Note: Descriptions are shown in the official language in which they were submitted.
CA 02883794 2016-02-11
Title: Cerebrospinal Fluid Neurotransmitter Tube Holder
Technical field: The Cerebrospinal Fluid Neurotransmitter Tube Holder will be
used in the field of pediatric neurological medicine by a medical professional
to
collect cerebrospinal fluid during a lumbar puncture for the purpose of
testing
neurotransmitter concentrations to diagnose and treat neurological disorders.
Cerebrospinal Fluid Neurotransmitter tube holder therefor
This invention provides a tube holder specifically designed for the collection
of
cerebrospinal fluid neurotransmitters. Prior to this date a Cerebrospinal
Fluid
Neurotransmitter Tube Holder did not exist to collect cerebrospinal fluid
neurotransmitters and the five tubes required for neurotransmitter collection
were
held by hand.
Background of the invention
Cerebrospinal fluid (CSF) is a clear fluid produced in the brain, which
circulates
around the brain and spinal cord. Sampling the CSF from the lumbar cistern by
lumbar puncture (LP) allows measurement of the neurotransmitter concentrations
in the cerebral milieu without the dangers of an open cranial procedure.
Neurotransmitters are how brain cells communicate. There are numerous rare
disorders in the pediatric population due to abnormal concentrations of CSF
neurotransmitters. These can only be diagnosed by measuring neurotransmitter
levels in the CSF. Many CSF neurotransmitter disorders are disabling, and some
are highly treatable. Diagnosis can be the difference between a life in a
wheelchair with frequent painful dystonia, and a normal life with
neurotransmitter
supplementation.
Standard collection of cerebrospinal fluid (CSF): cerebrospinal fluid is
collected
by a physician or medical student trained in the procedure using standardized
sterile techniques. There are standard commercial sterile kits for either
pediatric
1
CA 02883794 2016-02-11
or adult lumbar puncture. Physicians are trained using these kits. Lumbar
puncture is performed for two reasons: to measure the opening pressure and to
collect CSF for investigations (bacterial and viral cultures, glucose,
protein,
lactate, white and red blood cells). The patient is positioned either laying
on their
side or seated with the spine curved. The spinal needle is inserted between
the
vertebrae after standardized sterile preparation, the opening pressure
measured,
then the fluid collected in four tubes. The tubes are sterile, and easily
manipulated by the physician performing the procedure. The physician holds the
tubes one or two at a time. When transitioning between collection tubes, it is
of
no consequence if several drops of CSF are lost.
Collection of cerebrospinal fluid for the purpose of measuring
neurotransmitter
concentrations: In contrast to usual CSF collection, CSF collection for
neurotransmitter testing requires that every single drop of CSF is collected.
This
is due to a rostral to caudal gradient of neurotransmitter concentration, thus
missed CSF volume can result in a false negative and a missed diagnosis. In
contrast to usual CSF collection, CSF is not collected in the four 10m1
sterile
tubes provided in the standard lumbar puncture kit, but instead in five much
smaller 1.5ml Eppendorf tubes. The laboratory that analyzes the CSF
neurotransmitters provides a "kit" of five 1.5m1 Eppendorf tubes. Each tube is
labeled with a number one through five, and each has a horizontal line drawn
to
indicate the required volume. The third tube contains reagent. The tubes are
not
sterile, due to the reagent. In contrast to the usual CSF collection, the
physician
performing the procedure (who is wearing sterile gloves) cannot touch the
tubes,
and requires an assistant. Prior to the Cerebrospinal Fluid Neurotransmitter
Tube Holder an assistant held all five tubes in their hands at one time, and
avoided touching either the sterile hands of the physician, or the sterile
surface of
the patient. The assistant had to be ready to catch the first drop of CSF, and
each subsequent drop, moving their hands laterally to transition between
tubes.
They had to take care to position their fingers in such a way so that the
volume
2
CA 02883794 2016-02-11
marking on each tube was visible. Collection of CSF in this manner took
between two and ten minutes to complete. Throughout this time the assistant
must lean over the physician performing the procedure. Thus measurement of
CSF neurotransmitters required a highly skilled physician and assistant,
performing the lumbar puncture procedure very differently from the standard
collection procedure that they were trained to perform. Prior to the
Cerebrospinal
Fluid Neurotransmitter Tube Holder it was difficult to collect the five
samples of
CSF without loosing a drop or more of CSF and thereby skewing the rostral to
caudal gradient of the neurotransmitter concentration with the result of a
false
negative and a missed or inaccurate diagnosis. In addition, holding the five
tubes
in a row in one or both hands was technically difficult and there was risk of
dropping one or more tubes. After collection, the tubes must be immediately
placed in a hazard material ice bucket to prevent degradation of the
neurotransmitters.
Description of Prior Art
There are no known prior patented inventions to safely, accurately, and
conveniently collect neurotransmitter fluid from pediatric patients. There is
anecdotal evidence that various institutions across North America use a
disposable cardboard tube holder or hold the five tubes in their hands.
Butler US 2002 0068882 describes a tube rack designed to hold the standard
10m1 sterile CSF collection tubes included in standard collection kits. Butler
US
2002 0068882 is not suitable for the collection of CSF neurotransmitters in
infants due to its large size, four-tube design instead of five, and design
for larger
tubes.
How the invention addresses a technical problem:
Prior to the Cerebrospinal Fluid Neurotransmitter Tube Holder a nurse or
physician trainee attempted to hold all five Eppendorf tubes in their hands
and
leant over the physician performing the lumbar puncture. This technique
resulted
3
CA 02883794 2016-02-11
in frequent missed drops of CSF with the possibility of a missed diagnosis.
Many
physicians performing the procedure were not adequately educated on the
importance of standardized collection, and would improvise easier, safer
collection techniques such as alternating CSF neurotransmitter tubes with
standard sterile tubes, resulting in possible false negative results and
missed
diagnosis.
There are no tube racks currently manufactured that are designed to hold five
1.5m1 Eppendorf tubes with the minimum profile of the Cerebrospinal Fluid
Neurotransmitter Tube Holder that provides for the non-sterile tubes to be
suspended in a sterile field by an assistant. This is of particular importance
in the
collection of neurotransmitter fluids from infants because their sterile field
is very
small. Currently existing tube holders are too large in height and width for
use in
the collection of neurotransmitter fluids from infants as they would touch the
infant patient, sterile-gloved physician, or other elements of the sterile
field.
The Cerebrospinal Fluid Neurotransmitter Tube Holder fills this void by
providing
a 2cm wide, 0.6cm high tube rack specifically designed to hold five 1.5m1
Eppendorf tubes with a handle on one end which can easily be manipulated by
an assistant and its clear acrylic material ensures an accurate evaluation of
the
volume of CSF within each of the Eppendorf tubes. The Cerebrospinal Fluid
Neurotransmitter Tube Holder ensures that up to five samples of CSF are
obtained consecutively without any missed drops of CSF. Advantageously, a
physician can now perform, for the first time, CSF neurotransmitter collection
independent of an assistant using the Cerebrospinal Fluid Neurotransmitter
Tube
Holder by "double gloving" (the practice of wearing two sterile gloves on each
hand) and removing the first pair of gloves after handling of the non-sterile
CSF
Neurotransmitter Tube Holder to continue with a safe sterile procedure. This
was
not possible without the CSF Neurotransmitter Tube Holder, as the physician
performing the procedure could not assemble the five small tubes in their
hands
quickly enough after inserting the needle to safely collect the fluid. The
4
CA 02883794 2016-02-11
improvement in the collection of CSF for the purpose of testing
neurotransmitter
concentrations with the use of the Cerebrospinal Fluid Neurotransmitter Tube
Holder has been demonstrated at our institution and presented at scientific
conferences. The Cerebrospinal Fluid Neurotransmitter Tube Holder would
improve the collection of CSF for the purpose of testing neurotransmitter
concentrations in all pediatric hospitals across North America.
In the drawings and photographs, which form a part of this specification
FIG. 1 is a perspective view of a preferred embodiment of the Cerebrospinal
Fluid Neurotransmitter Tube Holder with five Eppendorf tubes with caps placed
in
its rack and held by a gloved hand holding its handle. The Cerebrospinal Fluid
Neurotransmitter Tube Holder is held within the sterile field adjacent to the
draped infant whose lumbar area is exposed for the lumbar puncture procedure.
A needle (such as a Quinke needle, known in the art) has been inserted in the
infant's lumbar cistern for collection of the CSF neurotransmitters into the
first of
the five Eppendorf tubes.
FIG. 2 is a top view of the Cerebrospinal Fluid Neurotransmitter Tube Holder
of
the preferred embodiment of FIG. 1.
FIG. 3 is a side view of the Cerebrospinal Fluid Neurotransmitter Tube Holder
of
the preferred embodiment of FIG. 1, illustrating the CSF visualized within the
tubes through the clear acrylic tube holder.
FIG. 4 is a perspective view of the Cerebrospinal Fluid Transmitter Tube
Holder
of the preferred embodiment of FIG. 1, securely positioned on the top of a
hazard
material ice bucket after the completion of CSF collection.
Detailed description of the invention
FIG. 1 is a perspective view of the Cerebrospinal Fluid Transmitter Tube
Holder
of the preferred embodiment illustrating a gloved hand 16 holding the tube
holder
20, which embodies herein a spinal fluid collection system for use by a
medical
professional for collecting, from a lumbar puncture into five Eppendorf tubes,
well
CA 02883794 2016-02-11
known in the art, multiple consecutive samples of CSF from a pediatric
patient.
Illustrated in FIG. 1 is a preferred embodiment of tube holder 20, embodying
herein a holder designed to stably hold five 1.5m1 Eppendorf tubes in an
upright
position. The tube holder 20 is made from transparent, lightweight acrylic.
The
tube holder 20 has a handle 3, an allowance 2, and vertical chambers for tube
insertion 6.
The tubes 8 are inserted at their midpoint of approximately 1.5cm through the
vertical chambers 6, and the caps 9 are opened. The infant patient is draped
with sterile drapes 15, which include an opening to expose the infant's lumbar
area for lumbar puncture 12. The cranial 11 and caudal 10 portions of the
infant
patient remain undraped for monitoring of vital signs. A needle 13 is inserted
into
the lumbar cistern of the pediatric patient, and CSF 17 flows from the open
end of
the needle 14. The Cerebrospinal Fluid Neurotransmitter Tube Holder is held by
the gloved hand 16 and positioned underneath the needle 14 ensuring neither
the Eppendorf tubes nor the Cerebrospinal Fluid Neurotransmitter Tube Holder
touch the infant's lumbar area exposed for lumbar puncture 12 or the sterile
drapes 15. The Cerebrospinal Fluid Neurotransmitter Tube Holder of the
preferred embodiment is designed to minimize contact with the sterile drapes
15
and with the infant's lumbar area exposed for lumbar puncture 12 with a width
4
of 2cm. CSF is collected in consecutive tubes to the requisite volume
demarcated by the CSF neurotransmitter analysis laboratory with a dark line 7.
FIG. 2 is a top view of the Cerebrospinal Fluid Neurotransmitter Tube Holder
of
the preferred embodiment 20. FIG. 2 illustrates the five Eppendorf tube
chamber
holes 6 arranged in a row. The preferred width of the chamber holes for the
stable, secure placement of the five Eppendorf tubes is 1cm. FIG. 2 also
illustrates the preferred size and shape of the handle 3 of a length of 5-6cm
to
allow for the easy grip by an average hand of standard glove size 6-8 and to
maintain a distance of at least 5cm of the hand from the sterile field 15. In
addition the allowance 1 is sized 1-2cm to permit secure suspension over a
6
CA 02883794 2016-02-11
receptacle such as a hazard material ice bucket. The distance 5 between holes
6 is 0.75-1.5cm to prevent breakage of the tube holder 20 with tube insertion
and
to minimize the distance between the tubes to consecutively collect CSF. The
width 4 is 2cm to occupy a minimum of space within the sterile field.
FIG. 3 is a side view of the Cerebrospinal Fluid Neurotransmitter Tube Holder
of
the preferred embodiment 20. FIG. 3 illustrates the five Eppendorf tubes 8
contained within the preferred embodiment. The tubes 8 have been filled with
CSF 17 to the preferred volume marked with a dark line 7, visualized through
the
transparent acrylic of the tube holder 20. There is an inter-tube distance
0.75-
1.5cm between the tube chamber holders 5 to accommodate the opened caps 9.
The height of the preferred embodiment 4 is 0.5-1 cm to prevent breakage and
minimize refractive error of the CSF volumes 17 visualized through the holder
20.
FIG. 4 is a perspective view of the Cerebrospinal Fluid Neurotransmitter Tube
Holder of the preferred embodiment 20 placed on a hazard material bucket 19
containing ice 18 after CSF collection. The tubes 8 are inserted firmly at the
midpoint 1.5cm height to ensure the ice 18 does not dislodge them. The caps 9
are secured to the tubes 8. The distance of 0.75 ¨ 1.5 cm between the holes 5
permits closure of the caps 9. The handle 3 and allowance 1 permit suspension
of the holder 20 across the top of the hazard material ice bucket 19.
Summary of the invention
According to a preferred embodiment of the present invention this
Cerebrospinal
Fluid Neurotransmitter Tube Holder is used by a physician for the collection
of
CSF from pediatric patients for the testing of neurotransmitter
concentrations.
The Cerebrospinal Fluid Neurotransmitter Tube Holder holds upright five 1.5ml
non-sterile Eppendorf tubes, each tube is spaced a distance of 0.75 ¨ 1.5 cm
apart for collecting up to five consecutive samples in a continuous manner
without any missed drops of CSF that occur when multiple Eppendorf tubes are
7
CA 02883794 2016-02-11
held by hand during a lumbar puncture and CSF collection procedure.
Advantageously, this improves the safety and ease of CSF collection for
neurotransmitter analysis. In addition, for the first time, the physician
performing
the procedure could collect CSF for neurotransmitter analysis independently
without a non-sterile assistant by wearing two pairs of sterile gloves and
removing the contaminated pair after CSF neurotransmitter collection. The
Cerebrospinal Fluid Neurotransmitter Tube Holder's clear acrylic composition
enables physicians to visualize the demarcations on the Eppendorf tubes for
the
collection of the requisite volumes of CSF. The Cerebrospinal Fluid
Neurotransmitter Tube Holder's handle can be held by either the right or left
handed for increased flexibility and safety of use. The Cerebrospinal Fluid
Neurotransmitter Tube Holder's size minimizes the possibility of disruption of
the
small sterile field of the pediatric patient by adding no additional height to
the
dimensions of the Eppendorf tubes and by restricting its width to 2cm.
Advantageously, the Cerebrospinal Fluid Neurotransmitter Tube Holder rack's
handle and allowance permit it to be secured across the top of a receptacle
such
as a hazard material ice bucket.
8
