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Method and a dual-array transducer probe for real time mechanical imaging of prostate

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Method and a dual-array transducer probe for real time mechanical imaging of prostate


The present invention relates to a transrectal probe and method for real time mechanical imaging of a prostate. The probe is equipped with dual-array pressure sensors—one on the probe head and another on the shaft of the probe spaced away from the head with an angular and linear offset forming an S-shaped transition between the shaft and the head of the probe. The addition of the shaft pressure sensor array together with orientation tracking sensors allows precise calculation of the current head position throughout the examination of the prostate. Display means are used to guide the user in the proper manipulation of the probe in order to reduce the forces on surrounding tissues and organs and to minimize patient's discomfort.

Browse recent Artann Laboratories, Inc. patents - Lambertville, NJ, US
Inventors: Armen P. Sarvazyan, Vladimir Egorov, Suren Avrapetyan
USPTO Applicaton #: #20120277632 - Class: 600587 (USPTO) - 11/01/12 - Class 600 
Surgery > Diagnostic Testing >Measuring Anatomical Characteristic Or Force Applied To Or Exerted By Body

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The Patent Description & Claims data below is from USPTO Patent Application 20120277632, Method and a dual-array transducer probe for real time mechanical imaging of prostate.

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CROSS-REFERENCE DATA

This application is a continuing application of a co-pending U.S. patent application Ser. No. 12/885,688 filed Sep. 20, 2010 with the same title, which in turn is a continuing application of U.S. patent application Ser. No. 11/146,367 filed on Jun. 6, 2005 with the same title, now U.S. Pat. No. 7,819,824, which in turn is a continuation-in-part of U.S. patent application Ser. No. 11/123,999 filed on May 6, 2005 and entitled “Method and device for real time mechanical imaging of prostate”, now U.S. Pat. No. 7,922,674.

STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT

This invention was made with government support under SBIR Grant 2 R44 CA82620-02A1 awarded by the National Institutes of Health, National Cancer Institute. The government has certain rights in this invention.

BACKGROUND OF THE INVENTION

The present invention relates generally to medical devices. More specifically, it relates to a mechanical imaging system and process for examining, mapping, and diagnosing diseases of a palpable organ such as a prostate gland in a male patient, especially the prostate cancer. It is also applicable more generally to mechanical imaging of palpable tissues, including but not limited to, through natural body openings in a human being, i.e. mouth, ear(s), rectum, and other body cavities. It is also applicable to determination of a relative stiffness or elasticity of tissues. The term “patient” includes human beings and animals, both alive and dead that can be subject to mechanical imaging.

The high incidence of prostate cancer, as well as benign prostatic hyperplasia (BPH), especially among the older male population, dictates the need for effective means of early detection. Prostate cancer is the cause of death in about 30,000 men each year, making it the number two cancer killer of men in the United States, second only to lung cancer. However, if prostate cancer is detected early and treated effectively, the chance of survival of one afflicted with this disease improves significantly. Current methods of early diagnosis of prostate cancer include digital rectal examination (DRE), measurement of serum levels of prostate specific antigen (PSA), and transrectal ultrasound (TRUS) examination.

The following discussion provides useful overview of various methods described in the prior art and applicable to prostate examination and imaging. Substantial prior art is accumulated describing various devices and techniques using ultrasound for the imaging of the prostate. U.S. Pat. No. 6,561,980 by Gheng describes the methods of processing ultrasound images to cause automatic segmentation of prostate, rectum, and urethra once the transverse cross-sectional image of prostate is acquired by ultrasound means. U.S. Pat. No. 6,824,516 by Batten describes a sophisticated system for examining, mapping, diagnosing, and treating prostate diseases based on ultrasonic imaging, this patent is incorporated herein in its entirety by reference. U.S. Pat. No. 6,778,690 by Ladak describes a method of processing 2D and 3D ultrasound images to determine the prostate boundaries and is also incorporated herein by reference in its entirety as it provides useful image processing methodology.

Unfortunately, to date the experience with TRUS as a means of prostate cancer screening and staging has been disappointing. It adds little to screening by DRE and PSA, and the small improvement in prostate cancer detection does not justify its cost. As a screening test, TRUS has a low specificity and a high false positive rate. Evaluation of pathologic specimens shows that a significant fraction of tumors are isoechoic and thus indistinguishable from surrounding tissue, while many palpable tumors could not be visualized by TRUS.

The most sensitive single test for prostate cancer is measurement of serum PSA levels. However, its positive predictive value is limited. The DRE alone is even less useful. However, combining the two modalities nearly doubles the cancer detection rate. Large-scale studies of systematic screening for prostate cancer using PSA, DRE and TRUS concluded that combining PSA and DRE provided the highest sensitivity and specificity for prostate cancer diagnosis. Therefore, the combination of the two methods for prostate cancer screening is currently recommended by the AUA and American Cancer Society, and has been approved by FDA for patients between the ages of 50 and 75 years.

At the present time, digital rectal examination is the most widely used method of prostate cancer screening. Approximately 30-50% of palpable prostate nodules prove to be malignant upon pathologic evaluation. Screening trials have demonstrated that 70% of men with abnormal DRE undergoing radical prostatectomy have organ-confined cancer. A strong association between abnormal DRE and prostate cancer mortality has been demonstrated and it was suggested that screening DRE could prevent as many as 50-70% of deaths due to prostate cancer. DRE also has been shown to be the most cost efficient prostate screening method, especially when combined with PSA.

The main disadvantage of DRE is its high degree of subjectivity. The user has to instinctively relate what he or she senses by the finger to previous DRE experience. There may not be a sufficient number of skilled users available for large-scale mass prostate screenings. Another limitation of DRE is that a physician performing the examination cannot objectively record the state of the examined prostate. Therefore, it is difficult to objectively compare the results of consecutive examinations of the same prostate. The need therefore exists for a device allowing conducting the prostate examination objectively and obtaining results consistently that are independent of the skills of individual operators.

A new method of prostate imaging based on principles similar to those of manual palpation has been developed by Sarvazyan et al. and described in the U.S. Pat. Nos. 6,569,108; 6,142,959; 5,922,018; 5,836,894; 5,785,663; and 5,524,636, as well as in a co-pending U.S. application Ser. No. 11/123,999 all incorporated herein in their entirety by reference. This method, termed Mechanical Imaging, provides the ability to “capture the sense of touch” and store it permanently for later temporal correlation and trending. The essence of mechanical imaging is measurement of the stress pattern on the surface of the compressed tissue and analyzing the changes of that pattern while moving the sensor array over the examined tissue. Temporal and spatial changes in the stress pattern provide information on the mechanical structure of the examined tissue and enable 3D reconstruction of internal structures and mechanical heterogeneities in the tissue. Mechanical imaging is free of many of the disadvantages of DRE. Mechanical imaging has been shown to exceed substantially the limits of lesion size and depth detectable by conventional manual palpation techniques [Weiss R., Hartanto V, Perrotti M, Cummings K, Bykanov A, Egorov V, Sobolevsky S. “In vitro trial of the pilot prototype of the prostate mechanical imaging system”, Urology, V.58, No. 6, 2001, p.1059-1063].

Recently, the American Urological Association issued recommendations to help physicians confirm the diagnosis of prostate cancer. According to these recommendations, a biopsy should be considered for any patient with an abnormal DRE and elevated PSA. The effectiveness and reliability of DRE are highly dependent on the skill of the user, since the finger does not provide a quantitative or objectively verifiable assessment. Thus, there is a great need for a new technology and a device to enable general practitioners and urologists alike to perform a reliable, accurate, sensitive, and quantitative assessment of the prostate using a computerized palpation-imaging device. Moreover, such accurate assessment of prostate size, shape, and elasticity is also important for diagnosing and monitoring of prostate cancer and BPH. Mechanical imaging technology and the low cost, prostate imaging device should improve significantly the ability of minimally trained individuals in primary care settings to assess, screen, and monitor prostate pathology in a reliable and valid manner in a male human, with a minimum of physical and mental discomfort.

While prior art mechanical imaging devices provided for data collection, the ability to recreate the 2D and 3D images of the prostate were limited by the insufficiently accurate information obtained from the transrectal probe with regard to the examined prostate in the course of examination. One reason for this is the sub-optimal shape of the probe device itself. Prior art probes are predominantly round and cylindrical in shape to repeat that of the rectum. Upon compressing the area about the prostate, it is difficult to obtain uniform compression of that area alone and not load surrounding tissues and organs, especially the sphincter.

The need exists for a novel method and probe adapted for uniform compression of the desired area in the vicinity of the prostate gland without compressing surrounding tissues such as a sphincter. Such compression of surrounding tissues and organs would distort data collection away from the desired area and introduce errors associated with tilting the probe and stretching the sphincter or other tissues of the rectum.

Another reason for reduced sensitivity is because the prostate can be hard to find initially and it can also shift from its original place during the examination procedure. Therefore, the prior art methods have a fundamental disadvantage in that as the examination progresses, no means are available to properly locate the prostate and then compensate for the probe position and orientation shift relative for the moving prostate.

The need exists therefore for a prostate examination means and method of use designed to eliminate the distortion in the position data of the prostate probe and make it independent of the internal movements of the prostate organ.

Finally, the need exists for devices and methods allowing training of medical personnel conducting prostate mechanical imaging.

SUMMARY

OF THE INVENTION

Accordingly, it is an object of the present invention to overcome these and other drawbacks of the prior art by providing a novel method and device for objective and consistent mechanical imaging of a palpable organ eliminating the influence of operator\'s skills on the results of such examination.

It is another object of the present invention to provide a mechanical imaging device for examination of prostate shaped in such a way as to allow proper compression of the prostate organ only and minimizing distortions caused by pressing the device against other surrounding tissues and organs.

It is another object of the present invention to provide a mechanical imaging device for examination of prostate having dual-array pressure transducer probe, one array on the head of the probe and another on the shaft of the probe.

It is another object of the present invention to provide a probe and a method of its use allowing teaching the medical personnel the proper technique of prostate examination.

The method of the invention is based on a method of real time mechanical imaging of the prostate organ with a probe inserted through a rectum. According to one aspect of the method of the invention, generating a two- or three-dimensional prostate mechanical image from a plurality of pressure response data and probe orientation data comprises the general steps of:

locating the prostate under the transrectal probe head pressure sensor array by first identifying the sphincter with a secondary pressure sensor array located on a probe shaft, then advancing the probe until the bladder is reached and then retracting it somewhat to identify the area of probable location of the prostate,

scanning the prostate by the probe head sensor array by pressing it repeatedly against the prostate,

incorporating newly acquired mechanical prostate information into a two-dimensional normalized mechanical image of the prostate, including using of the sphincter as a secondary reference object,

visualizing that two-dimensional normalized mechanical image of the prostate in real time to reveal possible areas of interest inside the prostate, and

calculating prostate features and constructing of composite two-dimensional and three-dimensional mechanical prostate images, using an image recognition technique.

Importantly, the processing of data is preferably conducted by using data from both the probe head pressure sensor array (used as a primary or first source of pressure data) and from shaft pressure sensor array (used as a secondary source of pressure data). This allows moving of the probe relative to the prostate while maintaining the common identified features of each obtained mechanical image. In other words, every time the probe is moved from one position to the next, the processing means of the device are adapted to follow certain identifiable features and the distance from the sphincter from the previous mechanical image to the next one such that a complete 2D or 3D image may be constructed. That way, there is less need for knowing the absolute position in space of both the prostate and the probe in order to accurately relate each successive pressure pattern to a certain part of the prostate.

In the preferred embodiment, the dual-array probe and the system of the invention include: an S-shaped probe shaft with pressure sensor array for collecting pressure response data in the vicinity of the sphincter; a probe head pressure sensor array for collecting data in the vicinity of the prostate volume; a probe orientation tracking sensors for collecting a probe orientation data; a processing apparatus for processing the pressure response and orientation data to generate mechanical image data and calculate prostate features; and a display device for representation of at least a two-dimensional image of the prostate.

Importantly, the shape and size of the head pressure sensor array is selected such that it provides for uniform compression of the area of interest about the prostate gland and not other areas of the rectum. Further facilitating this aspect of the invention is the S-shaped design and an angular offset between the head of the probe and the shaft of the probe. Such advantageous shape increases the accuracy of obtained pressure data and reduces the artifacts caused by inadvertent tilting of the probe to avoid sphincter trauma.

Preferably, in order to further increase the accuracy of the results, the probe head orientation and its position relative to examined prostate is calculated from orientation data recorded from 3D magnetic sensors and a 2D accelerometer sensor, and combined with the pressure response data recorded from the head pressure sensor array and the shaft pressure sensor array.

As opposed to the devices of the prior art, the present invention takes advantage combining three independent sources of positioning information:

using the prostate itself as a reference object by providing real time calculation and visualization of the probe head positioning relative to the examined prostate

having more than one pressure sensor arrays working together in an integrated manner to take advantage of locating the prostate in its relationship to a nearby organ, which is more stable in its position such as sphincter, and finally

calculating of probe head position from probe orientation data.

Combining all these sources of information, the device of the invention provides calculations including both the orientation and pressure response data. The device and method of the present invention are created with a design philosophy to create a patient-friendly system, which is easy and intuitive to use by the examining physician. As a result, the present invention advantageously provides for:

early prostate cancer detection;

quantitative classification of prostate geometrical and mechanical features;

automatic identification of what has changed between successive examinations;

tracking and trending treatment impact for certain treatment modalities;

matching the system output with pathology findings as proof of system performance.

BRIEF DESCRIPTION OF THE DRAWINGS

A more complete appreciation of the subject matter of the present invention and the various advantages thereof can be realized by reference to the following detailed description in which reference is made to the accompanying drawings in which:

FIG. 1 is a schematic diagram illustrating the functional structure of the system in accordance with the present invention,

FIG. 2 is a side view of the probe with a head pressure sensor array, a shaft pressure sensor array, and orientation sensors,

FIGS. 3A and 3B are cross-sectional views of the probe head and the probe shaft respectively in accordance with the present invention,

FIG. 4 is a diagram of an orientation tracking system used in the preferred embodiment of the present invention,

FIG. 5 represents an electronic unit schematic diagram of the device,



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stats Patent Info
Application #
US 20120277632 A1
Publish Date
11/01/2012
Document #
13527759
File Date
06/20/2012
USPTO Class
600587
Other USPTO Classes
International Class
61B5/103
Drawings
11



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