Disposable apparatus for monitoring intrauterine pressure and fetal heart rate
First Claim
1. An apparatus for monitoring intrauterine pressure pulses and fetal heart rate, comprising:
- a pressure transducer having a diaphragm with first and second sides, said first side being in communication with said intrauterine pressure pulses;
cable means for providing a plurality of electrical conductors, at least two of said plurality of conductors being connected to said pressure transducer;
vent means for introducing atmospheric pressure to said second side of said diaphragm;
means for connecting the plurality of electrical conductors to a monitoring device; and
a pair of electrode means for independently receiving electrical signals through amniotic fluid generated by the heart of a fetus, each said electrode means being located on an outside surface of said cable means so as to be in electrical contact with said amniotic fluid and being positioned at a leading end of said cable means adjacent said transducer such that when said leading end is inserted into the uterus of a patient, each said electrode means senses fetal heart rate through amniotic fluid within the uterus, each said electrode means being connected to at least one of the plurality of electrical conductors such that the fetal heart rate and the intrauterine pressure may be displayed by said monitoring device.
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Accused Products
Abstract
A disposable apparatus for monitoring intrauterine pressure and fetal heart rate during labor and childbirth. The apparatus includes a semiconductor pressure transducer mounted on a substrate. In one embodiment, the substrate is secured within a flexible boot adapted to allow the pressure pulses present in a uterus to be communicated to the pressure transducer by way of a gel placed in aligned holes provided in both the substrate and the flexible boot. The pressure transducer is located at the leading end of a cable which includes electrical conductors. A plurality of electrodes are also disposed along the outer surface of the cable so as to be able to receive the electrical signals generated by the heart of the fetus. Each of the electrodes and the pressure transducer are connected to a monitor/display device by way of the conductors within the cable. The cable may be provided with an internal stiffening stylet to facilitate insertion of the apparatus into the uterus or other body compartment. The internal structure of the cable is provided with a vent channel which communicates with the semiconductor transducer and extends along the cable to a hole in the plug on the distal end of the cable, to permit calibration and/or referencing of the transducer to atmospheric pressure. In one embodiment a lumen is provided in the cable to allow sampling of body fluids or infusion of fluids into the body.
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Citations
44 Claims
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1. An apparatus for monitoring intrauterine pressure pulses and fetal heart rate, comprising:
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a pressure transducer having a diaphragm with first and second sides, said first side being in communication with said intrauterine pressure pulses; cable means for providing a plurality of electrical conductors, at least two of said plurality of conductors being connected to said pressure transducer; vent means for introducing atmospheric pressure to said second side of said diaphragm; means for connecting the plurality of electrical conductors to a monitoring device; and a pair of electrode means for independently receiving electrical signals through amniotic fluid generated by the heart of a fetus, each said electrode means being located on an outside surface of said cable means so as to be in electrical contact with said amniotic fluid and being positioned at a leading end of said cable means adjacent said transducer such that when said leading end is inserted into the uterus of a patient, each said electrode means senses fetal heart rate through amniotic fluid within the uterus, each said electrode means being connected to at least one of the plurality of electrical conductors such that the fetal heart rate and the intrauterine pressure may be displayed by said monitoring device. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21)
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22. An apparatus for monitoring intrauterine pressure pulses and fetal heart rate, comprising:
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a pressure transducer having a diaphragm with first and second sides; means for communicating said intrauterine pressure pulses to the first side of said diaphragm; means for venting the second side of said diaphragm to atmospheric pressure; cable means for providing a plurality of individual conductors, at least two of the individual conductors being connected to said pressure transducer; means for connecting the individual conductors to monitoring equipment; and a first pair of electrodes spaced one from the other and disposed on said cable means on an exterior surface at a leading end thereof, said first pair of electrodes being adapted for receiving independent of one another electrical signals through amniotic fluid generated by the heart of a fetus when inserted into the uterus of a patient, each of said electrodes being individually connected to at least one of said plurality of individual conductors such that the fetal heart rate may be displayed by said monitoring equipment simultaneously with the intrauterine pressure pulses. - View Dependent Claims (23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41)
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42. A disposable apparatus for monitoring intrauterine pressure pulses and fetal heart rate, comprising:
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a dielectric substrate, said substrate having a hole formed therethrough; a semiconductor pressure transducer having a pressure diaphragm with first and second sides, the pressure transducer being mounted on said substrate such that the first side of the pressure diaphragm is positioned over said hole in the substrate; a dielectric material positioned over said diaphragm, said dielectric material communicating the pressure pulses to the first side of the pressure diaphragm; a cable having a sheath covering a plurality of wires, at least two of the wires being electrically connected to the pressure transducer, said cable comprising a vent channel formed therethrough; a plug connected to the cable, the plug having a channel formed therethrough in communication with the vent channel, said channel of the plug terminating at one end in a hole formed in a side of the plug; a lumen disposed within said cable, said lumen having an opening toward the leading end of the cable and having an outlet adjacent the distal end of the cable; a removable stylet adapted to be inserted into and withdrawn from said lumen so as to stiffen said cable when inserted therein; and at least three electrodes spaced one from the other along the length of said cable and disposed on the exterior surface of the sheath near the leading end thereof, each of the electrodes receiving independent of one another the electrical signal generated through the amniotic fluid by the heart of a fetus. - View Dependent Claims (43, 44)
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Specification