Surgery – Means and methods for collecting body fluids or waste material
Reexamination Certificate
2000-12-18
2002-08-27
Jackson, Gary (Department: 3731)
Surgery
Means and methods for collecting body fluids or waste material
C606S120000, C606S167000, C606S119000
Reexamination Certificate
active
06440110
ABSTRACT:
TECHNICAL FIELD
This invention is directed to an apparatus and method for collecting blood from an umbilical cord after delivery of a baby.
BACKGROUND OF THE INVENTION
Fetal blood is a source of numerous blood factors that have important commercial and therapeutic uses in a number of different fields, such as tissue culture, bone marrow transplantation, stem cell collection, pharmacology, and biologic research. While this need for fetal blood factors can be met for some purposes with non-human fetal blood (e.g., fetal calf serum is a common component of growth media used for mammalian cell cultures), some applications require the use of human fetal blood, principally due to biocompatability with the human immune system.
For example, although aggressive anti-cancer treatments systematically kill tumor cells, they also destroy blood-forming cells, namely, stem cells. Cancer patients undergoing aggressive therapy therefore require an infusion of stem cells to reconstitute their blood and immune system. Traditionally, bone marrow was thought to be the best source of stem cells, and gave rise to bone marrow transplantation. More recently, blood extracted from umbilical cords immediately following a child's birth has been identified as a rich and readily accessible source of stem cells.
Currently, the sole commercial source of human fetal blood is blood obtained from the placenta and umbilical cord of newborns after delivery. This blood is often referred to as “cord blood,” as it is typically obtained by draining the placenta and umbilical cord through the severed umbilical cord after delivery.
At the present time, cord blood is typically collected by draining blood from a placenta into an open container by “milking” the umbilical cord. This rather crude procedure has several disadvantages in that it is awkward to perform and it is difficult to control the sterility of the collected cord blood. In another currently available method, blood is collected from the umbilical cord vein via a conventional large-gauge needle and syringe, although this procedure is also awkward to perform and exposes the medical personnel to potential needle sticks.
Accordingly, there is a need in the art for an improved apparatus and method for maximizing a volume of cord blood collected from an umbilical cord, in an aseptic manner, and in particular, a method and apparatus that are more simple and efficient to use. The present invention fulfills these needs, and provides further related advantages.
SUMMARY OF THE INVENTION
Briefly, the present invention provides an improved method and apparatus for collecting a large volume of blood from an umbilical cord, in an aseptic environment. In a preferred embodiment, a housing is provided, having a channel extending longitudinally through an upper, internal region of the housing, and an opening in communication with the channel and a region external to the housing. In use, shortly after the delivery of a baby and severing of the umbilical cord, the clamped, severed umbilical cord is placed in the housing such that it passes through the channel and extends through the opening. In a first embodiment, a blade is movably coupled to the housing, the blade moving from a first position, across the opening to a second position, thereby cutting the umbilical cord which extends through the opening. The inner region of the housing engages only a portion of the umbilical cord in the housing, such that the newly cut end of the umbilical cord falls and hangs freely in the inner region, blood flowing from the umbilical cord via gravity into a blood collection region of the housing. The housing is substantially closed to the external environment, and the blood is therefore collected in a substantially aseptic environment.
In a preferred, alternative embodiment, the housing is comprised of a first portion coupled to a second portion which slideably move from a first extended position to a second collapsed position. A blade is provided on one portion of the housing, such that as the two portions are moved to the second collapsed position, the blade cuts an umbilical cord held by the housing. The newly cut end of the umbilical cord falls freely into an inner region of the housing, and blood flows from the cord via gravity into a blood collection region.
To maximize the volume of blood collected from the umbilical cord, a container is provided to receive the placenta, the container having an opening in a bottom surface to allow the umbilical cord to pass through the bottom surface of the container. In a preferred embodiment, an inflatable bladder or other means for compressing the placenta is provided, thereby forcing blood to flow from the placenta into the umbilical cord, and in turn into the blood collection region. In a preferred embodiment, a conventional blood collection bag is coupled to the housing, in fluid communication with the blood collection region, such that the blood is collected in a container in which the blood may be stored or transferred for further processing.
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Cole Robert B.
Gorton Lanny A.
Kuypers Franciscus A.
Meyst Richard P.
Wright James I.
Children's Hospital Medical Center of Northern California
Jackson Gary
Seed Intellectual Property Law Group PLLC
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