Other

Triton Technology, Inc.

Michael P Guberek

W Scott Kemper

Michael A Harrison

David L Gibbs

Gerd Heusch

Kelli M Bullard

A flexible elastomeric annulus-shaped membrane having a shape-retentive memory and exerting a force so as to assume and to maintain a predetermined closed-loop geometric shape, normally a circle, fits circumferentially about the cervix os of a human female so as to hold and retain medical instrumentation probes, preferably two opposed wire-connected ultrasonic transducers of a real-time transit-time ultrasonic monitor of cervical dilatation and effacement. The annular membrane may optionally extend as a tube downwards in the vaginal canal, in the manner of a female diaphragm, as to shield the wires from the walls of the vagina. The membrane expands and contracts with such cyclical variation in the dilatation and effacement of the cervix os as occurs from the earliest onset of labor until imminent childbirth. The membrane holding the transducer probes of an ultrasonic cervimeter may be situated in place about the cervix os for prolonged periods ranging to several months, or may be placed only at the onset of full labor, for monitoring purposes.

Device for holding medical instrumentation sensors at and upon the

The onset of spontaneous abortion or premature labor of a pregnant human female is continuously monitored, potentially for periods of several months and longer, by a real-time transit-time ultrasonic monitor of the dilatation and/or effacement of the cervix os, preferably by a computerized ambulatory monitor. The preferred computerized monitor sounds an alarm upon the detection of variably present conditions, normally the compound conditions of five or more 10% cyclical variations in the dilatation or effacement of the cervix os within a period of one hour, coupled with a greater than 1 centimeter increase over baseline of either dilatation or effacement, which compound conditions normally indicate the early onset of labor. The monitor connects to an infusion pump, likewise preferably ambulatory, for directing and controlling the infusion of one or more tocolytic, labor-preventing, drugs if labor continues. In this manner patient activity and patient chemistry can be early detected, early alarmed and early beneficially altered even before it is possible to receive the diagnosis or treatment of a physician of other health care provider.

System and method for the infusing of tocolytic drugs in response to the

Preferred transducers in the substantial shapes of a three-dimensional bodies, normally spheres or cylinders, emit ultrasound omni-directionally. The transducers are secured to the wall of the cervix uteri of human female, preferably by a barb or corkscrew coil, so that a straight line ultrasonic acoustic path exists between them. An ultrasonic transit time sonomicrometer detecting a variable propagation delay between the transducers dependent upon the dilatation or effacement of the cervix uteri serves as a ultrasonic cervimeter. Cervical dimension, and changes in dimension, developed by the ultrasonic cervimeter directly in millimeters are (i) validated for reasonableness, (ii) monitored so as to generate several alarms upon the occurrence(s) of several predetermined conditions, (iii) displayed, and (iv) archived all in a battery-powered ambulatory instrument.

Ambulatory, ultrasonic transit time, real-time, cervical effacement and

Microspheres labeled with a dye for which the absorption spectra is known permit the measurement of blood flows, particularly regional myocardial blood flow (RMBF), without radiation safety concerns and radioactive waste disposal problems. Polystyrene spheres, nominally of diameter 15.+-.0.1 [SD] um and density 1.09 g/ml, are dyed with a fixed quantity, nominally 30 picograms per microsphere, with one of several, nominally 5, colored dyes. The colored microspheres (CM) are injected into the left atrium or into a coronary perfusion. The CM are extracted from myocardium and blood by digestion with KOH and subsequent microfiltration. The dyes are then recovered from the CM within a defined volume of a solvent, and their concentrations are determined by spectrophotometry. The composite absorbance or emission spectra of several dyes are mathematically resolved using matrix inversion. Leaching of dye from the CM was less than 0.1% over a two months period in vitro, and did not occur during 8 hours in blood and myocardium of 4 anesthetized dogs in vivo. For further validation of this method, pairs of CM and RM (15.5.+-.0.1 [SD] um) were simultaneously injected under 5 different RMBF conditions (range: 0-10 ml/(min g)) into the left anterior descending coronary artery of 4 anesthetized pigs, with coronary inflow as a flow-reference, or into the left atrium of 4 anesthetized dogs using aortic blood withdrawal as a reference.

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Encinitas, CA, United States of America

Michael P Guberek