Surgery – Instruments – Obstetric or gynecological instruments
Reexamination Certificate
2001-05-04
2002-06-04
Philogene, Pedro (Department: 3732)
Surgery
Instruments
Obstetric or gynecological instruments
C606S119000, C606S121000
Reexamination Certificate
active
06398790
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
The invention relates to obstetrical devices in general and to devices for assisting delivery of a human fetus in particular.
2. Prior Art
The principle delivery assistance device in the prior art are forceps. Forceps generally comprise a pair of opposed metal arms that are separately placed on either side of the fetus's head. Once the arms are in place, they are typically joined together at a centrally located hinge so that inward pressure on the control end of the two arms will result in the inward movement of the gripping ends of the arms against the fetus's head. Through this gripping, traction is obtained with the fetus's head, and by exerting lateral force against the forceps, the fetus may be extracted from the birth canal.
Several problems can arise in the use of the forceps. When properly applied, the gripping end of the forceps are positioned over the upper jaw bone of the fetus in line with the ear. However, properly placing the forceps can be difficult. Frequently, only the top of the fetus's head is visible in the birth canal when the forceps are applied. Particularly when the fetus is not properly positioned in a face down position in the birth canal, it can be difficult for the physician or other medical professional to locate the appropriate place on the fetus to position the forceps. Thus, instead of the bones of the upper jaw, the forceps may be placed against the nose, eye, temple, or other inappropriate portion of the fetus's head. When the forceps are tightened, pressure is exerted against this fetus's head with the gripping points of the forceps. If these points are positioned improperly, pressure may be exerted on an eye, an ear, a temple, or other portions of the fetus's head which may be injured or deformed under such pressure, and in fact such injuries are all too common in forceps assisted deliveries.
One delivery assistance device that attempts to address this problem is the sock-like axial gripping delivery assistance device such as that illustrated in U.S. Pat. No. 5,910,146 (the '146 Patent) which is hereby incorporated by reference in its entirety. These devices use an elongated hollow member comprised of a plurality of fibers loosely woven together and having an open mouth. In operation, the open mouth of delivery assistance devices such as that disclosed in the '146 Patent will be placed over the head of the fetus. When the physician pulls on the end of the tube opposite the fetus, the fibers will tighten and axially grip the head of the fetus, much like the way that the novelty item, “Chinese finger cuffs,” grip the fingers of a user. Unlike forceps, such gripping will be spread out across the fall surface area of the fetus's head, rather than being concentrated in two points. By spreading the gripping force out across the entire fetal head, the risk of injury or deformation is greatly reduced.
Delivery assistance devices such as that disclosed in the '146 Patent work very well once they are inserted over the fetal head. However, positioning the device over the fetal head can be problematic. When a delivery assistance device of any type is needed, the fetus has usually descended into the birth canal, but is not moving forward or is not moving forward fast enough. Unless a breach birth is underway, the fetus will be positioned head first in the birth canal, which will be pressed tightly around the head so that only a small circle at the top of the fetal head is exposed. Forcing a woven sock-like member between the fetal head and the birth canal walls can be difficult, as the loose edges of the elongated hollow sock-like member tend to gather at the boundary between the fetal head and the birth canal. This can prevent the mouth of the delivery device from being placed completely over the fetus's head, making the initiation of axial gripping and traction difficult. Therefore, what is needed is a delivery assistance device that meets the following objectives.
OBJECTS OF THE INVENTION
It is an object of the invention to provide a device capable of assisting in the delivery of a fetus.
It is another object of the invention to provide a device capable of gripping the head of a fetus and distributing that gripping pressure evenly across the fetal head.
It is another object of the invention to provide a device for assisting in the delivery of a fetus that will reduce or eliminate the injuries inherent in forceps or vacuum type assisted delivery systems.
It is still another object of the invention to provide a device for assisting in the delivery of a fetus that may be quickly and easily placed over the head of the fetus by the physician or other medical professional, and quickly and easily removed if necessary.
Still other objects and advantages of the invention will become apparent from the following description of the invention.
SUMMARY OF THE INVENTION
The invention comprises an elongated gripping member for assisting in the delivery of a fetus. Although the invention is described in terms of a human fetus, it is to be understood that the invention is equally applicable to non-human fetuses, and that it may be used in the delivery of the same. The elongated gripping member is made up of two separate sheets of loosely knitted fibers, preferably interlocking loops of polypropylene or nylon monofilarnent. Each sheet has a control end and a mouth end opposite the control end and a pair of insertion arms attached to each end of the sheets. Located between the insertion arms is a central insertion arm. The outside insertion arms of each sheet will slidingly engage one another. Thus, one half of the elongated gripping member may be inserted between the fetal head and the birth canal wall until the first half is properly placed around the fetal head. The second half of the elongated gripping member can then engage the first half and slide into position around the fetal head as well, thereby forming the elongated gripping member in place to engage the fetal head. A drawstring is provided in one half of the elongated gripping member to allow the mouth of the gripping member to tighten slightly before traction is initiated. This will prevent the elongated gripping member from slipping until compression gripping is initiated. Once compression gripping is commenced, tension on the drawstring will no longer be required. Additionally, pressure on the fetal head will be uniformly distributed by the elongated gripping member, thereby reducing the likelihood of injury to or deformation of the fetus.
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PCT/FR89/00252 WO89/11253, Nov. 30, 1989, Bernon, France, (Abstract Only).
Medisys Technologies, Inc.
Philogene Pedro
Roy, Kiesel, Keegan & DeNicola
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