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US4873986A Expired / Lapsed US ⏱️ 0.0 years remaining

Disposable apparatus for monitoring intrauterine pressure and fetal heart rate

Assignee: Utah Medical Products Inc
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Filing: 1988-04-27
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Granted: 1989-10-17
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Expires: 2008-04-27
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Abstract

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.

Inventors

  • 👤 William D. Wallace

Bibliographic Details

Application Number —
Jurisdiction US
Data Source google_patents
Last Synchronized 2026-10-23 12:10
CPC Classifications
A; A61; A61B; A61B5/00; A61B5/03; A61B5/033; A61B5/035

Claims Analysis

Total Claims: 47
Claim 1
Independent Claim 203 words
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.
Claim 2
Independent Claim 203 words
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.
Claim 3
Dependent Claim 29 words
An apparatus for monitoring intrauterine pressure pulses and fetal heart rate as defined in claim 1 wherein each said electrode means comprises an electrode disposed on said cable means.
Claim 4
Dependent Claim 54 words
An apparatus for monitoring intrauterine pressure pulses and fetal heart rate as defined in claim 2 wherein said electrode means further comprises a third electrode and a fourth electrode disposed on said cable means and said third and fourth electrodes are each individually connected to at least one of said plurality of electrical conductors.
Claim 5
Dependent Claim 33 words
An apparatus for monitoring intrauterine pressure pulses and fetal heart rate as defined in claim 2 or claim 3 wherein said electrodes comprise metallic bands disposed about the circumference of said cable means.
Claim 6
Dependent Claim 31 words
An apparatus for monitoring intrauterine pressure pulses and fetal heart rate as defined in claim 2 or claim 3 wherein said electrodes are spaced a distance apart on said cable means.
Claim 7
Dependent Claim 42 words
An apparatus for monitoring intrauterine pressure pulses and fetal heart rate as defined in claim 1 wherein said pressure transducer is positioned near the leading end of the cable means and said pressure transducer fits within the diameter of said cable means.
Claim 8
Dependent Claim 48 words
An apparatus for monitoring intrauterine pressure pulses and fetal heart rate as defined in claim 1 further comprising a hydrogel coating applied to the circumference of said cable means at said leading end thereof, the hydrogel coating adapted to decrease the coefficient of friction of said cable means.
Claim 9
Dependent Claim 47 words
An apparatus for monitoring intrauterine pressure pulses and fetal heart rate as defined in claim 1 wherein said pressure transducer comprises substrate means onto which said diaphragm is mounted, and cap means joined to said substrate means so as to form a protective cover over said diaphragm.
Claim 10
Dependent Claim 49 words
An apparatus for monitoring intrauterine pressure pulses and fetal heart rate as defined in claim 1 wherein the leading end of said cable means is rounded so as to avoid tissue damage and is sufficiently small so as to be easily inserted past a fetus in the cervical region.
Claim 11
Dependent Claim 26 words
An apparatus for monitoring intrauterine pressure pulses and fetal heart rate as defined in claim 1 further comprising a cushioned boot disposed about the pressure transducer.
Claim 12
Dependent Claim 35 words
An apparatus for monitoring intrauterine pressure pulses and fetal heart rate as defined in claim 10 further comprising means for communicating the pressure pulses through the cushioned boot to the first side of the diaphragm.
Claim 13
Dependent Claim 51 words
An apparatus for monitoring intrauterine pressure pulses and fetal heart rate as defined in claim 11 wherein said communication means comprises a dielectric material and openings formed through said substrate means and said cushioned boot, said openings receiving and holding said dielectric material adjacent to said first side of said diaphragm.
Claim 14
Dependent Claim 50 words
An apparatus for monitoring intrauterine pressure pulses and fetal heart rate as defined in claim 1 wherein said means for connecting the plurality of electrical conductors comprises a plug connected to the cable means, the plug having a channel formed therein, said channel being in communication with said vent means.
Claim 15
Dependent Claim 41 words
An apparatus for monitoring intrauterine pressure pulses and fetal heart rate as defined in claim 1 further comprising a stiffener means associated with said cable means for stiffening said cable means to accommodate insertion within a body compartment of a patient.
Claim 16
Dependent Claim 46 words
An apparatus for monitoring intrauterine pressure pulses and fetal heart rate as defined in claim 14 wherein said cable means comprises means for removably receiving said stiffener means so that said stiffener means may be withdrawn and removed from said cable means after insertion is accomplished.
Claim 17
Dependent Claim 45 words
An apparatus for monitoring intrauterine pressure pulses and fetal heart rate as defined in claim 15 wherein said cable means further comprises means for guiding said stiffener means through said cable means as said stiffener means is inserted into and removed from the cable means.
Claim 18
Dependent Claim 46 words
An apparatus for monitoring intrauterine pressure pulses and fetal heart rate as defined in claim 16 wherein the means for guiding said stiffener means comprises a lumen disposed within said cable means, said lumen having a first opening near the leading end of the cable means.
Claim 19
Dependent Claim 23 words
An apparatus for monitoring intrauterine pressure pulses and fetal heart rate as defined in claim 15 wherein said stiffener means comprises a stylet.
Claim 20
Dependent Claim 39 words
An apparatus for monitoring intrauterine pressure pulses and fetal heart rate as defined in claim 1 further comprising a lumen disposed in said cable means, said lumen having a first opening near the leading end of said cable means.
Claim 21
Dependent Claim 49 words
An apparatus for monitoring intrauterine pressure pulses and fetal heart rate as defined in claim 1 wherein the vent means comprises a vent tube leading from said second side of said diaphragm to said means for connecting the plurality of electrical connectors, said vent tube opening to the atmosphere.
Claim 22
Dependent Claim 45 words
An apparatus for monitoring intrauterine pressure pulses and fetal heart rate as defined in claim 1 further comprising a dielectric gel material disposed over said first side of said diaphragm, said dielectric gel material being adapted for communicating the intrauterine pressure pulses to said diaphragm.
Claim 23
Independent Claim 175 words
An apparatus for monitoring intrauterine pressure pulses and fetal heart rate, comprising: 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.
Claim 24
Independent Claim 175 words
An apparatus for monitoring intrauterine pressure pulses and fetal heart rate, comprising: 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.
Claim 25
Dependent Claim 53 words
An apparatus for monitoring intrauterine pressure pulses and fetal heart rate as defined in claim 22 wherein said electrode means further comprises a second pair of electrodes disposed on the cable means and wherein said second pair of electrodes are each individually connected to at least one of said plurality of electrical conductors.
Claim 26
Dependent Claim 33 words
An apparatus for monitoring intrauterine pressure pulses and fetal heart rate as defined in claim 22 or claim 23 wherein said electrodes comprise metallic bands disposed about the circumference of said cable means.
Claim 27
Dependent Claim 33 words
An apparatus for monitoring intrauterine pressure pulses and fetal heart rate as defined in claim 23 wherein said first and second pair of electrodes are spaced a distance apart on said cable means.
Claim 28
Dependent Claim 28 words
An apparatus for monitoring intrauterine pressure pulses and fetal heart rate as defined in claim 22 wherein said pressure transducer fits within the diameter of said cable means.
Claim 29
Dependent Claim 49 words
An apparatus for monitoring intrauterine pressure pulses and fetal heart rate as defined in claim 22 further comprising a hydrogel coating applied to the circumference of said cable means at the leading end thereof, the hydrogel coating being adapted to decrease the coefficient of friction of said cable means.
Claim 30
Dependent Claim 47 words
An apparatus for monitoring intrauterine pressure pulses and fetal heart rate as defined in claim 22 wherein said pressure transducer comprises substrate means onto which said diaphragm is counted and cap means joined to said substrate means so as to form a protective cover over said diaphragm.
Claim 31
Dependent Claim 39 words
An apparatus for monitoring intrauterine pressure pulses and fetal heart rate as defined in claim 22 wherein the leading end of said cable means is rounded and small so as to avoid uterine wall perforation, irritation or placental abruption.
Claim 32
Dependent Claim 26 words
An apparatus for monitoring intrauterine pressure pulses and fetal heart rate as defined in claim 22 further comprising a cushioned boot disposed about the pressure transducer.
Claim 33
Dependent Claim 35 words
An apparatus for monitoring intrauterine pressure pulses and fetal heart rate as defined in claim 30 further comprising means for communicating the pressure pulses through the cushioned boot to the first side of the diaphragm.
Claim 34
Dependent Claim 54 words
An apparatus for monitoring intrauterine pressure pulses and fetal heart rate as defined in claim 31 wherein said communication means comprises a dielectric material and openings formed through said substrate means and said cushioned boot, said opening being adapted for receiving and holding said dielectric material adjacent to said first side of said diaphragm.
Claim 35
Dependent Claim 48 words
An apparatus for monitoring intrauterine pressure pulses and fetal heart rate as defined in claim 22 wherein said means for connecting the plurality of electrical conductors comprises a plug connected to the cable means, the plug having a channel formed therethrough in communication with said means for venting.
Claim 36
Dependent Claim 41 words
An apparatus for monitoring intrauterine pressure pulses and fetal heart rate as defined in claim 22 further comprising a stiffener means associated with said cable means for stiffening said cable means to accommodate insertion within a body compartment of a patient.
Claim 37
Dependent Claim 46 words
An apparatus for monitoring intrauterine pressure pulses and fetal heart rate as defined in claim 34 wherein said cable means comprises means for removably receiving said stiffener means so that said stiffener means may be withdrawn and removed from said cable means after insertion is accomplished.
Claim 38
Dependent Claim 45 words
An apparatus for monitoring intrauterine pressure pulses and fetal heart rate as defined in claim 35 wherein said cable means further comprises means for guiding said stiffener means through said cable means as said stiffener means is inserted into and removed from said cable means.
Claim 39
Dependent Claim 46 words
An apparatus for monitoring intrauterine pressure pulses and fetal heart rate as defined in claim 36 wherein the means for guiding said stiffener means comprises a lumen disposed within said cable means, said lumen having a first opening near the leading end of the cable means.
Claim 40
Dependent Claim 23 words
An apparatus for monitoring intrauterine pressure pulses and fetal heart rate as defined in claim 35 wherein said stiffener means comprises a stylet.
Claim 41
Dependent Claim 41 words
An apparatus for monitoring intrauterine pressure pulses and fetal heart rate as defined in claim 22 further comprising a lumen disposed in said cable means, said lumen having an opening disposed at a position along the length of said cable means.
Claim 42
Dependent Claim 50 words
An apparatus for monitoring intrauterine pressure pulses and fetal heart rate as defined in claim 22 wherein the means for venting comprises a vent tube leading from said second side of said diaphragm to said means for connecting the plurality of electrical connectors, said vent tube opening to the atmosphere.
Claim 43
Dependent Claim 49 words
An apparatus for monitoring intrauterine pressure pulses and fetal heart rate as defined in claim 22 wherein the means for communicating comprises a dielectric gel material disposed over said first side of said diaphragm, said dielectric gel material being adapted for communicating the intrauterine pressure pulses to said diaphragm.
Claim 44
Dependent Claim 256 words
A disposable apparatus for monitoring intrauterine pressure pulses and fetal heart rate, comprising: 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.
Claim 45
Dependent Claim 256 words
A disposable apparatus for monitoring intrauterine pressure pulses and fetal heart rate, comprising: 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.
Claim 46
Dependent Claim 29 words
An appaaratus for monitoring intrauterine pressure pulses and fetal heart rate as defined in claim 42 wherein said electrodes comprise metallic bands disposed about the circumference of said cable.
Claim 47
Dependent Claim 27 words
An apparatus for monitoring intrauterine pressure pulses and fetal heart rate as defined in claim 42 wherein said pressure transducer fits within the diameter of said cable.

USPTO Annuity & Maintenance Windows

Annuity Stage Window Opens Payment Deadline Surcharge Period Until Estimated Fee Status
3.5 Years (Year 4) 1992-10-16 1993-04-17 1993-10-17 $2000.00 Window Closed / Lapsed
7.5 Years (Year 8) 1996-10-16 1997-04-17 1997-10-17 $3760.00 Window Closed / Lapsed
11.5 Years (Year 12) 2000-10-16 2001-04-17 2001-10-17 $7700.00 Window Closed / Lapsed

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