reference herein in their entirety, as though individually incorporated by reference. In the event of inconsistent usages between this documents and those documents so incorporated by reference, the usage in the incorporated reference(s) should be considered supplementary to that of this document; for irreconciliable inconsistencies, the usage in this document controls. In this document, the term "minimally-invasive" refers to techniques that are less invasive than conventional surgery; the term "minimally-invasive" is not intended to be restricted to the least-invasive technique possible.

1.

Examples of Fiber Bragg Grating Acousto-Optic Sensors

<figref idref="f0001">Figure <b>1</b></figref> is a cross-sectional side view illustrating generally, by way of example, but not by way of limitation, one example of a strain-detecting FBG sensor <b>100</b> in an optical fiber <b>105.</b> FBG sensor <b>100</b> senses acoustic energy received from a nearby area to be imaged, and transduces the received acoustic energy into an optical signal within optical fiber <b>105.</b> In the example of <figref idref="f0001">Figure <b>1</b></figref><b>,</b> FBG sensor <b>100</b> includes Bragg gratings <b>110A-B</b> in an optical fiber core <b>115</b> surrounded by an optical fiber cladding <b>120.</b> Bragg gratings <b>110A-B</b> are separated by a strain sensing region <b>125,</b> which, in one example, is about a millimeter in length. This example senses strain by detecting an "optical displacement" between these gratings <b>110A-B.</b>

A fiber Bragg grating can be conceptualized as a periodic change in the optical index (which is inversely proportional to the speed of light in the material) of a portion of the optical fiber core <b>115.</b> Light of a specific wavelength traveling down such a portion of core <b>115</b> will be reflected; the period (distance) <b>130</b> of the change in the optical index determines the particular wavelength of light that will be reflected. The degree of index change and the length <b>135</b> of the grating determine the ratio of light reflected to that transmitted through the grating.

<figref idref="f0001">Figure 2</figref> is a cross-sectional side view illustrating generally, by way of example, but not by way of limitation, an operative example of an interferometric FBG sensor <b>100.</b> The example of <figref idref="f0001">Figure 2 </figref>includes two FBGs <b>110A-B.</b> FBG <b>110A</b> is partially reflective at a specific wavelength of light passing through fiber core <b>115.</b> FBG <b>110B</b> is substantially fully reflective of such light. This interferometric arrangement of FBGs <b>110A-B</b> is capable of discerning the "optical distance" between FBGs <b>110A-B</b> with extreme sensitivity. The "optical distance" is a function of the velocity of light in the material of fiber core <b>115</b> as well as the length <b>125</b> between FBGs <b>110A-B.</b> Thus, a change in the velocity of light can induce a change in optical distance even though the physical distance <b>125</b> between FBGs <b>110A-B</b> has not changed.

An interferometer such as FBG sensor <b>100</b> can be conceptualized as a device that measures the interference between two paths taken by an optical beam. A partially reflecting FBG <b>110A</b> (or a partially reflecting mirror) is used to split the incident beam of light into two parts. In an interferometer, one part of the beam travels along a path that is kept constant (i.e., a control path) and the other part travels a path where some change is to be monitored (i.e., a test path). Using partially reflecting FBG <b>110A</b> (or a partially reflecting mirror, either of which may alternatively be in addition to FBG <b>110A),</b> the two parts of the beam are combined. If the two paths are identical, the parts combine to form the original beam. If the two paths are different, the two parts will add or subtract from each other. This addition or subtraction is known as interference. A complete subtraction is called a null and occurs at a precise wavelength of light for a given difference in paths. Measuring the wavelength where this null occurs yields an indication of the difference in optical paths between the two beams. In such a manner, an interferometer such as FBG sensor <b>100</b> senses small changes in distance, such as a change in the optical distance <b>125</b> between FBGs <b>110A-B</b> resulting from received ultrasound or other received acoustic energy.

In one example, such as illustrated in <figref idref="f0001">Figure <b>2,</b></figref>the interferometric FBG sensor <b>100</b> causes the interference between that portion of the optical beam that is reflected off the first (partially reflective) FBG 110A with that reflected from the second (substantially fully reflective) FBG <b>110B</b>. The wavelength of light where an interferometric null will occur is very sensitive to the "optical distance" <b>125</b> between the two FBGs <b>110A-B.</b> This interferometric FBG sensor <b>100</b> of <figref idref="f0001">Figure 2</figref> has another very practical advantage. In this example, the two optical paths along the fiber core <b>115</b> are the same, except for the sensing region between FBGs <b>110A-B.</b> This shared path ensures that any optical changes in the shared portion of optical fiber <b>105</b> will have substantially no effect upon the interferometric signal; only the change in the sensing region between FBGs 125 is sensed.

2.

Examples of Devices and Methods Improving FBG Reception

In one example, an FBG sensor <b>100</b> senses strain generated by ultrasound or other acoustic energy received from a nearby imaging region to be visualized and, in response, modulates an optical signal in an optical fiber. Increasing the sensitivity of the FBG sensor <b>100</b> provides improved imaging. A first example of increasing sensitivity is to increase the amount of strain induced in the FBG sensor <b>100</b> for a given dynamic pressure provided by the acoustic energy. A second example is to increase the modulation of the optical signal for a given change in strain of the FBG sensor <b>100.</b>

One technique of increasing the strain induced in the FBG sensor <b>100</b> is to design the physical attributes of the FBG sensor <b>100</b> to increase the degree of strain for a given externally applied acoustic field. In one such example, increased strain is obtained by using material that has a high degree of strain for a given stress. Calculations indicate that over two orders of magnitude increase in strain vs. stress (also referred to as "compliance") is obtained by using an optical grade plastic, rather than glass, in the fiber core <b>115</b> of the FBG sensor <b>100.</b> One example of a suitable optical grade plastic used in fiber core <b>115</b> is poly-methyl-methacrylate (PMMA).

In a second example, the FBG sensor <b>100</b> is shaped so as to increase the strain for a given applied acoustic pressure field. <figref idref="f0002">Figure <b>3A</b></figref> is a cross-sectional schematic diagram illustrating one such example in which the FBG sensor <b>100</b> is shaped such that it mechanically resonates at the frequency of the acoustic energy received from the nearby imaging region, thereby resulting in increased strain. In the example of <figref idref="f0002">Figure <b>3A</b></figref><b>,</b> all or a portion of the strain sensing region between FBGs <b>110A-B</b> is selected to provide a resonant thickness <b>300</b> that promotes mechanical resonance of the received acoustic energy, thereby increasing the resulting strain sensed by FBG sensor <b>100.</b> In one example, such as illustrated in <figref idref="f0002">Figure <b>3A</b></figref><b>,</b> this is accomplished by grinding or otherwise removing a portion of fiber cladding <b>120,</b> such that the remaining thickness of fiber core <b>115</b> and/or fiber cladding <b>120</b> between opposing planar (or other) surfaces is selected to mechanically resonate at the frequency of the acoustic energy received from the nearby imaging region.

In one example, for a particular material, mechanical resonance is obtained by making the resonant thickness <b>300</b> of the strain sensing region substantially the same thickness as ½ the acoustic wavelength (or an odd integer multiple thereof) in the material(s) of FBG sensor <b>100</b> at the acoustic center frequency of the desired acoustic frequency band received from the imaging region. In other examples, such as for other materials, the resonant thickness 300 is selected to match a different proportion of the acoustic wavelength that obtains the desired mechanical resonance for that material. Calculations indicate that obtaining such mechanical resonance will increase the strain sensitivity by about an order of magnitude over that of a sensor that is not constructed to obtain such mechanical resonance.

In a third example, a special coating <b>305</b> is applied to the FBG sensor <b>100</b> to increase the acoustic pressure as seen by the FBG sensor <b>100</b> over a band of acoustic frequencies, thereby improving its sensitivity over that band. The difference between the mechanical characteristics of water (or tissue and/or blood, which is mostly comprised of water) and glass material of the optical fiber <b>105</b> carrying the FBG sensor <b>100</b> is typically so significant that only a small amount of acoustic energy "enters" the FBG sensor <b>100</b> and thereby causes strain; the remaining energy is reflected back into the biological or other material being imaged. For a particular range of acoustic frequencies, one or more coatings <b>305</b> of specific thickness <b>310</b> and/or mechanical properties (e.g., the particular mechanical impedance) of the coating material can dramatically reduce such attenuation due to the different mechanical characteristics. One example uses quarter wave matching, providing a coating <b>305</b> of a thickness <b>310</b> that is approximately equal to one quarter of the acoustic signal wavelength received from the region being imaged. Using such matching, the sensitivity of the FBG sensor <b>100,</b> over a given band of acoustic frequencies of interest, is expected to increase by about an order of magnitude.

In one example, using the above-discussed quarter wave matching and sensor shaping techniques, the sensitivity of the FBG sensor <b>100</b> approaches that of a piezoelectric transducer. Additionally using optical grade plastic for fiber core <b>115,</b> in conjunction with one or the other of these techniques, will further increase the sensitivity of the FBG sensor <b>100.</b>

Additionally (or alternatively) to the above techniques of increasing the strain of the FBG sensor <b>100</b> for a particular level of acoustic energy, in one example, the optical sensitivity of the FBG sensor <b>100</b> to strain is increased, thereby increasing the sensitivity of the FBG sensor <b>100</b> to an acoustic field. In one example, this is accomplished by improved techniques of optical wavelength discrimination, such as by using a fiber-based Mach-Zehnder interferometer or by construction of improved optical fiber geometries that increase the optical sensitivity of the FBG sensor <b>100</b> to strain.

3.

Examples of Systems and Methods Improving Ultrasound Transmission

The present applicant has recognized that while it may be possible to implement an imaging guidewire that transmits ultrasound using a piezoelectric transducer, such a design may involve a trade-off. If the piezoelectric transducer radiates the ultrasonic energy in a broad radial pattern, imaging quality may be degraded. Conversely, using smaller piezoelectric transducers to transmit ultrasound may require significant electrical voltages in a guidewire in order to achieve needed acoustic transmit energy. This is because a smaller transducer has a higher electrical impedance, needing a higher voltage to achieve the same acoustic power. Such a guidewire must also use materials of sufficient dielectric properties to ensure patient safety. Moreover, adding electrically conducting wires to a guidewire assembly complicates its manufacture.

However, optical energy can be converted to acoustic energy. In one example, therefore, such problems are overcome using an optical-to-acoustic transmitter, which, in one example, is integrated with an acoustic-to-optical receiver such as FBG sensor <b>100.</b>

<figref idref="f0002">Figure <b>3B</b></figref> is a cross-sectional schematic diagram illustrating generally one example of a distal portion of an imaging guidewire that combines an acousto-optic FBG sensor <b>100</b> with an photoacoustic transducer <b>325.</b> In this example, photoacoustic transducer <b>325</b> includes a blazed Bragg grating <b>330.</b> In the illustrative example of <figref idref="f0002">Figure <b>3B</b></figref><b>,</b> blazed Bragg grating <b>330</b> is implemented in the strain sensitive region of the FBG sensor <b>100,</b> between FBGs <b>110A-B,</b> however, this is not a requirement. Unlike an unblazed Bragg grating, which typically includes impressed index changes that are substantially perpendicular to the longitudinal axis of the fiber core <b>115</b> of the optical fiber <b>105,</b> the blazed Bragg grating <b>330</b> includes obliquely impressed index changes that are at a nonperpendicular angle to the longitudinal axis of the optical fiber <b>105.</b>

A standard unblazed FBG partially or substantially fully reflects optical energy of a specific wavelength traveling down the axis of the fiber core <b>115</b> of optical fiber <b>105</b> back up the same axis. Blazed FBG <b>330</b> reflects this optical energy away from the longitudinal axis of the optical fiber <b>105.</b> For a particular combination of blaze angle and optical wavelength, the optical energy will leave blazed FBG <b>330</b> substantially normal (i.e., perpendicular) to the longitudinal axis of the optical fiber <b>105.</b> In the illustrative example of <figref idref="f0002">Figure <b>3B</b></figref><b>,</b> an optically absorptive photoacoustic material <b>335</b> (also referred to as a "photoacoustic" material) is placed on the surface of optical fiber <b>105.</b> The optically absorptive photoacoustic material <b>335</b> is positioned, with respect to the blazed grating <b>330,</b> so as to receive the optical energy leaving the blazed grating. The received optical energy is converted in the optically absorptive material <b>335</b> to heat that expands the optically absorptive photoacoustic material <b>335.</b> The optically absorptive photoacoustic material <b>335</b> is selected to expand and contract quickly enough to create and transmit an ultrasound or other acoustic wave that is used for acoustic imaging of the region of interest about the distal tip (or other desired portion) of the imaging guidewire. In one example, the optically absorptive photoacoustic material <b>335</b> is the same material as the acoustic matching material <b>305</b> discussed above.

<figref idref="f0003">Figure <b>4</b></figref> is a cross-sectional schematic diagram illustrating generally one example of the operation of photoacoustic transducer <b>325</b> using a blazed Bragg grating <b>330.</b> Optical energy of a specific wavelength, λ₁, travels down the fiber core <b>115</b> of optical fiber <b>105</b> and is reflected out of the optical fiber <b>105</b> by blazed grating <b>330.</b> The outwardly reflected optical energy impinges on the photoacoustic material <b>335.</b> The photoacoustic material <b>335</b> then generates a responsive acoustic impulse that radiates away from the photoacoustic material <b>335</b> toward nearby biological or other material to be imaged. Acoustic energy of a specific frequency is generated by optically irradiating the photoacoustic material <b>335</b> at a pulse rate equal to the desired acoustic frequency.

In another example, the photoacoustic material <b>335</b> has a thickness <b>340</b> (in the direction in which optical energy is received from blazed Bragg grating <b>330)</b> that is selected to increase the efficiency of emission of acoustic energy. In one example, thickness <b>340</b> is selected to be about ¼ the acoustic wavelength of the material at the desired acoustic transmission/reception frequency. This improves the generation of acoustic energy by the photoacoustic material.

In yet a further example, the photoacoustic material is of a thickness <b>300</b> that is about 1/4 the acoustic wavelength of the material at the desired acoustic transmission/reception frequency, and the corresponding glass-based optical fiber sensing region resonant thickness <b>300</b> is about ½ the acoustic wavelength of that material at the desired acoustic transmission/reception frequency. This further improves the generation of acoustic energy by the photoacoustic material and reception of the acoustic energy by the optical fiber sensing region.

In one example of operation, light reflected from the blazed grating excites the photoacoustic material in such a way that the optical energy is efficiently converted to substantially the same acoustic frequency for which the FBG sensor is designed. The blazed FBG and photoacoustic material, in conjunction with the aforementioned FBG sensor, provide both a transmit transducer and a receive sensor, which are harmonized to create an efficient unified optical-to-acoustic-to-optical transmit/receive device. In one example, the optical wavelength for sensing is different from that used for transmission. In a further example, the optical transmit/receive frequencies are sufficiently different that the reception is not adversely affected by the transmission, and vice-versa.

<figref idref="f0003">Figure <b>5</b></figref> is a schematic diagram comparing an expected angular sensitivity pattern of an exemplary blazed FBG optical-to-acoustic and acoustic-to-optical combined device <b>500</b> to that of a piezoelectric transducer 505. As seen in the example of <figref idref="f0003">Figure <b>5</b></figref><b>,</b> the optical-to-acoustic-to-optical sensor assembly <b>500</b> is expected to be capable of operating over a specific angular range that is substantially similar to that of the piezoelectric transducer 505 of similar dimensions. Therefore, in one example, the blazed FBG optical-to-acoustic and acoustic-to-optical combined device <b>500</b> is capable of using conventional intravascular ultrasound ("IVUS") techniques.

<figref idref="f0004">Figure 6</figref> is a schematic diagram illustrating generally one technique of generating an image of a vessel wall <b>600</b> by rotating the blazed FBG optical-to-acoustic and acoustic-to-optical combined transducer <b>500</b> and displaying the resultant series of radial image lines to create a radial image. In another example, phased array mages are created using a substantially stationary (i.e., non-rotating) set of multiple FBG sensors, such as FBG sensors <b>500A</b>-<b>J</b>. <figref idref="f0004">Figure 7</figref> is a schematic diagram that illustrates generally one such phased array example, in which the signal to/from each array transducer <b>500A-J</b> is combined with the signals from one or more other transducers <b>500A-J</b> to synthesize a radial image line. In this example, other image lines are similarly synthesized from the array signals, such as by using specific changes in the signal process used to combine these signals.

4.

Examples of Guidewire Design

<figref idref="f0005">Figure <b>8</b></figref> is a schematic diagram that illustrates generally an example of a side view of a distal portion <b>800</b> of an imaging guidewire <b>805</b> or other elongate catheter (in one example, the guidewire <b>805</b> is capable of being used for introducing and/or guiding a catheter or other medical instrument, e.g., over the guidewire <b>805).</b> In this example, the distal portion <b>800</b> of the imaging guidewire <b>805</b> includes one or more imaging windows <b>810A, 810B, ..., 810N</b> located slightly or considerably proximal to a distal tip 815 of the guidewire 805. Each imaging window <b>810</b> includes one or more optical-to-acoustic transducers 325 and a corresponding one or more separate or integrated acoustic-to-optical FBG sensors <b>100.</b> In one example, each imaging window <b>810</b> includes an array of blazed FBG optical-to-acoustic and acoustic-to-optical combined transducers <b>500</b> (such as illustrated in <figref idref="f0004">Figure 7</figref>) located slightly proximal to distal tip 815 of guidewire <b>805</b> having mechanical properties that allow the guidewire 805 to be guided through a vascular or other lumen. In one example, the different imaging windows <b>810A, 810B</b>, . . . , <b>810N</b> are designed for different optical wavelengths, such that individual windows can be easily addressed by changing the optical wavelength being communicated through fiber core <b>115.</b>

<figref idref="f0005">Figure <b>9</b></figref> is a schematic diagram that illustrates generally one example of a cross-sectional side view of a distal portion <b>900</b> of another guidewire <b>905.</b> In this example, the guide-wire <b>905</b> includes a solid metal or other core <b>910</b> that tapers down in diameter (e.g., from an outer diameter of about 0.011 inches) at a suitable distance <b>915</b> (e.g., about 50 cm) from the distal tip <b>920,</b> to which the tapered core <b>910</b> is attached. In this example, optical fibers <b>925</b> are distributed around the outer circumference of the guidewire core <b>910,</b> and attached to the distal tip <b>920.</b> In this example, the optical fibers <b>925</b> are at least partially embedded in a polymer matrix or other binder material that bonds the optical fibers <b>925</b> to the guidewire core <b>910</b> and/or the distal tip <b>920.</b> The binder material may also contribute to the torsion response of the resulting guidewire assembly <b>905.</b> In one example, the optical fibers <b>925</b> and binder material is overcoated with a polymer or other coating <b>930,</b> such as for providing abrasion resistance, optical fiber protection, and/or friction control. In this example, the composite structure of the distal region <b>900</b> of the guidewire <b>905</b> provides, among other things, flexibility and rotational stiffness, thereby allowing the guidewire <b>905</b> to be maneuvered to an imaging region of interest within a vascular or any other lumen.

<figref idref="f0006">Figure <b>10</b></figref> is a schematic diagram that illustrates generally one example of a cross-sectional end view of a proximal portion <b>1000</b> of guidewire <b>905,</b> which includes guidewire core <b>910,</b> optical fibers <b>925,</b> binder material <b>1005,</b> and outer coating <b>930.</b> In this example, but not by way of limitation, the diameter of the core <b>910</b> is about 11/1000 inch, the diameter of the optical fibers <b>925</b> is about (1.25)/1000 inch, and the optional outer coating <b>930</b> is about (0.25)/1000 inch thick.

<figref idref="f0006">Figure <b>11</b></figref> is a schematic diagram that illustrates generally one example of a cross-sectional end view of distal portion <b>900</b> of guidewire <b>905,</b> e.g., adjacent to distal tip <b>920.</b> In this example, but not by way of limitation, the diameter of core <b>910</b> has tapered down to about (1.5)/1000 inch, circumferentially surrounded by a void <b>1100</b> of about the same diameter (e.g., about 11/1000 inch) as the core <b>910</b> near the proximal end <b>100</b> of the guidewire <b>905.</b> In this example, the optical fibers <b>925</b> are circumferentially disposed in the binder material <b>1005</b> around the void <b>1100.</b> Binder material <b>1005</b> provides structural support. Optical fibers <b>925</b> are optionally overlaid with the outer coating <b>930.</b>

<figref idref="f0007">Figure <b>12</b></figref> is a schematic diagram that illustrates generally one example of a cross-sectional side view of a distal portion <b>900</b> of a guidewire <b>905.</b> In this example, at least one metallic or other bulkhead <b>1200</b> is provided along the tapered portion of the guidewire core <b>910.</b> The optical fibers <b>925</b> and binder <b>1005</b> are attached to a proximal side of the bulkhead <b>1200</b> near its circumferential perimeter. A distal side of the bulkhead <b>1200</b> is attached, near its circumferential perimeter, to a coil winding <b>1205</b> that extends further, in the distal direction, to a ball or other distal tip <b>920</b> of the guidewire <b>905.</b>

5.

Examples of Acoustic Transducer Construction

In one example, before the acoustic transducer(s) is fabricated, the guidewire <b>905</b> is assembled, such as by binding the optical fibers <b>925</b> to the core <b>910</b> and distal tip <b>920</b> or bulkhead <b>1200,</b> and optionally coating the guidewire <b>905.</b> The optoacoustic transducer(s) are then integrated into the guidewire assembly <b>905,</b> such as by grinding one or more grooves in the guidewire at the locations of the optoacoustic transducer windows <b>810.</b> In a further example, the depth of these groove(s) in the optical fiber(s) <b>925</b> defines the resonant structure(s) of the optoacoustic transducer(s).

After the optoacoustic transducer windows <b>810</b> have been defined, the FBGs added to one or more portions of the optical fiber <b>925</b> within such windows <b>810.</b> In one example, the FBGs are created using an optical process in which the portion of the optical fiber <b>925</b> is exposed to a carefully controlled pattern of UV radiation that defines the Bragg gratings. Then, a photoacoustic material is deposited or otherwise added in the transducer windows <b>810</b> over respective Bragg gratings. One example of a suitable photoacoustic material is pigmented polydimethylsiloxane (PDMS), such as a mixture of PDMS, carbon black, and toluene. Thus, in this example, the FBGs are advantageously constructed after the major elements of the guidewire are mechanically assembled into the guidewire assembly <b>905.</b>

6.

Examples of Proximal End Interface

In one example, the guidewire <b>905</b> allows for over-the-guidewire or other insertion of a catheter at the proximal end of the guidewire. Therefore, in such an example, the guidewire <b>905</b> (including any proximal end interface) has an outer diameter that is less than or equal to the inner diameter (e.g., 0.014 inches) of a catheter to allow the catheter with a similarly-sized inner diameter to travel over the guidewire <b>905.</b><figref idref="f0007">Figures <b>13A</b></figref> and <figref idref="f0008"><b>13B</b></figref> provide illustrative examples of an optical coupler that easily engages and disengages guidewire <b>905.</b> Among other things, this facilitates over-the-guidewire catheter insertion, and viewing an imaging region either before, during, or after such a catheter is inserted over-the-guidewire.

<figref idref="f0007">Figure <b>13A</b></figref> is a cross-sectional schematic diagram illustrating generally one example of a proximal portion <b>1300</b> of guidewire <b>905,</b> which is communicatively coupled to an instrumentation/control interface via an optical coupler <b>1305.</b> In this example, proximal portion <b>1300</b> of guidewire 905 is received within a receptacle <b>1310</b> portion of optical coupler <b>1305,</b> and includes one or more blazed FBGs <b>1315</b> to couple light into and/or out of one or more respective optical fibers <b>925</b> of guidewire <b>905.</b> Optical coupler <b>1305</b> includes one or more corresponding blazed FBGs <b>1320</b> to couple light into and/or out of one or more respective optical fibers <b>1325</b> of optical coupler <b>1305.</b> In the example of <figref idref="f0007">Figure <b>13A</b></figref><b>,</b> the FBGs <b>1320</b> of optical coupler <b>1305</b> are located substantially adjacent to corresponding FBGs <b>1315</b> of guidewire <b>905</b> when guidewire <b>905</b> is engaged within receptacle <b>1310</b> of optical coupler <b>1305.</b> Although <figref idref="f0007">Figure <b>13A</b></figref> illustrates a multiple-fiber embodiment of guidewire <b>905,</b> the illustrated techniques for coupling to an instrumentation/control interface are also applicable to a guidewire that includes a single optical fiber.

<figref idref="f0008">Figure <b>13B</b></figref> is a cross-sectional schematic diagram illustrating generally a further example of a proximal portion <b>1300</b> of guidewire <b>905</b> that is communicatively coupled to an instrumentation/control interface using an optical coupler <b>1305.</b> In the example of <figref idref="f0008">Figure <b>13B</b></figref><b>,</b> at least one optical fiber <b>925</b> transmits light at a different wavelength from that at which it receives light. Therefore, such an optical fiber <b>925</b> includes two separate blazed FBGs that couple light into and out of each such optical fiber <b>925.</b> For example, as illustrated in <figref idref="f0008">Figure <b>13B</b></figref><b>,</b> optical fiber <b>925A</b> includes a first blazed <b>FBG 1315A</b> operating at the transmit wavelength, and a second blazed FBG <b>1330A</b> operating at the receive wavelength. Optical coupler <b>1305</b> includes a corresponding first blazed FBG <b>1320A</b> operating at the transmit wavelength and a second blazed FBG <b>1335A</b> operating at the receive wavelength. When a proximal portion <b>1300</b> of guidewire <b>905</b> is fully inserted into receptacle <b>1310,</b> blazed FBGs <b>1320A</b> and <b>1315A</b> are located substantially adjacent to each other, and blazed FBGs <b>1335A</b> and <b>1330A</b> are located substantially adjacent to each other. Similarly, optical fiber <b>925B</b> and optical coupler <b>1305</b> respectively include substantially adjacent transmit FBGs <b>1315B</b> and <b>1320B</b> and substantially adjacent receive FBGs <b>1330B</b> and <b>1335B.</b>

For additional optoacoustic transducer windows <b>810</b> at or near the distal portion 900 or elsewhere along guidewire <b>905,</b> corresponding additional blazed FBGs may similarly be included on optical coupler <b>1305</b> at the appropriate wavelength for transmitting and/or receiving optical energy with respect to such additional optoacoustic transducer windows <b>810.</b> Moreover, optical coupler <b>1305</b> need not be located exactly at the proximal end of the guidewire <b>905,</b> but may instead be located anywhere near the proximal portion <b>1300</b> of the guidewire <b>905</b> or even further toward the distal portion <b>900</b> of the guidewire <b>905.</b> Also, alignment of the optical coupler <b>1305</b> to guidewire <b>905</b> need not be limited to butting guidewire <b>905</b> into receptacle <b>1310</b> of optical coupler <b>1305;</b> any other alignment mechanism and/or technique is also included.

7.

Examples of Process and Control Imaging Electronics

<figref idref="f0009">Figure <b>14A</b></figref> is a block diagram illustrating generally one example of the imaging guidewire <b>905</b> and associated interface components. The block diagram of <figref idref="f0009">Figure <b>14A</b></figref> includes the imaging guidewire <b>905,</b> which is coupled by optical coupler <b>1305</b> to an optoelectronics module <b>1400.</b> The optoelectronics module <b>1400</b> is coupled to an image processing module <b>1405</b> and a user interface <b>1410</b> that includes a display providing a viewable still and/or video image of the imaging region near one or more acoustic-to-optical transducers using the acoustically-modulated optical signal received therefrom. In one example, the system <b>1415</b> illustrated in the block diagram of <figref idref="f0009">Figure <b>14A</b></figref> uses an image processing module <b>1405</b> and a user interface <b>1410</b> that are substantially similar to existing acoustic imaging systems.

<figref idref="f0010">Figure <b>14B</b></figref> is a block diagram illustrating generally another example of the imaging guidewire <b>905</b> and associated interface components. In this example, the associated interface components include a tissue (and plaque) characterization module <b>1420</b> and an image enhancement module <b>1425.</b> In this example, an input of tissue characterization module <b>1420</b> is coupled to an output from optoelectronics module <b>1400.</b> An output of tissue characterization module <b>1420</b> is coupled to at least one of user interface <b>1410</b> or an input of image enhancement module <b>1425.</b> An output of image enhancement module <b>1425</b> is coupled to user interface <b>1410,</b> such as through image processing module <b>1405.</b>

In this example, tissue characterization module <b>1420</b> processes a signal output from optoelectronics module <b>1400.</b> In one example, such signal processing assists in distinguishing plaque from nearby vascular tissue. Such plaque can be conceptualized as including, among other things, cholesterol, thrombus, and loose connective tissue that build up within a blood vessel wall. Calcified plaque typically reflects ultrasound better than the nearby vascular tissue, which results in high amplitude echoes. Soft plaques, on the other hand, produce weaker and more texturally homogeneous echoes. These and other differences distinguishing between plaque deposits and nearby vascular tissue are detected using tissue characterization signal processing techniques.

For example, such tissue characterization signal processing may include performing a spectral analysis that examines the energy of the returned ultrasound signal at various frequencies. A plaque deposit will typically have a different spectral signature than nearby vascular tissue without such plaque, allowing discrimination therebetween. Such signal processing may additionally or alternatively include statistical processing (e.g., averaging, filtering, or the like) of the returned ultrasound signal in the time domain. Other signal processing techniques known in the art of tissue characterization may also be applied. In one example, the spatial distribution of the processed returned ultrasound signal is provided to image enhancement module <b>1425,</b> which provides resulting image enhancement information to image processing module <b>1405.</b> In this manner, image enhancement module <b>1425</b> provides information to user interface <b>1410</b> that results in a displaying plaque deposits in a visually different manner (e.g., by assigning plaque deposits a discernable color on the image) than other portions of the image. Other image enhancement techniques known in the art of imaging may also be applied. In a further example, similar techniques are used for discriminating between vulnerable plaque and other plaque, and enhancing the displayed image provide a visual indicator assisting the user in discriminating between vulnerable and other plaque.

8.

Examples of Opto-Electronics Module

The opto-electronics module <b>1400</b> may include one or more lasers and fiber optic elements. In one example, such as where different transmit and receive wavelengths are used, a first laser is used for providing light to the guidewire <b>905</b> for the transmitted ultrasound, and a separate second laser is used for providing light to the guidewire <b>905</b> for being modulated by the received ultrasound. In this example, a fiber optic multiplexer couples each channel (associated with a particular one of the guidewire's optical fibers 925) to the transmit and receive lasers and associated optics. This reduces system complexity and costs.

In one example, the sharing of transmit and receive components by multiple guidewire channels is possible at least in part because the acoustic image is acquired over a relatively short distance (e.g., millimeters). The speed of ultrasound in a human or animal body is slow enough to allow for a large number of transmit/receive cycles to be performed during the time period of one image frame. For example, at an image depth (range) of about 2 cm, it will take ultrasonic energy approximately 26 microseconds to travel from the sensor to the range limit, and back. In one such example, therefore, an about 30 microseconds transmit/receive (T/R) cycle is used. In the approximately 30 milliseconds allotted to a single image frame, up to 1,000 T/R cycles can be carried out. In one example, such a large number of T/R cycles per frame allows the system to operate as a phased array even though each sensor is accessed in sequence. Such sequential access of the photoacoustic sensors in the guidewire permits (but does not require) the use of one set of T/R opto-electronics in conjunction with a sequentially operated optical multiplexer.

9.

Example of Use For 3-Dimensional (3-D) Imaging

In one example, instead of presenting one 2-D slice of the anatomy, the system is operated to provide a 3-D visual image that permits the viewing of a desired volume of the patient's anatomy or other imaging region of interest. This allows the physician to quickly see the detailed spatial arrangement of structures, such as lesions, with respect to other anatomy. In one example, in which the guidewire 905 includes 30 sequentially-accessed optical fibers having up to 10 photoacoustic transducer windows per optical fiber, 30 X 10 = 300 T/R cycles are used to collect the image information from all the transducer windows for one image frame. This is well within the allotted 1,000 such cycles for a range of 2 cm, as discussed above. Thus, such an embodiment allows substantially simultaneous images to be obtained from all 10 transducer windows at of each optical fiber at video rates (e.g., at about 30 frames per second for each transducer window). This allows real-time volumetric data acquisition, which offers a distinct advantage over other imaging techniques. Among other things, such real-time volumetric data acquisition allows real-time 3-D vascular imaging, including visualization of the topology of a blood vessel wall, the extent and precise location of plaque deposits, and, therefore, the ability to identify vulnerable plaque.

10.

Alternate Example of Acoustic-To-Optical Receiver

<figref idref="f0011">Figure <b>15</b></figref> is a cross-sectional schematic diagram illustrating generally one example of an alternate acoustic-to-optical transducer <b>1500,</b> which in this example is integrated into an optical fiber <b>105,</b> including fiber core <b>105</b> and fiber cladding <b>120</b> and covered by coating <b>930.</b> In the illustrative example of <figref idref="f0011">Figure <b>15</b></figref><b>,</b> transducer <b>1500</b> includes a blazed FBG <b>330</b> in core <b>115,</b> a translucent deformable (or empty) region <b>1505</b> in cladding <b>120,</b> and an acoustically-deformable light-reflective surface region <b>1510</b> overlaying at least a portion of translucent region <b>1505.</b> In one example, acoustic-to-optical transducer <b>1500</b> is fabricated in a window <b>810</b> of an imaging guidewire <b>805</b> along with an optical-to-acoustic transducer <b>325,</b> which generates acoustic energy in a nearby imaging region of interest to be received by acoustic-to-optical transducer <b>1500.</b>

<figref idref="f0012">Figure <b>16</b></figref> is a cross-sectional schematic diagram illustrating generally one example of acoustic-to-optical transducer <b>1500</b> in operation. FBG <b>330</b> receives light from a proximal end of fiber core <b>105,</b> and directs the received light outward through translucent region <b>1505</b> such that the light impinges upon, and is reflected by, reflective region <b>1510.</b> At least some of the reflected light is received at FBG <b>330</b> and directed back toward the proximal end of fiber core <b>105.</b> As illustrated in <figref idref="f0012">Figure <b>16</b></figref><b>,</b> reflective region <b>1510</b> deflects in response to acoustic energy received from the nearby imaging region of interest as a result of insonification by a nearby optical-to-acoustic transducer <b>325.</b> The deflection of reflective region <b>1510</b> modulates the distance that the light travels between FBG <b>330</b> and reflective region <b>1510.</b> The resulting change in wavelength or intensity is monitored by interface optoelectronics coupled to a proximal end of optical fiber <b>105,</b> such as using the above-described components and techniques.

As illustrated in the example of <figref idref="f0011">Figures <b>15</b></figref> and <figref idref="f0012"><b>16</b></figref><b>,</b> acoustic-to-optical transducer <b>1500</b> need only include a single FBG (e.g., blazed FBG <b>330).</b> Moreover, acoustic-to-optical transducer <b>1500</b> need not rely on the Poisson effect in which received acoustic energy "squeezes" in a first direction, thereby modulating an interferometric strain-sensing distance in a second direction that is normal to the first direction. An acoustic-to-optical transducer using the Poisson effect typically suffers from some attenuation in translating the mechanical force from the first direction to the orthogonal second direction. As illustrated in <figref idref="f0012">Figure <b>16</b></figref><b>,</b> however, the acoustic-to-optical transducer <b>1500</b> detects a modulating distance that is in the substantially the same direction as the received acoustic energy. Moreover, because region <b>1510</b> is reflective, a given deflection results in a modulation of twice the number of wavelengths of light in that deflection distance. This further increases the sensitivity of acoustic-to-optical transducer <b>1500.</b>

In one example, region <b>1505</b> is filled with a transparent polymer to allow optical energy to pass through. In a further example, region <b>1505</b> has a thickness <b>1515</b> that is ¼-wave resonant with the received acoustic pressure wave. In such an example, the resonance of the polymer-filled region <b>1505</b> serves to increase the motion of the reflective region <b>1510</b> over that which would occur if region <b>1505</b> were formed of glass. In a further example, the polymer-filled region <b>1505</b> includes an acoustic impedance that is close to that of water and, therefore, human or animal tissue.

11.

Conclusion

Although certain of the above examples have been described with respect to intravascular imaging (e.g., for viewing and/or identifying vulnerable plaque), the present systems, devices, and methods are also applicable to imaging any other body part. For example, for example guidewire or other elongate body as discussed above could be inserted into a biopsy needle, laparoscopic device, or any other lumen or cavity for performing imaging. Moreover, such imaging need not involve insertion of an elongate body into a lumen, for example, an imaging apparatus could alternatively be wrapped around a portion of a region to be imaged.

In another example, this technology can be used to process the Doppler shift in acoustic frequency to image blood flow. The operation would be similar to that described above, however, this would increase the length of the transmitted acoustic signal, and would use known Doppler signal processing in the image processing portion of the control electronics. The transmitted acoustic signal can be lengthened by repeatedly pulsing the transmit optical energy at the same rate as the desired acoustic frequency.

It is to be understood that the above description is intended to be illustrative, and not restrictive. For example, the above-described embodiments may be used in combination with each other. Many other embodiments will be apparent to those of skill in the art upon reviewing the above description. The scope of the invention should, therefore, be determined with reference to the appended claims. In the appended claims, the terms "including" and "in which" are used as the plain-English equivalents of the respective terms "comprising" and "wherein." Moreover, the terms "first," "second," and "third," etc. are used merely as labels, and are not intended to impose numerical requirements on their objects.