SBIR-STTR Award

Reliable Non-Invasive Uterine Activity Monitor
Award last edited on: 12/16/14

Sponsored Program
SBIR
Awarding Agency
NIH : NICHD
Total Award Amount
$400,000
Award Phase
2
Solicitation Topic Code
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Principal Investigator
Page F Read

Company Information

Page Read and Company

Box 17824
Seattle, WA 98107
   (206) 861-0625
   N/A
   N/A
Location: Single
Congr. District: 07
County: King

Phase I

Contract Number: 1R43HD023420-01
Start Date: 00/00/00    Completed: 00/00/00
Phase I year
1987
Phase I Amount
$50,000
Current non-invasive monitoring of uterine activity in the pregnant woman is accomplished by tocotonometer devices which monitor continuously the hardness of the abdominal wall by measuring the force needed to push against the device. These electro-mechanical devices must be located over the fundus (top) of the uterus, fastened to the abdomen with a belt and electronically connected to a fetal monitor. The devices are placement and artifact sensitive, bulky and uncomfortable for the patient, require frequent adjustment and they are delicate and expensive. The objective of this project is the development of a soft air- filled pressurized "bladder" ("air-cushion tocotonometer") that is held onto the abdomen with a belt. The bladder is compressed between the belt and the uterus and the pressure increase is measured by any variety of standard pressure measuring devices. It may be necessary to develop and include an electronic transducer interface to amplify the signals generated by the pressure changes. The performance is expected to be equivalent to standard tocotonometers. They will be comfortable, rugged and inexpensive. In Phase I we will demonstrate engineering models of the "air- cushion tocotonometer", characterize their performance and conduct clinical trials to confirm our in-house findings.

Thesaurus Terms:
biomedical engineering, instrumentation clinically oriented, biomedical systems automated, monitoring devices, biomedical systems automated, patient monitoring (monitoring devices), biophysical chemistry study section, muscle function, muscle contraction, reproductive system female, uterus diagnostic tests, non-invasive, pregnancy, birth, pregnancy, embryo-fetus monitoring human, clinical

Phase II

Contract Number: 2R44HD023420-02
Start Date: 00/00/00    Completed: 00/00/00
Phase II year
1991
Phase II Amount
$350,000
The opportunity exists for greatly improving the state of the art of external uterine contraction monitoring through the development of an innovative concept for a new contraction sensor (tocotonometer). Uterine contraction monitoring is extremely important during labor and delivery, as it provides quantitative data for the diagnosis of fetal distress, and for the regulation of therapeutic measures. Current external uterine contraction monitoring methods are regarded as qualitative, marginally reliable representations of intrauterine pressure (IUP) monitoring methods. In addition, current torotonometers suffer from problems of accuracy, reliability, patient comfort, and difficulty in use and cleaning. The specific aim is to complete the product development of a reliable, disposable uterine contraction sensor. An innovative concept for a new contraction sensor led to the design, construction, and clinical testing of product prototypes during Phase I of the grant. During Phase II, the product version of the disposable air bladder and its associated electronic interface module will be designed, prototyped, bench tested, and clinically tested. Following successful testing, a preproduction run of 100 disposables and 10 interfaces will be produced and qualified. The necessary manufacturing documentation will be prepared, and the first production run will be produced, qualified, and released for sale.Awardee's statement of the potential commercial applications of the research:Presently available tocotonometers are not disposable, unreliable, expensive, inaccurate, and hard to clean. The ACTtm has the potential to replace current tocotonometers in every instance of use. Assuming 100% market penetration, given 3.4 million births a year in the U. S. at a disposable price of $10.00 each, the potential market is $34 million per year.National Institute of Child Health and Human Development (NICHD)