Surgery – Instruments – Obstetric or gynecological instruments
Reexamination Certificate
2002-05-09
2004-08-24
Shaver, Kevin (Department: 3732)
Surgery
Instruments
Obstetric or gynecological instruments
C606S157000, C606S174000, C606S183000
Reexamination Certificate
active
06780195
ABSTRACT:
BACKGROUND OF THE INVENTION
The present invention relates to a surgical instrument for clamping and severing the umbilical cord of a newborn infant and a methods of constructing and utilizing such instrument. In particular, this invention relates to an instrument that first clamps and immediately afterwards cuts the umbilical cord all in one continuous action. The instrument can also be used to clamp and cut any artificial or natural deformable tube that is capable of being clamped and then severed, particularly tubes containing flowing fluid such as body fluid or water. Examples of such tubes are umbilical cords, infusion tubes, dialysis tubes, irrigation tubes, etc.
The umbilical cord is a flexible tube that connects the fetus to the placenta and contains two arteries and one vein that carry blood in and out between the fetus and the placenta.
A common method today for clamping the umbilical cord prior to cutting it is to use V shaped clamps. These clamps are fabricated from flexible material and comprise a pair of arms joined together at one end by an integral hinge-forming loop of substantial diameter. The free ends of the arms terminate in head portions that are normally spaced apart. The arms are movable towards each other by a compressive force. The head portions of the V clamps have means for locking the arms when pressed together thereby clamping the umbilical cord therebetween.
After an infant is born, the umbilical cord is clamped by a first V clamp as close as possible to the infant and then cut. In order to avoid blood squirting out of the open end of the cut cord another common method uses two V clamps. The second clamp is clamped about 5 centimeters towards the placenta and a pair of scissors is used to cut the cord between the clamps.
Another method is to use four V clamps, where the third clamp is placed about 10 centimeters from the second clamp and the fourth clamp is placed about 5 centimeters further towards the placenta. The umbilical cord is then cut twice, first between the first and second V clamps and then between the third and fourth clamps. This way a sausage like tube, of about 10 centimeters long, is formed containing infant's blood which is then used for testing.
The above described methods still have some disadvantages since they require precious seconds to clamp and cut the umbilical cord, seconds than may make the difference between a routine delivery or one complicated by serious lung problems.
Various devices and procedures have been developed to clamp and cut the umbilical cord.
U.S. Pat. No. 3,150,666 discloses a device for clamping one end of an umbilical cord and then applying an elastic band around the umbilical.
U.S. Pat. No. 3,166,071 discloses a device for simultaneously applying two spaced umbilical cord clamps and severing the umbilical cord there between.
U.S. Pat. No. 4,026,294 requires two actions, first to clamp and then open the scissors to move them, and then to cut.
U.S. Pat. Nos. 4,428,374 and No. 4,648,401 disclose simultaneously clamping and severing the umbilical cord. This simultaneous action is dangerous as previously explained.
U.S. Pat. Nos. 4,556,058, 4,469,346, 4,576,165 and 4,572,181 disclose devices that are not scissors shaped and their action is by means of a vertical movement which first clamps the umbilical cord and later severs it by moving a blade through the clamped cord. This procedure requires bringing the cord into the device manually with one hand and using the other hand to operate the instrument. In a scissors action, only one hand is needed and the other hand is free.
U.S. Pat. Nos. 4,716,886 and 4,938,215 do not use a scissors like instrument to clamp and sever the umbilical clamp. They use a shear pin between the two clamps that is severed by the blade as well, enabling the two clamps to separate. Such a shear pin is dangerous as it might break into smaller pieces endangering the infant.
U.S. Pat. No. 4,870,965 discloses a double upper handle, the first one to clamp the clamps and the second to eject the clamped umbilical cord from the device.
U.S. Pat. No. 5,009,657 also simultaneously clamps and severs the umbilical cord. A tab (
62
), formed on the central section of the clip, is used to release the clamps from the device after the cord is severed and not before the act of severing as suggested in this invention.
U.S. Pat. No. 5,127,915 discloses simultaneously clamping and severing the umbilical cord. The device disclosed therein allows release of the clamp immediately after the severance, again, not before the act of severing as invented in this invention.
U.S. Pat. Nos. 5,190,556, 5,415,665, 5,520,699 and 5,575,796 disclose instruments that are not scissors like, and their main objective is to collect the blood from the mothers end of the cord.
U.S. Pat. No. 5,462,555 also discloses an instrument that is not scissors like and that does not use handles to clamp and later sever the cord.
U.S. Pat. Nos. 5,584,840, 5,667,516 and 5,817,103 disclose instruments that are also not scissors like.
U.S. Pat. No. 5,676,672 of suggests a method to clamp and sever the umbilical cord using a tube like device, which does not resemble scissors.
U.S. Pat. No. 5,591,173 discloses a scissors like apparatus for clamping a compressible body prior to cutting it, such as an umbilical cord, which is different from the device of this invention.
The major problem with scissors-like devices is that there is always the risk that the cord will be severed before it is completely clamped and squashed. It is essential that first—the umbilical cord be safely clamped and only afterwards—that it be cut. Some instruments clamp and sever the umbilical cord simultaneously and this is very dangerous. If the clamps are not yet completely closed before the cutting action, blood will spurt out of the infant's side with all its consequences. In a worst case scenario, the umbilical cord will be cut before the clamps are completely closed and secured. In this case, the ends of the cord may slip out of the clamp leaving the severed cord open allowing blood to burst from the infant end. In the case of scissors-like devices, which have the V clamps mounted on the scissor jaws, the clamps can be completely closed, however, further movement of the handles on the other side of the pivot to completely close them is not possible. This inability to continue the movement of the handles after the clamps are securely closed prevents the clamping and severing of the cord in one continuous action.
The World Health Organization (WHO) has emphasized in it's three latest publications regarding childbirth (“Care in Normal Birth: a practical guide”, 1999; and “Essential Newborn Care, Report of a Technical Working Group (Trieste, 25-29 Apr. 1994)”; and “Care of the Umbilical Cord, A review of the evidence” 1999) that only after secure clamping of the umbilical cord has been completed, the cord should be cut.
It is a preferred object of the current invention, to provide a scissors like surgical instrument that will clamp the umbilical cord and sever it-near the clamp. By exerting pressure on the handles of the instrument two operations will be performed by the jaws at the other end of the pivot. The V clamp held in the jaws will clamp the cord securely closed and only afterwards will the blades cut the cord when xerting additional pressure on the handles. As stated before, it is essential that first the umbilical cord is safely clamped and only afterwards that it will be cut.
SUMMARY OF THE INVENTION
Our invention consists of a scissors like device onto which on the blades side is attached at least one clamp in a V shape, or two clamps in a V shape, one on each side of the scissors jaws. The V shaped clamps are fabricated of semi-rigid material and comprise a pair of arms joined together at the apex of the V by an integral hinge-forming loop of substantial diameter. The free ends of the arms are normally spaced apart and terminate in head portions. The head portions of the V clamps carry means for locking the arms together in the clamping po
Dennison Schultz Dougherty & MacDonald
Ramana Anuradha
Shaver Kevin
Starburst Technologies Limited
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