Abstract: A hand-held probe is configured for a prostate cancer screening test and includes a pressure sensor array, a test progression indicator, a display, and an electronic circuit for processing pressure data. The test progression indicator is configured to guide the operator during the test as to the proper position of the probe about the prostate and the progress of collecting and accumulating test data. Data quality thresholds are used to accept or reject readings from the pressure sensor array. The results are presented as either a high or low probability of prostate cancer. The probe is adapted for easy use in an office of a general practitioner.

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: Ultrasound-assisted particle agglutination assay methods and apparatuses are described based on first providing a standing wave ultrasound field at a resonance frequency of a test liquid in a resonator cell containing microparticles covered with a binding agent with high affinity to an analyte sought to be detected by the assay test. Formation of the specifically-bound and nonspecifically-bound aggregates of these microparticles is then followed by effective stirring of the liquid with swept-frequency sonication causing disintegration of nonspecifically-bound aggregates and leaving specifically-bound aggregates in place for further detection and measurement. The methods and devices of the invention allow significant improvement in the sensitivity and specificity of agglutination tests and are advantageously applicable to detecting various proteins, DNA, RNA and other biologically active substances. Specific examples are provided.

Abstract: An ultrasound beacon is incorporated into a needle of a drug delivery system utilizing high intensity ultrasound energy during certain cancer treatments. The beacon is configured to generate a electrical feedback signal in response to an initial ultrasound signal sent by an ultrasound transmitter. The electrical feedback signal is then sent along two electrical conductors of the needle and further over a cable back to the electronic unit. The feedback signal is then used to generate high intensity focused ultrasound using time-reversal acoustics principles. Therapeutic application of the system of the invention includes applying high intensity focused ultrasound at the site of drug delivery to enhance local tissue uptake of injected medication.

Abstract: Ultrasound-assisted contactless stirring of liquids in a resonator cell by microparticles is achieved by repeated creating and destruction of nodal patterns associated with standing waves of various resonance frequencies causing continuous movements of microparticles inside the cell. Swept-frequency sonication technique includes using constant or variable rate of frequency change as well as a stepwise change of frequency of the transducer within a predefined range. Other useful provisions include initial detection of the set of resonance frequencies and periodic refreshing of that set. Control systems are described including means to automatically detect the resonance frequencies and maintain the operation of the transducer thereon. Advantageous designs of the apparatus are described for use in microstirring, mixing of liquids using magnetic microbeads, microbubbles, microtiter plates, microarray plates, etc.

Abstract: The present invention relates generally a device for locating an indwelling catheter relative to its initial location. The system of the invention is based on emitting light from an optical probe placed on the patient to an optical marker on the tip of the catheter. The reflected light from the optical marker is then detected by the optical probe and the reading is recorded to memory as the reference measurement. The position of the optical probe on the patient is marked so that future measurements are taken from the same location. These future measurements will be compared to the reference measurement and from this comparison the displacement of the tip of the catheter is found and can be corrected. This system is fast, non-invasive, radiation free, and accurate to within 2-3 mm.

Abstract: An ultrasound diagnostic and therapeutic device includes a catheter equipped with an intracorporeal ultrasound transducer at its tip, an extracorporeal ultrasound transmitter, an imaging electronic unit and a time-reversal electronic unit. The intracorporeal transducer may be used to record an image of surrounding tissues so as to identify a treatment site. The same transducer is then used as a beacon to receive an ultrasound impulse from the extracorporeal transmitter. The impulse response signal from the intracorporeal transducer is then time-reversed so that high-intensity focused ultrasound can be generated at the location of the intracorporeal transducer. The device is capable of shaping the area of focused ultrasound to correspond to that of the treatment site.

Abstract: Methods for assessing viscoelastic properties of soft tissues are based on detecting an inflection point on a pressure-time plot when air is aspirated from a cavity placed over the tissue sample. A small diameter tube through which air aspiration is conducted is ultimately closed off by tissue being drawn into the cavity causing an abrupt change in pressure slope. First or second derivatives of the pressure-time plot can be used to detect the inflection point. Repeating the test with a different aspiration rates or after a predetermined relaxation time allows determining tissue viscosity and tissue creep in addition to tissue elasticity expressed as Young's modulus.

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: Methods for assessing viscoelastic properties of soft tissues are based on detecting an inflection point on a pressure-time plot when air is aspirated from a cavity placed over the tissue sample. A small diameter tube through which air aspiration is conducted is ultimately closed off by tissue being drawn into the cavity causing an abrupt change in pressure slope. First or second derivatives of the pressure-time plot can be used to detect the inflection point. Repeating the test with a different aspiration rates or after a predetermined relaxation time allows determining tissue viscosity and tissue creep in addition to tissue elasticity expressed as Young's modulus.

Abstract: A spatial profile of structural and elastic parameters along a lumen of a hollow organ is determined based on obtaining the functional dataset of pressure P, balloon volume V, and balloon linear coordinate X while continuously moving the balloon along the lumen. A comprehensive characterization of elastic properties of the tissue and geometrical parameters of the lumen are then determined using a previously obtained calibration curve of balloon pressure vs. balloon volume when the balloon is expanded freely. As opposed to prior art devices for measuring tissues elasticity at one or several distinct locations by having deploying a balloon locally, the present invention describes a device in which the balloon is continuously moved through the lumen of the hollow organ whereby allowing elasticity determination over a significant portion or the entire length of the organ.

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: An ultrasonometer for bone assessment in infants includes a focusing acoustic wave transducer, an acoustic wave detector, and an elongated chamber filled with an acoustically-coupling fluid. The chamber is equipped with an acoustically-transparent flexible membrane facing the extremity of the infant. Supporting means such as a gliding rod is adapted to retain at least one of the transducer or the detector inside the chamber facing the subject. Supporting means is further adapted to move the transducer or detector along the chamber to perform the bone scanning without repositioning of the probe. A focused ultrasound transducer is adapted to remotely generate an acoustic wave in the bone by acoustic radiation force.

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: A pain monitor for a patient undergoing a medical procedure includes a housing adapted to fit in a hand of the patient, a force sensor, and a battery-powered data processor. The patient is instructed to squeeze the housing with a force representing his level of pain. That force is measured by the sensor, acquired by the data processor and then wirelessly transmitted to an outside data receiver for further processing and recording. This device allows the patient to non-verbally express his perception of the level of pain which in turn allows a physician to adjust the course of the procedure or the level of pain-reducing medication. The pain monitor of the invention is particularly useful during a colonoscopy procedure.

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.