Technology CAUTION: INVESTIGATIONAL DEVICE. LIMITED BY U.S. LAW TO INVESTIGATIONAL USE. The SureTOUCH Collascope® was developed by Scientists and Engineers at the University of Texas Medical Branch in Galveston, Texas (“UTMB”). Advanced electronics, optics and software have been developed in collaboration with engineers from Texas A&M University, College Station, Texas. Cervical Function Assessment: Integral to the normal birthing process and the birth of a healthy baby is the softening or “ripening” of the cervix. Presently, there is no objective method to evaluate changes associated with dilation and effacement of the cervix during pregnancy.  While several methods have been adopted to identify, monitor, and predict labor, they are subjective and rarely accurately predict true labor. The methods range in complexity from simple patient self-awareness to complex electronic pressure sensors.  At present, the only method to diagnose preterm labor is to document cervical change, either dilatation or effacement. Delaying treatment until cervical change is documented may decrease the effectiveness of treatment, while starting treatment before true labor is recognized would result in overuse of tocolytic medications. The Cervix:  During pregnancy, the cervix is normally firm and closed.  At the end of pregnancy, the cervix becomes softer and dilates as the uterine contractions increase during labor.  Often, however, the cervix fails to soften and dilate with advancing labor or dilates prematurely before labor.  The attending physician currently monitors progress of the cervix by visual inspection or by manual examination.  These subjective tests are inadequate and vary from physician to physician. The cervix is composed of smooth muscle (ca. 10%) and a large component of connective tissue (90%) consisting of collagen, elastin, and macromolecular components that make up the extracellular matrix.  Many biochemical and functional changes occur in cervical connective tissue at the end of pregnancy.  This process, often called cervical ripening, results in softening, dilatation, and effacement of the cervix.  Ripening is required for appropriate progress of labor and delivery of the fetus.  The exact mechanisms controlling the cervical ripening process are largely unknown. The Problem:  A more accurate method for the diagnosis of cervical problems such as premature dilation or prolonged labor due to delayed cervical dilation would be invaluable. This would also assist in determining cervical status before induction of labor. Such a method could lead to appropriate treatments to either dilate or prevent dilation of the cervix. The SureTOUCH™ Collascope Technology:  A team of Scientists and Engineers at UTMB were the first to use light-induced auto-fluorescence (LIF) for the measurement of changes in the cervical tissue during gestation and labor. The SureTOUCH™ Collascope measures the fluorescence of collagen in the cervical tissue as an indicator of cervical “softness.” Working in collaboration with engineers from Texas A&M University, College Station, Texas, the electronics, optics and software components have recently been substantially enhanced. Fluorescence spectroscopy is a widely used research tool in biomedical research, primarily because of the amount of information that it can reveal in terms of molecular and physical states.  Fluorescent spectra offer important details on the structure and dynamics of macromolecules and their locations at microscopic levels.  Fluorescence spectroscopy has been used to examine collagen content of a variety of issues. Research conducted at UTMB has demonstrated that the process of cervical ripening observed by physicians as a softening of the cervix upon palpation can be measured by collagen auto-fluorescence. Cervical ripening is a biochemical process where the cervix is conditioned in preparation for delivery of the baby. This conditioning reduces the rigidity and increases the extensibility of the birth canal. Numerous biochemical agents cause an increase in the amount of proteoglycan (decorin) in the cervical tissue. The result is an enzymatic degradation of collagen fibers and a reduction in the concentration of collagen in the cervical tissue that can be measured by optical methods. The SureTOUCH Collascope® is a non-invasive device for the measurement of cervical “ripening”. The Collascope induces the auto-fluorescence of the collagen cross-links by using a light source to excite the cervical tissue. The concentration of collagen cross links is determined by measuring the intensity of the auto-fluorescence using standard spectroscopy methods. This measurement determines the amount of cervical ripening. The SureTOUCH Collascope® consists of an optical probe that connects through a fiber optic cable to a main unit consisting of a controlled light source and a spectrometer with a computer for data display, system control, and data storage. Working under an NIH grant, over 650 patient studies have been successfully completed at UTMB. The current SureTOUCH Collascope® medical device instrument is designed primarily for research applications. The instrument is a “user friendly” device that can be utilized easily in a laboratory environment, in a physician’s office, or in a hospital or clinic setting to provide the researcher or clinician with an objective assessment of cervical “ripening.” For normal pregnancies, the SureTOUCH Collascope® can accurately and quantitatively monitor the course of pregnancy as the cervix softens in preparation for delivery. This is in place of the subjective palpation method currently employed. For pregnancies with difficulties, the SureTOUCH  Collascope® can  alert  clinicians  to  impending  pre-term  delivery,  differentiate  between  true and  false labor, play a primary role in the monitoring of the effectiveness of induced labor and tocolytic therapy, all in order to assist in the prevention and management of preterm births.  In the research environment, this instrument can quantitatively measure the cervical response to pharmacological treatment protocols. Intellectual Property Protection: One U.S. patent has been issued and is exclusively licensed to RRT. More patents are expected to be issued. Potential Benefits: Data regarding recordings of cervical light-induced auto-fluorescence for the measurement of changes in the cervical tissue can be extremely useful for a variety of obstetrical indications and problems. The potential benefits from the use of this technology include the reduction in preterm delivery rate and improved perinatal outcome, the identification of treatment regimens, and a decrease in cesarean section rates. These methods can be used in research to define mechanisms that regulate normal and abnormal function of the cervix and ways to control it pharmacologically. For more information, click on the "Benefits" tap near the top of this page. Distinctive Advantage: The SureTOUCH Collascope® represents the only quantitative method to assess and quantify the ripening of the cervix in preparation for childbirth. It is the first quantitative measurement tool for assessing the ripening of the cervix, there is no real competition – except for the current digital examination by the physician. However, the existing approach is subjective. This new technology offers an objective, quantitative, consistent measurement device that can be used effectively, particularly in conjunction with pharmacological protocols. RRT believes that the clinical advantages, reduced morbidity and cost savings associated with the use of the Collascope® will quickly justify its acceptance.   For more information, please see the following articles under the "Links" tab: Uterine Electromyography and Ligh-Induced Fluorescence in the Management of Term and Preterm Labor Methods and Devices for the Management of Term and Preterm Labor