In this paper, we analyze the physical basis for elasticity imaging of the breast by measuring breast skin stress patterns that result from a force sensor array pressed against the breast tissue. Temporal and spatial changes in the stress pattern allow detection of internal structures with different elastic properties and assessment of geometrical and mechanical parameters of these structures. The method entitled mechanical imaging is implemented in the breast mechanical imager (BMI), a compact device consisting of a hand held probe equipped with a pressure sensor array, a compact electronic unit, and a touchscreen laptop computer. Data acquired by the BMI allows calculation of size, shape, consistency/hardness, and mobility of detected lesions. The BMI prototype has been validated in laboratory experiments on tissue models and in an ongoing clinical study. The obtained results prove that the BMI has potential to become a screening and diagnostic tool that could largely supplant clinical breast examination through its higher sensitivity, quantitative record storage, ease-of-use, and inherent low cost.

We have developed a device entitled the 'Tissue Elastometer' (TE) for evaluating the Young's modulus of soft tissues. Soft tissue specimens are compressed between the object plate of an electronic balance and a linearly actuated indenter with a small rounded tip. The hardware of the device was designed such that a deformation model for semi-infinite media is applicable for calculating the Young's modulus of test specimens from their collected force-displacement data.Force-elongation measurements were performed on long strips of cured silicone mixtures to produce calibrated, tissue-mimicking test samples for the TE in a Young's modulus range of 10-400 kPa. When tested with the TE, the Young's moduli of the silicone samples demonstrated accuracy to within 1-10% of their calibrated values. Testing on excised tissue samples (fresh store-bought poultry breast; bovine liver, kidneys, hind shanks; porcine) was also performed, and a repeatability of elasticity measurements was demonstrated in the range of 8-14%. Results indicate that the TE can be effectively used in laboratory and clinical environments to evaluate the elasticity modulus of tissues.

Mechanical imaging yields tissue elasticity map and provides quantitative characterization of a detected pathology. The changes in the surface stress patterns as a function of applied load provide information about the elastic composition and geometry of the underlying tissue structures. The objective of this study is the clinical evaluation of breast mechanical imager for breast lesion characterization and differentiation between benign and malignant lesions. The breast mechanical imager includes a probe with pressure sensor array, an electronic unit providing data acquisition from the pressure sensors and communication with a touch-screen laptop computer. We have developed an examination procedure and algorithms to provide assessment of breast lesion features such as hardness related parameters, mobility, and shape. A statistical Bayesian classifier was constructed to distinguish between benign and malignant lesions by utilizing all the listed features as the input. Clinical results for 179 cases, collected at four different clinical sites, have demonstrated that the breast mechanical imager provides a reliable image formation of breast tissue abnormalities and calculation of lesion features. Malignant breast lesions (histologically confirmed) demonstrated increased hardness and strain hardening as well as decreased mobility and longer boundary length in comparison with benign lesions. Statistical analysis of differentiation capability for 147 benign and 32 malignant lesions revealed an average sensitivity of 91.4% and specificity of 86.8% with a standard deviation of ±6.1%. The area under the receiver operating characteristic curve characterizing benign and malignant lesion discrimination is 86.1% with the confidence interval ranging from 80.3 to 90.9%, with a significance level of P = 0.0001 (area = 50%). The multisite clinical study demonstrated the capability of mechanical imaging for characterization and differentiation of benign and malignant breast lesions. We hypothesize that the breast mechanical imager has the potential to be used as a cost effective device for cancer diagnostics that could reduce the benign biopsy rate, serve as an adjunct to mammography and to be utilized as a screening device for breast cancer detection.

We have developed a method and a device entitled prostate mechanical imager (PMI) for the real-time imaging of prostate using a transrectal probe equipped with a pressure sensor array and position tracking sensor. PMI operation is based on measurement of the stress pattern on the rectal wall when the probe is pressed against the prostate. Temporal and spatial changes in the stress pattern provide information on the elastic structure of the gland and allow two-dimensional (2-D) and three-dimensional (3-D) reconstruction of prostate anatomy and assessment of prostate mechanical properties. The data acquired allow the calculation of prostate features such as size, shape, nodularity, consistency/hardness, and mobility. The PMI prototype has been validated in laboratory experiments on prostate phantoms and in a clinical study. The results obtained on model systems and in vivo images from patients prove that PMI has potential to become a diagnostic tool that could largely supplant DRE through its higher sensitivity, quantitative record storage, ease-of-use and inherent low cost.

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, a highly prevalent condition affecting at least 50% of women in the United States during their lifetimes. It creates two predominant concerns specific to the biomechanical properties of pelvic support tissues: how does tissue elasticity affect the development of pelvic organ prolapse and how can functional elasticity be maintained through reconstructive surgery. We designed a prototype of vaginal tactile imager (VTI) for visualization and assessment of elastic properties of pelvic floor tissues. In this paper, we analyze applicability of tactile imaging for evaluation of reconstructive surgery results and characterization of normal and pelvic organ prolapse conditions. A pilot clinical study with 13 patients demonstrated that VTI allows imaging of vaginal walls with increased rigidity due to implanted mesh grafts following reconstructive pelvic surgery and VTI has the potential for prolapse characterization and detection.

Affordability of healthcare is highly limited by its skyrocketing cost. Access to screening and diagnostic medical equipment and medicine in developing countries is inadequate for the majority of the population. There is a tremendous worldwide need to detect breast cancer at its earliest stage. These needs must be balanced by the ability of countries to provide breast cancer screening technology to their populations. We reviewed the diagnostic accuracy, procedure cost and cost-effectiveness of currently available technique for breast screening and diagnosis including clinical breast examination mammography, ultrasound, magnetic resonance imaging, biopsy and a new modality for cancer diagnostics termed elasticity imaging that has emerged in the last decade. Clinical results demonstrate that elasticity imaging even in its simplest and least sophisticated versions, like tactile imaging, has significant diagnostic potential comparable and exceeding that of conventional imaging techniques. In view of many countries with limited resources, effective yet less expensive modes of screening must be considered worldwide. The tactile imaging is one method that has the potential to provide cost-effective breast cancer screening and diagnostics.

IntroductionFew means exist to provide quantitative and reproducible assessment of vaginal conditions from biomechanical and functional standpoints.AimTo develop a new approach for quantitative biomechanical characterization of the vagina.MethodsVaginal tactile imaging (VTI) allows biomechanical assessment of soft tissue and function along the entire length of the anterior, posterior, and lateral vaginal walls. This can be done at rest, with applied vaginal deformation, and with pelvic muscle contraction.ResultsData were analyzed for 42 subjects with normal pelvic floor support from an observational case-controlled clinical study. The average age was 52 years (range = 26–90 years). We introduced 8 VTI parameters to characterize vaginal conditions: (i) maximum resistance force to insertion (newtons), (ii) insertion work (millijoules), (iii) maximum stress-to-strain ratio (elasticity; kilopascals per millimeter), (iv) maximum pressure at rest (kilopascals), (v) anterior-posterior force at rest (newtons), (vi) left-right force at rest (newtons), (vii) maximum pressure at muscle contraction (kilopascals), and (viii) muscle contraction force (newtons). We observed low to moderate correlation of these parameters with subject age and no correlation with subject weight. 6 of 8 parameters demonstrated a P value less than .05 for 2 subject subsamples divided by age (≤52 vs >52 years), which means 6 VTI parameters change with age.ConclusionsVTI allows biomechanical and functional characterization of the vaginal conditions that can be used for (i) understanding “normal” vaginal conditions, (ii) quantification of the deviation from normality, (iii) personalized treatment (radiofrequency, laser, or plastic surgery), and (iv) assessment of the applied treatment outcome.Egorov V, Murphy M, Lucente V, et al. Quantitative Assessment and Interpretation of Vaginal Conditions. Sex Med 2018;6:39–48.

The Vaginal Tactile Imager (VTI) records pressure patterns from vaginal walls under an applied tissue deformation and during pelvic floor muscle contractions. The objective of this study is to validate tactile imaging and muscle contraction parameters (markers) sensitive to the female pelvic floor conditions. Twenty-two women with normal and prolapse conditions were examined by a vaginal tactile imaging probe. We identified 9 parameters which were sensitive to prolapse conditions (p < 0.05 for one-way ANOVA and/or p < 0.05 for t-test with correlation factor r from −0.73 to −0.56). The list of parameters includes pressure, pressure gradient and dynamic pressure response during muscle contraction at identified locations. These parameters may be used for biomechanical characterization of female pelvic floor conditions to support an effective management of pelvic floor prolapse.