Surgery – Instruments – Obstetric or gynecological instruments
Reexamination Certificate
2001-10-16
2003-10-28
Milano, Michael J. (Department: 3731)
Surgery
Instruments
Obstetric or gynecological instruments
C606S157000
Reexamination Certificate
active
06638282
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
This invention relates broadly to umbilical cord clamps. More particularly, this invention relates to a device that simultaneously severs and clamps an umbilical cord.
2. State of the Art
The umbilical cord serves as the conduit between a mother and a fetus developing in the womb of the mother. Nutrients and oxygen within the blood of the mother pass through the umbilical cord to the fetus. Immediately after a baby is born, the umbilical cord must be clamped to stop the flow of blood therethrough and the cord must then be severed to separate the baby from the placenta. For many years, this procedure utilized two separate clamps to clamp the cord, and a scalpel to cut the cord between the clamps.
Over the past thirty years, a number of devices have been proposed for both clamping and cutting the cord in an abbreviated procedure, although few of them have been used commercially. For example, U.S. Pat. No. 3,323,208 to Hurley, Jr. shows an umbilical cord clamping device which includes two clamps held in side-by-side positioning by pins on one clamp which frictionally fit into holes on an abutting edge of the other clamp. A blade is positioned between the clamps and cuts the cord as the clamps are closed on the cord. However, the clamping jaws are the only mechanism securing the device to the cord, and are also the only mechanism restricting the blood flow pathway of the cord.
U.S. Pat. No. 4,807,622 to Ohkaka et al. shows a tube cutting and separating implement for severing a conduit (e.g. medical tubing). The patent discloses a grasping body having two sections integrally formed at a severable interior end and each section having an outside end which is flexible and curves and projects upward and inward toward the other outside end. Holding portions secure a tubing along a longitudinal axis of the grasping body. A blade is attached to one of the outside ends of the grasping body. When the outside ends of the grasping body are squeezed or otherwise directed toward the inside ends, flow restricting portions pinch off the tubing, and the blade first severs the tubing and then severs the interior ends of the integrally formed sections of the grasping body. A latching mechanism secures the ends of the grasping body. The device has a few drawbacks. First, the device does not adequately clamp the tubing to restrict fluid flow. Second, it requires enormous strength to puncture through both the tubing and the grasping body. Third, directing the blade through the grasping body in order to separate the sections further exposes the operator to injury due to potential contact with the blade.
U.S. Pat. No. 4,781,188 to Collins discloses an umbilical cord clamping and cutting device that includes two spaced apart clamps positioned within a clamping applicator. Closing the applicator simultaneously closes the two clamps. A blade is attached to one arm of the applicator, such that when the clamps are simultaneously closed on the cord, the blade automatically cuts the cord. The applicator is then opened and separated from the clamps which remain closed over the severed ends of the cord. The device requires an applicator and uses a relatively large number of parts.
U.S. Pat. No. 4,856,517 to Collins et al. discloses a similar device that includes two clamps positioned within an applicator. The clamps are locked in a closed position about an umbilical cord by a latch. A knob having a blade is fitted within a slot in the applicator and is manually moved forward to sever the cord with the blade. When the knob reaches the end of the slot, the latch is engaged and released by the knob to allow the opening and removal of the applicator, leaving the clamps fixed around the umbilical cord. The device requires two steps to operate; first, clamping the cord and, second, moving the blade. Furthermore, the device requires an applicator and has a relatively large number of parts, making manufacture of the device relatively expensive.
Each of the above patents pose serious drawbacks in their use and manufacture. First, as discussed above, many require the use of multiple steps, and/or are difficult to operate, and/or require the breaking frangible connections, and/or require the use of application devices. Second, the devices tend to have a large number of parts, making their manufacture expensive and complex. Third, the devices fail to securely grip the cord prior to cutting. Fourth, the devices further fail to securely hold the cut ends of the umbilical cord. As such, the cut ends of the umbilical cord may come loose or drip blood.
Co-owned U.S. Pat. Nos. 5,584,840 and 5,913,862 both to Ramsey et al. propose a solution to the shortcomings of previous devices. Both patents to Ramsey et al. disclose a device including two clamps friction fit in a side-by-side abutting relation, with a blade coupled between the clamps. Each clamp includes a molded outer guard. Using only two fingers, a practitioner may bring the arms of the clamps toward each other, such that the guards enclose and hold fast a section of umbilical cord, the blade projects into a space between the two clamps severing the cord, and interior serrated surfaces of the clamps provide clamping action. After the cord is clamped and severed, the two clamps may be easily separated using the same hand which operated to close the device, with one clamp remaining on the umbilical cord of the infant and the second clamp with blade attached being discarded along with the placenta. The Ramsey et al. devices are not only easy to operate, but are very easy and inexpensive to manufacture as they comprise only two molded clamps and an integrally positioned blade.
Though the devices of Ramsey et al. offer significant improvements over the prior art, clinical tests suggest that it is desirable to more effectively hold the umbilical cord prior to cutting and as well as to further limit potential blood splatter when cutting the cord.
SUMMARY OF THE INVENTION
It is therefore an object of the invention to provide an umbilical cord cutting and clamping device which is easy to operate and which cuts and clamps in a single motion.
It is another object of the invention to provide an umbilical cord cutting and clamping device which stably and securely holds the umbilical cord prior to complete cutting.
It is a further object of the invention to provide an umbilical cord cutting and clamping device which stably holds the cut ends of the umbilical cord.
It is an additional object of the invention is to provide an umbilical cord cutting and clamping device which reduces blood splatter.
It is yet another object of the invention to provide an umbilical cord cutting and clamping device which has absorbent surfaces.
It is yet a further object of the invention to provide an umbilical cord cutting and clamping device which is easy to manufacture.
In accord with these objects, which will be discussed in detail below, an umbilical cord cutting and clamping device includes first and second clamps each having an upper arm and a lower arm, and a cutting blade attached adjacent a medial side of one of the first and second clamps. According to the invention, the upper arms of the first and second clamps are each provided with an upper clamping surface, and a directing member having a deformable upper cord gripping surface. The lower arms of the first and second clamps are each provided with a lower clamping surface, and a lower cord gripping surface. The clamping surfaces function to occlude the flow of blood through cut ends of the cord after the cord is cut by the blade, while the cord gripping surfaces function to prevent cord slippage prior to clamping by the clamping surfaces.
According to one embodiment, the cord gripping surfaces include a compressible foam. According to another embodiment, the cord gripping surfaces of the upper arms include resilient strips provided with teeth, and the cord gripping surfaces of the lower arms includes mating teeth.
Additional objects and advantages of the invention will become apparent to those
Cocke David
Price Bret
Puchek Daniel R.
Ramsey James
Cetus, LC
Gordon & Jacobson P.C.
Milano Michael J.
Pantuck Bradford C
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