WO2014042890A1 - Tissue specimen examination systems and methods - Google Patents

Tissue specimen examination systems and methods Download PDF

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Publication number
WO2014042890A1
WO2014042890A1 PCT/US2013/057335 US2013057335W WO2014042890A1 WO 2014042890 A1 WO2014042890 A1 WO 2014042890A1 US 2013057335 W US2013057335 W US 2013057335W WO 2014042890 A1 WO2014042890 A1 WO 2014042890A1
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Prior art keywords
system
container
position
ultrasound
image
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PCT/US2013/057335
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French (fr)
Inventor
Scott P. Huntley
Bruce A. Robinson
Philip E. Eggers
Eric A. Eggers
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Tractus Corporation
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    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N29/00Investigating or analysing materials by the use of ultrasonic, sonic or infrasonic waves; Visualisation of the interior of objects by transmitting ultrasonic or sonic waves through the object
    • G01N29/22Details, e.g. general constructional or apparatus details
    • G01N29/225Supports, positioning or alignment in moving situation
    • G01N29/226Handheld or portable devices
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B8/00Diagnosis using ultrasonic, sonic or infrasonic waves
    • A61B8/42Details of probe positioning or probe attachment to the patient
    • A61B8/4245Details of probe positioning or probe attachment to the patient involving determining the position of the probe, e.g. with respect to an external reference frame or to the patient
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N29/00Investigating or analysing materials by the use of ultrasonic, sonic or infrasonic waves; Visualisation of the interior of objects by transmitting ultrasonic or sonic waves through the object
    • G01N29/04Analysing solids
    • G01N29/06Visualisation of the interior, e.g. acoustic microscopy
    • G01N29/0654Imaging
    • G01N29/0672Imaging by acoustic tomography
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00Investigating or analysing materials by specific methods not covered by the preceding groups
    • G01N33/48Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/483Physical analysis of biological material
    • G01N33/4833Physical analysis of biological material of solid biological material, e.g. tissue samples, cell cultures
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B8/00Diagnosis using ultrasonic, sonic or infrasonic waves
    • A61B8/42Details of probe positioning or probe attachment to the patient
    • A61B8/4245Details of probe positioning or probe attachment to the patient involving determining the position of the probe, e.g. with respect to an external reference frame or to the patient
    • A61B8/4254Details of probe positioning or probe attachment to the patient involving determining the position of the probe, e.g. with respect to an external reference frame or to the patient using sensors mounted on the probe
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N2291/00Indexing codes associated with group G01N29/00
    • G01N2291/02Indexing codes associated with the analysed material
    • G01N2291/024Mixtures
    • G01N2291/02475Tissue characterisation

Abstract

Systems, devices, and methods disclosed provide for ultrasound examination of excised or ex vivo tissue specimens. An exemplary system for acoustically examining an excised tissue specimen includes an acoustically conductive container adapted to hold the excised tissue specimen in an acoustically conductive material; an ultrasound system comprising an ultrasound probe to generate an ultrasound image from scan information received from the probe; a position tracking system configured to track and record position data for the container; and an image recording and review system configured to electronically receive and record at least one ultrasound image generated by the ultrasound system, and the image recording and review system configured to generate position data for the recorded image based on the container position data. Other aspects of the invention provide for methods of using described systems and devices.

Description

TISSUE SPECIMEN EXAMINATION SYSTEMS AND METHODS

CROSS REFERENCE TO RELATED APPLICATIONS

[0001] This application claims the benefit of U.S. Patent Application No. 61/700,797, titled "Apparatus for Obtaining Specimen Sonogram", filed September 13, 2012, the disclosure of which is incorporated herein by reference.

INCORPORATION BY REFERENCE

[0002] All publications and patent applications mentioned in this specification are herein incorporated by reference to the same extent as if each individual publication or patent application was specifically and individually indicated to be incorporated by reference.

FIELD

[0003] Aspects of the invention relate generally to methods, systems, and devices for ultrasound examination of a tissue specimen removed from a patient. Some embodiments provide for an acoustically conductive container adapted to facilitate ultrasound examination of an excised tissue specimen contained within. Other embodiments include an image recording and review system configured to receive and record tissue specimen images scanned by an ultrasound device. The image recording and review system may generate position and/or orientation dataj r recorded images based on position or orientation data received from a location tracking system that may track an ultrasound probe and/or an acoustically conductive specimen container.

BACKGROUND

[0004] The surgical act of removing or excising tissue from a patient typically requires that the surgeon resect (cut) tissue structures, including vascular supplies, fatty tissue, glandular tissue, and connective tissue. In order to reduce bleeding it is common for the surgeon to use a thermal cutting tool or a thermal cautery tool. The nature of the procedure is that the resulting procedure produces a specimen, the outer surface of which is often bloody and which often has a burned appearance.

[0005] When removing a cancerous lesion it is desirable to remove all of the malignant tissue. To assure that the entire cancer has been removed it is necessary that the removed tissue, or specimen, contain a significant layer of surrounding normal tissue, or margin. Distinguishing normal tissue from malignant tissue on the surface of the specimen has been the standard procedure for determining whether the lesion has been completely removed. The assumption associated with this method is that the identification of cancerous tissue on the surface of a lesion is an indication that there is some amount of cancerous tissue still within the patient, and that the

"margins" (that is, outside of the specimen) are not "clean". Margin may be referred to describe the status of the surface of the specimen. If the surface is all normal tissue, then the cancerous lesion is completely encapsulated within the body of the specimen. A specimen with a completely encapsulated lesion is said to have "clean" or "negative" margins (that is, the surface tests negative for cancer). If the surface has any cells which can be identified as cancer the margins are said to be "dirty" or "positive".

[0006] Referring to FIG. 1, the excised tissue specimen 300 includes a tumor 304 surrounded by normal healthy tissue 302. The healthy tissue between the outer perimeter of the specimen and the tumor provides a "negative" margin 306 of healthy tissue surrounding the tumor. This is not always the case, however. FIG. 2 shows a specimen 310 with normal healthy tissue 312 partially surrounding a tumor 314. The positive margin 316 indicates that a portion of the lesion 314 has not been removed from the patient.

[0007] The current method (in 2012) relies on visual inspection of the specimen at the time of surgery, followed by histopathological analysis of the specimen after the procedure, and is associated with a high failure rate. McCahill et al. (JAMA. 2012 Feb l ;307(5):467-75) described a 23% rate of reexcision following partial mastectomy (lumpectomy) procedures. Guidroz et al., reported a 31% reexcision rate (Surgery. 201 1 Oct;150(4):802-9.). Sabel et al., reported that follow up surgeries (for incomplete lesion removal) was 26% (Am J Surg. 201 1 Dec 16. [Epub ahead of print]).

[0008] Significantly, Guidroz reported that the cancer recurrence rate was twice as high in the patient cohort where complete excision was not achieved during the initial procedure (that is, in the cohort that required reexcision). Sabel further reported that intraoperative measurement of margin status using frozen section analysis (FSA) pathology analysis, a semi-real-time tissue analysis, reduced the reexcision rate from 26% to 6%. In addition to the increase in patient safety (from fewer procedures and more thorough lesion removal) there was a concomitant reduction in patient treatment cost (from $400 to $600 per patient).

[0009] Unfortunately, improving the ability to distinguish only the surface features would not improve patient outcomes. Lagios and Silverstein demonstrated that the primary factor influencing the recurrence rate of ductal carcinoma in-situ was the amount of clean margin (Surg Oncol Clin N Am. 1997 Apr;6(2):385-92.), not the mere fact that clean margins existed. A significant reduction in local recurrence was noted with patients whose excision procedures resulted in specimens with 10mm or more of margins, compared with those whose margins were less than 10mm. These results are reasonable as one would expect that a 10mm buffer of normal tissue between the cancer and the surface of the specimen is a better predictor of complete lesion removal than would be expected if there were only a single layer of cells around the cancer.

Several methods have been employed to improve the ability of surgeons to assess the margin status of specimens during surgery.

[00010] One way to reduce re-excision rates has been to transport the specimen, during the surgical procedure, to a pathology lab for immediate analysis. However, this approach requires quite a bit of time to transport the specimen from the operating room to the pathology lab, to freeze the specimen and perform the analysis, and to have the pathologist report those findings back to the team in the operating room. During this process, the operating room and staff are unproductive. With operating room costs averaging $50 per minute in 2012, the costs of the pathological analysis can quickly add significant expense to procedures.

[00011] Alternatively, specimen radiology, or taking an x-ray image of the specimen, has been used successfully as an intraoperative margin analysis tool (Am J Surg. 201 1

Oct;202(4):387-94. The specimen X-ray device is a cabinet X-ray in which the specimen is placed in a cabinet which has an X-ray source and a digital X-ray detector. The cabinet protects personnel from radiation exposure. The digital X-ray image of the specimen is transmitted to radiology electronically and the radiologist can provide an opinion on the margin status. FIG. 3 shows an x-ray of a specimen with a tumor 324 surrounded by normal tissue 320 and a margin 322. As shown, an X-ray of a specimen can often provide intraoperative margin analysis by distinguishing normal tissue from cancerous tissue.

[00012] Although specimen radiography can be an effective method for intraoperative margin assessment, the method can be compromised by different tissue types. Glandular and connective tissue absorb x-rays and appear white on the specimen radiograph. Fatty tissue does not absorb x-ray and appears dark on the specimen radiograph. Cancer tissue is a deviant form of glandular tissue and also absorbs x-ray. It also appears white on the specimen radiograph. As such, for a specimen having glandular tissue around or near a lesion, the x-ray will show both normal and cancerous tissue as white sections, which makes it difficult for a physician to distinguish the cancer on the white background of the glandular specimen. FIGS. 4A-4C shows x-rays for fatty tissue (FIG. 4A), glandular or "dense tissue" (FIG. 4B), and a cancerous lesion (FIG. 4C).

[00013] Alternatively, ultrasound can be used to distinguish cancerous lesions from normal tissue. In the ultrasound image the cancer appears dark and the normal tissue appears white. FIG. 5 shows an ultrasound image 330 with a tumor 334 in healthy tissue 332. Using ultrasound as an operative guidance method has demonstrated that the rate of positive surgical margins (that is, tissue specimens that did not remove all of the cancerous lesion) can be reduced if ultrasound is used as a guidance method) Am Surg. 201 1 May;77(5):640-6. Doyle et al., describe a method which utilizes ultrahigh frequency ultrasound to distinguish between cancerous tissue and normal tissue (BMC Cancer. 201 1 Oct 12; 1 1 :444). Thill et al, reported a method which utilizes radiofrequency spectral analysis to assess tissue margins (Breast. 201 1 Dec;20(6):579-80. Epub 201 1 Aug 31.) Wang, Cupples, and Cheng describe a method which uses ultrasound to characterize a specimen (US Patent No. 7,018,333). One drawback with the Wang approach is the need for coupling the ultrasound probe to a robotic arm to scan the probe in a predetermined path.

[00014] Additionally, all of these previous systems require that the containers be fixed in space during the scanning procedure so that the relative location of the container and the scanning arm can be known. This can be cumbersome for several reasons. Principally, if the container must remain in a fixed location it reduces the flexibility of the room layout and may not be easily stored. Also, in some cases, the specimen is loaded into the container by placing it in the top of the container while the most accessible means of scanning is when the container is at a 45 degree angle to the user. In order to accomplish this change in spatial position, the box may be rotated after the specimen is loaded. One way to accomplish this is to hold the probe in one hand and the container in the other. Although this methodology may be comfortable for the scanning procedure, the changed or changing location of the container during scanning makes it impossible to generate accurate image representations of the specimen.

[00015] As such, there is a need for tissue specimen examination systems, methods, and devices that address at least these concerns. For example, contemplated systems, methods, and devices allow for time and cost efficient ultrasound examination of excised tissue specimens during or after surgical procedures. SUMMARY OF THE DISCLOSURE

[00016] Some embodiments provide for a system for acoustically examining an excised tissue specimen including an acoustically conductive container having an internal volume and at least one acoustically conductive surface, the container being adapted to hold the excised tissue specimen in an acoustically conductive material within the internal volume; an ultrasound system comprising an ultrasound probe and a first controller in communication with the probe, wherein the first controller is configured to generate an ultrasound image from scan information received from the probe; a position tracking system configured to track and record position data for the ultrasound probe as the probe scans the container; and an image recording and review system comprising a second controller in communication with the position tracking system and the ultrasound system, the second controller comprising a recording unit configured to electronically receive and record at least one ultrasound image generated by the first controller of the ultrasound system, wherein the second controller is configured to electronically receive the ultrasound probe position data from the position tracking system and to output an ultrasound image recorded by the recording unit to a display coupled to the image recording and review system.

[00017] In any of the preceding embodiments, the at least one ultrasound image may be recorded by the recording unit as a first recorded image. In any of the preceding embodiments, the second controller is configured to generate position data for the first recorded image based on the ultrasound probe position data received from the position tracking system.

[00018] In any of the preceding embodiments, the second controller is configured to derive orientation data for the first recorded image based on the ultrasound probe position data received from the position tracking system.

[00019] In any of the preceding embodiments, the position tracking system is configured to track and record the orientation of the ultrasound probe.

[00020] In any of the preceding embodiments, the first recorded image is a digital image comprising a plurality of pixels and the second controller is configured to determine and record a spatial position (Px,y,z) for each pixel of the plurality of pixels in the first recorded image.

[00021] In any of the preceding embodiments, the at least one ultrasound image recorded by the recording unit comprises a plurality of recorded images and the second controller is configured to generate a three-dimensional representation of the excised tissue specimen from the plurality of recorded images. In any of the preceding embodiments, the second controller is configured to generate a three-dimensional representation from the plurality of recorded images.

[00022] In any of the preceding embodiments, the container is adapted to suspend the excised tissue specimen in the acoustically conductive material.

[00023] In any of the preceding embodiments, the acoustically conductive material surrounds the excised tissue specimen but does not completely fill the internal volume of the container.

[00024] In any of the preceding embodiments, the container comprises wires adapted to suspend the excised tissue specimen in the container.

[00025] In any of the preceding embodiments, the container is configured to hold the excised tissue sample in an acoustically conductive lumen formed by the acoustically conductive material.

[00026] In any of the preceding embodiments, the acoustically conductive lumen is sealed around the excised tissue specimen.

[00027] Any of the preceding embodiments further comprising a vacuum adapted to remove material, fluid, or gas from the container. [00028] In any of the preceding embodiments, the container is configured to hold the excised tissue specimen in a sealed lumen around the excised tissue specimen.

[00029] In any of the preceding embodiments, the container is configured to hold the excised tissue specimen such that the held tissue specimen does not directly contact a surface of the container.

[00030] In any of the preceding embodiments, the position tracking system comprises a plurality of position registers coupled to the ultrasound probe, the plurality of position registers comprising a first position register and a second position register. In any of the preceding embodiments, at least one of the plurality of position registers is adapted to reflect

electromagnetic radiation. In any of the preceding embodiments, at least one of the plurality of position registers reflects radiation having a wavelength in the optical range of the

electromagnetic spectrum between about 380nm to about 760nm. In any of the preceding embodiments, at least one of the plurality of position registers reflects radiation having a wavelength between about 1 mm to about 760nm. In any of the preceding embodiments, at least one of the plurality of position registers reflects infrared radiation. In any of the preceding embodiments, at least one of the plurality of position registers reflects radiation having a wavelength between about 1mm to about 750nm. In any of the preceding embodiments, at least one of the plurality of position registers reflects radiation in the ultraviolet bandwidth of the electromagnetic spectrum. In any of the preceding embodiments, at least one of the plurality of position registers reflects radiation having a wavelength between about lOnm to about 490nm.

[00031] In any of the preceding embodiments, a first position register comprises a geometric pattern different from a second position register. In any of the preceding embodiments, the first and second position registers comprise the same geometric patterns with a different color arrangement.

[00032] Other embodiments provide for a system for acoustically examining an excised tissue specimen including an acoustically conductive container having an internal volume and at least one acoustically conductive surface, the container adapted to hold the excised tissue specimen in an acoustically conductive material within the internal volume; an ultrasound system comprising an ultrasound probe and a first controller in communication with the probe, wherein the first controller is configured to generate an ultrasound image from scan information received from the probe; a position tracking system configured to track and record position data for the container; and an image recording and review system comprising a second controller in communication with the position tracking system and the ultrasound system, the second controller comprising a recording unit configured to electronically receive and record at least one ultrasound image generated by the first controller of the ultrasound system, wherein the second controller is configured to electronically receive the container position data from the position tracking system and to output an ultrasound image recorded by the recording unit to a display coupled to the image recording and review system.

[00033] In any of the preceding embodiments, the at least one ultrasound image recorded by the recording unit comprises a first recorded image; and the second controller is configured to generate position data for the first recorded image based on the container position data received from the position tracking system.

[00034] In any of the preceding embodiments, the second controller is configured to derive orientation data for the first recorded image based on the container position data received from the position tracking system.

[00035] In any of the preceding embodiments, the position tracking system is configured to track and record the orientation of the container.

[00036] In any of the preceding embodiments, the first recorded image is a digital image comprising a plurality of pixels and the second controller is configured to determine and record a spatial position (Px,y,z) for each pixel of the plurality of pixels in the first recorded image.

[00037] In any of the preceding embodiments, the at least one ultrasound image recorded by the recording unit comprises a plurality of recorded images and the second controller is configured to generate a three-dimensional representation of the excised tissue specimen from the plurality of recorded images.

[00038] In any of the preceding embodiments, the second controller is configured to generate a three-dimensional representation from the plurality of recorded images.

[00039] In any of the preceding embodiments, the container is adapted to suspend the excised tissue specimen in the acoustically conductive material.

[00040] In any of the preceding embodiments, the acoustically conductive material surrounds the excised tissue specimen but does not completely fill the internal volume of the container.

[00041] In any of the preceding embodiments, the position tracking system includes a plurality of position registers coupled to the container, the plurality of position registers including a first position register and a second position register. In any of the preceding embodiments, at least one of the plurality of position registers is adapted to reflect

electromagnetic radiation. In any of the preceding embodiments, at least one of the plurality of position registers reflects radiation having a wavelength in the optical range of the

electromagnetic spectrum between about 380nm to about 760nm. In any of the preceding embodiments, at least one of the plurality of position registers reflects radiation having a wavelength between about 1mm to about 760nm. In any of the preceding embodiments, at least one of the plurality of position registers reflects infrared radiation. [00042] Other embodiments provide for a method of ultrasonically examining an excised tissue specimen including the steps of scanning at least one acoustically conductive surface of a specimen container with an ultrasound probe while the excised tissue specimen resides within the specimen container, wherein an ultrasound processor receives scanning information from the probe to thereby generate a first generated image and a second generated image of the excised tissue specimen in the container; tracking the position of the ultrasound probe during the ultrasonically scanning step with a position tracking system, wherein the position tracking system electronically communicates position data for the ultrasound probe to an image recording and review system; electronically communicating the first generated image from the ultrasound processor to the image recording and review system; recording of the first generated image as a first recorded image by the image recording and review system, wherein the image recording and review system generates position data for the first recorded image based on the position data for the probe received from the position tracking system; and displaying the first recorded image.

[00043] In any of the preceding embodiments, the methods include the step of recording of the second generated image as a second recorded image by the image recording and review system, wherein the image recording and review system generates position data for the second recorded image based on the position data for the probe received from the position tracking system; and generating of a three-dimensional representation of the excised tissue specimen by the image recording and review system, wherein the image recording and review system generates the three-dimensional representation from the first and second recorded images.

[00044] In any of the preceding embodiments, the methods include the step of forming an acoustically conductive lumen in the specimen container, wherein the acoustically conductive lumen is adapted to receive the excised tissue specimen. In any of the preceding embodiments, the acoustically conductive lumen is formed in an acoustically conductive material in the specimen container.

[00045] In any of the preceding embodiments, the methods include the step of conforming the acoustically conductive lumen to a shape of the excised tissue specimen. In any of the preceding embodiments, the methods include the step of surrounding the excised tissue specimen in the container with an acoustically conductive material. In any of the preceding embodiments, the methods include the step of vacuum sealing the excised tissue specimen in the acoustically conductive material. In any of the preceding embodiments, the methods include the step of suspending the excised tissue specimen in the specimen container with an acoustically conductive material. [00046] Further embodiments provide for a method of ultrasonically examining an excised tissue specimen including scanning at least one acoustically conductive surface of a specimen container with an ultrasound probe while the excised tissue specimen resides within the specimen container, wherein an ultrasound processor receives scanning information from the probe to thereby generate a first generated image and a second generated image of the excised tissue specimen in the container; tracking the position of the specimen container during the ultrasonically scanning step with a position tracking system, wherein the position tracking system electronically communicates position data for the specimen container to an image recording and review system; electronically communicating the first generated image from the ultrasound processor to the image recording and review system; recording of the first generated image as a first recorded image by the image recording and review system, wherein the image recording and review system generates position data for the first recorded image based on the position data for the specimen container received from the position tracking system; and displaying the first recorded image.

[00047] In any of the preceding embodiments, the methods include the step of recording of the second generated image as a second recorded image by the image recording and review system, wherein the image recording and review system generates position data for the second recorded image based on the position data for the specimen container received from the position tracking system; and generating of a three-dimensional representation of the excised tissue specimen by the image recording and review system, wherein the image recording and review system generates the three-dimensional representation from the first and second recorded images.

[00048] In any of the preceding embodiments, the three-dimensional representation is configured to show the tissue specimen such that one of skill in the art can interpret to determine if adequate shows margin between a lesion and healthy tissue in the excised tissue specimen exists.

[00049] In any of the preceding embodiments, the methods include the step of forming an acoustically conductive lumen in the specimen container, wherein the acoustically conductive lumen is adapted to receive the excised tissue specimen. In any of the preceding embodiments, the acoustically conductive lumen is formed in an acoustically conductive material in the specimen container.

[00050] In any of the preceding embodiments, the methods include the step of conforming the acoustically conductive lumen to a shape of the excised tissue specimen. In any of the preceding embodiments, the methods include the step of surrounding the excised tissue specimen in the container with an acoustically conductive material. In any of the preceding embodiments, the methods include the step of suspending the excised tissue specimen in the specimen container with an acoustically conductive material.

[00051] In any of the preceding embodiments, the methods include the step of tracking the position of the probe during the ultrasonically scanning step with the position tracking system, wherein the position tracking system electronically communicates position data for the probe to the image recording and review system. In any of the preceding embodiments, the image recording and review system is configured to generate position data for the first recorded image based on the position data for both the specimen container and probe received from the position tracking system.

[00052] In any of the preceding embodiments, the position tracking system includes a plurality of position registers coupled to the container, each of the plurality of position registers adapted to reflect electromagnetic radiation.

[00053] In another aspect, embodiments provide for a system for acoustically examining an excised tissue specimen including an acoustically conductive container having an internal volume and at least one acoustically conductive surface, the container adapted to hold the excised tissue specimen in an acoustically conductive material within the internal volume; an ultrasound system comprising an ultrasound probe and a first controller in communication with the probe, wherein the first controller is configured to generate an ultrasound image from scan information received from the probe; a position tracking system configured to independently track and record position data for the container and the probe; and an image recording and review system comprising a second controller in communication with the position tracking system and the ultrasound system, the second controller comprising a recording unit configured to electronically receive and record at least one ultrasound image generated by the first controller of the ultrasound system, wherein the second controller is configured to electronically receive the container and probe position data from the position tracking system and to output an ultrasound image recorded by the recording unit to a display coupled to the image recording and review system.

[00054] In any of the preceding embodiments, the at least one ultrasound image recorded by the recording unit comprises a first recorded image; and wherein the second controller is configured to generate position data for the first recorded image based on the container and probe position data received from the position tracking system.

[00055] In any of the preceding embodiments, the second controller is configured to derive orientation data for the first recorded image based on the container and probe position data received from the position tracking system. [00056] In any of the preceding embodiments, the second controller is configured to generate a three-dimensional representation of the tissue specimen from the first and second recorded images, the three-dimensional representation configured to be bisected along a plane to thereby provide a two-dimensional cross-sectional view of the tissue specimen.

[00057] In any of the preceding embodiments, the position tracking system is configured to track and record the orientation of the container and probe.

BRIEF DESCRIPTION OF THE DRAWINGS

[00058] The novel features of the invention are set forth with particularity in the claims that follow. A better understanding of the features and advantages of the present invention will be obtained by reference to the following detailed description that sets forth illustrative embodiments, in which the principles of the invention are utilized, and the accompanying drawings of which:

[00059] FIG. 1 shows a tissue sample with a margin between a tumor and health tissue.

[00060] FIG. 2 shows a tissue sample with a positive margin.

[00061] FIG. 3 is an x-ray image showing a tumor and margin in a tissue sample.

[00062] FIGS. 4A-C show x-ray images of breast tissue and a cancerous lesion.

[00063] FIG. 5 is an ultrasound image of a lesion and surrounding tissue.

[00064] FIG. 6 is an exemplary tissue examination system according to described embodiments.

[00065] FIG. 7 is an exemplary tissue examination system with an optical location tracking system.

[00066] FIGS. 8A-C show a location markers on a probe.

[00067] FIG. 9 show color patterns for various location markers.

[00068] FIG. 10 illustrates a specimen container with a specimen scanned by an ultrasound probe.

[00069] FIGS. 1 1 A-B depict an acoustically conductive lumen in a container.

[00070] FIG. 12 illustrates a hook suspended specimen in a container.

[00071] FIG. 13A is a cross-sectional view of the ex vivo tissue ultrasound scanning system showing a cylindrical container, lid, evacuation unit, ultrasound degassing unit, specimen support fiber, specimen and ultrasound probe.

[00072] FIG. 13B is a cap used to seal opening provided to accommodate insertion of ultrasound degassing unit in lid of container. [00073] FIG. 14A is perspective and exploded view of the ex vivo tissue ultrasound scanning system showing a flat-sided container, lid, cap, evacuation unit, specimen support fiber, specimen and ultrasound probe.

[00074] FIG. 14B is an ultrasound degassing unit shown disconnected from lid of container.

[00075] FIG. 15 is a cross-sectional view of the fiber anchor.

[00076] FIG. 16 is a cross-sectional view of the specimen support plate.

[00077] FIG. 17 is a cross-sectional view of the septum and septum support unit.

[00078] FIG. 18 is a cross-sectional view of an outer cylindrical tube of evacuation unit.

[00079] FIG. 19 is a cross-sectional view of the piston of evacuation unit.

[00080] FIG. 20 is a cross-sectional view of the fiber anchor, fiber and septum piercing needle.

[00081] FIG. 21 is perspective and exploded view of the ex vivo tissue ultrasound scanning system showing a flat-sided container, lid, cap, evacuation unit, specimen support fiber, specimen, ultrasound probe, liquid injection syringe and extension tubing.

[00082] FIGS. 22A-22C combine as labeled thereon to show a flow chart of the procedure associated with an embodiment of the present invention for performing an ultrasound scan of an ex vivo tissue specimen.

[00083] FIG. 23 shows a scan procedure on a stationary container.

[00084] FIG.24 shows a scan procedure on a stationary probe.

[00085] FIG. 25 shows a scan procedure for a moving probe and container.

[00086] FIG. 26 shows a scan procedure for a moving probe and container.

[00087] FIG. 27 shows a scan procedure for a rotating probe and container.

[00088] FIG. 28 shows a container with an acoustically conductive support member.

[00089] FIG. 29 shows a container having at least one location sensor.

[00090] FIG. 30 shows a probe having at least two location sensors.

[00091] FIG. 31 shows a container having at least two location sensors.

[00092] FIG. 32 shows a probe having at least one location sensor.

DETAILED DESCRIPTION

[00093] In one aspect, embodiments described provide for a tissue specimen examination system that can be used to show cross-sectional characteristics of an excised or ex vivo tissue specimen. The contemplated systems may provide images of a cross-section of an excised tissue specimen where the cross-sectional images show the structure of the excised tissue. In some cases, a surgeon, technician, or other person of ordinary skill in the art may review one or more of the provided images to determine the presence or absence of a margin. The reviewer may also determine whether a positive or negative margin exists based on review provided images. In some cases, the systems may also generate three-dimensional representations of the excised tissue specimen that allow a reviewer to determine the presence and characteristics of a margin.

This may include the dimensions of the margin, including, but not limited to, the depth or width of the margin from the outer surface of the specimen to a cancer in the specimen.

[00094] Generally, contemplated systems include an ultrasound system, an image recording and review system, a position and/or position and orientation tracking system, and an acoustically conductive container. In operation, an excised tissue specimen is placed into the acoustically conductive container, which holds the specimen for scanning by the ultrasound system. The ultrasound system typically includes a manual probe that is passed over an acoustically conductive surface of the container. The probe transmits scan information, which can be generally described as electric signals generated by transducers on the probe upon acoustic excitation. The ultrasound system processes the received scan information and generates ultrasound images.

[00095] The image recording and review system may grab images generated by the ultrasound system (e.g. via video output connector). The image recording and review system may generate recorded images from the grabbed images. Additionally, the image recording and review system may use position and/or orientation data from the position/position and orientation tracking system to generate position (and/or orientation data) for each recorded image. This may include generating spatial position information for each pixel in each digital image recorded by the image recording and review system. Additionally, the image recording and review system may display recorded images as two-dimensional images of the specimen or as a three-dimensional representation of the excised tissue specimen. In either case, the margin for the excised tissue specimen may be determined from the recorded images of the image recording and review system.

[00096] Referring to FIG. 6, a tissue specimen examination system 400 is shown. The tissue specimen examination system 400 includes a hand-held imaging system 412. The hand-held imaging system 412 (e.g. ultrasound system) may include a hand-held imaging monitor console 418, display 417, hand-held imaging probe 414 and connecting cable 416. The tissue specimen examination system 400 may also include an image recording and review system 410. The image recording and review system 410 includes a data acquisition and display

module/controller 440 including a microcomputer/storage/DVD ROM recording unit 441 and display 403.

[00097] The image recording and review system 410 is in communication with a position tracking system (or a position and orientation tracking system) 420, which includes, by way of example, position tracking module 422 and position sensor/register locator, such as a magnetic field transmitter 424. The position tracking system may include a plurality of position sensors or registers 432a, 432b and 432c affixed to the hand-held imaging probe 414.

[00098] Still referring to FIG. 6, hand-held imaging system 412 is connected to data acquisition and display module/controller 440 via data transmission cable 446 to enable each frame of imaging data to be received by the microcomputer/storage/DVD ROM recording unit 441 the frequency of which is a function of the recording capabilities of the

microcomputer/storage/DVD ROM recording unit 441 and the image data transmission capabilities, whether it is raw image data or video output of the processed image data, of the hand-held imaging system 412. Cable 446 is removably attached to

microcomputer/storage/DVD ROM recording unit 441 of data acquisition and display module/controller 440 with removably attachable connector 443 (video out) and is removably connected to diagnostic ultrasound system 412 with connector 447.

[00099] Position (and/or orientation) information from the plurality of position

sensors/registers 432a, 432b, and 432c, is transmitted to the data acquisition and display module/controller 440 via the transmission cable 448. The position tracking module 422 is connected to data acquisition and display module/controller 440 via data transmission cable 448 wherein cable 448 is removably attached to microcomputer/storage/DVD ROM recording unit 441 of data acquisition and display module/control 440 with connector 445 and is removably connected to position tracking module with connector 449. Position sensor locator, such as a magnetic field transmitter 424 may be connected to position tracking module 422 via cable 426. In some embodiments, the position sensors or registers 432a-432c may be coupled or affixed to hand-held imaging probe 414 and communicate position data to position tracking module 422. In other variations, the position sensors or registers 462a-b may be coupled to a specimen container 450.

[000100] Any suitable tracking system may be used to provide location data for the probe and/or the container. There are a variety of these tracking methodologies including

radiofrequency identification (RFID) magnetic, infrared emission, etc. that can be used. In some cases, the tracking system includes a sensor (or sensors) and a detection device which processes the information emitted by the sensor and reduces that information in to a spatial location for the individual sensor. If location of three or more of the sensors is known, then the location of the probe, including its orientation, may also be determined. Magnetic sensors, optical markers (e.g. to be imaged by cameras), infrared markers, and ultraviolet sensors are additional examples of tracking suitable options. Additionally, the tracking system may track position, orientation, and/or both position and orientation for a target object. [000101] In another variation, the tracking system is optically based. Such embodiments do not require active sensors on either the probe or the container. Instead, the tracking system relies on geometric registers on the probe, and possibly the container. These registers, which reflect electromagnetic radiation, allow imaging by a camera. The most common

electromagnetic radiation cameras are the standard optical cameras with digital detectors which are commonly available from many sources. Variation on these same technologies are used to detect radiation outside of the visible spectrum, thus allowing the ability to image geometric patterns affixed to the probe and correlate those image patterns to a location in space.

[000102] FIG. 7 shows an exemplary embodiment of a contemplated excised tissue specimen examination system 500 that includes an optically based tracking system. As shown, the examination system has a diagnostic ultrasound system 512 with an ultrasound monitor console 518, display 517, and hand-held ultrasound probe 514. The tissue examination system 500 also includes an image recording and review system 510 that comprises a data acquisition and display module/controller 540 and a microcomputer/storage/DVD ROM recording unit 541 and display 513.

[000103] The diagnostic ultrasound system 512 is connected to an image recording and review system 510 via data transmission cable 546 to enable each frame of ultrasound data to be received by the microcomputer/storage/DVD ROM recording unit 541 at the end of each individual scan. Cable 548 is removably attached to microcomputer/storage/DVD ROM recording unit 541 of data acquisition and display module/controller 540 with removably attachable connector 545 and is removably connected to diagnostic ultrasound system 512 with connector 547.

[000104] The image recording and review system 510 is connected to a location tracking system (e.g. position and/or position and orientation tracking system) 520, which includes location tracking module 522 and two or more, preferably three or more cameras 535a-c (e.g., infrared cameras). The location tracking system 520 may include two or more optically unique (i.e., uniquely identifiable) location markers 532a-c on the hand-held ultrasound probe and/or specimen container 550. Said two or more, preferably three or more, cameras may operate in the visible spectrum or infrared spectrum.

[000105] By way of example and still referring to FIG. 7, four infrared cameras 535a-535d are shown at predetermined fixed positions whose fields of view include the hand-held ultrasound probe 514 including six optically unique markers with three markers 532a-532c visible on the front side of hand-held ultrasound probe 514. The infrared cameras are removably connected to location tracking module 522. [000106] In other embodiments, the location tracking markers are placed on the specimen container. The tracking markers may be placed on both the probe and the container.

Alternatively, only the container or the probe, but not both, may have tracking markers.

[000107] Continuing with the exemplary embodiment of FIG. 7 and referring to FIGS. 8A-8C, three optically unique position markers 532a-532c are placed to the exterior surface of the probe 514. As shown, each of the tracking markers may provide varying patterns, colors, or geometric features distinct from other tracking markers. Additionally, each tracking marker may include a surface with varying patterns, colors, or geometric features on different portions of the marker surface. In some cases, markers may have the same or different patterns, colors, or geometric features. The number of markers may be limited only by the ability to generate optically unique geometries and colors and the amount of surface area on the probe.

[000108] Referring to FIG. 8B, three cameras 571a-c individually locate three markers 532b, 532h, 532i. Since the locations of the markers 532b, 532h, 532i relative to the geometry of the probe 514 are known, the location and calculated orientation of the probe assembly 530 can be determined. The location and calculated orientation of the probe assembly 530 can be determined even if one or more or all of the original markers 532b, 532h, 532i are obscured from the line-of-site of the cameras 571a-571c. As depicted in FIG. 8C, this may be accomplished as the cameras 571 a-c can locate an additional marker such as 532j, 532k for each marker that is obscured 532b, 532i.

[000109] In addition to pattern recognition, other embodiments provide for tracking based on color. Referring to FIG. 9, depict 4 registers which have identical geometric patterns, but which may be distinguished because of the different colors used in each register. In this example, the pattern recognition software can be simplified to look for only one pattern type, but the registers may be individualized because of the differences in the reflected wavelengths. The markers or registers selectively reflect wavelengths based on absorptive characteristics of the markers. A feature of this embodiment is that it may rely on color identification, rather than pattern recognition.

[000110] Any suitable absorptive or reflective characteristic may be employed for the markers. In some embodiments, a tracking marker is adapted to reflect electromagnetic radiation. In other embodiments, a tracking marker reflects a wavelength in the optical range of the electromagnetic spectrum between about 380nm to about 760nm. In other cases, a tracking marker or register reflects radiation having a wavelength between about 1mm to about 760nm. In other cases, the tracking marker or register reflects infrared radiation. In farther variations, the location marker or register reflects radiation having a wavelength between about 1mm to about 750nm. In other cases, the location marker or register reflects radiation in the ultraviolet bandwidth of the electromagnetic spectrum. In additional embodiments, the tracking register or marker reflects radiation having a wavelength between about l Onm to about 490nm.

[000111] In further variations, a location marker or register may or may not be a separate sensor or element added to the imaging device or container. In some cases, location and motion detection systems can be used to track of a target object based on geometric or landmark features of the target object. For example, a location system may track the corners or edges of an ultrasound imaging probe while it is scanned across the specimen container. In some embodiments, the optical, infrared, or ultraviolet cameras may capture an image of the probe and interpret a landmark feature as a unique position on the imaging device.

[000112] Additionally, the sensors/markers may also provide orientation data such as pitch, roll, and yaw. Such sensors or markers may be position or orientation sensors/markers that detect either position or orientation data but not both. In some cases, a position sensor may only detect position. The system may then derive the undetected orientation information if needed. In other cases position and orientation data are detected.

[000113] As described, in further embodiments, the position of the container may itself be tracked by at least the described methods. For example, FIGS. 6 and 7 show containers 450, 550 with sensors/registers/markers 462a-b, 562a-b. Where the container location is tracked, the container can be moved in addition to the probe during scanning.

[000114] Referring again generally to FIG. 6, the tissue examination system 400 includes an acoustically conductive container 450 having at least one acoustically conductive surface 452. As shown, the container holds a tissue specimen 454 in an internal volume of the container 450.

[000115] In practice, an imaging probe 414 can be passed over the acoustically conductive surface to generate electrical signals corresponding to acoustic information for the container and, more importantly, the contents of the container. An ultrasound controller in the ultrasound system 412 receives the electrical signals from the probe 414 and generates a series of ultrasound images of the excised tissue specimen.

[000116] Generally, the generated ultrasound images are two-dimensional digital

representations of a cross-section of the scanned site. The generated images may show a cross- section of the specimen and/or the container depending on the location of probe when the scanning information was sent to the ultrasound processor. Each generated image includes a plurality of pixels arranged in a pixel array.

[000117] Once an image is generated by the ultrasound system 412, the image recording and review system 410 may electronically receive a generated image through an output from the ultrasound system 412. The image recording and review system 410 may record a generated image to create a recorded image. The recording feature is optional and the image recording and review system 410 may not record every image generated by the ultrasound system 412.

[000118] For each image recorded, the image recording and review system 410 may provide location information for the recorded image. For example, the image recording and review system 410 may append location identifier information to the image file format for a recorded image. Each recorded image may include a pixel array for which each pixel in the array is given location information. This may include a first pixel po with spatial designation of x0,yo,zo (x, y, and z axis locations in space), a second pixel p2 (x2,y2,z2), a third pixel p3 (x3,y3,z3), a fourth pixel

P4 (x4,y4,z4), and a nth pixel pn (x„,yn,zn).

[000119] This pixel location information may be based on the tracked location for the probe and/or the container. For example, if the spatial location of three or more sensors/registers on a probe can be determined, and if the spatial location of those sensors relative to the spatial geometry of the tracked probe is known, then the spatial location of the probe is known. Since the projection of images scanned from the probe are a fixed function of the geometry of the probe and the location of the transducer element array, the spatial location of the two- dimensional images (and the pixels within each image) can be determined. Additional details regarding a similar process are described in commonly assigned International Patent Application No. PCT/US2012/059176, titled Method, Apparatus and System for Complete Examination of Tissue with Hand-Held Imaging Devices filed Oct. 9, 2012, and incorporated by reference in its entirety.

[000120] In some embodiments the location of the container and the probe are measured independently. For example, referring again to FIG. 10, the container 712 includes a set of location markers 718 and the probe 725 includes a set of location markers 706. The respective location markers allow a location tracking system 707 to track the location (e.g. position and/or orientation) of the container 712 and probe 725 independently. In some cases, more than one location tracking system may be used to track more than one target object. However, this is not necessary.

[000121] Additionally, any number of suitable registers, sensors, or markers may be used to track location information for the container or the probe. Referring to FIG. 6, the probe 414 may include three position sensors 432a-432c that can be used to detect position information. The position information from the position sensors may be used to derive orientation data for the probe. In another embodiment, the container may include three registers, sensors, or markers 708 that can provide position information for the container. The position information may also be used to derive orientation information for the container. [000122] Alternatively, FIG. 32 and FIG. 29 show other embodiments having a single sensor, register, or marker. FIG. 32 shows a probe 2514 with at least one sensor 2532. The sensor 2532 may be configured to detect position, orientation, and/or both position and orientation. In some embodiments, the sensor 2532 detects only position. In other embodiments, the 2532 sensor detects position and orientation. In further variations, the sensor 2532 is configured to detect only orientation. Similarly, as shown in FIG. 29, the container 1912 may include at least one sensor 1920 that can detect position, orientation, and/or both position and orientation in various embodiments. In some cases, the at least one sensor 1920 detects only position for the container.

In other cases, the at least one sensor 1920 detects only orientation for the container. In further variations, the at least one sensor 1920 detects both position and orientation for the container.

[000123] Referring to FIG. 30 and FIG. 31, in another variation, the container 2912 or the probe 3514 may include a position sensor/marker/register and an orientation

sensor/marker/register. FIG. 30 shows the probe 3514 with a position sensor 3001 and an orientation sensor 3003. FIG. 31 shows the container 2912 with a position sensor 2920 and an orientation sensor 2922.

[000124] Advantageously, tracking the container position and/or orientation allows mapping of the container and its contents, especially where the container may be moved during the scanning procedure. Including location markers/sensors/registers on the container allows the relative geometry of the container to be determined. This then further provides a basis for determining the location information for a recorded image of the container. For example, if a container is at a first position during a first scan and then tilted to 45 degrees for a second scan, the position information for the container can be used to determine the relative location of an image recorded from the first scan and a second image recorded from the second scan. In some cases, the first recorded image from the un-tilted container may show a section of the specimen adjacent to what is shown in the second recorded image taken from the tilted container. By tracking the container position and/or orientation, the system can determine that the first and second recorded images show adjacent cross-sections of the specimen. Additionally, the system can modify the recorded images if needed to reflect a consistent view of the specimen. For example, the second recorded image may be adjusted to compensate for the tilt angle and provide a viewing perspective similar to that of the first recorded image.

[000125] As described, the image recording and review system may be configured to generate location information for recorded images based on the container location during a scanning procedure that generated the recorded image. The image recording and review system may be able to assess the container location information to compensate for container movement or position/orientation changes during a scan. The image recording and review system may then append location information to the recorded image files where the appended image location information is computed from the container location information.

[000126] The image recording and review system may also generate a tissue map or representation of the scanned specimen based on the container location information. For example, recorded images are typically two-dimensional digital images. The image recording and review system may construct a three-dimensional representation of the excised tissue specimen from the recorded images. For example, standard three-dimensional image reconstruction may render a series of recorded two-dimensional images into a three-dimensional representation of the internal geometry of the container. The three-dimensional representation may show a cross-section of the tissue specimen allowing a viewer to determine the presence, absence, and characteristics of a margin in the specimen. Additionally, the viewer may be able to manipulate the three-dimensional representation to select cross-sectional views of the three- dimensional representation. The image recording and review system may use the location information for the container to determine what portions of the specimen and container is shown in recorded images. This allows the system to determine which images are suitable for generating a three-dimensional map or representation of the tissue specimen.

[000127] In some cases, since the specimen is relatively fixed within the container, and does not move relative to the container, the specimen and its surroundings may be mapped ultrasonically by recording a series of images that bisect the inside of the container. These images produce a plurality of pixels that may be reduced to voxels or other three-dimensional representation techniques. The resultant three-dimensional image data set may be bisected along any plane to produce a two-dimensional view (e.g. cross-sectional view of the three-dimensional representation). The cross-sectional view may be a new view not scanned by the probe but generated by the image recording and review system from the scanned information. For those skilled in the art, looking at these two-dimensional views from many directions will assist them to analyze lesions and surrounding tissue to determine whether the removed specimen represents the entirety of that specimen, or whether there are tissue structures remaining in the patient that are of concern.

[000128] As can be appreciated, independent tracking of the container and probe provides several options for scanning the tissue specimen. FIGS. 23-27 provide exemplary scanning methods that can be used. In FIG. 23, the container 950 remains stationary while the probe 925 is translated linearly along its face. The probe 925 is translated 952 across the container 950 from left to right 953a-d. For each scan row 953a-d, a plurality of images are generated by the probe system. An image recording and review system can receive the plurality of images and record one or more images from the scanned rows. As described above, each of the recorded images contains pixels and the location of the pixels of each image with relation to the geometry of the container is unique. Knowing the position of the pixels relative to the container geometry allows the system to determine what the image shows, such as, a tilted or non-tilted slice of the specimen.

[000129] In FIG. 23, the probe 925 is moved across the container 950 without moving the container 950. This scanning procedure 951 can be understood as a stationary container 950 scanned by a moving probe 925. The same effect may be obtained if the probe 925 remains stationary, but the container 950 is moved linearly 954 with relation to the probe 925 (FIG. 24), as long as the position of the probe 925 and the position of the container 950 are known when each image is recorded.

[000130] The same or similar images, with the same or similar orientation to the container geometry may be obtained if the probe 925 moves in the linear direction 956 and the container 950 is moves in the opposite linear direction 958 with relation to the probe 925 (FIG. 25), as long as the position of the probe and the position of the container are known when each image is recorded.

[000131] The same or similar images, with the same or similar orientation to the container geometry may be obtained if the probe 925 scans in a direction 962 that is not orthogonal to the face of the container 950 (FIG. 26). The container 950 may also be moved orthogonally to the probe, as shown in FIG. 26. In either of these cases, as long as the position of the probe and the position of the container are known when each image is recorded, the image recording and review system can treat the scan like a scan procedure 951 with a stationary container or probe to obtain the same or similar types of images.

[000132] Additionally, the same or similar images, with the same or similar orientation to the container geometry may be obtained if the probe and container are rotated (FIG. 27), as long as the position of the probe and the position of the container are known when each image is recorded.

[000133] The image recording and review system may include computer software instructions or groups of instructions that cause a computer or processor to perform an action(s) and/or to make decisions. In some variations, the system may perform functions or actions such as by functionally equivalent circuits including an analog circuit, a digital signal processor circuit, an application specific integrated circuit (ASIC), or other logic device. In some embodiments, the system includes a processor or controller that performs the reconstruction functions or actions as described. The processor, controller, or computer may execute software or instructions for this purpose. [000134] "Software", as used herein, includes but is not limited to one or more computer readable and/or executable instructions that cause a computer or other electronic device to perform functions, actions, and/or behave in a desired manner. The instructions may be embodied in various forms such as objects, routines, algorithms, modules or programs including separate applications or code from dynamically linked libraries. Software may also be implemented in various forms such as a stand-alone program, a function call, a servlet, an applet, instructions stored in a memory, part of an operating system or other type of executable instructions. It will be appreciated by one of ordinary skill in the art that the form of software may be dependent on, for example, requirements of a desired application, the environment it runs on, and/or the desires of a designer/programmer or the like. It will also be appreciated that computer-readable and/or executable instructions can be located in one logic and/or distributed between two or more communicating, co-operating, and/or parallel processing logics and thus can be loaded and/or executed in serial, parallel, massively parallel and other manners.

[000135] In another aspect, the invention provides for an acoustically conductive container for containing the tissue specimen during ultrasonic scanning. FIG. 10 shows an acoustically conductive container 712 having at least one acoustically conductive surface 714. The container 712 may be configured to hold, carry, and/or suspend a specimen within the container 712. In some cases, the container includes an interior, internal, or inner volume adapted to receive the tissue specimen.

[000136] As can be appreciated, any suitable container shape or form may be used. In FIG. 10, the container 712 has a rectangular shape forming a cube container. In other variations, the container may have a circular, triangular, or other applicable shape. In other cases, the container may have an irregular shape that does not confirm to a specific geometric category. In further variations, the container may have a conformable shape such as a flexible bag that can hold the tissue specimen.

[000137] In some variations, the specimen may lay against a container side in the interior of the container. For example, the specimen may lie against an acoustically conductive side having an acoustically conductive surface and cross-section that allows ultrasound examination of the specimen through the container.

[000138] Additionally, the interior of the container may also be adapted to maintain the position of the specimen within the container. In some variations, hooks, clamps, wires, anchors, etc. may be used to maintain the specimen position in the container. In other cases, the specimen may be held in a position by an acoustically conductive material such as an acoustically conductive material or fluid. In one embodiment, a part of the container volume may be filled with the acoustically conductive material or fluid to prevent substantial movement of the specimen in the container. Advantageously, this allows the ultrasound technician to move the container during the scanning process while maintaining the position and orientation of the specimen within the container. As can be appreciated, a freely moving specimen in a moving container may make it difficult for performing adequate scanning.

[000139] In some cases, the internal volume of the container is substantially completely filed with an acoustically conductive material or fluid. Referring to FIG. 10, the container 712 holds the specimen 71 1 in an interior of the container. The interior is filled with an acoustically conductive material or fluid 713 to maintain the position of the specimen 711 during scanning by the ultrasound probe 725.

[000140] In other embodiments, it may be desirable, but not necessary, to suspend the specimen within the container. In some cases, the specimen is suspended by an acoustically conductive material. Although the ultrasound method will transmit through the acoustically conductive material and through the specimen itself without suspending the tissue, it may be preferential to suspend the specimen.

[000141] As an example, FIGS. 1 1 A-l IB show a container 812 having a conduit or port 810 and an interior. A specimen 81 1 is placed in the interior of the container 812. A suspending lumen 814 is formed in the container 812 to suspend the specimen 81 1 in the container 812. As shown, the lumen 814 is formed by an acoustically conductive material 809 in the container 812. In some cases, the acoustically conductive material 809 fills the container volume and surrounds the specimen. In other cases, the acoustically conductive material forms a lumen around the specimen. The lumen may be conformed to the specimen shape. FIG. 1 1A shows lumen 814 around portions of the tissue specimen 81 1. The lumen 814 in FIG. 1 1A does not completely surround or conform to the shape of the tissue specimen 81 1. However, material or fluid or gas can be removed from the lumen 814 to seal the lumen around the specimen 81 1. As shown in FIG. 1 IB, a vacuum is applied to the conduit 810 to remove material or fluid and/or gas from the lumen 814. This thereby causes the lumen 814 to surround and conform to the specimen 81 1 shape. Additionally, in some cases, the lumen 814 supports the specimen 81 1 in the container 812 to maintain the position of the specimen 811 during ultrasound scanning.

[000142] Moreover, in some cases, there is also direct coupling between the acoustically conductive material and the specimen. By way of example, FIGS. 28A-B depicts a container 1000 with a three-pronged, acoustically-transmissive cradle 1002. If the specimen 1004 is dropped in to the cradle 1002 it settles in to the base 1006 and is stabilized by the arms. The cradle 1002 may be any acoustically transmissive material, such as silicone, latex, ballistic gel, or hydrogel. The best results may be achieved by choosing a material with acoustic properties similar to the surrounding material within the container. [000143] Alternatively, the specimen may be suspended in an acoustically conductive material by a variety of methods. FIG. 12 shows one example where the specimen 91 1 is suspended by hooked wires 913 in the container 912. The container 912 may also be filled with an acoustically conductive fluid or material 909.

[000144] Additionally, as shown in FIG. 10, the container and/or the ultrasound system may include sensors, markers, and/or registers for tracking the position and/or orientation of the container or the ultrasound probe. FIG. 10 shows markers 706 on the probe 725 and markers

708 on the container 712. In some cases, only the container or the probe may have tracking elements. In other cases, both the container and the probe are tracked. Tracking the container and probe provides position and/or orientation data that can be used by the image recording and review system to generate location information for recorded ultrasound images. This location information may be used to develop three-dimensional representations of the specimen as well as help show the presence and size of a margin in the tissue specimen.

[000145] In another aspect, contemplated embodiments also provide for methods of ultrasonically examining an excised tissue specimen. In some cases, the method includes the steps of scanning at least one acoustically conductive surface of a specimen container with an ultrasound probe while an excised tissue specimen resides within the specimen container.

Referring to FIG. 10, the probe 725 may be passed over the container to scan an interior of the container containing the tissue specimen. The probe 725 generates electrical signals based on acoustic feedback information received from the scan. The electrical signals are typically received by an ultrasound processor, such as the ones shown in FIG. 6 and FIG. 7. Once received, the ultrasound processor generates ultrasound images from the received electrical signals. Generally, the processor will generate a scan track (or series/sequence of images). For example, passing the probe 725 from top to bottom of the acoustically conductive surface 714 once may generate a first scan track having a sequence individual images in the scan track.

Passing the probe 725 over the acoustically conductive surface 714 again may generate a second scan track with another sequence of individual images.

[000146] The ultrasound processor may be in communication with an image recording and review system with a separate controller or processor. The image recording and review system may grab or retrieve images from the ultrasound system such as by way of a video output connection. The image recording and review system (e.g. controller of the system) may record one or more images received from the ultrasound system. The image recording and review system does not necessarily record every image received. For example, the image recording and review system may receive a first generated image and a second generated image from the ultrasound processor. The image recording and review system may, however, only record the first generated image as a first recorded image.

[000147] Additionally, the image recording and review system may be configured to generate location data (e.g. position data) for the first recorded image based on the location data of the probe and/or container. For example, during the scanning maneuver, the location of the probe and/or container may be tracked by a location tracking system (e.g. position and/or orientation tracking). The location tracking system may include markers, registers, and/or sensors as described for providing location information of the container and/or probe during scanning. In some cases, the location markers are registers adapted to reflect electromagnetic radiation. Any markers, registers, or sensors as described may be used to track the location of a target object.

[000148] In one embodiment, the probe position is tracked by a position tracking system. The probe position data is electronically received by the image recording and review system. The image recording and review system generates position data for the first recorded image based on the received probe position data. Where container position data is received, the image recording and review system may generate position data for the first recorded image based on the container position data, or, alternatively based on both the container and probe position data.

[000149] The image recording and review system may also output the first recorded image to a display for review by a physician or other medical personnel. The image recording and review system may output two-dimensional or three-dimensional representations of the excised tissue specimen. In the former case, the two-dimensional representations may be digitally recorded two-dimensional images showing cross-sectional views of the tissue specimen. In the latter case, the three-dimensional representation may show a volumetric depiction of the tissue specimen. The image recording and review system may also show the presence and dimensions (e.g. size) of a margin in the tissue specimen.

[000150] In other embodiments, the contemplated methods include recording of a second generated image as a second recorded image by the image recording and review system. The second recorded image also has location data (e.g. position and/or orientation) data generated by the image recording and review system based on location data received from a location tracking system. The image recording and review system may generate a three-dimensional

representation of the tissue specimen based on the first and second recorded images.

[000151] In other embodiments, the contemplated methods include forming an acoustically conductive lumen in the specimen container. As shown in FIGS. 1 1 A-l IB, an acoustically conductive lumen may be adapted to receive a tissue specimen. In some cases, the acoustically conductive lumen is flexible and/or constructed from a flexible material. In other cases, the acoustically conductive lumen is elastic and is formed from an elastic material. In other variations, the acoustically conductive lumen is formed from an elastomeric material such as silicone or other suitable materials. In further variations, the lumen may be formed from a material is adapted to conform to the shape of the tissue specimen.

[000152] Additionally, the lumen may be formed in an acoustically conductive fluid or material in the container. In some cases, the contemplated examination methods include the step of conforming the acoustically conductive lumen to a shape of the tissue specimen. This may be accomplished by surrounding the excised tissue specimen in the container with an acoustically conductive material or fluid. Additionally, the method may include vacuum sealing the excised tissue specimen in the acoustically conductive material or fluid. Furthermore, the examination methods may include suspending the excised tissue specimen in the specimen container with an acoustically conductive material or fluid.

[000153] As described, some embodiments provide for methods of examining an excised tissue specimen that include the steps of scanning at least one acoustically conductive surface of a specimen container with an ultrasound probe while the excised tissue specimen resides within the specimen container, wherein an ultrasound processor receives scanning information from the probe to thereby generate a first generated image and a second generated image of the excised tissue specimen in the container; tracking the position of the specimen container during the ultrasonically scanning step with a position tracking system, wherein the position tracking system electronically communicates position data for the specimen container to an image recording and review system; electronically communicating the first generated image from the ultrasound processor to the image recording and review system; and recording of the first generated image as a first recorded image by the image recording and review system, wherein the image recording and review system generates position data for the first recorded image based on the position data for the specimen container received from the position tracking system.

[000154] Additionally, the method may include the steps of recording of the second generated image as a second recorded image by the image recording and review system, wherein the image recording and review system generates position data for the second recorded image based on the position data for the specimen container received from the position tracking system; and generating of a three-dimensional representation of the excised tissue specimen by the image recording and review system, wherein the image recording and review system generates the three-dimensional representation from the first and second recorded images. In some cases, the three-dimensional representation can be reviewed to determine the presence or absence of a margin between a lesion and healthy tissue in the excised tissue specimen.

[000155] In another aspect, an ex vivo tissue ultrasound scanning system is shown in FIG. 13 A. As seen in FIG. 13A, the ex vivo tissue ultrasound scanning system comprises container 22 and lid 24 illustrated, by way of example, with Acme type external threads 17 and internal threads 19 on the container and lid, respectively. As seen in FIG. 13A, O-ring 26 provides an air-tight seal at the base of lid 24 to enable evacuation of region 13 above the upper surface level 140 of liquid 70. Said evacuation of region 13 is provided by evacuation unit 12 comprising outer cylindrical tube 14 and inner piston 16 incorporating O-ring 18 to enable a negative pressure to be achieved as the piston 16 is withdrawn within the outer cylindrical tube 14.

[000156] Still referring to FIG. 13 A, the inner surface of the outer cylindrical tube 14 is coated with low vapor pressure vacuum grease or silicone lubricant (e.g., Dow Corning High Vacuum Grease, Dow Corning Corporation, Midland, Michigan) to improve the level of vacuum achieved as the piston 16 is withdrawn within the outer cylindrical tube 14. In a preferred embodiment of the evacuation unit 12 in the present invention, the withdrawal of the piston 16 is accomplished with Acme type external threads 5 and internal threads 7 on the piston 16 and outer cylindrical tube 14 in conjunction with the manual rotation of piston 16 using knurled knob 20. As the knurled knob is rotated counter-clockwise, the threaded portion of evacuation unit 12 causes the piston 16 to be withdrawn. The air-tight seals provided by O-ring 18 on Piston 16 and O-ring 26 supported by shelf 27 on container 22 enable a negative pressure to be achieved in region 13 above surface of liquid 70 (e.g., a pressure within region 13 and zone of withdrawn piston 16 of 100 to 250 mm Hg where 760 mm Hg refers to normal atmospheric pressure). The negative pressure within region 13 increases the rate of extracting air bubbles from liquid 70 and interface between liquid 70 and the surface of specimen 100.

[000157] In another embodiment of the present invention shown in FIG. 13A, an ultrasound degassing unit 30 is removably inserted into cavity of container 22 through lid opening 39 and end face 41 of ultrasound degassing unit 30 is inserted below the surface of liquid 70. See, for example, Barbell Horn ultrasonic product manufactured by Industrial Sononmechanics, LLC, New York, New York. An O-ring 40 is provided at nodal point or location of zero vibrational amplitude at working end 32 of ultrasound degassing unit 30 to effect air-tight seal between ultrasound degassing unit 30 and lid 24 at lid opening 39. A shoulder 99 is located around the perimeter at working end 32 of ultrasound degassing unit 30 proximal to O-ring 40 to prevent displacement of the ultrasound degassing unit 30 into the cavity of container 22 in the event simultaneous negative pressure is achieved in region 13 using evacuation unit 12. Vibrational energy applicator 34 located at proximal end of ultrasound degassing unit 30 (e.g., piezoelectric energy source) is removably connected to power source (not shown) via ultrasound horn cable 36 terminated at connector 38. When the ultrasound degassing unit 30 is energized with appropriate frequency (e.g., a frequency in the range 15 to 100 kHz) and amplitude (e.g., peak- to-peak amplitudes ranging from about 10 to less than 100 microns), the alternating cycles of high and low pressure cause an increase in the size of any bubbles within liquid 70 as well as induce vibrations at interface of specimen 100 and liquid 70, thereby expelling any entrapped air bubbles at this liquid/specimen interface. The pulsed application of ultrasonic energy to liquid 70 for brief periods (e.g., 2 to 20 seconds) and, indirectly, to specimen 100 followed by brief periods of no ultrasonic energy application (e.g., 2 to 10 seconds) enables the coalesced and expelled air bubbles to rise to the surface of liquid 70. The removal of air bubbles from liquid 70 and interface between liquid 70 and specimen 100 in the region of specimen 70 defined by dimension, Dl in FIG. 13A improves the quality of the ultrasound image acquired by ultrasound probe 120 since air bubbles induce distortions in the image derived by the ultrasonic scanning process. It is therefore highly advantageous to remove as many air bubbles as possible (in the field of view of the ultrasonic scanning procedure). In a preferred embodiment of the present invention, a negative pressure may be achieved in region 13 using evacuation unit 12, as described above, in combination with the pulsed application of ultrasound energy using ultrasound degassing unit 30 to increase the efficiency and effectiveness of removal of air bubbles in the field of view of the ultrasonic scanning procedure. In this embodiment, following the completion of the application of ultrasound energy to facilitate degassing of liquid 70 and interface between the liquid 70 and specimen 100, the region 13 may be returned normal atmospheric pressure using evacuation unit 12 (viz., by returning piston 16 to its approximate original position prior to evacuation step). Once region 13 is returned to atmospheric condition, ultrasound degassing unit may be removed and replaced with cap 90 comprising O-ring 96 and shoulder 92 around its periphery just proximal to O-ring 92 as seen in FIG. 14A. If needed, evacuation unit 12 can be employed to create a negative pressure in region 13 to initiate or continue the process of degassing of liquid 70 within container 22.

[000158] Returning to FIG. 13A, a fiber 44 is secured to the base of container 22 by adhesively bonding fiber anchor 46 to receptacle 28. Specimen support plate 52 is supported by enlargement 50 of fiber, e.g., knot in fiber or crimped ferrule whose effective diameter is greater than through hole (not shown) in specimen support plate 52. In the use of the present invention, specimen 100, whose envelope diameter and height dimensions are about 5 cm or less, is pierced through its approximate central axis 130 using needle 98 securely attached to specimen support assembly 1 13 shown in FIG. 20. Once the needle 98 and attached fiber 44 have been threaded through the specimen 100 and the specimen has been positioned against specimen support plate 52, the needle 98 is used to pierce septum 43 located in septum support unit 42 and the excess portion of fiber 44 is withdrawn as the threads 19 of lid 24 engage threads 17 of container 22 and the lid 24 is rotated until it engages O-ring 27 to effect a air-tight seal. Following the removable attachment of lid 24 onto container 22, needle 98 and fiber 44 are withdrawn until all slack in fiber 44 is removed to secure specimen 100 in a stable position as seen in FIG. 1A. Once the lid 24 is secured onto the container 22 with the specimen 100 in its preferred and stable position as shown in FIG. 13 A, water or other suitable ultrasound transmissive liquid 70 is added to container 22 incorporating supported specimen 100 until liquid level reaches upper surface level 140 as seen in FIG. 13 A.

[000159] In yet another embodiment of the present invention, a rotating platform unit 61 supports base of container 22 to enable rotation of specimen 100 past stationary ultrasound probe 120. Said rotating platform unit 61 comprises rotating platform 62 mechanically driven by rotation drive unit 64 connected to power source (not shown) via cable 66 and removably attachable connector 68. Two or more ears 62 affixed to rotating platform 62 engage matching insets 69 at the base of container 22 to removably attach container to rotating platform 62 and thereby effect rotation of container with powered rotation of rotating platform 62.

[000160] In all of the embodiments of the ex vivo tissue ultrasound scanning system shown with respect to FIG. 13A, an ultrasound scanning and imaging system is used to examine specimen 100. Said ultrasound scanning and imaging system comprises ultrasound probe 120 incorporating a ultrasound transducer array at its distal end (not shown) connected to ultrasound energy source and recording system (not shown) by cable 124. An ultrasound coupling agent 122 (e.g., Parker Ultrasonic 100, Parker Laboratories, Orange, New Jersey) is applied between the ultrasound transducer array and the surface of the container to increase level of transmission of ultrasound waves into and reflected back from the specimen 100 during the scanning process.

[000161] In another preferred embodiment of the present invention seen in FIG. 2A, the ex vivo tissue ultrasound scanning system comprises a container 22 with three or more, preferably four, flat sides 108 with circular opening 1 10. As seen in FIG. 14A, the ex vivo tissue ultrasound scanning system comprises container 22 and lid 24 illustrated, by way of example, with Acme type external threads 102 and internal threads 104 on the container and lid, respectively. As seen in FIG. 14A, O-ring 142 located at base of internal threads 104 provides an air-tight seal between base of lid 24 and top edge 144 of opening 100 of container 22. Said air-tight seal enables evacuation of air space region (not shown) between upper surface level 140 of liquid 70 and bottom interior face of lid 24. Said evacuation of air space region (not shown) is provided by evacuation unit 12 comprising outer cylindrical tube 14 and inner piston 16 incorporating O-ring 18 to enable a negative pressure to be achieved as the piston 16 is withdrawn within the outer cylindrical tube 14.

[000162] Referring now to FIGS. 13A and 14A, the inner surface of the outer cylindrical tube 14 is coated with low-vapor pressure vacuum grease or silicone lubricant (e.g., Dow Corning High Vacuum Grease, Dow Corning Corporation, Midland, Michigan) to improve the level of vacuum achieved as the piston 16 is withdrawn within the outer cylindrical tube 14. In a preferred embodiment of the evacuation unit 12 in the present invention, the withdrawal of the piston 16 is accomplished with Acme type external threads 5 and internal threads 7 on the piston 16 and outer cylindrical tube 14 in conjunction with the manual rotation of piston 16 using knurled knob 20. , As the knurled knob is rotated counter-clockwise, the threaded portion of evacuation unit 12 causes the piston 16 to be withdrawn. The air-tight seals provided by O-ring 18 on Piston 16 and O-ring 26 supported by shelf 27 on container 22 enable a negative pressure to be achieved in air space region (not shown) between upper surface level 140 of liquid 70 and bottom interior face of lid 24 above surface of liquid 70 (e.g., a pressure within this region and zone of withdrawn piston 16 of 100 to 250 mm Hg where 760 mm Hg refers to normal atmospheric pressure). The negative pressure within these air space regions increases the rate of extracting air bubbles from liquid 70 and interface between liquid 70 and the surface of specimen 100. Following the optional augmented degassing procedure using ultrasound degassing unit 30, said ultrasound degassing unit 30 may be removed and replaced with cap 90 seen in FIG. 13B.

[000163] Referring now to FIGS. 14A and 14B, ultrasound degassing unit 30 is shown removed from but removably insertable into lid 24 at lid opening 39. The positioning and operation of ultrasound degassing unit 30 is the same as described above in conjunction with the ex vivo tissue ultrasound scanning system seen in FIGS. 13A and 13B. Also, the positioning of the specimen within the container using needle 98 and fiber 44 is the same as described above in conjunction with FIG. 13 A. Once the lid 24 is secured onto the container 22 with the specimen 100 in its preferred position as shown in FIG. 14A, water or other suitable ultrasound transmissive liquid 70 is added to container 22 incorporating supported specimen 100 until liquid level reaches upper surface level 140 as seen in FIG. 14A.

[000164] In the embodiment of the present invention seen in FIG. 14A, the ultrasound probe 120 (as described in greater detail above in conjunction with FIG. 13 A) is moved back and forth across flat face 108 of container 22 to effect ultrasound scanning and imaging of specimen 100 while a layer of ultrasound coupling gel 122 is maintained at the interface between the ultrasound transducer array located at the distal end (not shown) of ultrasound probe 120 and flat face 108 of container 22.

[000165] Referring to FIGS. 13A, 13B and 14A, the materials of construction of container 22, lid 24 and cap 90 may include polyethylene, polyvinyl chloride, polypropylene, polycarbonate or other plastic suitable for forming into the desired final shapes by injection molding and/or blow molding. In particular, the container 22 of the ex vivo tissue ultrasound scanning system would be preferably manufactured using well-known and commercially available blow molding techniques. [000166] Referring now to FIG. 15, fiber anchor is shown in greater cross-sectional detail comprising through-hole 47 having inner diameter D5 sized to be larger than fiber 44 seen in FIGS. 13A and 14A. Counterbore 146 having diameter D6 and Length L9 with overall height of fiber anchor 46 designated by dimension L4. The material of construction of fiber anchor 46 may include polyethylene, polyvinyl chloride, polypropylene, polycarbonate or other plastic suitable for forming into the desired final shape by injection molding.

[000167] Referring now to FIG. 16, specimen support plate 52 is shown in greater cross- sectional detail comprising through hole 53 having inner diameter D5 sized to be larger than fiber 44 seen in FIGS. 13A and 14A. Said specimen support plate 52 preferably comprises a flat circular or square plate of plastic having a thickness tl and diameter or principal dimension D8. The material of construction of specimen support plate 52 may include polyethylene, polyvinyl chloride, polypropylene, polycarbonate or other plastic suitable for forming into the desired final shape by injection molding or stamping from sheet stock.

[000168] Referring now to FIG. 17, septum support unit 42 is shown in greater cross-sectional detail comprising septum 43 having a diameter D3 and septum support unit 42 having major and minor diameters D4 and D12. A reduced diameter, D4 of length, L10 is provided at one end of septum support unit 42 to facilitate adhesively bonded attachment of outer septum support unit 42 to lid 24 as seen in FIGS. 13A and 14A. The material of construction of septum support unit 42 may include polyethylene, polyvinyl chloride, polypropylene, polycarbonate or other plastic suitable for forming into the desired final shape by injection molding. The material of construction of septum 43 is preferably silicone and may be cast into opening in septum support unit 42 or septum support unit 42 may be over-molded around septum 43.

[000169] Referring now to FIG. 18, outer cylindrical tube 14 of evacuation unit 12 is shown in greater cross-sectional detail having inner diameter D2, outer diameter, D9 and length, L5. In a preferred embodiment, Acme type threads 23 are molded into inner wall of outer cylindrical tube 14 at its proximal end as seen in FIG. 18. A reduced diameter, Dl 1 of length, LI 1 is provided at the distal end of outer cylindrical tube 14 to facilitate adhesively bonded attachment of outer cylindrical tube 14 to lid 24 as seen in FIG. 13A and 14A. The material of construction of outer cylindrical tube 14 may include polyethylene, polyvinyl chloride, polypropylene, polycarbonate or other plastic suitable for forming into the desired final shape by injection molding.

[000170] Referring now to FIG. 19, piston 16 of evacuation unit 12 is shown in greater cross- sectional detail having outer diameter D10 and length, L6. In a preferred embodiment, Acme type threads 21 are molded into of outer surface of piston 16 at its proximal end as seen in FIG. 19. The distal end of piston 16 incorporates O-ring 18 to effect air-tight seal in combination with vacuum grease or silicone oil applied to inner surface of outer cylindrical tube 14 seen in FIGS. 18, 13A and 13B. A knurled knob 20 is provided at proximal end of piston 16 to facilitate rotation of piston 16 to effect creation of negative pressure within air space above liquid level 140 in container 22. The material of construction of piston 16 may include polyethylene, polyvinyl chloride, polypropylene, polycarbonate or other plastic suitable for forming into the desired final shape by injection molding.

[000171] Referring now to FIG. 20, specimen support assembly 1 13 is shown in greater cross- sectional detail comprising fiber anchor 46, fiber 44 with a knot or crimped ferrule at one end to prevent pulling through hole 47 in fiber anchor 46. A needle 98 having diameter, D12 and length, L8 is attached to the other end of fiber 44 having sufficient sharpness to readily pierce tissue specimen 100 and septum 43 as seen in FIGS. 13 A, 13B, 17 and 20. Said needle 98 may be constructed by using a 20 or 22 gauge hypodermic needle with the unsharpened end crimped onto fiber 44. Said fiber 44, having a diameter, D13, may be nylon "fishing line" or Kevlar material.

[000172] Referring now to FIG. 21 , a perspective view of another preferred embodiment of the ex vivo tissue ultrasound scanning system is shown illustrating the use of a liquid injection unit 158 comprising a syringe 160 and extension tubing 162. The syringe 160 has a capacity that is sufficient to completely fill the container 22 to the pre-determined upper surface level 140 of liquid 70. By way of example, syringe 160 is Hamilton Model S-1000 with capacity of 1000 ml (Hamilton Company, Reno, Nevada). In use, syringe 160 and extension tubing 162, with plunger 166 fully advanced in syringe 160, withdraws liquid 70 (e.g., isotonic saline) from source (not shown) to completely fill extension tubing 162 and syringe 160. Next, extension tubing 162 is inserted through lid opening 39 and advanced until the distal end 164 of extension tubing 162 is just above the bottom surface of container 22. The syringe plunger 166 is slowly advanced to fill container 22 with liquid 70 while minimizing the creation of air bubbles normally produced when a liquid is poured into a vessel as a result of entrapped air during the pouring process.

[000173] An exemplary range of dimensions for the embodiments of the present invention shown in FIG. 13 A through FIG. 20 are presented below:

Dl= about 2.5 to 4.0 inches

D2= about 0.50 to 1.50 inches

D3= about 0.3 to 0.7 inches

D4= about 0.4 to 0.8 inches

D5= about 0.025 to 0.050 inches

D6= about 0.12 to 0.25 inches

D7= about 0.25 to 0.50 inches D8= about 0.5 to 1.0 inches

D9= about 0.6 to 1.75 inches

D10 = about 0.49 to 1.49 inches

Dl l = about 0.6 to 1.2 inches

D12 = about 0.020 to 0.040 inches

D13 = about 0.010 to 0.022 inches

D14 = about 0.50 to 1.65 inches

L I = about 0.6 to 1.5 inches

L2 = about 0.5 to 1.5 inches

L3 = about 0.25 to 0.40 inches

L4 = about 0.10 to 0.25 inches

L5 = about 2.0 to 4.0 inches

L6 = about 2.3 to 4.3 inches

L7 = about 6.0 to 10.0 inches

L8 = about 0.75 to 1.50inches

L9 = about 0.05 to 0.12 inches

L10 = about 0.10 to 0.25 inches

Ll l = about 0.10 to 0.25 inches

Wl = about 2.5 to 4.0 inches

W2 = about 2.5 to 4.0 inches

HI = about 2.5 to 4.0 inches

tl = about 0.02 to 0.08 inches

[000174] A general flow chart of the operation of one embodiment of the ex vivo ultrasound scanning system of the present invention is described in FIGS. 22A through 22C. These figures are combined as labeled thereon to provide a flow chart describing the system and method for the ultrasound examination of ex vivo tissue specimens. The specified ex vivo ultrasound scanning system can utilize the following protocol without extensive experimentation.

[000175] Beginning as represented by symbol 200 and continuing as represented by arrow 202 to block 204 in FIG. 22A, a tissue specimen, as illustrated as 100 in FIG. 13A and 14A, is obtained from the patient and irrigated/rinsed with isotonic saline to remove any blood from the specimen surface. Said tissue sample will typically have a circumscribing diameter and height of about 5 cm. Next, as represented by arrow 206 and block 208, provided needle and attached fiber secured to base of interior of container is threaded through central axis of specimen 100, as illustrated as 98, 44 and 46 in FIGS. 13A and 14A. Specimen 100 is advanced towards distal end of fiber until it reaches the specimen support plate 52 as seen in FIG. 13 A.

[000176] Next, as represented by arrow 210 and block 212, said needle is inserted through bottom face of lid via septum and lid is then rotated onto container until air-tight seal is achieved between lid and container as a result of compression of O-ring as seen in FIG. 13 A. Needle and attached fiber are withdrawn until excess fiber is removed between top of specimen and bottom face of lid to achieve stable and stationary position of specimen as seen in FIG. 13 A.

[000177] Next, as represented by arrow 214 and block 216, advance piston inside evacuation unit 12 by turning knob 20 fully clockwise until its rotation can no longer be continued as seen in FIG. 13A and 13B. This step prepares evacuation unit 12 for subsequent creation of negative pressure in container.

[000178] Next, as represented by arrow 218 and block 220, position bottom surface of container 22 on horizontal surface (e.g., table top) and add ultrasound transmissive liquid 70 (e.g., isotonic saline) to container until it reaches upper surface level 140 designated on container 70. In a preferred embodiment, said ultrasound transmissive liquid 70 is injected into container through lid opening 39 as illustrated in FIG. 21 using syringe 160 and extension tubing 162 by positioning distal end 164 of extension tubing 162 in close proximity with bottom surface of container 22 to minimize entrainment of air during the filling operation of container 22 as seen in FIG. 13A. Once the filling of container 22 with liquid 70 to pre-determined upper surface level 140 is completed, extension tubing 162 is withdrawn from container 22 via opening 39.

[000179] Next, as represented by arrow 222 and block 224, ultrasound degassing unit 30 is inserted into lid opening 39 until insertion is stopped by shoulder 99 on working end 32 of ultrasound degassing unit 30, thereby effecting air-tight seal at O-ring 40 as seen in FIG. 13 A. With correct level of liquid 70 in container 22, end face 41 of working end 32 of ultrasound degassing unit 30 will be located below the upper surface level 140 of liquid 70.

[000180] Next, as represented by arrow 226 and block 228, rotate knob 20 at proximal end of piston 16 counter-clockwise until its rotation can no longer be continued. At his position of piston 16, the maximum level of negative pressure has been achieved to facilitate extraction of air bubbles from liquid 70 in container 22 as well as from interface between specimen 100 and surrounding liquid within container 22 as seen in FIG. 13 A.

[000181] Next, as represented by arrow 230 and block 232, the ultrasound degassing unit is energized using pre-selected frequency (e.g., 15 to 20 kHz), oscillation amplitude (e.g., 30 to 50 microns) and on/off cycle periods (e.g., 5.0 seconds "On" and 5.0 seconds "Off) to allow coalesced air bubbles to rise to the surface of liquid 70 under the buoyant forces acting on any air bubbles within liquid 70. By way of example, the on and off cycle may be continued for two minutes to further facilitate extraction of air bubbles and operating in combination of negative pressure achieved using evacuation unit 12.

[000182] Next, as represented by arrow 234 and block 236, rotate knob 20 at proximal end of piston 16 in clockwise direction to return piston 16 in evacuation unit 22 to original starting position, as seen in FIG. 13 A, thereby returning pressure inside container 22 to atmospheric pressure in preparation for removal of ultrasound degassing unit 30.

[000183] Next, as represented by arrow 238 and block 240, remove ultrasound degassing unit 30 from lid opening 39 and insert cap 90 into lid opening 39 as seen in FIGS. 13A, 13B and 14A. Next, as represented by arrow 242 and block 244, apply ultrasound coupling gel to entire surface of container 22 that is to be contacted by transducer array of ultrasound probe 120 during ultrasound scanning procedure as seen in FIG. 14A.

[000184] Next, as represented by arrow 246 and block 248, turn on ultrasound scanning system and manually translate transducer array of ultrasound probe 120 across surface of container 22 adjacent to location of specimen 100 to achieve complete ultrasound scan of entire specimen 100. As represented by arrow 250 and block 250, the completeness of the ultrasound scan of the specimen is queried and it is determined whether it is complete and image quality is adequate. If not, arrow 254 returns to block 248 and the scanning of specimen 100 using ultrasound probe 120 is repeated. If the ultrasound scan of specimen 100 is complete and the image quality is adequate, then proceed by arrow 256 to block 258 indicating the end of the test.

[000185] As for additional details pertinent to the present invention, materials and

manufacturing techniques may be employed as within the level of those with skill in the relevant art. The same may hold true with respect to method-based aspects of the invention in terms of additional acts commonly or logically employed. Also, it is contemplated that any optional feature of the inventive variations described may be set forth and claimed independently, or in combination with any one or more of the features described herein. Likewise, reference to a singular item, includes the possibility that there are plural of the same items present. More specifically, as used herein and in the appended claims, the singular forms "a," "and," "said," and "the" include plural referents unless the context clearly dictates otherwise. It is further noted that the claims may be drafted to exclude any optional element. As such, this statement is intended to serve as antecedent basis for use of such exclusive terminology as "solely," "only" and the like in connection with the recitation of claim elements, or use of a "negative" limitation. Unless defined otherwise herein, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. The breadth of the present invention is not to be limited by the subject specification, but rather only by the plain meaning of the claim terms employed.

Claims

CLAIMS What is claimed is:
1. A system for acoustically examining an excised tissue specimen comprising:
an acoustically conductive container having an internal volume and at least one acoustically conductive surface, the container adapted to hold the excised tissue specimen in an acoustically conductive material within the internal volume;
an ultrasound system comprising an ultrasound probe and a first controller in communication with the probe, wherein the first controller is configured to generate an ultrasound image from scan information received from the probe;
a position tracking system configured to track and record position data for the ultrasound probe as the probe scans the container; and
an image recording and review system comprising a second controller in communication with the position tracking system and the ultrasound system, the second controller comprising a recording unit configured to electronically receive and record at least one ultrasound image generated by the first controller of the ultrasound system, wherein the second controller is configured to electronically receive the ultrasound probe position data from the position tracking system and to output an ultrasound image recorded by the recording unit to a display coupled to the image recording and review system.
2. The system of claim 1, wherein the at least one ultrasound image recorded by the
recording unit comprises a first recorded image; and wherein the second controller is configured to generate position data for the first recorded image based on the ultrasound probe position data received from the position tracking system.
3. The system of claim 2, wherein the second controller is configured to derive orientation data for the first recorded image based on the ultrasound probe position data received from the position tracking system.
4. The system of claim 1, wherein the position tracking system is configured to track and record the orientation of the ultrasound probe.
5. The system of claim 2, wherein the first recorded image is a digital image comprising a plurality of pixels and the second controller is configured to determine and record a spatial position (Px,y,z) for each pixel of the plurality of pixels in the first recorded image.
6. The system of claim 1 , wherein the at least one ultrasound image recorded by the
recording unit comprises a plurality of recorded images and the second controller is configured to generate a three-dimensional representation of the excised tissue specimen from the plurality of recorded images.
7. The system of claim 6, wherein the second controller is configured to generate a three- dimensional representation from the plurality of recorded images.
8. The system of claim 1, wherein the container is adapted to suspend the excised tissue specimen in the acoustically conductive material.
9. The system of claim 1, wherein the acoustically conductive material surrounds the
excised tissue specimen but does not completely fill the internal volume of the container.
10. The system of claim 1, wherein the container comprises wires adapted to suspend the excised tissue specimen in the container.
1 1. The system of claim 1, wherein the container is configured to hold the excised tissue sample in an acoustically conductive lumen formed by the acoustically conductive material.
12. The system of claim 1 1, wherein the acoustically conductive lumen is sealed around the excised tissue specimen.
13. The system of claim 1, further comprising a vacuum adapted to remove material and gas from the container.
14. The system of claim 1 , container is configured to hold the excised tissue specimen in a sealed lumen around the excised tissue specimen.
15. The system of claim 1, wherein the container is configured to hold the excised tissue specimen such that the held tissue specimen does not directly contact a surface of the container.
16. The system of claim 1, wherein the position tracking system comprises a plurality of position registers coupled to the ultrasound probe, the plurality of position registers comprising a first position register and a second position register.
17. The system of claim 16, wherein at least one of the plurality of position registers is adapted to reflect electromagnetic radiation.
18. The system of claim 16, wherein at least one of the plurality of position registers reflects radiation having a wavelength in the optical range of the electromagnetic spectrum between about 380nm to about 760nm.
19. The system of claim 16, wherein at least one of the plurality of position registers reflects radiation having a wavelength between about 1mm to about 760nm.
20. The system of claim 16, wherein at least one of the plurality of position registers reflects infrared radiation.
21. The system of claim 16, wherein at least one of the plurality of position registers reflects radiation having a wavelength between about 1mm to about 750nm.
22. The system of claim 16, wherein at least one of the plurality of position registers reflects radiation in the ultraviolet bandwidth of the electromagnetic spectrum.
23. The system of claim 16, wherein at least one of the plurality of position registers reflects radiation having a wavelength between about lOnm to about 490nm.
24. The system of claim 16, wherein the first position register comprises a geometric pattern different from the second position register.
25. The system of claim 16, wherein the first and second position registers comprise the same geometric patterns with a different color arrangement.
26. A system for acoustically examining an excised tissue specimen comprising:
an acoustically conductive container having an internal volume and at least one acoustically conductive surface, the container adapted to hold the excised tissue specimen in an acoustically conductive material within the internal volume;
an ultrasound system comprising an ultrasound probe and a first controller in communication with the probe, wherein the first controller is configured to generate an ultrasound image from scan information received from the probe;
a position tracking system configured to track and record position data for the container; and
an image recording and review system comprising a second controller in communication with the position tracking system and the ultrasound system, the second controller comprising a recording unit configured to electronically receive and record at least one ultrasound image generated by the first controller of the ultrasound system, wherein the second controller is configured to electronically receive the container position data from the position tracking system and to output an ultrasound image recorded by the recording unit to a display coupled to the image recording and review system.
27. The system of claim 26, wherein the at least one ultrasound image recorded by the
recording unit comprises a first recorded image; and wherein the second controller is configured to generate position data for the first recorded image based on the container position data received from the position tracking system.
28. The system of claim 27, wherein the second controller is configured to derive orientation data for the first recorded image based on the container position data received from the position tracking system.
29. The system of claim 26, wherein the position tracking system is configured to track and record the orientation of the container.
30. The system of claim 26, wherein the first recorded image is a digital image comprising a plurality of pixels and the second controller is configured to determine and record a spatial position (Px,y,z) for each pixel of the plurality of pixels in the first recorded image.
31. The system of claim 26, wherein the at least one ultrasound image recorded by the
recording unit comprises a plurality of recorded images and the second controller is configured to generate a three-dimensional representation of the excised tissue specimen from the plurality of recorded images.
32. The system of claim 31, wherein the second controller is configured to generate a three- dimensional representation from the plurality of recorded images.
33. The system of claim 26, wherein the container is adapted to contain the excised tissue specimen in the acoustically conductive material.
34. The system of claim 26, wherein the acoustically conductive material surrounds the excised tissue specimen but does not completely fill the internal volume of the container.
35. The system of claim 26, wherein the position tracking system comprises a plurality of position registers coupled to the container, the plurality of position registers comprising a first position register and a second position register.
36. The system of claim 35, wherein at least one of the plurality of position registers is
adapted to reflect electromagnetic radiation.
37. The system of claim 35, wherein at least one of the plurality of position registers reflects radiation having a wavelength in the optical range of the electromagnetic spectrum between about 380nm to about 760nm.
38. The system of claim 35, wherein at least one of the plurality of position registers reflects radiation having a wavelength between about 1mm to about 760nm.
39. The system of claim 35, wherein at least one of the plurality of position registers reflects infrared radiation.
40. A method of ultrasonically examining an excised tissue specimen comprising:
scanning at least one acoustically conductive surface of a specimen container with an ultrasound probe while the excised tissue specimen resides within the specimen container, wherein an ultrasound processor receives scanning information from the probe to thereby generate a first generated image and a second generated image of the excised tissue specimen in the container;
tracking the position of the ultrasound probe during the ultrasonically scanning step with a position tracking system, wherein the position tracking system electronically communicates position data for the ultrasound probe to an image recording and review system;
electronically communicating the first generated image from the ultrasound processor to the image recording and review system;
recording of the first generated image as a first recorded image by the image recording and review system, wherein the image recording and review system generates position data for the first recorded image based on the position data for the probe received from the position tracking system; and
displaying the first recorded image.
41. The method of claim 40, further comprising:
recording of the second generated image as a second recorded image by the image recording and review system, wherein the image recording and review system generates position data for the second recorded image based on the position data for the probe received from the position tracking system; and
generating of a three-dimensional representation of the excised tissue specimen by the image recording and review system, wherein the image recording and review system generates the three-dimensional representation from the first and second recorded images.
42. The method of claim 40, further comprising forming an acoustically conductive lumen in the specimen container, wherein the acoustically conductive lumen is adapted to receive the excised tissue specimen.
43. The method of claim 42, wherein the acoustically conductive lumen is formed in an acoustically conductive material in the specimen container.
44. The method of claim 42, further comprising conforming the acoustically conductive lumen to a shape of the excised tissue specimen.
45. The method of claim 40, further comprising surrounding the excised tissue specimen in the container with an acoustically conductive material.
46. The method of claim 44, further comprising vacuum sealing the excised tissue specimen in the acoustically conductive material.
47. The method of claim 40, further comprising suspending the excised tissue specimen in the specimen container with an acoustically conductive material.
48. A method of ultrasonically examining an excised tissue specimen comprising:
scanning at least one acoustically conductive surface of a specimen container with an ultrasound probe while the excised tissue specimen resides within the specimen container, wherein an ultrasound processor receives scanning information from the probe to thereby generate a first generated image and a second generated image of the excised tissue specimen in the container;
tracking the position of the specimen container during the ultrasonically scanning step with a position tracking system, wherein the position tracking system electronically communicates position data for the specimen container to an image recording and review system;
electronically communicating the first generated image from the ultrasound processor to the image recording and review system;
recording of the first generated image as a first recorded image by the image recording and review system, wherein the image recording and review system generates position data for the first recorded image based on the position data for the specimen container received from the position tracking system; and
displaying the first recorded image.
49. The method of claim 48, further comprising:
recording of the second generated image as a second recorded image by the image recording and review system, wherein the image recording and review system generates position data for the second recorded image based on the position data for the specimen container received from the position tracking system; and
generating of a three-dimensional representation of the excised tissue specimen by the image recording and review system, wherein the image recording and review system generates the three-dimensional representation from the first and second recorded images.
50. The method of claim 49, further comprising reviewing the three-dimensional
representation to determine the presence of a margin between a lesion and healthy tissue in the excised tissue specimen.
51. The method of claim 48, further comprising forming an acoustically conductive lumen in the specimen container, wherein the acoustically conductive lumen is adapted to receive the excised tissue specimen.
52. The method of claim 51, wherein the acoustically conductive lumen is formed in an acoustically conductive material in the specimen container.
53. The method of claim 51 , further comprising conforming the acoustically conductive lumen to a shape of the excised tissue specimen.
54. The method of claim 48, further comprising surrounding the excised tissue specimen in the container with an acoustically conductive material.
55. The method of claim 48, further comprising suspending the excised tissue specimen in the specimen container with an acoustically conductive material.
56. The method of claim 48, further comprising tracking the position of the probe during the ultrasonically scanning step with the position tracking system, wherein the position tracking system electronically communicates position data for the probe to the image recording and review system.
57. The method of claim 57, wherein the image recording and review system generates position data for the first recorded image based on the position data for both the specimen container and probe received from the position tracking system.
58. The method of claim 48, wherein the position tracking system comprises a plurality of position registers coupled to the container, each of the plurality of position registers adapted to reflect electromagnetic radiation.
59. A system for acoustically examining an excised tissue specimen comprising:
an acoustically conductive container having an internal volume and at least one acoustically conductive surface, the container adapted to hold the excised tissue specimen in an acoustically conductive material within the internal volume;
an ultrasound system comprising an ultrasound probe and a first controller in communication with the probe, wherein the first controller is configured to generate an ultrasound image from scan information received from the probe;
a position tracking system configured to independently track and record position data for the container and the probe; and
an image recording and review system comprising a second controller in communication with the position tracking system and the ultrasound system, the second controller comprising a recording unit configured to electronically receive and record at least one ultrasound image generated by the first controller of the ultrasound system, wherein the second controller is configured to electronically receive the container and probe position data from the position tracking system and to output an ultrasound image recorded by the recording unit to a display coupled to the image recording and review system.
60. The system of claim 59, wherein the at least one ultrasound image recorded by the
recording unit comprises a first recorded image; and wherein the second controller is configured to generate position data for the first recorded image based on the container and probe position data received from the position tracking system.
61. The system of claim 60, wherein the second controller is configured to derive orientation data for the first recorded image based on the container and probe position data received from the position tracking system.
62. The system of claim 60, wherein the second controller is configured to generate a three- dimensional representation of the tissue specimen from the first and second recorded images, the three-dimensional representation configured to be bisected along a plane to thereby provide a two-dimensional cross-sectional view of the tissue specimen.
63. The system of claim 59, wherein the position tracking system is configured to track and record the orientation of the container and probe.
64. A system for acoustically examining an excised tissue specimen comprising:
an acoustically conductive container having an internal volume and at least one acoustically conductive surface, the container adapted to hold the excised tissue specimen in an acoustically conductive material within the internal volume;
an ultrasound system comprising an ultrasound probe;
a location tracking system configured to track and record position data for the ultrasound probe as the probe scans the container; and
an image recording and review system comprising a controller in communication with the location tracking system and the ultrasound system, the controller comprising a recording unit configured to electronically receive and record at least one ultrasound image generated by the ultrasound system, wherein the controller is configured to electronically receive the ultrasound probe position data from the location tracking system and to output an ultrasound image recorded by the recording unit to a display coupled to the image recording and review system.
65. The system of claim 64, wherein the location tracking system is configured to track and record orientation data for the ultrasound probe as the probe scans the container.
66. The system of claim 64, wherein the location tracking system comprises at least one location sensor coupled to the ultrasound probe.
67. The system of claim 66, wherein the location sensor is configured to detect position data for the probe.
68. The system of claim 66, wherein the location sensor is configured to detect orientation data for the probe.
69. The system of claim 66, wherein the location sensor is configured to detect orientation data and position data for the probe.
70. A system for acoustically examining an excised tissue specimen comprising: an acoustically conductive container having an internal volume and at least one acoustically conductive surface, the container adapted to hold the excised tissue specimen in an acoustically conductive material within the internal volume;
an ultrasound system comprising an ultrasound probe and a first controller in communication with the probe, wherein the first controller is configured to generate an ultrasound image from scan information received from the probe;
a location tracking system configured to track and record location data for the container; and
an image recording and review system comprising a second controller in communication with the position tracking system and the ultrasound system, the second controller comprising a recording unit configured to electronically receive and record at least one ultrasound image generated by the first controller of the ultrasound system, wherein the second controller is configured to electronically receive the container position data from the position tracking system and to output an ultrasound image recorded by the recording unit to a display coupled to the image recording and review system.
71. The system of claim 70, wherein the location tracking system is configured to track and record orientation data for the container.
72. The system of claim 70, wherein the location tracking system comprises at least one location sensor coupled to the container.
73. The system of claim 72, wherein the location sensor is configured to detect position data for the container.
74. The system of claim 72, wherein the location sensor is configured to detect orientation data for the container.
75. The system of claim 72, wherein the location sensor is configured to detect orientation data and position data for the container.
76. A method of ultrasonically examining an excised tissue specimen comprising:
scanning at least one acoustically conductive surface of a specimen container with an ultrasound probe while the excised tissue specimen resides within the specimen container, wherein an ultrasound processor receives scanning information from the probe to thereby generate a first generated image and a second generated image of the excised tissue specimen in the container;
tracking the location of the specimen container during the ultrasonically scanning step with a location tracking system, wherein the location tracking system electronically communicates location data for the specimen container to an image recording and review system;
electronically communicating the first generated image from the ultrasound processor to the image recording and review system;
recording of the first generated image as a first recorded image by the image recording and review system, wherein the image recording and review system generates location data for the first recorded image based on the location data for the specimen container received from the location tracking system; and
displaying the first recorded image.
77. The method of claim 76, wherein the location tracking system is configured to track and record orientation data for the container.
78. The system of claim 76, wherein the location tracking system comprises at least one location sensor coupled to the container.
79. The system of claim 78, wherein the location sensor is configured to detect position data for the container.
80. The system of claim 78, wherein the location sensor is configured to detect orientation data for the container.
81. The system of claim 78, wherein the location sensor is configured to detect orientation data and position data for the container.
PCT/US2013/057335 2012-09-13 2013-08-29 Tissue specimen examination systems and methods WO2014042890A1 (en)

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