Abstrict
A blood pressure monitor kit suitable for use in emergency scenarios
such as cardiopulmonary arrest situations. The kit includes a catheter
for insertion in the femoral artery of the patient, a transducer
arranged to receive blood pressure signals from the catheter and
operative to convert the blood pressure signals into electric signals;
a housing; a monitor mounted in the housing and including electric
circuitry arranged to receive the electric signals from the transducer
and operative to generate at least one display indicative of a condition
of the patient's blood pressure; a battery positioned within the
housing and operative to power the electric circuitry; a switch
associated with the housing for connecting the battery into the
electrical circuitry to power the circuitry; and a securement device
on the housing operative to secure the housing to a patient's body
at a location proximate the location of the catheter insertion.
The entire kit is packaged in a container which totally envelops
the catheter, transducer, and monitor and forms a sealed, sterile
package which may be opened upon demand. The kit is intended for
one time use and is suitably disposed of after the single use.
Claims
I claim:
1. A miniature blood pressure monitoring kit comprising:
a housing;
a catheter adapted to be inserted into a blood vessel of a patient;
a conduit formed of a tubular material and including a flexible
connector portion in fluid communication with the catheter and an
operative portion carried by the housing and in fluid communication
with the connector portion;
a transducer carried by the housing and positioned in operative
association with the operative portion of the conduit and operative
to receive blood pressure signals from the operative portion of
the conduit and convert the blood pressure signals into electrical
signals;
a monitoring device mounted in the housing and including electric
circuitry arranged to receive the electrical signals from the transducer
and operative to generate at least one display indicative of a condition
of the patient's blood pressure;
a battery positioned within the housing and operative to power
the electric circuitry;
a switch associated with the housing for connecting the battery
into the electric circuitry to power the circuitry;
securement means on the housing operative to secure the housing
to a patient's body at a location proximate the location of the
catheter insertion; and
a reservoir containing a flushing solution and having an outlet
for communication with the conduit to flush the conduit.
2. A monitor according to claim 1 wherein the kit further includes
a container totally enveloping the catheter, transducer and monitoring
device and forming a sealed, sterile package which may be opened
upon demand to provide a disposable blood pressure monitor kit for
emergency use applications.
3. A blood pressure monitor kit according to claim 1 wherein the
conduit further includes a flushing portion communicating with the
operative portion and the outlet of the reservoir communicates with
the conduit flushing portion.
4. A monitor according to claim 3 wherein the kit further includes
a container totally enveloping the catheter, transducer and monitoring
device and forming a sealed, sterile package which may be opened
upon demand to provide a disposable blood pressure monitor kit for
emergency use applications.
5. A miniaturized blood pressure monitor kit according to claim
3 wherein the kit further includes a stopcock at a free end of the
conduit flushing portion, the reservoir outlet communicating with
the stopcock to flush the conduit.
6. A blood pressure kit according to claim 5 wherein the kit is
totally enveloped in a container and the kit further includes a
tray positioned removably within the container and containing the
catheter.
7. A kit according to claim 6 wherein the kit includes a plurality
of catheters of varying sizes and configurations and all of the
catheters are positioned in the tray so as to provide a selection
of catheters for use with the monitor.
8. A kit according to claim 5 wherein the kit further includes
a further stopcock in the conduit between the catheter and the conduit
operative portion.
9. A method of monitoring the blood pressure of a patient in an
emergency situation comprising the steps of:
providing a disposable sterile blood pressure monitor kit including
a housing; a catheter adapted to be inserted into a blood vessel
of the patient; a conduit formed of a tubular material and having
a flexible connector portion and an operative portion carried by
the housing and communicating with the connector portion; a transducer
carried by the housing, juxtaposed to the operative portion of the
conduit, and operative to receive blood pressure signals from the
operative portion of the conduit and convert the blood pressure
signals into electrical signals; a battery positioned in the housing;
a switch on the housing connected to the battery; a monitoring device
positioned in the housing, powered by the battery, controlled by
the switch, and including electric circuitry arranged to receive
electrical signals from the transducer and operative to generate
at least one display indicative of an aspect of the patient's blood
pressure; securement means on the housing operative to secure the
housing to a patient's body at a location proximate the location
of the catheter insertion; and a reservoir containing a flushing
solution and having an outlet for communication with the conduit;
moving the kit to a location proximate a blood vessel of the patient;
inserting the catheter into the blood vessel;
securing the housing to the patient's body at a location proximate
the location of the catheter insertion; and
flushing the conduit utilizing flushing solution delivered from
the reservoir outlet to the conduit.
10. A method according to claim 9 wherein the blood vessel is the
femoral artery and the housing is secured to the patient's thigh.
11. A method according to claim 10 wherein the housing is adapted
to be secured to the patient's thigh utilizing said securement means
in the form of a strap connected to the housing.
12. A method according to claim 9 wherein
the housing is secured to the patient's thigh utilizing said securement
means in the form of a self-adhering surface provided on the housing.
13. A miniaturized blood pressure monitor kit according to claim
7 wherein:
the container defines a lower level below the tray and the transducer
and monitoring device are positioned in the lower level of the container
beneath the tray.
14. A method according to claim 9 wherein the kit is provided as
a sealed kit which is opened upon the occurrence of the emergency
situation and disposed of after usage in association with the emergency
situation.
15. A miniaturized blood pressure monitor kit comprising:
a catheter adapted to be inserted into a blood vessel of a patient;
a transducer arranged to receive blood pressure signals from the
catheter and operative to convert the blood pressure signals into
electric signals;
a housing;
securement means on the housing operative to secure the housing
to a patient's body at a location proximate the location of the
catheter insertion;
a monitoring device mounted in the housing and including electric
circuitry arranged to receive the electrical signals from the transducer
and operative to generate at least one display indicative of a condition
of the patient's blood pressure;
a battery positioned within the housing and operative to power
the electric circuitry; and
a switch associated with the housing for connecting the battery
into the electric circuitry to power the circuitry;
the kit further including a conduit having a first end in fluid
communication with the catheter, a second end, and an intermediate
operative portion juxtaposed to the transducer and operative to
conduct blood pressure signals from the catheter to the transducer;
the kit further including means for flushing the conduit;
the conduit flushing means comprising a pressurized reservoir mounted
on the housing, containing a flushing solution, and having an outlet
communicating with the conduit at a location between the second
conduit end and the transducer.
16. A miniature blood pressure monitoring kit comprising:
a housing;
a catheter adapted to be inserted into a blood vessel of a patient;
a conduit formed of a tubular material and including a first end
in fluid communication with the catheter, a flexible connector portion
extending between the first conduit end and the housing, and an
operative portion carried by the housing and communicating in fluid
communication with the connector portion;
a transducer carried by the housing and positioned in operative
association with the operative portion of the conduit and operative
to receive blood pressure signals from the operative portion of
the conduit and convert the blood pressure signals into electrical
signals;
a monitoring device mounted in the housing and including electric
circuitry arranged to receive the electrical signals from the transducer
and operative to generate at least one display indicative of a condition
of the patient's blood pressure;
a battery positioned within the housing and operative to power
the electric circuitry;
a switch associated with the housing for connecting the battery
into the electric circuitry to power the circuitry; and
securement means on the housing operative to secure the housing
to a patient's body at a location proximate the location of the
catheter insertion;
the conduit including a second end position exteriorly of the housing
and the kit further including a stopcock secured to the second end
of the conduit to enable flushing of the conduit and catheter through
the second end of the conduit, the conduit flushing means comprising
a pressurized reservoir mounted on the housing and containing a
flushing solution.
Description BACKGROUND OF THE INVENTION
This invention relates to blood pressure monitor devices and more
particularly to a blood pressure monitor device particularly suitable
for use in emergency environments.
There are currently 450-500,000 sudden deaths per year in the U.S.
with 250,000 patients receiving cardiopulmonary resuscitation (CPR)
by trained medical personnel. In order to optimize CPR procedures
it is essential that an accurate blood pressure reading be provided
during the procedure. Current blood pressure monitoring techniques
during CPR are crude at best and include finger palpation and the
use of a sphygmomanometer (blood pressure cuff). Only a very small
fraction of patients undergoing CPR receive true arterial blood
pressure monitoring. Achieving near physiologic arterial blood pressure
is critical during cardiopulmonary resuscitation. Without arterial
pressure monitoring there is no way to determine if CPR is effective.
Currently, arterial blood pressure monitoring requires an indwelling
catheter, a pressure transducer, and monitoring equipment that typically
only exist in an intensive care type unit. Obtaining effective arterial
blood pressure through monitoring during CPR has been shown to be
essential in animal studies for satisfactory outcome. Human studies
center on the quality of CPR as measured by blood pressure in the
laboratory setting and also correlate improvement in outcome with
improvement in blood pressure during CPR. In the sudden death patient
group alone, improvement in the survival rate from 10 to 20% would
result in at least 25,000 lives saved each year.
SUMMARY OF THE INVENTION
The primary object of the present invention is to provide a blood
pressure monitor kit suitable for use during CPR and other emergency
situations.
The blood pressure monitor kit of the invention includes a catheter
adapted to be inserted into the artery of a patient; a transducer
arranged to receive blood pressure signals from the catheter and
operative to convert the blood pressure signals into electrical
signals; a miniaturized monitor mounted in a housing and including
electrical circuitry arranged to receive the electrical signals
from the transducer and operative to generate at least one display
indicative of a condition of the patient's blood pressure; a battery
positioned within the housing and operative to power the electrical
circuitry; and a switch associated with the housing for connecting
the battery into the electrical circuitry to power the circuitry.
This arrangement allows the kit to be provided as standard, required
equipment on all code cards in all hospital emergency rooms and
ambulances since the kit provides a sterile, portable, and disposable
mechanism for monitoring blood pressure.
According to a further feature of invention, the kit further includes
securement means on the housing operative to secure the housing
to a patient's body at a location proximate the location of the
catheter insertion. This arrangement further facilitates the convenience
of the kit by allowing the main body of the kit to be attached directly
to the patient's body rather than requiring a separate support apparatus.
According to a further feature of the invention, the kit further
includes a container totally enveloping the catheter, transducer,
and monitor and forming a sealed sterile package. This arrangement
allows the container to be opened upon demand to provide a disposable,
sterile blood pressure monitor.
According to a further feature of the invention, the kit further
includes a conduit for conducting blood from the catheter to the
monitor and means for flushing the conduit. The flushing means may
comprise a syringe in communication with the conduit and operative
when actuated to deliver a flushing solution to the conduit, or
may comprise a pressurized reservoir mounted on the housing and
containing a flushing solution which is continuously fed to the
conduit.
According to a further feature of the invention a stop cock is
positioned in the conduit between the catheter and the housing.
Using this stop cock arrangement, arterial blood gases can be readily
sampled for analysis.
In the disclosed embodiment of the invention, the kit further includes
a tray positioned removably within the container; the kit includes
a plurality of catheters of varying sizes and configurations and
all the catheters are positioned in the tray so as to provide a
selection of catheters for use with the monitor; the container defines
a lower level below the tray; and the transducer and monitor are
positioned in the lower level of the container beneath the tray.
This specific packaging allows the kit to be provided in a compact,
sterile, readily-usable form.
According to the invention methodology, the kit is moved to a location
proximate an artery of the patient and the catheter of the kit is
inserted into the patient's artery. This methodology, which capitalizes
on the lightweight and small size of the invention kit, allows accurate
blood pressure monitoring to be provided in virtually all emergency
scenarios.
According to a further feature of the invention methodology, the
housing mounting the monitoring device is secured to the patient's
body at a location proximate the location of the catheter insertion.
This methodology, which again capitalizes on the lightweight and
small size of the invention kit, allows the secure positioning of
the monitoring device on the patient's body adjacent the insertion
location.
BRIEF DESCRIPTION OF THE DRAWING
FIG. 1 is a perspective view showing the invention blood pressure
monitor kit in use to monitor the blood pressure of a patient in
an emergency situation;
FIG. 2 is a perspective view of the blood pressure monitor kit;
FIG. 3 is a cross-sectional view of the kit taken on line 3--3
of FIG. 2;
FIG. 4 is a view of the kit with a sterile cover peeled back;
FIG. 5 is a view of the kit with an upper tray removed;
FIG. 6 is a top view of the operative elements of the kit removed
from the container;
FIG. 7 is a side view of the operative elements of the kit removed
from the container; and
FIG. 8 is a bottom view of the operative elements of the kit removed
from the container.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT
The invention blood pressure monitor kit in the form in which it
is supplied to emergency rooms, ambulances, and other emergency
scenarios is seen in FIG. 2, and the kit as it is utilized in a
typical emergency scenario is seen in FIG. 1.
The operative elements of the kit constitute a blood pressure monitor
10. Monitor 10 includes a catheter 12, a first stop cock 14, a conduit
16, a second stop cock 18, and a housing assembly 20.
Catheter 12 includes an operative end 12a for insertion in an artery
of a patient undergoing trauma and a connector end 12b.
Stop cock 14 is connected at one end 14a by a LUER connection to
the connector end 12b of the catheter and includes a valve 14b and
an orthogonal branch 14c.
Conduit 16 is formed of a suitable flexible plastic material and
includes a connector portion 16a connected to the other end 14d
of the stop cock, an operative portion 16b, and a flushing portion
16c.
Stop cock 18 is secured to the free end 16d of the flushing portion
16c of the conduit and includes a valve 18a and an orthogonal branch
18b.
Housing assembly 20 includes a housing 22, a transducer 24, a monitoring
device 26, a reservoir 28, and housing attachment means 30,32.
Housing 22 has a generally rectangular configuration, may be formed
of a suitable molded plastic material, and is operatively associated
with and secured to conduit portions 16b and 16c along one edge
22a of the housing.
Transducer 24 is mounted in the housing 22 with one edge 24a of
the transducer in operative association with the operative portion
16b of conduit 16 so that the transducer may operate, in known manner,
to receive blood pressure signals from the catheter 12, as delivered
to the operative portion 16b of the conduit, and convert the blood
pressure signals into analog electric signals having a waveform
corresponding to the waveform of the rising and falling blood pressure
of the patient.
Monitoring device 26 is mounted in housing 22 immediately above
transducer 24 and includes an analog/digital convertor arranged
to receive the analog signals from the transducer for conversion
to digital signals and further electric circuitry operative to generate
at least one display indicative of a condition of the patient's
blood pressure. In the embodiment illustrated, the displays include
a plurality of vertically stacked windows 26a for displaying successively
higher blood pressure readings, a systolic blood pressure window
26b, a diasystolic blood pressure window 26c, a mean blood pressure
window 26d and a heart rate or pulse window 26e. Displays 26a-26e
may comprise Light Emitting Diode (LED) displays or liquid crystal
displays in known manner.
Reservoir 28 is mounted in housing 22 along side of monitoring
device 26 and comprises a heparinized saline pressurized reservoir
28a connected to the flushing portion 16c of conduit 16 via a flushing
conduit 28b. Reservoir 28a comprises a pressurized plastic bag containing
the pressurized saline solution and the flow of the saline solution
out of the bag 28a into conduit portion 16c is controlled by a valve
28c.
Attachment means 30 comprises a sticky surface 30a provided on
the bottom 22a of the housing and paper segments 30b. Segments 30b
normally cover the sticky surface 30a and may be removed in known
manner to provide a self-adhering surface to facilitate attachment
of the housing to the patient.
Attachment means 32, which may be provided in addition to attachment
means 30 or as an alternative to attachment means 30, comprises
a strap having coacting attachment portions 32a, 32b secured to
opposite side edges 22b, 22c of the housing and operative in known
manner to strap the housing to a limb of a patient.
Housing assembly 20 further includes a battery 34 positioned in
a suitable compartment provided within the housing and a switch
36 provided on the housing and operative when moved from an OFF
to an ON position to place the battery in electrical communication
with the electrical circuitry of the monitor so as to power the
monitor. Since the power requirements of the monitor are very low,
battery 34 may comprise, for example, a miniature watch battery.
The invention blood pressure monitor kit further includes a container
assembly 38 for housing the monitor 10. Container assembly 38 includes
a container 40, a lower tray 42 sized to fit in the lower region
of the container, and an upper tray 44 sized to fit in an upper
region of the container in overlying relation to lower tray 42.
Container 40 and trays 42 and 44 are formed of a suitable molded
plastic material, have a rectangular configuration, and are arranged
so that the trays may be positioned within the interior of container
40 in nesting relation.
Lower container 42 is provided in known manner with suitable grooves
and indentations in its upper face to nestingly receive the monitor
10 with the exception of catheter 12. Specifically, as best seen
in FIG. 5, the upper face of tray 42 receives stop cock 14, conduit
16, transducer 24, monitor 26, reservoir 28, and stop cock 18 in
suitable indentations in the upper face of the tray so that, once
the upper tray 44 has been removed from container 40, monitor 10
(excluding catheter 12) may be readily removed from the tray 42.
Alternatively, tray 42 may be removed from container 40 whereafter
monitor 10 may be removed from the tray.
Upper tray 44 includes a plurality of suitable grooves and indentations
to receive one or more catheters 12 as well as accessory equipment
such as a scalpel, guide wires, syringes, needles, Lidocaine, antiseptic
skin preparation solution, sutures, bandages, and a small drape
46.
Upper and lower trays 42 and 44 are wrapped in a sterile manner
in a large drape 48 which extends completely around the stacked
trays in the container assembly 38. Container 40 is sealed in a
sterile manner by a plasticized paper cover 50 which is normally
securely bonded to the upper rim 40a of container 40 but which can
be readily peeled back, as seen in FIGS. 4 and 5, to expose the
contents of trays 42 and 44.
A typical application of the invention blood pressure monitor kit
is seen in FIG. 1 wherein a patient 52 is undergoing CPR in an emergency
setting such as in an ambulance or in an emergency room. As previously
noted, it is extremely important to provide an accurate and ongoing
indication of the patient's blood pressure during the CPR procedure
so as to judge the effectiveness of the CPR.
In the use of the invention blood pressure monitor kit to provide
an accurate and ongoing indication of the patient's blood pressure
during an emergency CPR procedure, the kit is moved to a location
proximate the femoral artery 54 of the patient; cover 50 is peeled
back to expose the contents of container 38; trays 42 and 44 are
removed from the container; large drape 48 is laid out at a convenient
location proximate the patient (for example, as illustrated, over
the mid-section of the patient) to provide a sterile field 48a;
trays 42 and 44 are positioned on sterile field 48a; monitor 10
(less catheter 12) is removed from lower tray 42; a suitable catheter
12 is selected by the attending medical person from the array of
catheters provided in upper tray 44 with the particular catheter
chosen depending upon professional preference and arterial size;
small drape 46 is positioned over the groin of the patient with
a central aperture 46a of the drape exposing the groin area and
thereby allowing access to femoral artery 54; the chosen catheter
12 is inserted into femoral artery 54 utilizing the Seldinger technique
(wherein a needle is placed in the artery, a wire is inserted through
the needle, the needle is removed, the catheter and a corresponding
dilator are placed over the wire, and the wire and dilator are removed);
the selected catheter 12 is connected by a LUER connection to stop
cock 14; housing 22 is secured to the patient's thigh 52a at a location
proximate the location of the catheter insertion utilizing either
the sticky self-adhering surface 30a on the bottom of the housing
and/or the strap 32 positioned around the leg of the patient; the
system is flushed with a saline or heparinized saline solution;
switch 36 is moved to an ON position to power the monitor; and the
catheter is sewn in position. The attending medical person is thereafter
provided with an ongoing and accurate indication of the blood pressure
of the patient so as to provide an ongoing indication of the effectiveness
of the CPR or other procedure being administered to the patient.
Specifically, once the blood pressure monitor is in place, the
attending medical person is provided with a continuous averaged
measure of the systolic, diastolic and mean blood pressure of the
patient, as well as a continuous indication of the pulse of the
patient. The rising and falling blood pressure is also presented
in graphic form in the series of windows 26a with windows 26a successively
lighting with each beat of the patient's heart to indicate the blood
pressure attained during that specific beat. During this procedure,
valve 28c is open to allow a continuous drain of a flush solution
(for example, heparinized saline) from reservoir 28a into conduit
portion 16c so as to ensure that the conduit will not clot during
use. The conduit 16 may also be flushed during use by a syringe
applied to stop cock 18 and arterial blood gases may be drawn at
any time during the procedure utilizing branch 14c of stop cock
14 in coaction with valve 14b.
Although the invention blood pressure monitor kit has been illustrated
as being employed in association with the femoral artery, it will
be apparent that the kit may also be employed with other arteries
such as the radial artery.
Monitoring device 26 preferably includes a microprocessor chip
and the chip preferably includes memory so that the blood pressure
and pulse information provided during a given CPR procedure may
be retrieved for downloading into a computer for subsequent analysis.
The retrieval may be accomplished by a plug 60 inserted into a jack
62 in housing 22 or by an infrared transmitter 64 provided on housing
22 and coacting with an infrared receiver 66. In addition to retrieving
the stored information relating to a particular procedure after
the procedure has been completed, the monitor may also be equipped
to transmit a continuing stream of blood pressure and pulse information,
as it is being received during a particular procedure, to a remote
receiving location, such as a hospital to which the patient is being
transported as the procedure is being performed. Monitoring device
26 also preferably includes an alarm to indicate that the patient's
blood pressure and/or pulse has gone out of a predetermined range
with lower and upper limits. For example, an LED 56 may be provided
in housing 22 controlled by a switch 58 so that, when the switch
is moved to an ON position, LED 56 will be energized whenever the
patient's pulse and/or blood pressure goes above or below the predetermined
range to serve as an alarm to the attending medical person. Alternatively,
an audible signal may be provided when the pulse and/or blood pressure
goes above or below the predetermined range.
Once the need for monitoring has ended, the entire blood pressure
monitor kit may be suitably disposed of since the kit is intended
for one time use and is not intended for resterilization.
The invention blood pressure monitor kit will be seen to provide
many important advantages as compared to current techniques utilized
to monitor blood pressure during emergency procedures. Specifically,
as compared to the finger palpation employed in many emergency CPR
scenarios, the invention kit provides an ongoing and accurate indication
of the patient's blood pressure; as compared to the use of a sphygmomanometry
device in situations where a blood pressure cuff is available, the
invention kit provides a continuous ongoing indication of blood
pressure as compared to the occasional readings provided by the
blood pressure cuff; as compared to an intensive care unit setting
in which permanently installed, expensive, bulky blood pressure
monitoring equipment is available, the invention kit requires an
investment that is only a tiny fraction of the investment required
for the permanently installed blood pressure monitoring equipment
and the invention kit, by virtue of its lightweight and small size,
may be delivered to the patient in the emergency scenario, such
as in an ambulance, and may be directly applied to the patient's
body. For example, a monitoring device 26 constructed in accordance
with the invention may have dimensions of 21/2 by 5 by 1 inch and
may have a weight of 125 grams. This extremely small size and extremely
lightweight, as compared to the prior art permanent blood pressure
monitoring devices, allows the invention blood pressure kit to be
readily moved to a location proximate an artery of the patient for
insertion of the catheter into the artery. The extremely small size
and lightweight also allow the monitoring device to be readily and
comfortably attached to the patient's body.
Whereas a preferred embodiment of the invention has been illustrated
and described in detail, it will be apparent that various changes
may be made in the disclosed embodiment without departing from the
scope or spirit of the invention.
|