Surgery – Instruments – Obstetric or gynecological instruments
Reexamination Certificate
2000-08-18
2002-02-19
Robert, Eduardo C. (Department: 3732)
Surgery
Instruments
Obstetric or gynecological instruments
Reexamination Certificate
active
06348057
ABSTRACT:
FIELD OF THE INVENTION
The present invention relates to a novel umbilical cord clamp and cutter, more particularly to a double clamp with an integral blade for first simultaneously clamping two locations on an umbilical cord and then cutting the cord in one simple action.
BACKGROUND OF THE INVENTION
The process of severing the umbilical cord during the birthing process is a crucial step in separating between the mother and child. Dangers involve possibilities of bleeding, infection and injury by the blade to the infant. In this process the time element is essential.
Current practice involves a three-step process involving the placing of two individual clamps on the umbilical cord at a distance from each other and then cutting between the two clamps. This is a relatively long process and usually requires more than one person to be involved. Additionally, cutting the cord at an indeterminate distance between the two clamps leaves an edge of the cord past the clamp, which is a site prime for infection. The gloved hands applying the clamps on a slippery cord require that the clamps must grasp the cord in a non-slip manner.
There have been a few attempts to make an integrated double clamp and cutter device, most of which have not been found practical enough to come into common use. Those which have actually reached the market are still relatively complicated and difficult to use, and do not necessarily have the safety precautions necessary.
Prior art U.S. Pat. Nos. 5,584,840 and 5,913,862 to Ramsey et al. disclose an umbilical cord cutting and clamping device that includes two clamps held together in a frictional engagement and an integrated blade. The clamp is larger than a standard clamp and different in its operation, such that the user must be trained in its use. As the clamp is closed the blade simultaneously cuts the cord. Because the blade is engaged before the clamp is closed there is a danger that the cut cord will slip out of the clamp. The clamp creates a loop that presses on the cord in such a way that it causes a bend in the cord resulting in additional tissue protruding from the clamp. This is an opening for infection. Additionally, this loop may cause dangerous pulling on the infant's navel. Once the clamp has been closed, the infant-side clamp must then be freed by separating pins from the device, thus requiring an additional complicating step. The device is awkward to use, as it is large and the opening for inserting the cord is narrow. The Ramsey device engages the blade simultaneously with the closing of the clamps, thereby increasing the danger of bleeding.
An additional danger inherent in the prior art double clamps is that there is no clear indication as to how to place the device so that the blade does not end up on the clamp which remains attached to the infant, but rather remains on the mother's side of the cord for discarding with the placenta.
Prior art U.S. Pat. No. 4,781,188 to Collins also discloses an umbilical cord cutting and clamping device that includes two clamps and an integrated blade. The Collins device also engages the blade simultaneously with the closing of the clamps, thereby increasing the danger of bleeding. The device is unwieldly in that it is comprised of multiple parts, which must be separated in a separate step after cutting. The user must be instructed in its use, as it is not similar to the commonly used clamps. The blade cuts the cord in such a way as to leave a significant amount of tissue after the clamp, inviting infection.
U.S. Pat. No. 4,428,374 to Auburn and U.S. Pat. No. 4,026,294 to Mattler disclose awkward solutions to this problem. These devices are equipped with scissor-type handles and require instruction as to their use. Additionally, the Mattler device has a pin which must be removed to separate the clamps, adding another action to an already complicated device (similarly, U.S. Pat. Nos. 5,997,548 and 4,870,965 to Jaahanger).
U.S. Pat. No. 4,716,886 to Schulman discloses a device which is complicated to use and in which an inexperienced user may cut the cord without closing the clamps (similarly, U.S. Pat. No. 4,938,216, also to Schulman and U.S. Pat. No. 5,667,516 to Allen).
U.S. Pat. No. 5,462,555 to Bolanos presents a different approach to an umbilical cord clamp and cutter that comes flat and is folded around the cord. This is large and very complicated to use.
Many of the prior art constructions are larger than a conventional clamp, thus incurring the expense of additional material. Additionally, they are constructed having a number of parts thereby making them difficult to use and dissimilar from the conventional clamp. This makes them undesirable for hospital use, for fear of misuse. (See also U.S. Pat. Nos. 5,190,556 and 5,520,699 to Hessel, U.S. Pat. No. 5,575,795 to Andersen, U.S. Pat. No. 4,856,517 to Collins and U.S. Pat. No. 5,676,672 to Watson et al.)
Therefore, it would be desirable to provide an economical double clamp that is easily assembled from two parts, closes and separates in an easy one-handed motion, first clamping the cord and then cutting through the cord without leaving a significant amount of tissue after the clamp.
SUMMARY OF THE INVENTION
Accordingly, it is a broad object of the present invention to overcome the problems of the prior art and provide an umbilical cord clamp and cutter assembly featuring simple one-handed cutting and clamping motion, to leave minimal tissue after the clamp so as to minimize the opportunity for infection.
In accordance with a preferred embodiment of the present invention, there is provided an umbilical cord clamp and cutter assembly comprising:
a first clamp comprising a first upper arm, a first lower arm, a first flexible region and a first closing mechanism for attaching to the infant side of an umbilical cord;
a second clamp comprising a second upper arm, a second lower arm, a second flexible region and a second closing mechanism for attaching to the placental side of the umbilical cord, the first and second clamps being connected in a side-by-side relationship and having between them at least one connecting strip; and
an outer housing comprising a third upper arm, a third lower arm, a third flexible region and a third closing mechanism, and having perpendicularly attached to the third upper arm, a cutting device extending downwardly in the direction of the third lower arm, the outer housing being formed so as to enclose the first and second clamps,
such that upon closing the housing, the first and second clamps close around the umbilical cord, the cutting device cuts through the cord and the at least one connecting strip, and the second clamp remains enclosed by the housing, while the first clamp becomes separated from the second clamp, housing and cutting device.
Additionally, there is provided a method of clamping and cutting and umbilical cord, the method comprising the steps of:
providing an umbilical cord clamp and cutter assembly, comprising:
a first clamp comprising a first upper arm, a first lower arm, a first flexible region and a first closing mechanism for attaching to the infant side of an umbilical cord;
a second clamp comprising a second upper arm, a second lower arm, a second flexible region and a second closing mechanism for attaching to the placental side of an umbilical cord, the first and second clamps being connected in a side-by-side relationship and having between them at least one connecting strip; and
an outer housing comprising a third upper arm, a third lower arm, a third flexible region and a third closing mechanism, and having perpendicularly attached to the third upper arm, a cutting device extending downwardly in the direction of the third lower arm, the outer housing being formed so as to enclose the first and second clamps;
inserting an umbilical cord into the umbilical cord clamp and cutter assembly; and
pressing upon the upper arm of the housing in a closing motion, such that in a first part of said closing motion the first and second clamps are closed, and in a continuation of said closing motion the cutti
Edward Langer, Pat. Atty.
Kencap Ltd.
Robert Eduardo C.
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