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Description  |
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BACKGROUND OF THE INVENTION
1. Field of the Invention
This invention relates to a clamping and cutting mechanism, particularly a
mechanism for clamping an umbilical cord at two spaced points, cutting the
cord between the two clamp points, and partially unclamping one of the
severed cord sections so that blood samples can be taken.
2. Prior Developments
In the practice of delivering a newborn infant it is necessary to sever the
umbilical cord, i.e. a tubular membrane containing the arteries and vein
which supply oxygen and nutrient enriched blood from the mother to the
fetus and which carries waste products from the fetus back to the mother.
As blood flows through the umbilical cord,it is essential that the cord be
sealed on both sides of where it is to be severed before any cutting takes
place. The conventional method to clamp and cut the umbilical cord is a
four step procedure. To accomplish this task the doctor must clamp one
hemostat (a locking scissors like instrument) onto the umbilical cord,
obtain another hemostat and clamp it on the cord a few inches away. After
the two clamps are set, the doctor obtains a pair of scissors and warns
the staff that he/she is about to cut so that they can avoid being sprayed
by blood. The doctor then cuts the cord between the two clamps with a pair
of scissors.
When the two hemostats are locked onto the cord, a bubble of blood forms in
the segment of cord between the two clamps. When this segment is cut,
blood tends to spray and often strikes the medical staff. Clamping and
cutting the umbilical cord by the conventional method while trying to hold
a slippery squirming infant in gloved hands can prove to be a challenge.
If the infant has any abnormalities or health problems, the procedural
difficulties are magnified, making speed and efficiency critical.
After the cord has been cut the number of arteries and veins in the cord
are counted, and blood samples are obtained from the mother's end of the
cord. In order to count the number of arteries and veins the doctor simply
looks at the free end of the cord. If the end of the cord does not have a
clean cut, it is sometimes necessary to make another cut in the cord in
order to get a better view. The blood sample is obtained from the cord by
placing a test tube in alignment with the free end of the cord and opening
the hemostat enough to allow blood to flow into the test tube. During this
procedure blood often sprays on the medical staff due to the cord slipping
out of the jaws of the hemostat or by mis-direction of the artery when the
hemostat jaws are opened. After enough blood is obtained, the hemostat is
reclamped. The hemostat stays attached to the umbilical cord until after
the placenta is extracted from the mother. The hemostat on the infant end
of the umbilical cord is replaced by a disposable plastic clamp which
stays with the baby until the umbilical cord falls off.
It is the object of the present invention to speed up the clamping and
cutting procedure in order to provide the doctor with more time to focus
on and administer to the needs of the patients and to protect the medical
staff from blood transmitted disease such as H.I.V. and Hepatitis. The
present invention includes a clamp section system design so that when it
is compressed around the umbilical cord the cord is clamped in two places;
both clamps are locked closed before any cutting takes place, and the
blood is squeezed out of the clamped-off section to eliminate the
possibility of blood become air borne when the cord is cut. The blade is
concealed in the body of the mechanism to eliminate the possibility of
anyone being injured by the blade. The mechanism of the present invention
is designed so that it can be used to draw blood from the cord in a
controlled manner, and to provide a cleanly severed end on the fetal side
of the umbilical cord, with sufficient length to view the number of
arteries and veins in the cord.
In the recent past, various umbilical cord clamping and cutting devices
have been designed to speed up the clamping and cutting process. Known
devices intended to perform cutting and clamping tasks are disclosed in
U.S. Pat. Nos. 5,190,556, Hessel, 5,127,915, Mattson, 5,009,657, Cotey et
al, 4,870,965, Jahanger, and 4,648,401, Mattson. None of these insure that
the cord is fully sealed before cutting begins, or that the cord will not
slide out when cutting without puncturing the cord. Also, U.S. Pat. Nos.
4,938,215 Schulman et al., 4,856,517, Collins et al., 4,781,188, Collins
et al., 4,781,188, Collins, 4,716,886, Schulman et al, 4,572,181, Mattler,
4,428,374, Auburn, 4,026,294, Mattler, 3,631,858, Ersek, 3,323,208,
Hurley, 3,166,071, Mayer, 3,106,919, Churchville, 2,524,337, Whittaker,
and 2,060,724, Carrol all show umbilical cord clamp and cutting devices.
Of these Patents, none allow the maternal clamp to be opened for the
taking of blood samples. The devices of these patents have generally
failed to meet all of the needs of the doctor and the patients.
U.S. Pat. No. 4,212,303, issued to John Nolan on Jul. 15, 1980, discloses
an umbilical cord clamp that comprises two clamp arms hingedly connected
together for closure on the cord. The free end of one clamp arm has a
deflectable tongue that is lockable in a recess in the free end of the
other arm when the clamp arms are closed on the umbilical cord.
U.S. Pat. No. 4,716,886 to Schulman et al, discloses an umbilical cord
cutting device that includes two similarly constructed clamps connected
together by a shear pin. A cutting blade is floatably positioned between
the clamps so that when the clamps are clamped to the umbilical cord the
blade can be moved through the space between the clamps to sever the cord
and the shear pin, thereby separating the clamps.
U.S. Pat. No. 4,856,517, issued to J. Collins et al on Aug. 15, 1989,
discloses an umbilical cord cutter mechanism that include a holder
containing a cutter blade and two detachable clamps on opposite sides of
the blade. Each clamp has latch means for holding the clamp in the closed
position when the holder is closed to operate the blade. The holder can be
removed from the clamps after the cord severing operation.
There is apparently no provision in the device of U.S. Pat. No. 4,856,517
for partially loosening either clamp to withdraw a blood sample from one
of the severed cord sections.
U.S. Pat. No. 4,870,965, issued to M. Johanger, discloses an umbilical cord
severing mechanism wherein a scissors cutter has a first cord clamp
affixed to the cutter structure, and a second fetal cord clamp detachably
mounted in the cutter structure, whereby the fetal clamp is ejected during
the cutting stroke. A leaf spring in the cutter structure acts as an
ejector device. The cutting action is achieved by two blade elements
carried by the opposed jaws of the scissors structure.
One disadvantage of the patented structure is that the blades begin the
cutting operation before the umbilical cord is fully clamped in the two
clamp mechanisms. Also, there is no provision for relaxing the clamp
pressure on the severed cord to facilitate drawing a blood sample.
U.S. Pat. No. 5,009,657, to J. Cotey et al, shows an umbilical cord cutting
mechanism that includes a jaw structure having an integral cutter blade
and a separable fetal chord clip. The jaw structure includes a hinge
structure that has a lug that normally holds the fetal chord clip in the
jaw structure; when the jaw structure is closed the lug is displaced so
that the fetal chord clip can separate from the jaw structure.
U.S. Pat. No. 5,127,915 to P. D. Mattson, discloses a scissors type
instrument for cutting an umbilical cord, said instrument having a
detachable clamp structure equipped with a latch means so that after the
cord is severed the clamp remains attached to the infant end of the cord.
The scissors type instrument can be removed from the clamp structure after
the cord-severing operation.
One disadvantage of the arrangement of U.S. Pat. No. 5,127,915 is that the
cord is clamped at only one point along the cord surface; the cord is thus
not fully compressed in the immediate vicinity of the cutting plane so
that there is a danger of blood spurting from the unclamped end of the
cord. The unclamped end of the severed cord is not sealed.
SUMMARY OF THE INVENTION
The present invention contemplates an umbilical cord cutting mechanism,
wherein the cord is fully clamped in two places before the cutter blade is
moved to sever the cord. The aim is to insure that the cord will be in a
relatively flat compressed condition containing minimal quantities of
blood when the cutting operation begins.
A further feature of the invention is an adjustable latch system that
allows the clamp on the maternal end of the cord to be partially loosened
whereby blood samples can be taken from the severed maternal cord section
while the cord is still in a clamped condition.
An additional feature of the invention is a fetal cord clamp that is
removably disposed in the main clamp housing so that its cord grip plane
is spaced from the blade cutting plane. This feature enables the fetal
cord to have a terminal section that is uncompressed, whereby arteries and
veins in the cord section can be easily examined.
It is a principal aim of the present invention to firstly increase the care
being given to the patient by reducing the number of unnecessary
distractions of the doctor, and furnishing the doctor with more time to
care for the patient. Secondly, it is an aim of the invention to decrease
the possibility of the medical staff being infected by a blood transmitted
disease, such as H.I.V. or Hepatitis, by reducing the amount of blood loss
from the umbilical cord, eliminating cord blood from becoming airborne and
eliminating the possibility of injury by the cutting blade. Thirdly, it is
an aim of the invention to reduce the possibility of infection to patients
by eliminating the possibility of external blood and bacteria entering the
patient's bloodstream through the cord where the cord is cut. And lastly,
the invention seeks to minimize the number of instruments needed to
perform the procedure, thus reducing the number of instruments needed to
be handled and cleaned.
The present invention relates to a clamping and cutting device that
comprises a double jaw clamping mechanism which incorporates a releasable
locking means, a double jaw fetal end cord clamp which separates from the
body of the device and remains locked to the fetal end of the cord, and a
hinged holder containing a blade for severing the cord through a secondary
action.
The functions and processes carried out by the present invention are simple
and direct. The cord is fitted through the opening of the device until it
clears the locking mechanism. By squeezing the upper and lower arms of the
clamp together the device closes around the cord, compressing it and
sealing the cord in two places. Further squeezing pressure forces the
cutting blade upward through the segments of the cord between the two
pairs of clamping jaws that are locked onto the cord. As the blade is
severing the cord wedge along side the blade applies force to the clamp
which is locked to the infant's end of the cord, causing it to eject out
of the device. This completes the separation of infant from mother. In
order to take blood samples from the placenta, a collection tube is
inserted into the side of the device which holds the mother's end of the
cord; the jaws of the device can be partially opened by the application of
forward pressure on a release lever to facilitate the collection of the
blood sample. The jaws can be opened enough to allow blood to flow out of
the cord, but not enough to allow the cord to slip out of the jaws of the
device. When enough blood has been taken from the placenta the cord can be
resealed by squeezing the device into the locked position thus stopping
the flow of blood through the cord.
Further structural details and operational details of the invention will be
apparent from the attached drawings and accompanying description of the
mechanisms shown in the drawings.
THE DRAWINGS
FIG. 1 is a side elevational view of a cutting and clamping mechanism
embodying the invention.
FIG. 2 is a second side elevational view of the FIG. 1 mechanism, taken
from the other side of the mechanism.
FIG. 3 is a sectional view of the FIG. 1 mechanism, taken generally on line
3--3 in FIG. 9.
FIG. 4 is a sectional view taken generally on line 4--4 in FIG. 9.
FIGS. 5 and 6 are partial sectional views taken in the same direction as
FIG. 3, but showing the mechanism in different conditions of adjustment.
FIG. 7 is a side elevational view of a fetal cord clamp used in the FIG. 1
mechanism.
FIG. 8 is an end view of the FIG. 1 mechanism, with the mechanism in a
closed condition.
FIGS. 9 and 10 are transverse sectional views taken through the mechanism.
FIG. 9 shows the mechanism in a closed position prior to a cord severing
operation. FIG. 10 shows the mechanism after the cord has been severed and
the fetal cord clamp has been separated from the mechanism.
DESCRIPTION OF A PREFERRED EMBODIMENT OF THE INVENTION
The drawings show a mechanism for cutting an umbilical cord 31 into two
sections, namely a cord section attached to the mother and a fetal cord
section attached to the new born infant. FIG. 9 shows the umbilical cord
prior to the cutting operation, whereas FIG. 10 shows the condition after
the cord cutting operation. In FIG. 10 the fetal section (attached to the
infant) has a fetal cord clamp 22 attached thereto; the maternal cord
section is attached to the clamping mechanism designated generally by
numeral 33. During the cord cutting operation the fetal cord clamp 22 is
ejected out of mechanism 33 in a generally rightward direction, as viewed
in FIGS. 9 and 10.
FIGS. 1, 2 and 3 show the general features of clamping mechanism 33. As
there shown, the clamping mechanism comprises a first jaw 1 and a second
jaw 3 hingedly joined together by a flexible wall type hinge. This hinge
is shown as an arcuate wall 7 integral with jaws 1 and 3, and centered
generally around an imaginary hinge axis 35. The arcuate length of wall 7
is approximately one hundred thirty degrees, measured around axis 35.
Arcuate hinge wall 7 is integral with a relatively thick rigid connector
wall 6 that joins wall 7 to a second arcuate wall 5 centered on an
imaginary hinge axis 37. Arcuate wall 5 has an arcuate length that
measures about ninety degrees, taken around axis 37.
Arcuate wall 5 has a lesser length than arcuate wall 7. Also, arcuate wall
5 is somewhat thicker than arcuate wall 7, such that hinge wall 7 has a
greater flexibility than hinge wall 5. Wall 6 is essentially non-flexible.
Arcuate wall 7 forms a hinge that enables jaw 1 to pivot toward or away
from jaw 3 around hinge axis 35. Arcuate wall 5 forms a second hinge that
enables an elongated blade holder arm structure 2 to pivot (or swing)
toward or away from jaw 3. The two hinge structures are connected to the
common connector wall 6.
FIGS. 1 and 2 show the jaw structure in an open position whereby the
mechanism can be moved to partially encircle the umbilical cord 31. FIG. 3
shows the jaw structure closed on the umbilical cord 31; jaw 1 is moved
downwardly toward jaw 3 to a position wherein the clamped umbilical cord
31 is located slightly above the sharpened edge 39 of a cutter blade 11.
Blade edge 39 appears in FIG. 4. Blade 11 is suitably anchored in holder
(arm structure) 2.
The aforementioned fetal cord clamp 22 (shown in FIGS. 7 and 8) is
removably disposed in mechanism 33 so that cord gripper elements 23 and 24
of the clamp move generally in synchronism with jaws 1 and 3. Thus, as jaw
1 moves toward jaw 3 the corresponding gripper element 23 moves toward
gripper element 24. When the jaws are in the FIG. 3 closed position
clamped on the umbilical cord, the corresponding gripper elements 23 and
24 will be in gripping engagement with the umbilical cord (but in a
different gripper plane).
FIG. 7 shows some features of fetal cord clamp 22. As there shown, the
clamp comprises an arcuate hinge wall 25 joining the two elongated gripper
elements 23 and 24. The free end of the gripper element 24 has a latch arm
29 that is adapted to lockably engage a shoulder 30 on gripper element 23
when the mechanism is in the FIG. 3 condition, i.e. when jaw 1 is closed
onto jaw 3, and gripper element 23 is closed onto gripper element 24.
Clamp 22 is removably disposed in mechanism 33 by positioning the arcute
hinge wall 25 within the circular packet 20 formed by arcuate wall 7
pocket 20 appears in FIGS. 9 and 10. Wall 7 partially surrounds wall 25 to
retain clamp 22 in mechanism 33. Additionally, as shown in FIG. 10,
gripper element 25 of the fetal cord clamp has a lug 27 thereon that is
adapted to fit into a slot 18 formed in jaw 1. FIG. 9 shows generally how
clamp 22 fits within a cavity in the right side of jaw 1. Gripper element
24 has a lug 28 (FIGS. 7 and 10) that registers with an upstanding wedge
element 9 carried on lower jaw 3, such that when jaw 1 is moved downwardly
a predetermined distance the wedge element exerts a cam action on the lug
28, thereby ejecting the clamp outwardly (or rightwardly in FIG. 10) from
mechanism 33. Surface 41 on lug 28 forms a cam follower surface cooperable
with the cam surface on wedge element 9 to achieve the clamp eject
operation.
FIG. 9 shows the cutting plane of blade 11 in relation to the clamp planes
of jaws 1 and 3 and the gripper elements 23 and 24. In FIG. 9 the plane of
blade 11 is designated by numeral 43, the clamp plane of jaws 1 and 3 is
designated by numeral 44, and the grip plane of gripper elements 23 and 24
is designated by numeral 47. Cutter plane 43 is located relatively close
to clamp plane 44, but relatively remote from grip plane 47. Therefore,
the severed fetal cord (in FIG. 10) will have an uncompressed terminal
section 49 that can be readily viewed by the doctor for examination of the
arteries and veins in the fetal cord section. This is an advantageous
feature of the illustrated construction.
FIG. 1 shows the umbilical cord 31 inserted into the opened mechanism 33.
Guard loops 8 and 26 on the jaws and gripper elements help to prevent
inadvertant movement of the cord into the hinge structure cavity. The
relative stiffness of hinge wall 5 (in relation to wall 7) is such that
when jaw 1 is moved from the FIG. 1 open position to the FIG. 3 closed
position the blade holder 2 remains essentially motionless relative to jaw
3.
However, when the jaws (and gripper elements) are brought together, as in
FIG. 3, continued manual squeezing pressure on the mechanism brings blade
holder 2 toward jaw 3, to the FIG. 4 position. Sharpened edge 39 on blade
11 severs the umbilical cord, but only after the cord is in a stabilized
(controlled) position clamped at two points by the jaws 1 and 3, and the
gripper elements 23 and 24. During the cord-severing operation blade edge
39 moves into a slot 21 in jaw 1.
FIG. 10 shows the blade in generally the same position as depicted in FIG.
4. During the cutting operation wedge block 9 ejects the fetal cord clamp
22 out of the clamp mechanism, as shown in FIG. 10.
FIGS. 5 and 6 show a latch feature whereby the severed maternal umbilical
cord can be partially unclamped from mechanism 33 to permit blood to be
drawn therefrom.
The latch structure comprises an upstanding deflectable tongue 4 extending
right angularly from the free end of blade holder 2. Tongue 4 has a
plurality of locking teeth 15 adapted to selectively engage a locking
detent 12 on the end surface of jaw 1, whereby jaw 1 can be retained in
various positions of adjustment, to achieve various degrees of clamping
engagement on the maternal cord. Tongue 4 is an integral plastic extension
of blade holder 2, such that the connection between the tongue and blade
holder is flexible, whereby the doctor can apply thumb pressure to the
upper end of tongue 4 to adjust the locking action.
Complete separation of jaw 1 from jaw 3 is prevented by the interengagement
of hook 51 on tongue 4 with shoulder 16 on the end surface of jaw, as
shown in FIG. 6. The length of tongue 4 is such that the person's thumb
can sense the upper end of tongue 4 to effect complete release of jaw 1
from the maternal cord section after the blood sample hs been taken, and
it is no longer necessary to maintain the clamp action.
The adjustable latch action enables the mechanism to conform to a range of
different umbilical cord thickness, and to respond to different conditions
of the maternal cord required to take blood samples without losing control
of the process.
The drawing shows a preferred form of the invention. The illustrated
apparatus is believed to have several advantages as heretofore indicated.
Other advantages and modifications suggested by the drawings and
description can be achieved, while still practicing the invention. The
mechanism is preferably formed as a plurality of low cost molded plastic
components, whereby the mechanism is disposable.
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Description  |
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