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The SureTOUCH Collascope

Advanced Maternity Innovations / The SureTOUCH Collascope

THE SURETOUCH COLLASCOPE

The SureTOUCH Collascope® is a non-invasive medical device for the measurement of cervical softening or “ripening” and objectively defining preterm labor. SureTOUCH applies well-understood ultraviolet light using fiber optic technology to accurately and objectively measure the condition of the cervix, and therefore the function of the cervix, during pregnancy.  The technology measures the fluorescence of collagen in the cervical tissue as an indicator of cervical softening or “ripening.” This information is critical to the management of both routine and premature labor.  Currently, this assessment is purely subjective, based on the clinician’s palpation and usual exam. Prototypes developed under NIH grants have been used in research studies to record over 500 patient sessions.

AT LAST…
A NON-INVASIVE MEDICAL DEVICE TO MEASURE OF CERVICAL PROGRESSION

The SureTOUCH COLLASCOPE® Is…

  • A non-invasive Medical Device
  • A Scientific Breakthrough Technology
  • Developed by Scientist and Engineers at the University of Texas Medical Branch, Galveston, Texas
  • Engineered with Advanced Electronics and Software in Collaboration with Scientists and Engineers from Texas A&M University, College Station, Texas
  • A Proven Technology that Measures, Records, and Displays Light-Induced Fluorescence from the Cervix
  • Operational for Research Purposes and Has Successfully Recorded Over 500 Patient Sessions
  • Patent Protected with More Pending
  • A “DISRUPTIVE” technological advancement

SureTOUCH COLLASCOPE® Does…

  • The Collascope Measures Cervical Ripening by Analyzing the Fluorescence of Collagen in Cervical Tissue

SureTOUCH COLLASCOPE® Will…

Become A MAJOR ADVANCEMENT IN OBSTETRICS and Will Make a Meaningful Contribution in the Reduction of the Cccurrence of Preterm Birth and the Problems Associated with Labor and Delivery

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 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 wand 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, studies consisting of over 500 patient recordings have been completed using the Collascope.

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.

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.

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. Advanced Maternity Innovations believes that the clinical advantages, reduced morbidity and cost savings associated with the use of the SureTOUCH Collascope® will quickly justify its acceptance.

Title
Date of Publication
Publication
SureCALL®
SureTOUCH Collascope®
Biophysical A Novel Method to Assess Cervical Changes During Pregnancy and Use to Evaluate the Effects of Progestins on Term and Preterm Labor
2011
American College of Obstetricians and Gynecologists
X
Biophysical Methods of Prediction and Prevention of Preterm Labor
2007
Preterm Birth: Mechanisms, Mediators, Prediction, Prevention, and Intervention
X
X
Uterine EMG and Cervical LIF – Promising Technologies in Obstetrics
2006
Current Women’s Health Reviews
X
X
Cervical Ripening: Biochemical, Medical and Clinical Considerations
2006
Clinical Obstetrics and Gynecology
X
Use of Uterine EMG and Cervical LIF in Monitoring Pregnant Patients
2005
BJOG: an International Journal of Obstetrics and Gynecology
X
X
Prediction of Term and Preterm Parturition and Monitoring by Measuring Cervical Cross-linked Collagen Using Light-induced Fluorescence
2004
Acta Obstet Gynecol Scand
.
X

The SureTOUCH Collascope® is an investigational device and limited by United States law to investigational use.