TRENTON, NJ, United States

Artann Laboratories, Inc.

www.artannlabs.com
TRENTON, NJ, United States

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A time-reversal acoustics system includes a transmitter configured to send a high intensity acoustic waveform signal focused on an implantable receiver. The receiver includes a piezoelectric transducer configured to convert received acoustic energy to an electrical signal used to energize an internal electrical circuit. Such circuit may be used to operate at least one tissue stimulating electrode, at least one sensor such as an ECG sensor, charge an internal battery or perform another useful function. The system of the invention may be used as a wireless cardiac pacemaker or a neurostimulator.


Methods for assessment of pelvic floor conditions based on tactile imaging are described. The vaginal wall is deformed before and after an interventional procedure 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 before and after profile values at specified locations are then compared to each other and to thresholds or profiles for normal conditions of vagina and its support structures. Methods of the invention may be used in estimating an improvement after an interventional procedure such as pelvic tissue regeneration, muscle repair or implantation of a supporting structure.


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 sensorsone 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 patients discomfort.


Patent
Artann Laboratories, Inc. | Date: 2011-10-06

A handgrip for a colonoscope shaft is equipped with a novel compact multifunction force and torque sensor allowing for a comprehensive characterization of colonoscope manipulation during a colonoscopy procedure. A two-part hinge design of the handgrip in combination with the multifunction sensor provides for a light weight design in a compact package making using the handgrip convenient and natural. An electronic unit is provided to receive the sensor 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.


Grant
Agency: Department of Health and Human Services | Branch: | Program: SBIR | Phase: Phase I | Award Amount: 147.02K | Year: 2012

DESCRIPTION (provided by applicant): Dehydration is a frequent cause of morbidity and mortality in the elderly. Identifying at risk individuals and maintaining adequate fluid balance is an essential component of health care in the aging population. Currently, there is no effective tool available to measure hydration status and distinguish those at risk. The reliability and validity of current hydration assessment methods and criteria such as thirst, skin turgor, blood pressure, pulse, urine output andspecific gravity, MRI, dilution methods and bioimpedance, are limited, and the methods are inaccurate or expensive. Given that dehydration is both preventable and reversible, the need for an easy- to-perform method for the detection of water imbalance isof the utmost clinical importance. The goal of this project is to develop an inexpensive and easy-to-use device that monitors changes in hydration status and predict those at risk in home-bound and institutionalized elderly. We propose to develop the Hydration Monitor (HM) that can objectively quantify changes in the body water content and hydration status. The method implemented in the device is based on the experimental fact that ultrasound velocity through soft tissue is a linear function of the tissuewater content. Because muscle provides the largest body reservoir for water, the assessment of water imbalance is conducted by measuring speed of ultrasound in muscle. Preliminary studies confirmed feasibility of Hydration Monitor, a compact hand-held device based on a proprietary ultrasonic technology developed in Artann Laboratories. The aims of this Phase I SBIR project include (1) designing and manufacturing of HM prototype, which will be tested for its ability of measuring ultrasound velocity in water as test medium with accuracy better than 1 m/s; (b) testing and validating HM prototype on tissue phantoms and excised animal tissues, demonstrating the sensitivity to water content changes should be better than 2%; and (3) designing the HM -prototypeand preparing documentation for building the HM -prototype in Phase II of the project for clinical studies. PUBLIC HEALTH RELEVANCE: Currently, there is no effective tool available to measure body dehydration, which is a frequent cause of morbidity and mortality in the elderly. We propose to develop a compact hand-held Hydration Monitor that can objectively quantify changes in the body water content and assess hydration status. The device is based on a proprietary patented ultrasonic technology developed in Artann Laboratories.


Grant
Agency: Department of Health and Human Services | Branch: National Institutes of Health | Program: SBIR | Phase: Phase II | Award Amount: 575.75K | Year: 2016

Pelvic organ prolapse POP is a highly prevalent condition affecting over of women in the US during their lifetimes Urinary incontinence UI affects an estimated of women Both POP and UI are more common in women than in men and their prevalence is increased with age Some loss of utero vaginal support occurs in most adult women however the true etiology of prolapse and differences seen among individuals are not entirely understood Changes in the elasticity of the vaginal walls connective support tissues and muscle function are thought to be significant factors in the development of the diseased conditions There is a strong need in pelvic floor structure and functional imaging to be integrated into mainstream diagnostics in obstetrics gynecology and urogynecology This integration will facilitate communications between different specialties and has the potential to greatly improve the multidisciplinary management of complex pelvic floor disorders In the Phases I IIB of this project we developed an innovative approach and the device Vaginal Tactile Imager VTI completed clinical studies received an FDA approval for the core technology and established manufacturing and distribution partnership with Advanced Tactile Imaging www tactile imaging com These were the critical steps that significantly reduced number of project risk factors However crossing the Valley of Death to make this innovative device commercially successful requires additional support in technical assistance as well as in later stage research and development We identified and proposed how to overcome four critical barriers to commercial success need for reimbursement CPT codes high manufacturing cost additional clinical evidence of VTI capabilities in diagnosis and aid for choice of applied treatment and FDA clearance for clinically relevant Indication for Use Removing these obstacles would lead to clinical acceptance and market penetration of this new technology Pelvic organ prolapse urinary incontinence and other pelvic diseased conditions affect over of women in the US during their lifetimes Prevalence of these conditions is increased with age Some loss of utero vaginal support occurs in most adult women however the true etiology of prolapse and differences seen among individuals are not entirely understood It impairs the quality of life and results in over surgical procedures annually in the US The goal of this project is to develop Vaginal Tactile Imager VTI for real time elasticity imaging quantitative characterization of pelvic floor support structures and muscle function The VTI has the potential to predict risk of developing diseased conditions aid in diagnosis monitoring and individually optimized treatment


Grant
Agency: Department of Health and Human Services | Branch: | Program: SBIR | Phase: Phase II | Award Amount: 972.69K | Year: 2011

DESCRIPTION (provided by applicant): Pelvic organ prolapse is a highly prevalent condition affecting at least 50% of women in the US during their lifetimes. Some loss of utero-vaginal support occurs in most adult women; however, the true etiology of prolapse and differences seen among individuals is not entirely understood. Changes in the elasticity of the vaginal walls, connective support tissues and muscles are thought to be significant factors in the development of pelvic organ prolapse. We propose to develop a device entitled Vaginal Tactile Imager (VTI) for 3-D visualization and assessment of mechanical properties of pelvic floor tissues. VTI is based on the Tactile Imaging (TI) technology based on principles similar to those of manual palpation. In Phase I we designed and build 1- prototype of VTI with tactile sensor array and a motion tracking sensor, tested the training procedure with the phantoms and initiated the clinical development study with 30 patients to optimize the VTI, examination procedure,data processing algorithms and visualization approaches. Clinical results demonstrate applicability of proposed approach for 3-D imaging of the vagina and surrounding structures and characterization of normal and pelvic organ prolapse conditions. In PhaseII we plan to build VTI 2-prototype, complete the bench verification studies, EMC and safety testing in the accordance with regulatory compliance to bring the device to clinical validation study with 200 patients, 2 sites, and 5 operators. The proposed device will quantitatively evaluate multiple mechanical and structural properties of vaginal walls, such as elasticity distribution, Young's modulus, elasticity contrast, size and shape of abnormal tissue, provide prolapse characterization and assess resultsof reconstructive surgery. The completion of proposed project promises to gain scientific knowledge, provide new technical capability and improve clinical practice in gynecology. PUBLIC HEALTH RELEVANCE: Pelvic organ prolapse is a highly prevalentcondition affecting at least 50% of women in the US during their lifetimes. The goal of this project is to develop Vaginal Tactile Imager (VTI) for 3-D elasticity imaging of pelvic floor tissues and prolapse characterization that could improve pelvic floordisorder diagnosis and treatment. Our clinical data have shown that VTI has the potential to predict the risk of developing prolapse and provide insight into optimal approaches for surgical repair.


Grant
Agency: Department of Health and Human Services | Branch: | Program: SBIR | Phase: Phase II | Award Amount: 3.35M | Year: 2011

DESCRIPTION (provided by applicant): Colonoscopy is the preferred method to screen for colorectal cancer, a disease that afflicts 115,000 new patients a year. Several million screening, diagnostic and therapeutic colonoscopies are performed each year in U.S. hospitals and ambulatory surgery centers. However, colonoscopy remains a highly operator dependent activity and no clear definition of skill exists. There is very limited understanding of the methods used by endoscopist to execute a safe and effective colonoscopy and there is a significant need for technology to improve training and to provide a means of assuring that examinations are performed in a safe and effective manner. The Colonoscopy Force Monitor (CFM), which is being developed under this grant,appears to fill the clinical void. CFM is a wireless force-measuring handle attached to the colonoscope shaft to provide a physician with a real-time feedback on the force and torque applied during colonoscopy. The CFM is designed to improve training of endoscopists and establish best practices for performing colonoscopy by quantitative characterization of examiner performance. In addition, the use of CFM could reduce or, under some circumstances, eliminate the use of deep sedation for colonoscopy, and lessen the overall cost of the exam. The main objective of this Phase II Competing Renewal grant is to advance the CFM to the pre-manufacturing level; to complete clinical studies required for the PMA application processes; and to prepare regulatory submission for the market clearance of the CFM technology. In Phase II of this project we developed the 2-prototype CFM hardware and software as a basis for a pre- - production prototype, built a preproduction prototype and obtained clinical feedback on its functionality; characterized CFM use by experienced endoscopists and defined CFM capability for colonoscopy training. Most of the technical requirements to the CFM technology including adequate range and accuracy of force measurement, convenient grip, disinfection and automated engage/disengage mechanism were implemented and tested in the CFM prototype. Laboratory validation tests and endoscopists' feedback confirmed the functionality of the CFM. Clinical studies performed by experienced endoscopists in communityand academic centers and trainees confirmed the clinical usefulness of CFM as practical tool that for the first time allows comprehensive characterization of a critical aspect of endoscopist behavior. The technical tasks of the current project will be related to the manufacturability aspects of CFM, further optimizing the device to address issues raised by the users during clinical testing of the Phase II prototype and development of a classifier system to efficiently characterize the colonoscope manipulation pattern. Large multi-site clinical study that will engage prominent academic institutions with the endoscopy training centers will be performed to collect evidence of clinical safety and efficacy for FDA review. Engineering documentation and all regulatory compliance activities for regulatory filing will be completed. PUBLIC HEALTH RELEVANCE: Several million colonoscopies are performed each year in the U.S. However, colonoscopy remains a highly operator dependent activity and no clear definition of skill exists. The aim of this project is to bring to clinical practice a technology and a device for quantitative characterization of examiner performance to improve training of endoscopists and establish best practices for performing colonoscopy.


Patent
Artann Laboratories, Inc. | Date: 2011-04-08

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.


Patent
Artann Laboratories, Inc. | Date: 2013-10-08

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. The probe is equipped with a two-dimensional head pressure sensor array, a supplemental shaft sensor array and orientation tracking sensors including a three-axis magnetic sensor and a two-axis accelerometer sensor for calculating elevation, rotation and azimuth angles of the probe.

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