U.S. patent application number 09/740616 was filed with the patent office on 2002-01-03 for apparatus and method for collecting blood from an umbilical cord.
Invention is credited to Cole, Robert B., Gorton, Lanny A., Kuypers, Franciscus A., Meyst, Richard P., Wright, James I..
Application Number | 20020002355 09/740616 |
Document ID | / |
Family ID | 26689825 |
Filed Date | 2002-01-03 |
United States Patent
Application |
20020002355 |
Kind Code |
A1 |
Kuypers, Franciscus A. ; et
al. |
January 3, 2002 |
Apparatus and method for collecting blood from an umbilical
cord
Abstract
An apparatus and method for collecting a large volume of blood
from an umbilical cord in a sterile environment are shown and
described. A housing having an inner region adapted to retain an
umbilical cord in a desired location is provided, the housing
having an opening through which the cord extends from the inner
region of the housing to a region external to the housing. The cord
is cut by a blade coupled to the housing, either by the motion of
the blade from a first position to a second position, or by the
movement of two portions of the housing from a first extended
position to a second collapsed position. The newly cut end of the
umbilical cord falls and hangs freely in the inner region of the
housing, blood flowing from the placenta and umbilical cord via
gravity into a blood collection region of the housing. The blood
collection region may be flexible, and may be coupled to a
conventional blood collection bag.
Inventors: |
Kuypers, Franciscus A.; (El
Cerrito, CA) ; Cole, Robert B.; (Alamo, CA) ;
Meyst, Richard P.; (Valley Center, CA) ; Gorton,
Lanny A.; (San Diego, CA) ; Wright, James I.;
(Villa Park, CA) |
Correspondence
Address: |
SEED INTELLECTUAL PROPERTY LAW GROUP PLLC
701 FIFTH AVE
SUITE 6300
SEATTLE
WA
98104-7092
US
|
Family ID: |
26689825 |
Appl. No.: |
09/740616 |
Filed: |
December 18, 2000 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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09740616 |
Dec 18, 2000 |
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09310895 |
May 12, 1999 |
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6190368 |
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09310895 |
May 12, 1999 |
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08856252 |
May 14, 1997 |
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5993429 |
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08856252 |
May 14, 1997 |
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08742438 |
Oct 30, 1996 |
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5919176 |
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60017402 |
May 14, 1996 |
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Current U.S.
Class: |
604/317 ;
606/119; 606/120; 606/167 |
Current CPC
Class: |
A61B 5/150221 20130101;
A61B 5/150038 20130101; A61B 5/150755 20130101; A61M 2202/0462
20130101; A61B 5/150213 20130101; A61B 5/150068 20130101; A61M 1/02
20130101; A61B 5/150045 20130101; A61B 5/150366 20130101 |
Class at
Publication: |
604/317 ;
606/120; 606/119; 606/167 |
International
Class: |
A61M 001/00 |
Claims
1. An apparatus for collecting blood from an umbilical cord,
comprising: a housing having a channel in an inner region, the
housing having an opening in communication with the channel and in
communication with a region external to the housing, the umbilical
cord passing through the channel and extending through the opening;
a blade moveably coupled to the housing, the blade being positioned
to move from a first position, across the opening to a second
position, thereby cutting the umbilical cord extending through the
opening, the inner region of the housing engaging only a portion of
the umbilical cord such that an end of the umbilical cord hangs
freely in the inner region; and a blood collection region in fluid
communication with the inner region of the housing, such that blood
flows via gravity from the umbilical cord into the blood collection
region, the housing being substantially closed to the external
environment such that the blood from the umbilical cord is
collected in a substantially aseptic environment.
2. The apparatus according to claim 1 wherein the housing further
comprises a first piece and a second piece, the first and second
pieces engaging each other after the umbilical cord is placed
between the first and second pieces, thereby surrounding the
umbilical cord.
3. The apparatus according to claim 2 wherein the first and second
pieces are hingedly connected.
4. The apparatus according to claim 2 wherein a locking mechanism
is provided on the housing such that the first and second pieces
are lockingly engaged.
5. The apparatus according to claim 2 wherein the first and second
pieces are matingly engaged.
6. The apparatus according to claim 2 wherein the first and second
pieces are each formed from a rigid external shell, a resilient
channel wall, and a resilient, porous fill material provided
between the shell and the channel wall.
7. The apparatus according to claim 1, further comprising opposed
grooves provided in an outer surface of the housing adjacent to the
opening, the blade moving from the first position to the second
position by sliding in the grooves.
8. The apparatus according to claim 1, further comprising an
inflatable bladder positioned in the inner region of the housing
concentric with the channel, a volume of gas being provided to
inflate the bladder, such that an inner surface of the bladder is
adjacent to an outer surface of the umbilical cord.
9. The apparatus according to claim 8 wherein an adhesive is
provided on the inner surface of the bladder.
10. The apparatus according to claim 1, further comprising a
plurality of resilient projections provided on an inner wall of the
channel, the resilient projections grasping and holding the
umbilical cord in a desired location.
11. The apparatus according to claim 1, further comprising a
one-way valve positioned in the housing in fluid communication with
the inner region and the blood collection region.
12. The apparatus according to claim 1, further comprising a
resilient bloodbag coupled to the blood collection region of the
housing.
13. The apparatus according to claim 1 wherein the blood collection
region is flexible.
14. The apparatus according to claim 1, further comprising a
container coupled to the housing, the container receiving a
placenta and having an opening through which the umbilical cord
extends.
15. The apparatus according to claim 14, further comprising means
for compressing the placenta in the container.
16. The apparatus according to claim 14 wherein the container has a
cover which isolates an inner region of the container from the
environment external to the container.
17. The apparatus according to claim 1, further comprising an air
vent in the blood collection region, the vent being sized to allow
air to flow therethrough into and out of the blood collection
region as the blood flows into the blood collection region.
18. The apparatus according to claim 17 wherein the air vent
includes a selected vent material having pores sized to allow air
to flow therethrough while preventing blood to pass
therethrough.
19. The apparatus according to claim 18 wherein the selected
material is hydrophobic to repel liquid while allowing air to flow
therethrough.
20. The apparatus according to claim 1, further comprising a
positioning flange connected to one of the housing and blood
collection region, the positioning flange being shaped to support
the housing and blood collection region in one of a plurality of
selected positions with the air vent being unblocked by blood in
the blood collection region.
21. The apparatus according to claim 20 wherein the positioning
flange has a generally triangular shape with three lobe portions
and the air vent is substantially adjacent to one of the lobe
portions.
22. The apparatus according to claim 20 wherein the positioning
flange has a plurality of lobe portions projecting away from the
blood collection region and the air vent is substantially adjacent
to one of the lobe portions.
23. The apparatus according to claim 20 wherein the air vent is a
first air vent and further comprising second and third air vents in
the blood collection region, and the positioning flange has a
generally tri-lobular shape with three lobe portions spaced around
the blood collection region, each of first, second, and third air
vents are substantially adjacent to a respective one of the three
lobe portions.
24. The apparatus according to claim 1 wherein the blood collection
region has an outlet therein positioned to allow blood in the blood
collection region to flow out of the blood collection region, and
the air vent is shaped and sized to allow air to flow therethrough
into the blood collection region as the blood flows out of the
blood collection region.
25. An apparatus for collecting blood from an umbilical cord,
comprising: a housing having a first portion and a second portion,
the first and second portions being slideably moveable from a first
extended position to a second collapsed position; a blade coupled
to the first portion of the housing, the blade cutting an umbilical
cord held by the housing when the first and second portions are
slideably moved to the second collapsed position, the cut end of
the umbilical cord falling freely into an inner region of the
housing; and a blood collection region in fluid communication with
the inner region such that blood flows from the umbilical cord into
the blood collection region via gravity.
26. The apparatus according to claim 25 wherein an upper region of
the housing further comprises a first piece and a second piece, the
first and second pieces engaging each other after the umbilical
cord is placed between the first and second pieces, thereby
surrounding the umbilical cord.
27. The apparatus according to claim 26 wherein the first and
second pieces are hingedly connected.
28. The apparatus according to claim 26 wherein a locking mechanism
is provided on the housing such that the first and second pieces
are lockingly engaged.
29. The apparatus according to claim 26, further comprising a
locking mechanism that prevents the first and second portions from
being moved to the second collapsed position until the first and
second pieces are engaged, thereby preventing the user from being
exposed to the blade.
30. The apparatus according to claim 26 wherein the first and
second pieces are matingly engaged.
31. The apparatus according to claim 25, further comprising an
inflatable bladder positioned in the inner region of the housing
concentric to a channel extending longitudinally through an upper
region of the housing, a volume of gas being provided to inflate
the bladder such that an inner surface of the bladder is adjacent
to an outer surface of the umbilical cord extending through the
channel.
32. The apparatus according to claim 31 wherein an adhesive is
provided on the inner surface of the bladder.
33. The apparatus according to claim 31, further comprising a
plurality of resilient projections provided on an inner wall of the
channel adjacent to the inflatable bladder, the resilient
projections grasping and holding the umbilical cord in a desired
location.
34. The apparatus according to claim 25, further comprising a
plurality of resilient projections provided on an inner wall of a
channel extending through an upper region of the housing, the
resilient projections grasping and holding the umbilical cord in a
desired position.
35. The apparatus according to claim 25, further comprising a
one-way valve positioned in the housing in fluid communication with
the inner region and the blood collection region.
36. The apparatus according to claim 25, further comprising a
resilient bloodbag coupled to the blood collection region.
37. The apparatus according to claim 25, further comprising an
anticoagulant coating provided on an inner surface of the blood
collection region.
38. The apparatus according to claim 25, further comprising a
container, the container receiving a placenta and having an opening
through which the umbilical cord extends.
39. The apparatus according to claim 38, further comprising means
for compressing the placenta in the container
40. The apparatus according to claim 25, further comprising a
support coupled to the housing such that when the umbilical cord is
held by the housing, the cord is positioned between the blade and
the support.
41. The apparatus according to claim 25, further comprising an air
vent in communication with the inner region and the blood
collection region to vent the blood collection region and minimize
pressure differentials within the blood collecting region as the
blood flows into the blood collecting region.
42. The apparatus according to claim 25, further including a
positioning member connected to one of the housing and blood
collection region, the positioning member being shaped to support
the housing and blood collection region in one of a plurality of
selected positions with the air vent being unblocked by blood in
the blood collection region.
43. The apparatus according to claim 42 wherein the positioning
member is a flange having a generally triangular shape.
44. The apparatus of claim 42 wherein the positioning member has a
plurality of lobe portions projecting away from the one of the
housing and blood collection region and the air vent is
substantially adjacent to one of the lobe portions.
45. The apparatus of claim 25 wherein the air vent includes a
selected material having pores sized to allow air to flow
therethrough while preventing blood to pass therethrough.
46. The apparatus of claim 45 wherein the selected material is
hydrophobic to repel fluid while allowing air to flow
therethrough.
47. An apparatus for collecting blood from an umbilical cord,
comprising: a housing having a first portion and a second portion,
the first and second portions being slideably moveable from a first
extended position to a second collapsed position; a blade coupled
to the first portion of the housing, the blade cutting an umbilical
cord held by the housing when the first and second portions are
slideably moved to the second collapsed position, the cut end of
the umbilical cord falling freely into an inner region of the
housing; a blood collection region in fluid communication with the
inner region such that blood flows from the umbilical cord into the
blood collection region via gravity; an upper region of the housing
further comprises a first piece and a second piece, the first and
second pieces engaging each other after the umbilical cord is
placed between the first and second pieces, thereby surrounding the
umbilical cord, a locking mechanism being provided on the housing
such that the first and second pieces lockingly engage; an
inflatable bladder positioned in the inner region of the housing
concentric to a channel extending longitudinally through an upper
region of the housing, a volume of gas being provided to inflate
the bladder such that an inner surface of the bladder is adjacent
to an outer surface of the umbilical cord extending through the
channel; and a plurality of resilient projections provided on an
inner wall of the channel adjacent to the inflatable bladder, the
resilient projections grasping and holding the umbilical cord in a
desired location.
48. The apparatus according to claim 47, further comprising a
one-way valve positioned in the housing in fluid communication with
the inner region and the blood collection region.
49. The apparatus according to claim 47 wherein an adhesive is
provided on the inner surface of the bladder.
50. The apparatus according to claim 47, further comprising a
resilient bloodbag coupled to the blood collection region.
51. The apparatus according to claim 50 further comprising an
anticoagulant coating provided on an inner surface of the bloodbag
and the blood collection region.
52. The apparatus according to claim 47, further comprising a
container, the container receiving a placenta and having an opening
through which the umbilical cord extends.
53. The apparatus according to claim 47, further comprising a
locking mechanism that prevents the first and second portions from
being moved to the second collapsed position until the first and
second pieces are engaged, thereby preventing the user from being
exposed to the blade.
54. The apparatus according to claim 47, further comprising an air
vent in the blood collecting region, the vent being sized to allow
air to flow into and out of the blood collecting region as the
blood flows into the blood collection region.
55. The apparatus according to claim 54, further comprising a
positioning member connected to one of the housing and blood
collection region, the positioning member being shaped to support
the housing and blood collection region in one of a plurality of
selected positions with the air vent being unblocked by blood in
the blood collection region.
56. A method for collecting a volume of blood from an umbilical
cord in an aseptic environment, comprising: placing an umbilical
cord into a housing having an inner region adapted to receive the
cord; isolating the inner region of the housing from the external
environment; and cutting the umbilical cord such that the cut end
of the cord is positioned in the inner region of the housing and
blood flows from the cord into the inner region via gravity
57. The method according to claim 56, further comprising: placing a
placenta coupled to the umbilical cord into a container having an
opening through which the umbilical cord extends; and compressing
the placenta.
58. The method according to claim 56, further comprising passing
air through an air vent that communicates with the inner region to
minimize a pressure differential between the inner region and the
external environment.
59. The method of claim 58, further comprising the step of
positioning the housing on a selected support structure with the
air vent being unobstructed by the blood.
60. A method for collecting a volume of blood from an umbilical
cord in an aseptic environment, comprising: placing the umbilical
cord into a housing having a first portion and a second portion,
the first and second portions being slideably movable from a first
extended position to a second collapsed position, the first portion
further comprising a first piece and a second piece that engage
each other to surround the umbilical cord; closing the first and
second piece of the housing to surround the umbilical cord;
inflating a bladder positioned in an inner region of the housing
concentric to a channel extending longitudinally through an upper
region of the housing, such that the bladder comes into contact
with, and conforms to, an outer surface of the umbilical cord; and
sliding the first and second portions of the housing from the first
extended position to the second collapsed position, thereby cutting
the umbilical cord via a blade coupled to the housing, the cut end
of the umbilical cord falling freely into the inner region of the
housing, blood flowing via gravity from the umbilical cord into a
blood collection region
61. A method for collecting a volume of blood from an umbilical
cord in an aseptic environment, comprising: placing an umbilical
cord into a channel provided in an inner region of a housing, and
extending an end of the umbilical cord through an opening that is
in communication with the channel and is in communication with a
region external to the housing, such that the umbilical cord passes
through the channel and extends through the opening; closing a
first and second portion of the housing to surround the umbilical
cord; and sliding a blade movably coupled to the housing from a
first position, across the opening to a second position, thereby
cutting the umbilical cord, the cut end of the umbilical cord
falling freely into the inner region of the housing and blood
flowing from the umbilical cord via a gravity into a blood
collection region.
Description
CROSS-REFERENCE TO RELATED APPLICATION
[0001] This application claims the benefit of U.S. Provisional
Application No. 60/017,402, filed May 14, 1996. This application is
also a continuation-in-part of U.S. patent application Ser. No.
08/742,438, filed Oct. 30, 1996, which also claims the benefit of
U.S. Provisional Application No. 60/017,402, filed May 14,
1996.
TECHNICAL FIELD
[0002] 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
[0003] 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.
[0004] 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.
[0005] 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.
[0006] 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.
[0007] 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
[0008] 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.
[0009] 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.
[0010] 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.
BRIEF DESCRIPTION OF THE DRAWINGS
[0011] FIG. 1 is a cross-sectional front-elevational view of a cord
blood collection apparatus provided in accordance with a first
embodiment of the present invention prior illustrated prior to
cutting of the umbilical cord.
[0012] FIG. 2 is a cross-sectional front-elevational view of the
apparatus of FIG. 1 illustrated after the umbilical cord is
cut.
[0013] FIG. 3 is a cross-sectional front-elevational view of the
cord blood collection apparatus provided in accordance with an
embodiment of the present invention, incorporating the apparatus
illustrated in FIG. 2.
[0014] FIG. 4 is a top plan view of an element of the cord blood
collection apparatus illustrated in FIG. 3.
[0015] FIG. 5A is a cross-sectional plan view of the apparatus of
FIG. 1.
[0016] FIG. 5B is an enlarged view of a portion of the apparatus
illustrated in FIG. 5A.
[0017] FIG. 6 is a cross-sectional plan view showing an element of
the apparatus illustrated in FIG. 5A in an alternative
position.
[0018] FIG. 7 is a cross-sectional front-elevational view of a
portion of the apparatus illustrated in FIG. 1.
[0019] FIG. 8A is a cross-sectional plan view of the apparatus
illustrated in FIG. 7, without the cord present.
[0020] FIG. 8B is a cross-sectional plan view taken along the line
8-8 of FIG. 7.
[0021] FIG. 9 is a schematic illustration of a cutting blade of the
apparatus of FIG. 1 shown in a first position.
[0022] FIG. 10 is a cross-sectional plan view taken along line
10-10 of FIG. 1.
[0023] FIG. 11 is a cross-sectional elevational view taken along
line 11-11 of FIG. 1.
[0024] FIG. 12 is a cross-sectional plan view taken along line
12-12 of FIG. 1.
[0025] FIG. 13A is a front isometric view of a cord blood
collection apparatus provided in accordance with a preferred
embodiment of the present invention illustrated in a first, open
position.
[0026] FIG. 13B is an enlarged, side cross-sectional elevational
view of a portion of the apparatus of FIG. 13A.
[0027] FIG. 14 is a top plan view of the apparatus of FIG. 13
illustrated in a closed position.
[0028] FIG. 15 is a cross-sectional plan view of the apparatus of
FIG. 14.
[0029] FIG. 16 is a cross-sectional plan view of the apparatus of
FIG. 15 shown in a second position.
[0030] FIG. 17 is a schematic illustration of a preferred
embodiment of the present invention.
[0031] FIG. 18 is a front isometric view of a cord blood collection
apparatus provided in accordance with an alternate embodiment of
the present invention illustrated in the first, open position.
DETAILED DESCRIPTION OF THE INVENTION
[0032] There is a need in the art for an improved apparatus and
method for collecting cord blood from an umbilical cord. In
particular, it is desirable to harvest a large volume of fetal cord
blood in an aseptic environment. In addition, the delivery room is
a hectic environment with many tasks to be completed by the
obstetrician and other delivery room personnel. The environment is
also biologically diverse, with a variety of contaminants such as
maternal blood and urine present on the umbilical cord and in the
surrounding area. The device and method must therefore be simple to
use, allowing the medical personnel to quickly and efficiently
collect the umbilical cord blood in an aseptic manner An apparatus
100 and method provided in accordance with a preferred embodiment
of the present invention meet these needs.
[0033] Generally, the apparatus 100 includes a housing that can be
attached to the end of an umbilical cord after the cord has been
surgically detached from a baby after delivery. (After a baby is
delivered, the umbilical cord is clamped and the baby is usually
placed on the mother's abdomen. Typically, the cord is clamped with
two Kelly clamps or a plastic umbilical cord clamp, and the cord is
severed between the two clamps.) The housing contains a cutting
blade that cuts the end of the umbilical cord on the placental side
of the clamped cord. The cut, free end of the cord falls into a
desired position in the housing, such that blood in the umbilical
cord flows via gravity into a blood collection region in an aseptic
environment. So placed, the apparatus of the present invention
provides a barrier to prevent the movement of maternal blood,
urine, and other contaminating fluids from moving along the outside
of the umbilical cord into the collection region. The apparatus
also shields against splashed and airborne contaminants. It is then
possible for the obstetrician, once the housing has been put in
place, to massage the uterine fundus prior to the time of
disengagement of the placenta from the implantation site, to create
a maximum pressure head over the placenta to allow for maximum
volume of blood to move into the blood collection region. By
massaging the uterus, the placenta is squeezed, thereby increasing
the flow of blood out of the umbilical cord and into the blood
collection region.
[0034] The apparatus further comprises a placenta bowl that holds
the placenta for easy collection of cord blood and which further
includes means for compressing the placenta in order to maximize
the expulsion of blood through the umbilical cord. Together, the
placenta bowl and the housing form a system that allows umbilical
cord blood to be collected in an aseptic environment in a manner
that is more simple and efficient than prior techniques. This
system can readily be provided in the form of an aseptic kit by
providing pre-sterilized individual components in aseptic
enclosures, boxed for convenient storage. Such a kit would also
include a cleaning composition for use in cleaning the umbilical
cord in the region where it is placed into the housing of the
invention; such cleaning compositions are common in the medical
arts
[0035] The invention will be better understood by reference to the
figures which show a number of preferred embodiments of the
invention but which are not intended to be otherwise limiting. In
the figures, the same reference numbers are used throughout for
corresponding parts of the device.
[0036] FIG. 1 is a cross-sectional front-elevational view of a
blood collection apparatus provided in accordance with a first
embodiment of the present invention. The apparatus includes a
housing 100 formed from three parts, which can be separate from
each other or flexibly attached to each other, or can themselves be
formed from smaller separate parts. The three parts include two
retaining portions and a sleeve used to collect blood.
[0037] In the embodiment shown in FIG. 1, a first retaining portion
10 and a second retaining portion 20 engage each other and together
form a unified retainer 30 that engages umbilical cord 5. Unified
retainer 30 has an external surface 32 and an interior channel 40
having two openings 42 and 44 to an external environment
surrounding the unified retainer. The channel 40 is adapted to
firmly contact an umbilical cord 5 without occluding the flow of
blood through the umbilical cord. The length of the retaining
portions and thus of channel 40 are selected so that the umbilical
cord extends through and beyond both ends of channel 40. In a
preferred embodiment, channel 40 is pre-formed, in part, in one of
the retaining portions, so that the umbilical cord 5 is pushed
through the pre-formed part of the channel 40 prior to being
subject to the retaining action of the two retaining portions 10
and 20.
[0038] In use, a regular cord clamp 8 is placed on the umbilical
cord 5 prior to cutting the cord at the time of delivery. The
regular cord clamp is not part of the invention and can be any type
of clamp sufficient to stop umbilical cord blood flow and that will
allow placement of the cord into the device. After the cord is cut,
the end of umbilical cord 5 that is clamped by clamp 8 is placed
between the two retaining portions 10 and 20, and the two portions
are engaged so that the umbilical cord 5 is held inside channel 40.
The two openings 42 and 44 of channel 40 are respectively
designated the proximal opening 42 and the distal opening 44 to
show their orientation relative to the placenta coupled to the
cord. A sufficient length of cord 5 extends from distal opening 44
so that the remaining operations described below can be carried
out.
[0039] The third portion of the housing 100, namely, blood
collection sleeve 50, engages with a lower region 34 of unified
retainer 30 that surrounds distal opening 44 of channel 40 The
adjacent surfaces form a junction 60 between sleeve 50 and unified
retainer 30 A window 62 is present in the junction, the window
being formed from a slot or slots present in either or both of the
unified retainer 30 and sleeve 50. Window 62 is sized to permit
passage of umbilical cord 5 through the window, as shown in FIG.
1.
[0040] As further illustrated in FIG. 1, blood collection sleeve 50
comprises upper portion 52, which engages lower portion 34 of the
unified retainer 30, and lower portion 51. The upper portion 52
contains the blade assembly, and the lower portion 51 serves to
collect (or funnel, if attached to an external bag) the cord blood.
Sleeve upper portion 52 and sleeve lower portion 51 may be
different regions of a single integral blood collection sleeve 50
or may be two separate parts which are joined together to form
collection sleeve 50. By having the sleeve formed in two parts,
visibility and ease of assembly of the sleeve to the unified
retainer are improved.
[0041] A blade is located in one of the parts used to form housing
100. In the embodiment shown in FIG. 9, blade 70, having cutting
edge 72, is located in sleeve 50 adjacent to window 62. Blade 70 is
moveable and cuts umbilical cord 5 when moved in an upward
direction as shown in FIG. 1. When the blade is in an upward
position, blade 70 is positioned across window 62, thus isolating
the interior of sleeve 50 from the external environment.
[0042] As shown in FIG. 2, movement of the blade cuts the umbilical
cord for a second time, the first time being during delivery when
the umbilical cord is severed to separate the placenta from the
newborn so that original clamp 8 and a stump portion 5 of the
terminal region of umbilical cord 5 are removed from the end of the
umbilical cord. The end of the umbilical cord then fails freely and
hangs in an interior region 55 of sleeve 50, such that blood flows
into and collects in sleeve 50
[0043] Further components of the blood-collection system are shown
in FIG. 3. The housing 100 is similar to the housing shown in FIG.
2, but the sleeve 50 is adapted so that blood is collected in an
external blood collection bag 80 attached to the sleeve via tubing
82, rather than being retained in the sleeve itself
[0044] Collection bag 80 is a conventional blood-collection bag,
such as those distributed by Baxter, Fenwal Division, and is both
flexible and aseptic, Flexibility of the terminal collection point
of the blood collecting system is desired to prevent build up of
internal back pressure when blood flows into the system. Therefore,
if a large quantity of blood is collected solely in sleeve 50,
sleeve 50 is desirably resilient and expandable. If sleeve 50 is
formed from two separate parts, sleeve upper portion 52 and sleeve
lower portion 51, then at least sleeve lower portion 51 is
resilient and expandable. In a preferred embodiment, the sleeve
lower portion 51 is constructed of bloodbag material coated with
anticoagulant. If an expandable blood collection bag 80 is attached
to the end of sleeve 50, as shown in FIG. 3, then sleeve 50 can be
either resilient or rigid.
[0045] The housing 100 is attached to a proximal end of umbilical
cord 5 and is suspended by the umbilical cord from placenta 2. In a
preferred embodiment, as illustrated in FIG. 3, the placenta is
placed in a placenta bowl 90 that has a slot 92 which allows the
umbilical cord 5 to pass through but which is sufficiently small to
retain placenta 2. The slot extends from an edge of the container
90 to a gravitational low point of the container when the container
is in its normal operating position. This allows blood in the
placenta to flow under the influence of gravity into the umbilical
cord which extends through slot 92 on the bottom of bowl 90. In an
alternative embodiment, the slot 92 can be closed using slot
closure arm 98 as shown in FIG. 4, while still allowing the cord to
extend through the center of the container
[0046] The system of the invention provides easy collection of
placental blood under aseptic conditions, and it is possible to
collect blood from the placenta and umbilical cord directly into a
conventional blood-collection bag, which can then be sealed in the
normal fashion at the point of entry of blood into the bag. The
remaining portions of the system can then be discarded, thereby
reducing the chance of biological contamination.
[0047] In an alternative embodiment also illustrated in FIG. 3,
placenta bowl 90 has a cover 94 and contains an inflatable bladder
96 Inflation of bladder 96 places pressure on the placenta to both
increase the rate of blood flow and to insure that the placenta
drains substantially completely. It will be understood by one of
ordinary skill in the art that other mechanical means for placing
external pressure on the placenta, including, but not limited to,
hydraulic systems, manually operated systems such as levers and
screws, weights, and the like, can be used in place of the
inflatable bladder 96. The inflatable bladder is used in a
preferred embodiment, however, because it is relatively inexpensive
and easy to manufacture.
[0048] FIGS. 5A and 5B show one embodiment of the two retaining
portions 10 and 20 and one manner in which they can be joined
together. A latch 14 is present on portion 10 with a corresponding
catch 24 present on portion 20 Latch 14 and catch 24 engage each
other when the first and second retaining portions 10 and 20 are
placed together to form unified retainer 30 In a preferred
embodiment, the latches are irreversible under normal operating
conditions. This can be accomplished by having the latching
operation occur in an interior space so that the latch is not
accessible after closure for disengagement.
[0049] FIGS. 5A and 6 together show how a single apparatus can
accommodate umbilical cords of different sizes. A semi-circular
bushing 61 of resilient material, for example rubber, is present in
each of the two retaining portions 10 and 20 so that when the
retaining portions are brought together, the bushings form a
ring-like structure 63 with an opening 65 in its center which
defines channel 40 through which the umbilical cord extends. The
resiliency of the bushing material is selected so that the bushing
will not unduly compress the umbilical cord but will itself be
compressed by the umbilical cord. As a result, the channel 40
expands as shown in FIG. 6 when an umbilical cord is placed in the
channel. The resiliency is sufficient, however, so that close
contact is maintained between the resilient material and the
exterior surface of the umbilical cord, thus helping to prevent
contaminants from passing down the exterior surface of the cord
into the collected blood.
[0050] FIGS. 7 and 8 illustrate an alternative embodiment of the
invention in which the two retaining portions 10 and 20 are formed
from three materials, namely, a rigid external shell 16, a
resilient channel wall 18, and an absorbent fill material 17
positioned between the shell 16 and the channel wail 18. As can be
seen in a comparison of FIG. 8A (without cord present) and FIG. 8B
(with cord present), both the resilient fill material 17 and the
resilient channel wall 18 are pressed outward by the cord in order
to accommodate the cord without interrupting blood flow through the
cord In a preferred embodiment, by-pass channels 15 open in
resilient wall 18, thereby allowing excess blood on the exterior of
cord 5 to drain through channels 15 and be absorbed by resilient
fill material 17
[0051] The resilient channel wall 18 has projections 19 that
mechanically engage umbilical cord 5 and prevent it from being
accidentally withdrawn from the housing 100. In an alternative
embodiment, retention of the cord is further achieved by two short
small-gauge needles in the housing that puncture the cord upon
closure of the assembly.
[0052] FIGS. 9 and 11 show details of a blade assembly used to cut
off the distal end of cord 5. As discussed previously, a window is
formed at junction 60 between unified retainer 30 and sleeve 50. In
a preferred embodiment, one-half of the window 62 is formed in the
retainer 30 and the other half of the window is formed in sleeve
50. The window 62 can have a resilient seal 64 lining its interior
surface, of the same type shown in FIGS. 5A and 6. Blade 70 has a
cutting edge 72 and is located in opposed grooves 54 and 55 formed
in the walls of both sleeve 50 and unified retainer 30. The lower
portion of grooves 54 and 55 in sleeve 50 as aligned with
corresponding grooves in the unified retainer.
[0053] Sliding the blade in an upward direction causes cutting edge
72 to pass across window 62, thereby cutting the umbilical cord
extending through the window. As blade 70 moves upward, it also
extends across window 62, thereby isolating the interior of the
assembly from the external environment. The blade can be moved by a
handle 76 attached to blade 70 than extends beyond the grooves 54
and 55 In a preferred embodiment, a latching mechanism for the
handle 76 is provided in an interior region of the blade housing
such that once the blade 70 is moved upward, it cannot be moved
back to its original position The cutting edge can be recessed in a
wall, for example, of the sleeve, and not moved out of its recess
until the umbilical cord is in position to be cut.
[0054] A number of alternative embodiments can be used to cut the
umbilical cord. For example, it is possible to form the blade 70
from a wall of either the unified retainer or the sleeve 50 and to
provide a sliding engagement of the unified retainer and sleeve so
that engaging the two parts causes the blade to cut the umbilical
cord when the umbilical cord is positioned in a desired
location.
[0055] FIGS. 10-12 show three cross-sectional plan views taken
along lines 10-10, 11-11, and 12-12, respectively, of FIG. 1. In a
preferred embodiment, the two retaining portions 10 and 20 of
unified retainer 30 are held together by hinge 36 which acts to
register the location of the two parts to allow the two parts to be
easily assembled. However, other forms of registration, for
example, corresponding pins and holes, can be provided in the two
parts of the retainer.
[0056] In the cross-sectional view illustrated in FIG. 10, only the
two retaining portions 10 and 20 are visible. The channel 40 will
be formed from the two semi-circular grooves 40a and 40b present in
the retaining portions 10 and 20, respectively.
[0057] FIG. 11 is a cross-sectional view taken at the junction
between sleeve 50 and the unified retainer 30, but with unified
retainer 30 shown in an open position. When retaining portion 10 is
closed around hinge 36 to engage with retaining portion 20, grooves
54 and 55 in the external wall of retaining portion 10 come into
alignment with grooves 54 and 55 in the sleeve. Blade 70 can then
slide readily into the grooves on the upper retainer portion from
its normal position in the sleeve.
[0058] FIG. 12 is a cross-sectional view taken at a lower position
on sleeve 50, showing blade 70 in its normal resting position in
the wall of sleeve 50.
[0059] In a preferred alternative embodiment, as illustrated in
FIGS. 13-16, the blood collecting apparatus 102 is comprised of a
housing 104 having a first portion 106 and a second portion 108
that are slideabiy movable from a first extended position 110, as
illustrated in FIGS. 14 and 15, to a second collapsed position 112,
as illustrated in FIG. 16.
[0060] As illustrated in FIG. 13, an upper region 120 of the
housing 104 is comprised of a first piece 122 and a second piece
124 that engage each other to surround an umbilical cord 5 placed
in the housing In a preferred embodiment, the first and second
pieces 122 and 124 are coupled via a continuous hinge comprised of
a pliable, thin section of material extending longitudinally along
the intersection between the two pieces. There is therefore no seam
or gap to seal, thereby contributing to the aseptic characteristics
of the device.
[0061] In a preferred embodiment, an inflatable bladder 128 is
provided in the upper region of the housing, the bladder being
inflatable by the introduction of a volume of gas into the bladder.
This may be achieved in a variety of ways, for example, by
incorporating a pump into the side of the housing, or using a
manual squeeze bulb attached to a stem 105 which is in fluid
communication with the bladder. In operation, an umbilical cord 5
is positioned along the length of the upper region of the housing
between the first and second pieces 122 and 124, the end of the
cord extending through opening 107 to a region external to the
housing, as illustrated in FIG. 1-4. The first and second pieces
122 and 124 are closed around the cord, engaging each other to form
an integral housing, as illustrated in FIG. 14. The bladder 128 is
inflated to a selected pressure and then allowed to deflate to the
extent that an inner surface 130 of the bladder is in contact with
an outer surface of the umbilical cord, but the pressure from the
bladder does not occlude the flow of blood through the cord.
Because the bladder is flexible, it conforms to the diameter and
irregular surface of the cord, creating a biological barrier to
prevent maternal blood and other contaminants from flowing down the
length of the cord into the collected blood. To further enhance the
biological barrier and ensure that the bladder stays in contact
with the cord as the pressure in the cord reduces, an adhesive is
provided on the inner surface 130 of the bladder. In a preferred
embodiment, a water-based adhesive is used. It will be understood,
however, that other adhesives, such as solvent-based adhesives,
two-part epoxy adhesives, and cyanoacrylate adhesives may be used.
In a preferred embodiment, the section of cord enclosed by the
bladder in the upper region of the housing is first wiped with
alcohol and then dried, prior to being inserted into the
housing.
[0062] The apparatus 102 is further provided with a plurality of
projections 132 provided in an inner region 114 of the housing
adjacent the bladder, the projections 132 grasping the cord and
holding it in a desired location. The projections 132 are flexible
enough to conform to the outer diameter of the cord without
constricting the flow of blood through the cord. However, the
projections 132 are also sufficiently rigid to keep the cord from
sliding. The projections 132 are further configured to accommodate
and grasp cords of various diameters, without constricting the flow
of blood. As illustrated in FIGS. 15 and 16, each of the
projections 132 has a slightly tapered thickness.
[0063] As illustrated in FIG. 14, a blade 116 is coupled to the
first portion 106 of the housing, such that when the first portion
106 and second portion 108 are moved to the second collapsed
position 112, the blade 116 cuts the umbilical cord 5 extending
through opening 107. In a preferred embodiment, a standard
double-bevel, mini-utility blade, such as those sold by American
Safety Razor Company, is used. As a result, the newly cut end of
the umbilical cord falls and hangs freely in the inner region 114
of the housing, as illustrated in FIG. 16. In a preferred
embodiment, as illustrated in FIGS. 13 and 13A, a support 113 is
coupled to bracket 111 behind the umbilical cord 5, relative to the
blade 116. Support 113 is made of an elastomeric material, such as
C-Flex, Kraton, or other synthetic rubber. As illustrated in FIG.
13A, the blade 116 cuts through the cord 5, and through a bottom
section of the support 113. In this manner, the blade cuts cleanly
and completely through the cord.
[0064] Once cut, blood from the placenta and umbilical cord is then
free to flow via gravity through one-way valve 134 into blood
collection region 118. The one-way valve 134 helps prevent the
collected blood from contacting the exterior of the umbilical cord,
and reduces the chance of leakage of the collected blood. In a
preferred embodiment, an interior surface of the one-way valve 134
and blood collection region 118 is covered with a conventional
anticoagulant, such as a heparin coating. A conventional blood bag
containing anticoagulant is coupled to the blood collection region
118 via conventional tubing coupled to the septum 109.
[0065] As illustrated in FIGS. 15 and 16, a locking mechanism 126
and corresponding locking holes 127 are provided in a side region
of the housing, such that when the first and second portions of the
housing are moved to the second collapsed position 112, the locking
mechanism 126 engages holes 127, thereby preventing the device from
being inadvertently opened Prior to being attached to a cord, the
tabs 111 are positioned in aperture 113 When the first and second
pieces 122 and 124 are closed, the tabs 111 are depressed, thereby
allowing the second portion 108 of the housing to slide towards the
first portion 106. The first and second portions 106 and 108 cannot
be slid together, which would expose the blade, until the first and
second pieces 122 and 124 are engaged. The blade therefore is never
exposed to the user, thereby reducing the risk of accidental cuts.
In an alternative embodiment, the apparatus 102 is provided with
ratchets so that the mechanism can move in only a single direction,
preventing the device from being collapsed part way, thereby
partially cutting the cord, and then accidentally re-extended
[0066] In an alternate embodiment illustrated in FIG. 18, the blood
collection region 118 of the housing's first portion 106 has a
proximal end portion 142, and microporous air vents 140 are
provided in the proximal end portion. The air vents 140 communicate
with the blood collection region's interior area to allow air to
flow into or out of the interior area during use of the blood
collecting apparatus 102. This air flow facilitates the blood flow
into and out of the blood collection apparatus during a collection
and draining process.
[0067] If the blood flow from the umbilical cord filling the blood
collection region 118 is greater than the ability of the blood
collecting apparatus 102 to drain into, as an example, a blood
collection bag, an increased pressure can occur within the blood
collection region that may reduce the blood flow rate into the
blood collection region, thereby slowing the blood collection
process. If the increased pressure in the blood collection region
118 is too high relative to the cord blood pressure, the blood flow
from the umbilical cord will be slowed. Accordingly, the air vents
140 minimize the pressure differential within the blood collection
region 118 by allowing air to exit the blood collection region as
the blood is collected in the blood collection region.
[0068] The air vents 140 also minimize negative pressures in the
blood collecting region 118 that may occur as the blood flows out
of the blood collecting region and into a blood bag or other
secondary blood collection container. Accordingly, the air vents
140 allow the blood to be quickly drained into the blood collection
bag to minimize the overall time required to collect and process
the umbilical cord and placenta blood.
[0069] The air vents 140 are positioned distally from the housing's
second portion 108, which contains the cutting blade 116, the
projections 132 and the bladder 128. The air vents 140 provides an
air passageway therethrough so that air flow is minimized through
other portions of the blood collection device. Air flowing
primarily through the blood collection device's second portion 108
and around, as an example the cutting blade 116, the projections
132 and the bladder could be contaminated. Such contaminated air
could contaminate the collected blood. Accordingly, the air vents
140 reduce the risk of the air that passes into the blood
collection chamber 118 from being contaminated and helps keep the
collected blood as aseptic as possible.
[0070] The micro-porous air vents 140 of the illustrated alternate
embodiment are made from a porous plastic material that allows air
to flow out of and into the blood collection region 118 as needed
as blood enters and exists the blood collection region,
respectively. The preferred porous plastic is also hydrophobic so
as to repel liquids, and particularly blood, while allowing air and
other gases to pass therethrough. At the operating pressures within
the blood collection region 118, the porous plastic is leak proof
to prevent loss of any blood through the air vents 140. The pore
size within the porous plastic is sufficiently large to allow a
free flow of air through the air vents 140 while being small enough
to substantially prevent airborne organisms from passing through
the air vent which could contaminate the collected blood.
[0071] In the illustrated alternate embodiment, the blood
collecting apparatus's housing 104 has generally
triangularly-shaped flanges 144 attached to the first and second
portions 106 and 108. When the first and second portions 106 and
108 are in the first position, the flanges 144 are spaced apart
from each other, and when the first and second portions are slid
together in the collapsed position, the flange portions are
adjacent to each other The flanges 144 are shaped such that when
the blood collection apparatus 102 is set on a table or other
support surface, the apparatus will be positioned in one of three
orientations as defined by the triangular-shaped flanges.
[0072] The flanges 144 each have three lobe portions 146 projecting
away from the respective first or second portion 106 or 108 The air
vents 140 on the blood collecting region's proximal portion are
each positioned generally adjacent to a respective lobe portion 146
At least one air vent 140 is always positioned so it faces upwardly
when the blood collection apparatus is set on a generally
horizontal support surface. Accordingly, at least one of the air
vents 140 is kept clear and not coated by the blood in the blood
collection region 118, thereby ensuring proper air flow through the
air vent to minimize any pressure differentials within the blood
collection region.
[0073] In one alternate embodiment, three air vents 140 are
provided in the housing's first portion 106, and each air vent is
adjacent to a respective one of the lobe portions 146. In an
alternate embodiment, two air vents 140 are positioned on opposite
sides of the blood collecting region 118 in a position that ensures
at least one air vent is kept clear when the blood collection
apparatus 102 is in any one of the three orientations. Other
configurations and positioning of the air vents 140 and flanges 144
can be provided so as to ensure that at least one air vent is
always kept clear from being coated by blood or the like during
operation.
[0074] The exterior surface of the housing is ribbed, allowing the
user to grasp it firmly. As the first and second portions are
collapsed together, the opening 107 is closed, thereby maintaining
the aseptic condition, and allowing the volume of blood to be
collected in an aseptic environment. A large quantity of blood may
therefore be collected from an umbilical cord in an aseptic manner
using an apparatus provided in accordance with a preferred
embodiment of the present invention, by placing an umbilical cord 5
into a housing having an inner region adapted to receive the cord,
step 135. The inner region of the housing is isolated from the
external environment, step 136, thereby allowing the collection to
proceed in an aseptic environment. The umbilical cord is cut such
that the cut end of the cord is positioned in the inner region of
the housing adjacent a blood collection region, step 137, and blood
flows from the cord into the blood collection region via gravity.
To maximize the volume of blood collected, the placenta coupled to
the umbilical cord is placed in a container having an opening
through which the umbilical cord extends, step 138, and the
placenta is compressed, step 139
[0075] An apparatus and method for collecting blood from an
umbilical cord has been shown and described. From the foregoing, it
will be appreciated that although embodiments of the invention have
been described herein for purposes of illustration, various
modifications may be made without deviating from the spirit of the
invention. Thus, the present invention is not limited to the
embodiments described herein, but rather is described by the claims
that follow.
* * * * *