Abstract: Methods for assessment of pelvic floor conditions based on tactile imaging are described. The vaginal wall is deformed using a transvaginal probe equipped with tactile pressure sensors and a motion tracking sensor. The vaginal wall coordinates and pressure patterns are obtained during the examination and used to build 3-D tactile image of the vagina and to calculate elasticity modulus profiles and spacing profiles along selected lines inside 3-D tactile image. The profile values at specified locations are then compared with thresholds or profiles for normal conditions of vagina and its support structures. Methods of the invention are disclosed to be used in assessing a risk of pelvic organ prolapse development, estimating an extent of pelvic floor organ traumatic damage after childbirth and estimating an improvement after an interventional procedure.

Abstract: The present invention relates to a method for real time mechanical imaging of a prostate with a transrectal probe. In the method, generating a composite two- and three-dimensional prostate mechanical image from a plurality of partial mechanical images extracted from pressure response data and a probe orientation data starts with examining the prostate by pressing a probe head pressure sensor array against it at various overlapping locations. Merging of partial mechanical images together is accomplished by analyzing an overlap between each subsequent and previous partial mechanical image. Finding the prostate is assisted with a supplemental pressure response data indicating the location of a sphincter known to be about 4-5 cm away from the prostate. Data processing is improved by including probe orientation data to further increase the accuracy and sensitivity of the method.

Abstract: A comprehensive system for objective assessment of colonoscope manipulation includes a handgrip for collecting and transmitting colonoscope handling data including force and motion data; a patient pain monitor for collecting and transmitting data on the level of patient's pain and discomfort; and digital processing means for extracting useful features such as colonoscope tip advancement speed from colonoscope-provided video images. All data is wirelessly transmitted to an electronic unit for processing and displaying on a monitor. A colonoscopy procedure is properly conducted when certain shaft advancement causes appropriate tip advancement, all without an increased level of patient's pain. The system of the invention is aimed at providing objective assessment data allowing for safer and less painful colonoscopies.

Abstract: The present invention relates to a method for real time mechanical imaging of a prostate with a transrectal probe. In the method, generating a composite two- and three-dimensional prostate mechanical image from a plurality of partial mechanical images extracted from pressure response data and a probe orientation data starts with examining the prostate by pressing a probe head pressure sensor array against it at various overlapping locations. Merging of partial mechanical images together is accomplished by analyzing an overlap between each subsequent and previous partial mechanical image. Finding the prostate is assisted with a supplemental pressure response data indicating the location of a sphincter known to be about 4-5 cm away from the prostate. Data processing is improved by including probe orientation data to further increase the accuracy and sensitivity of the method.

Abstract: A comprehensive system for objective assessment of colonoscope manipulation includes a handgrip for collecting and transmitting colonoscope handling data including force and motion data; a patient pain monitor for collecting and transmitting data on the level of patient's pain and discomfort; and digital processing means for extracting useful features such as colonoscope tip advancement speed from colonoscope-provided video images. All data is wirelessly transmitted to an electronic unit for processing and displaying on a monitor. A colonoscopy procedure is properly conducted when certain shaft advancement causes appropriate tip advancement, all without an increased level of patient's pain. The system of the invention is aimed at providing objective assessment data allowing for safer and less painful colonoscopies.

Abstract: A handgrip for colonoscope shaft is equipped with force, torque, and acceleration sensors allowing for a comprehensive characterization of colonoscope shaft motion, including recognition of obstacles and recording of forces and torques applied at various times during a colonoscopy procedure. An electronic unit is adapted to receive sensors data wirelessly and calculate a variety of motion parameters guiding a medical practitioner during the procedure and aimed at making colonoscopy safer and less painful.

Abstract: Methods for characterizing elasticity of vaginal tissue are provided. A transvaginal probe is used to deform vaginal tissue during examination. The probe is equipped with pressure sensors and a motion tracking sensor. Stress and strain data is recorded during examination. Elasticity of vaginal tissue is then characterized by calculating a stress gradient defined as a ratio of stress over strain for each point of measurement. Vaginal tactile image may also be compiled to include a family of surfaces representing locations of measurement points at predefined constant levels of stress. Pelvic organ abnormality condition may be detected if the stress gradient is below either a predetermined threshold or a normal stress gradient obtained from clinical data.

Abstract: 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.

Abstract: 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.

Abstract: A novel method for soft tissue characterization includes obtaining a sequence of surface stress patterns as a function of an increasing compression force when a probe is pressed against the tissue over the location of the lesion of interest. A number of elasticity features are then calculated to characterize the tissue and the lesion located therein including strain hardening, loading curve average slope, lesion peak signal under a predetermined load, tissue heterogeneity, lesion shape and lesion mobility. At least three elasticity features are provided as an input to a statistical Bayesian classifier trained on a clinical database to calculate the probability of the lesion being benign or malignant. Additional patient-related parameters may be further provided as inputs to the classifier to increase the accuracy of differentiation between benign and malignant lesions.

Abstract: The present invention relates to a method for real time mechanical imaging of a prostate with a transrectal probe. In the method, generating a composite two- and three-dimensional prostate mechanical image from a plurality of partial mechanical images extracted from pressure response data and a probe orientation data starts with examining the prostate by pressing a probe head pressure sensor array against it at various overlapping locations. Merging of partial mechanical images together is accomplished by analyzing an overlap between each subsequent and previous partial mechanical image. Finding the prostate is assisted with a supplemental pressure response data indicating the location of a sphincter known to be about 4-5 cm away from the prostate. Data processing is improved by including probe orientation data to further increase the accuracy and sensitivity of the method.

Abstract: 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.

Abstract: Disclosed are human tissue phantoms mimicking the mechanical properties of real tissue, and methods for manufacturing thereof including the steps of obtaining a computer aided three-dimensional design of a phantom mimicking the tissue in shape and size; fabrication of a mold form facilitating the production of the designed phantom; molding said phantom with the use of two-component silicon gels as a bulk tissue-mimicking material having Young's modulus in the range of 2 to 30 kPa; filling the enclosed volume of said phantom with anatomical and pathological tissue structures mimicking their respective mechanical properties and having Young's modulus in the range of about 30 to 600 kPa; covering said phantom by a protective layer having mechanical properties to a human tissue protective layer; and securing the phantom perimeter on a supporting plate by a rubber barrier.

Abstract: An Internet-based system is described including a number of patient terminals equipped with tactile imaging probes to allow conducting of breast examinations and collecting the 2-D digital data from the pressure arrays of the tactile imaging probes. The digital data is processed at the patient side including a step of detecting moving objects and discarding the rest of the data from further analysis. The data is then formatted into a standard form and transmitted over the Internet to the host system where it is accepted by one of several available servers. The host system includes a breast examination database and a knowledge database and is designed to further process, classify, and archive breast examination data. It also provides access to processed data from a number of physician terminals equipped with data visualization and diagnosis means.

Abstract: Methods and apparatus are disclosed for non-invasive bone evaluation based on a broadband ultrasonic transducer emitting a train of ultrasonic wave packets of multiple carrier frequencies ranging from about 50 kHz to about 2 MHz. Receiving broadband ultrasonic transducer accepts broadband ultrasonic signal propagated through the bone. Computer processing means provide for data analysis and feature extraction allowing diagnostic evaluation of the bone, including comparing the features of the received signal to a database of known bone conditions.

Abstract: Disclosed are human tissue phantoms mimicking the mechanical properties of real tissue, and methods for manufacturing thereof including the steps of obtaining a computer aided three-dimensional design of a phantom mimicking the tissue in shape and size; fabrication of a mold form facilitating the production of the designed phantom; molding said phantom with the use of two-component silicon gels as a bulk tissue-mimicking material having Young's modulus in the range of 2 to 30 kPa; filling the enclosed volume of said phantom with anatomical and pathological tissue structures mimicking their respective mechanical properties and having Young's modulus in the range of about 30 to 600 kPa; covering said phantom by a protective layer having mechanical properties to a human tissue protective layer; and securing the phantom perimeter on a supporting plate by a rubber barrier.

Abstract: A method and device for breast examination adapted for easy home use including a tactile imager probe equipped with a pressure sensor array and a motion tracking system for simultaneously recording pressure and positioning data during the examination of a breast or any other soft tissue. The method includes a step of starting the examination from a known point or an anatomical mark such as a nipple or a sternum; moving the probe towards the area of interest and oscillating it thereabout while manually or automatically recording pressure and positioning data. Subsequent data analysis identifies the presence of a lesion, calculates its location relative to the probe, estimates the location of the probe relative to the anatomical landmark and finally calculates the location of the lesion relative to that anatomical landmark. The method allows repeating examinations over time with great accuracy as they all start from the same anatomical landmark.

Abstract: A method and device for breast examination adapted for easy home use including a tactile imager probe equipped with a pressure sensor array and a motion tracking system for simultaneously recording pressure and positioning data during the examination of a breast or any other soft tissue. The method includes a step of starting the examination from a known point or an anatomical mark such as a nipple or a sternum; moving the probe towards the area of interest and oscillating it thereabout while manually or automatically recording pressure and positioning data. Subsequent data analysis identifies the presence of a lesion, calculates its location relative to the probe, estimates the location of the probe relative to the anatomical landmark and finally calculates the location of the lesion relative to that anatomical landmark. The method allows repeating examinations over time with great accuracy as they all start from the same anatomical landmark.