Surgery – Instruments – Obstetric or gynecological instruments
Reexamination Certificate
2000-11-30
2003-09-16
Izaguirre, Ismael (Department: 3765)
Surgery
Instruments
Obstetric or gynecological instruments
Reexamination Certificate
active
06620171
ABSTRACT:
TECHNICAL FIELD
The invention relates to childbirth, and more specifically, the invention relates to vacuum extraction deliveries. More particularly still, the invention relates to systems, devices, and methods for monitoring vacuum extraction deliveries.
STATEMENT OF A PROBLEM ADDRESSED BY THIS INVENTION
When operative vaginal deliveries are necessary, there are presently two options—forceps extraction, or vacuum extraction. Vacuum extraction in labor/delivery suites has become a well-accepted and commonly performed form of vaginal delivery because it may be less hazardous to the mother and fetus than forceps extraction. However, there is the potential for harm to the fetus from prolonged suction application to the fetal head. In addition, there are guidelines prolonged suction application to the fetal head. In addition, there are guidelines governing the amount of vacuum pressure that should be applied to the fetal head, as well as guidelines regarding the duration of time that the vacuum pressure is applied to the fetal head during vacuum extraction (these guidelines are printed by the manufacturers of vacuum devices, and are also available in medical literature).
Exemplary effects of vacuum extraction on an infant during delivery include: fetal hypoxia, retinal hemorrhage, chignon-scalp marking and abrasion, cephalhematoma and subcutaneous hematoma, neonatal jaundice, intra-cranial hemorrhage, shoulder dystocia, and subgaleal hemorrhage. Subgaleal hematoma is a particularly dangerous condition. Subgaleal hematoma is formed when bleeding occurs into the potential beneath the aponeurosis of an infant's scalp. It may be a life threatening condition for a newborn baby, and is often considered the most serious complication associated with the vacuum extraction. One danger associated with subgaleal hematoma arises because the subaponeurotic space stretches over the whole part of the cranial vault of the infant, and a large proportion of the baby's blood volume can accumulate in this space (typically, from damage to the emissary veins). Although subgaleal hematoma may occur after forceps and natural deliveries, the incidents of subgaleal hematoma is increased considerably in vacuum extractions since the introduction of the vacuum device pulls the aponeurosis from the cranium and may injure the underlying veins. Furthermore, because hemorrhaging into the subgaleal space may occur slowly, and for several hours following delivery, bleeding into the subgaleal space may be difficult to initially detect.
Accordingly, there are occasions when a fetus does poorly during and after vacuum extraction. Often, a legal claim is made against a doctor, hospital, nurses, and others associated with the delivery, alleging that the guidelines regarding the use of the vacuum device were not followed.
Other complications involved with using vacuum devices include attention being diverted away from the delivery process itself when attention is given to the vacuum pressure being applied to the fetal head. Furthermore, large amounts of activity by different personnel who participate in the delivery may create confusion and chaos in which the monitoring of a vacuum pressure in the vacuum device goes undocumented. The present invention provides a solution that overcomes these and other disadvantages associated with the prior art.
SELECTED OVERVIEW OF SELECTED EMBODIMENTS
The present invention provides technical advantages as systems, devices, and methods for aiding a person who is assisting with fetal extraction. The invention is attachable to a vacuum device, and may incorporate a vacuum device. Accordingly, the pressure inside the vacuum device is monitored and recorded by a recording device. Thus, the invention allows the measurement of, and provides for the recording of the amount of pressure and the duration of pressure applied to a fetus's head during vacuum extraction. Furthermore, the invention lowers litigation costs because a permanent record of vacuum pressures applied during delivery is created.
In another embodiment, the invention is a vacuum device for aiding a person who is assisting with fetal extraction. The invention includes a suction device that is enabled for vacuum attachment to a fetus, a pump that is capable of producing a vacuum pressure, and tubing that fluidly couples the suction device to the pump.
In another embodiment, the invention is a method of aiding a person who is assisting with fetal extraction. The method includes attaching a suction device to a fetus, preferably at a vacuum pressure, detecting the vacuum pressure, and recording the vacuum pressure.
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