U.S. patent application number 09/977105 was filed with the patent office on 2002-02-07 for rapid infusion system.
Invention is credited to Cartledge, Richard G..
Application Number | 20020016570 09/977105 |
Document ID | / |
Family ID | 22628019 |
Filed Date | 2002-02-07 |
United States Patent
Application |
20020016570 |
Kind Code |
A1 |
Cartledge, Richard G. |
February 7, 2002 |
Rapid infusion system
Abstract
A rapid infusion system for rapidly delivering blood and/or
volume expanding fluid to a patient, said rapid infusion device
comprising in combination: a portion which includes an adjustable
drive means and related control means therefor, and a portion which
includes components that come into contact with the fluid infused
to the patient, and optionally wherein said system can be
portable.
Inventors: |
Cartledge, Richard G.;
(Macon, GA) |
Correspondence
Address: |
William L. Warren
SUTHERLAND ASBILL & BRENNAN LLP
999 Peachtree Street, NE
Atlanta
GA
30309-3996
US
|
Family ID: |
22628019 |
Appl. No.: |
09/977105 |
Filed: |
October 12, 2001 |
Related U.S. Patent Documents
|
|
|
|
|
|
Application
Number |
Filing Date |
Patent Number |
|
|
09977105 |
Oct 12, 2001 |
|
|
|
09172512 |
Oct 14, 1998 |
|
|
|
09172512 |
Oct 14, 1998 |
|
|
|
08608291 |
Feb 28, 1996 |
|
|
|
5840068 |
|
|
|
|
Current U.S.
Class: |
604/131 |
Current CPC
Class: |
A61M 5/142 20130101;
F04B 2203/0209 20130101; F04B 17/03 20130101 |
Class at
Publication: |
604/131 |
International
Class: |
A61M 037/00 |
Claims
What is claimed is:
1. An infusion system for rapidly delivering a fluid such as blood,
blood components, oxygen-carrying substances, plasma, plasma
components, contrast material, drugs, physiologic fluids, and/or
volume expanding components to a patient, said system comprising: a
fluid conduit means having a proximal end and a distal end, the
proximal end of said fluid conduit means containing at least one
fluid reservoir, a propelling means for propelling the infusium,
said propelling means in fluid communication with the at least one
fluid reservoir through a connection at the distal end of said
fluid conduit means, said propelling means including an adjustment
means for selecting the fluid flow rate of the propelling means,
said propelling means further comprising a pump means for imparting
motion to the infusium, said pump means having a drive means for
driving the pump means wherein the pump means is separable from the
drive means.
2. The system of claim 1 wherein said pump means is selected from
the group consisting of gear pumps, turbine pumps, screw pumps,
diaphragm pumps, centrifugal pumps, centripetal pumps, piston
pumps, peristatic pumps, roller head occlusive pumps and
nonocclusive centrifugal pumps.
3. The system of claim 1 wherein only said separable pump means
contacts the infusium.
4. The system of claim 3 wherein said pump means is a roller
mechanism.
5. The system of claim 4 wherein said roller mechanism includes a
disposable flexible length of tubing serving as a pumping
chamber.
6. The system of claim 1 which can provide fluid flow rates from
about 40 cc/hour to about 2.5 l/minute.
7. The infusion system of claim 1 including means to measure a
bodily pressure.
8. The infusion system of claim 1 including means to measure urine
output.
9. The infusion system of claim 7 including pump control means
responsive to at least one bodily pressure measurement.
10. The infusion system of claim 8 including pump control means
responsive to said urine output.
11. The infusion system of claim 9 wherein the bodily pressure is
the central venous pressure measured during infusion using a single
venous catheter.
12. The infusion system of claim 9 wherein the bodily pressure
measured is the pulmonary capillary wedge pressure.
13. The infusion system of claim 9 wherein the bodily pressure
measured is the arterial pressure.
14. The system of claim 1 further including a separate container
for fluid not obtained directly from the patient to be furnished to
the reservoir.
15. A method for rapid infusion of a fluid such as blood, blood
components, oxygen-carrying substances, plasma, plasma components,
contrast material, drugs, physiologic fluids, and/or volume
expanding components into the venous system of a patient,
comprising the steps of: a. providing a reservoir of the fluid to
be infused into a patient; and b. propelling the fluid from the
reservoir into the venous system of the patient by an adjustable
flow rate portable infusion mechanism having a pump drive means for
driving a pump means, said pump means being separable from the
drive means.
16. The method of claim 15 wherein the fluid is propelled at flow
rates from about 40 cc/hour to about 2.5 l/minute.
17. The method of claim 15 including measuring a bodily pressure of
a patient.
18. The method of claim 15 including measuring the urine output of
a patient.
19. The method of claim 17 including pump control means responsive
to said bodily pressure measurement.
20. The method of claim 18 including pump control means responsive
to said urine output.
21. A power infuser comprising at least one fluid reservoir, fluid
conduit means communicating with the reservoir, an adjustable fluid
propelling means downstream of the reservoir, means to control the
pressure/flow of the fluid, said fluid conduit means including
tubing means in fluid communication with the reservoir, and
separate means in fluid communication with the tubing means near
the reservoir to selectably discharge fluid to a patient, wherein
said propelling means comprises pump means for imparting motion to
the infusium, said pump means having a drive means for driving the
pump means wherein the pump means is separable from the drive means
and wherein only the separable pump means contacts the fluid.
22. The power infuser of claim 21 which can provide fluid flow
rates from about 40 cc/hour to about 2.5 l/minute.
23. The power infusion of claim 21 including a Y-connector in the
fluid conduit to the patient providing branched conduits to the
patient, the branched conduits each including means to provide
communication with a separate intravenous infusion system and means
for access with a syringe.
24. The power infuser of claim 21 wherein the at best one fluid
reservoir is of sufficient capacity to transfuse the entire blood
volume of an adult patient.
25. The power infuser of claim 21 being of a size and weight such
that it can be easily held by a person while in use.
26. The power infuser of claim 21 wherein said pump means is
energized by D.C. current.
27. The power infuser of claim 21 wherein said pump means is
energized by A.C. current.
28. The power infuser of claim 21 having more than one pump means
and the capability to increase the fluid flow rate, infuse fluids
into a person at multiple points, and to infuse multiple types of
fluids into a person.
29. The power infuser of claim 21 including means to measure a
bodily pressure.
30. The power infuser of claim 29 including pump control means
responsive to said bodily pressure measurement.
31. The rapid infusion system of claim 1 which is portable.
32. The power infuser of claim 26 wherein said pump means is
energized by a battery selected from the group consisting of
standard and rechargeable batteries.
33. The power infuser of claim 21 including a means for changing
the temperature of the fluid.
34. The power infuser of claim 21 wherein said pump means includes
a releasably attached portion which enables removal of the fluid
contacting part.
35. The power infuser of claim 33 wherein the means for changing
the temperature of the fluid includes a portion having at least one
channel through which the fluid flows.
36. The power infuser of claim 35 wherein the portion having at
least one channel is removably attached within the power
infuser.
37. The power infuser of claim 36 wherein the removably attached at
least one channel is a serpentine opening formed in the portion,
which portion slidably engages an opening in the power infuser.
38. The power infuser of claim 36 wherein the means for changing
the temperature of the fluid is attached to the removable
portion.
39. The power infuser of claim 33 including means to sense the
temperature of the fluid.
40. The power infuser of claim 29 including a means to monitor the
bodily pressure.
41. The power infuser of claim 21 including a means to sense the
fluid flow to a patient.
42. The power infuser of claim 33 wherein the means for changing
the temperature of the fluid is a heating means.
43. The power infuser of claim 33 wherein the means for changing
the temperature of the fluid is a cooling means.
44. The power infuser of claim 21 including a means for sensing the
presence of air in the fluid prior to discharging the fluid to a
patient.
45. The power infuser of claim 21 including irrigator means
attachable to the infuser to apply fluid to irrigate an area of a
patient.
46. The power infuser of claim 21 including means to inject
contrast medium into a vein or artery of a patient.
47. The power infuser of claim 21 wherein said pump means is
removable and disposable.
48. The power infuser of claim 21 wherein the pump means is
detachable and components thereof which come into contact with the
fluid being infused are removable and disposable.
49. The power infuser of claim 33 wherein the means for changing
the temperature of the fluid has increased surface area to impart
desired temperature to the fluid.
50. The power infuser of claim 33 wherein the means for changing
the fluid temperature includes tubing which is disposable.
51. The power infuser of claim 37 wherein the means for changing
the fluid temperature is disposable.
52. The power infuser of claim 21 wherein said pump means includes
a head portion with attached tubing that is removable and
disposable.
53. The power infuser of claim 21 including a heat exchange
cassette for changing the temperature of the fluid.
54. The power infuser of claim 21 wherein said pump means includes
an openable portion allowing access and removal of the tubing which
comes in contact with the fluid.
55. The power infuser of claim 21 wherein the pump means and
associated tubing is removable and disposable.
Description
FIELD OF THE INVENTION
[0001] This invention relates to an apparatus for the rapid
infusion of circulatory supportive fluids such as blood into a
patient. The system comprises permanent and disposable components.
The various components which physically come into contact with the
fluid being infused can easily be removed and disposed. The
principal advantage achieved from this arrangement resides in the
fact that it is small, lightweight, and portable. The system can be
of a size to fit in a person's hand and is ideal for use by
emergency personnel.
BACKGROUND OF THE INVENTION
[0002] During surgery or in the emergency room, it is frequently
necessary to infuse blood or volume expanding fluids rapidly into a
patient, particularly when massive blood losses have occurred.
Patients having inadequate blood volume can suffer serious
consequences.
[0003] There are many situations where large amounts of blood can
be lost in a very short period of time, for example, in cases of
serious automobile accidents, gun shot wounds in critical areas of
the body, and a variety of plural surgeries including cancer
surgery and heart and liver transplants.
[0004] In the past, the replacement of large amounts of blood loss
has been a major problem to the surgical teams attending a
suffering patient. A common method of rapid infusion includes the
use of a plurality of infusion sites simultaneously. Infusion bags
or bags of stored banked blood are interconnected by intravenous
tubing. Frequently, a plurality of medical personnel are required
to oversee the various infusion sites and to personally ensure the
flow of blood from the blood bags.
[0005] Anesthesiologists and/or other ancillary staff are regularly
involved with cardiopulmonary resuscitation, trauma and organ
transplantation procedures, and with maintenance of patient
hemodynamics during any operative or emergency procedure. During
such procedures, patient blood loss cannot, practically speaking,
always be contained by the operating surgeon and such blood must be
replaced by the anesthesiologists standing in attendance. It is not
uncommon for multiple anesthesiologists or technicians to stand in
attendance during lengthy operations attempting to infuse massive
quantities of blood through five or six venous catheters.
[0006] Clinical records obtained from actual operations involving
trauma and liver transplantations reveal blood losses estimated to
be in excess of two hundred and fifty liters, a volume
approximately fifty times a normal adult's total blood volume.
Although it is not uncommon for an anesthesiologist or trauma
surgeon to encounter massive exsanguination (ten liters and more)
in a major trauma and transplantation center, it is, however,
unusual to successfully resuscitate a patient with such massive
blood volume loss with traditional methods.
[0007] Stephens, Jr., et al., U.S. Pat. No. 5,061,241, disclose a
rapid infusion device capable of high volume pumping composed of
two units. A permanent unit comprising a base portion which houses
an AC/DC motor, a roller pump, and other associated gauges and
switches. A disposable unit includes a filter reservoir, heat
exchange component, and associated tubing leading to the roller
pump. The roller pump increases the volume of fluid being pumped by
increasing the rpm of the pumping unit and includes a pressure
control valve.
[0008] Sassano, U.S. Pat. No. 4,747,826, discloses an infusion
apparatus consisting of supply sources, reservoirs, and associated
tubes and valves leading to an infusion pump which can either be a
roller head occlusive or centrifugal pump.
[0009] The rapid infusion of IV fluids has proven to save lives in
patients suffering from blood loss. All rapid infusion devices
presently available are large, heavy, prohibitively expensive, and
extremely costly to operate because of special, extremely expensive
components that have to be discarded after each use. All of these
devices are large, cumbersome, difficult to use, require
specialized training, require long set up time, use specialized
tubing, do not have their own power supply and are not suitable to
ambulance or field use. The prior art rapid-infusion devices cannot
be used with typical peripheral IV cannulas but require large-bore
central-line or venous cut-down catheters which can be inserted
only by physicians. Although rapid infusion, or hyperinfusion, is a
proven life saver, this technology is not commonly available to the
public in most hospitals because of the aforementioned reasons.
SUMMARY OF THE INVENTION
[0010] With knowledge of the shortcomings of present day blood
infusion apparatuses noted above, applicant has developed the rapid
infusion system disclosed and claimed in the instant
application.
[0011] An object of the present invention is the provision of an
apparatus which satisfies the various requirements of rapid
infusion while at the same time reduces the number of medical
and/or technical personnel required to monitor the equipment, a
much desired improvement over presently known systems and practices
used in critical, life threatening situations.
[0012] A further object of the present invention is to provide an
adjustable system which is capable of high volume infusion of
blood, blood components, oxygen-carrying substances, plasma, plasma
components, contrast material, drugs, any physiological fluid,
and/or volume expanding fluids, all of which are hereinafter
referred to as "fluids," into a patient.
BRIEF DESCRIPTION OF THE DRAWINGS
[0013] Referring to the drawings:
[0014] FIG. 1 is a front elevational view of the rapid infusion
system.
[0015] FIG. 2 is a schematic of one embodiment of the present
invention.
[0016] FIG. 3 is a schematic of another embodiment of the present
invention.
[0017] FIG. 4 is a sectional view of a pump mechanism used in one
embodiment of the present invention.
[0018] FIG. 5 is a sectional view of a pump mechanism used in
another embodiment of the present invention.
[0019] FIG. 6 is a side view of a pump mechanism showing the
connections to the rapid infusion unit.
[0020] FIG. 7 is a frontal view showing an IV pole, fluid bag and
the rapid infusion system of the present invention.
[0021] FIG. 8 is a frontal view of the present invention showing
the optional C.V.P. monitoring apparatus.
[0022] FIG. 9 is a frontal view of another embodiment of the
present invention.
[0023] FIG. 10 is a top view of the embodiment shown in FIG. 9.
[0024] FIG. 11 is a fragmentary view depicting one connection means
usable in the present invention.
[0025] FIG. 12 is a fragmentary view depicting another connection
means usable with the present invention.
[0026] FIG. 13 is a sectional top view of a variable speed portable
roller pump embodiment of the present invention.
[0027] FIG. 14 is a bottom view of the embodiment shown in FIG.
13.
[0028] FIG. 15 is a sectional side view of the embodiment depicted
in FIG. 13.
[0029] FIG. 16 is a side view of the embodiment depicted in FIG.
13.
[0030] FIG. 17 is a top view of the drive unit with a permanent
pump head.
[0031] FIG. 18 is a side view of the permanent pump having a flip
top for easy access, showing disposable tubing.
[0032] FIG. 19 is a side view of a removable fluid channel
cassette.
[0033] FIG. 20 is a top view of a disposable pump head unit showing
the channels therein.
[0034] FIG. 21 is a sectioned top view of a motor drive unit of the
present invention showing optional heating coils.
[0035] FIG. 22 is a sectioned bottom view of the disposable pump
head of the present invention showing the fluid channels.
DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0036] The rapid infusion device of the present invention solves
many problems present in prior art devices. It is small and
portable, and if desired can be constructed so as to fit in the
palm of the hand. It is inexpensive and thus can be made available
to patients even in small rural hospitals. It can be used with any
IV tubing or other commonly available hospital equipment and can
generate equivalent or greater flow rates than existing rapid
infusion devices. The present inventive device can be used with
central lines, venous cut-down catheters, or peripheral IVs that
nurses and paramedics can insert, therefore, it has potential
application for use in ambulances, in the field, in emergency
rooms, military applications, battlefield situations and the
like.
[0037] The device can be used for blood transfusions imparting
motion by a pressure change, i.e., it can add fluid to tubing which
already contains the same or different fluid and thereby impart
increased motion to the fluid already in the tubing without such
fluid coming into contact with any other portion of the device,
therefore any pump mechanism can be used. The present invention
also has excellent potential for military applications. Current
hyperinfusion devices have no place in the military/battlefield
areas. Their cost, size, lack of efficiency and lack of qualified
field personnel preclude use of prior art hyperinfusion devices in
such a setting.
[0038] Therefore, the military has no access to hyperinfusion
technology due to the size, cost and complexity of current devices.
The present invention is small and portable. It can be sized to fit
in a person's hand and can be powered by A.C. or D.C. current. If
powered by D.C. current, standard batteries can be used, including
rechargeable batteries. Preferably when the infuser of the present
invention is used in the field or in military applications, it can
be less than about 5 inches by about 5 inches by about 3 inches,
however the size is dependent upon the components used.
[0039] In patients suffering blood loss, measuring the pressure in
the large central veins, (central venous pressure or C.V.P.)
assesses the efficacy of volume replacement. If the C.V.P. is low,
the patient does not have adequate intravascular volume and thus
further fluid resuscitation is necessary. A high C.V.P. is an
indication of volume overload and can result in heart failure and
pulmonary edema (or fluid) in the lungs. Presently, to measure
C.V.P., a large catheter is placed in the patient's neck and
connected to a pressure transducer which converts pressure changes
into an electrical signal displayed on an oscilloscope-type
monitor. Intensive care units and operating rooms are usually the
only hospital areas capable of measuring C.V.P. In the ER setting,
fluid administration is gauged empirically using only the patient's
blood pressure and pulse to assess the adequacy of volume
replacement. Hyperinfusion devices are best used while
simultaneously monitoring C.V.P. The volume and rate of flow into
the patient can then be quickly and accurately adjusted to sustain
an adequate C.V.P. The hyperinfuser of the present invention can
optionally infuse fluids and measure C.V.P. through a single
central venous catheter. The small device not only rapidly infuses
fluid and monitors C.V.P., but can adjust the flow rate
automatically to achieve any C.V.P. the physician desires. The
present invention not only insures the ideal infusion rate for any
particular patient, but is an inexpensive alternative to large,
expensive C.V.P. monitors and obviates the need to place a second
venous catheter dedicated only to C.V.P. readings. The present
invention can include a dial to set the desired C.V.P., a screen
that displays the actual C.V.P., and a mechanism that stops the
pump at pre-set, time intervals in order to accurately measure the
C.V.P. The operator need only select how many times per minute the
pump should stop, read the C.V.P., and adjust the flow rate
accordingly. A manual mode is provided to infuse at a simple fixed
rate with a switch that will halt the pump and give the operator an
instantaneous C.V.P. reading. An automated control means may be
optionally used which maintains the C.V.P. within a preset range.
The adjustable pump means responds to signals from the control
means and increases or decreases the fluid pressure and/or flow
rate in response thereto. Advantageously, the inventive device has
an alarm indicating when the IV fluid bag approaches empty. The
central venous pressure previously mentioned is measured by
attaching directly into a vein within the chest. The present
invention can also respond to pulmonary capillary wedge pressure,
i.e., an output from a different machine, by having the separate
machine provide information to the base unit. The pumping mechanism
of the present invention optionally is adjustable based upon data
received from any type of physiologic monitoring that indicates
intervascular volume status, artery or vein pressure, urinary
output, cardiac output and any type of bodily pressure measurement
device. One such device determines the pulmonary capillary wedge
pressure, an indirect measure of left ventricular filling pressure.
Another device determines the urine output of the patient and the
pumping mechanism responds to and is adjustable based upon this
data. The present invention can also analyze and respond to various
parameters which are indicated or set by the physician or
technician.
[0040] The rapid infusion system is composed of two major portions.
One portion includes permanent equipment, i.e., equipment which
need not be sterilized and can be used over and over again, such as
the pump motor and its related controls and optional equipment such
as a C.V.P. monitor and related controls, optionally a heating
element, conductive, convective, radiant, microwave, or other means
of imparting heat to the fluid infused, and related controls and
attachment means. The other portion includes the removable
components of the system which may be disposable and/or
semi-permanent equipment such as the pump and pump gears or
rollers, which advantageously are reusable, and blood or fluid
reservoir, valves and tubing, which advantageously are
disposable.
[0041] The disclosed rapid infusion system is an adjustable
mechanical pumping system for rapidly delivering blood and/or
volume expanding fluids to a patient suffering from acute
hypovolemia. The principle of operation of the disclosed invention
is one of mechanically overcoming resistance. "Blood" is used
herein to describe or refer to blood, blood components, and/or
volume expanding fluids or colloids delivered by the system since
not only blood, but any other desired fluid may be delivered by the
system. "Reservoir" as used herein includes one or more standard IV
bags or separate container(s) where such containers are more
practical than an IV bag.
[0042] The subject invention pertains to a novel system for rapid
intravenous infusion of a physiologic fluid, such as blood, which
can include in combination a reservoir for the physiologic fluid
having an inlet port for receiving the physiologic fluid and an
outlet port for dispensing the physiologic fluid, an infusion pump
to propel the physiologic fluid through the system, optional means
for controlling the temperature of the physiologic fluid, optional
means for filtering occlusive materials from the physiologic fluid,
optional means for sensing the pressure of the physiologic fluid,
means for infusing the physiologic fluid into a venous system and
means for conveying the physiologic fluid to and from each of the
components of the system.
[0043] In a preferred embodiment, the adjustable rapid infusion
system comprises a reservoir that can have a capacity that can
exceed several liters for holding a supply of physiologic fluid,
the inventive infusion pump selected from known pumps, including,
but not limited to the group consisting of gear pumps, turbine
pumps, screw pumps, diaphragm pumps, centrifugal pumps, centripetal
pumps, piston pumps, peristatic pumps, roller head occlusive pumps,
nonocclusive centrifugal pumps and the like; optional portions such
as a flow rate feed back means that can adjust the fluid flow rate
responsive to inputs, a temperature controlling means; a filter to
remove any occlusive material from the physiologic fluid; a sensor
for detecting the presence of air, tube occlusion, or increased
pressure in the physiologic fluid in conjunction with means for
cutting off the flow in the conduit in response to a detected
predetermined quantity of air, presence of an occlusion or
increased pressure. The pump advantageously is infinitely
adjustable and can provide fluid flow rates from about 40 cc/hour
to about 2.5 l/minute. Optionally, the present rapid infusion
system may employ two or more pumps depending upon the amount of
fluid needed.
[0044] Optionally, the system may further include temperature
sensors, if used in conjunction with the optional heater, at the
output of the temperature controlling means for measuring and
adjusting the physiologic temperature to maintain the temperature
within acceptable limits. The system may also have readout means,
which display fluid temperature, line pressure, fluid flow rate,
total volume of fluid infused, and other parameters that imply the
volume status of the patient.
[0045] The inventive system has a variable speed pump motor so that
the amount of volume being pumped in can be increased merely by
increasing the rpm of the motor. The reservoir may contain plural
stages of filters and be provided with a plurality of inlets
whereby volume from multiple sources can be fed into the reservoir
to satisfy any high demand requirements of a patient. As set forth
above, the system comprises a permanent portion and a removable and
disposable portion. The removable portion can include any pumping
means and components with which the fluid may come into
contact.
[0046] Referring now in detail to FIG. 1, the rapid infusion device
10 of the present invention includes an on/off power switch 11, a
C.V.P., or other bodily pressure measurement device for determining
when the measured pressure is within or outside set parameters, a
feedback mode on/off switch 12 for activating the measurement
device, a variable flow rate control 13 for use when a bodily
pressure measurement device is not being monitored and a liquid
crystal display bodily pressure measurement readout 14. Pump
mechanism 15 is driven by and removably connected to device 10 by
attachment to shaft 16. Optionally, pump mechanism 15 may be
recessed within device 10 so that it does not extend outside device
10. Device 10 also includes a C.V.P. data input jack 17, a fluid
flow meter 18, an A.C./D.C. power selector switch 19, a bodily
pressure measurement device setting 20 for use in the feedback mode
and an external supply/charger port 21.
[0047] FIG. 2 is a schematic of one embodiment of the present
invention wherein rapid infusion device 40 has a battery pack 41
connected to a central venous pressure feedback regulator 42. A
drive gear box 43 is connected to a shaft 44 for driving a pump
mechanism (not shown) and is driven by motor 45. Means, 46, to vary
the resistance is connected to battery pack 41 and motor 45 and can
vary the speed of motor 44 and thus the rotational speed input to
gear box 43 and the pump mechanism. Gear box 43 may also include
adjustable gearing to enable easily switching from a gear pump
mechanism to a roller pump mechanism and vice-versa.
[0048] FIG. 3 is a schematic of another embodiment of the present
invention having optional multiple pump mechanisms wherein rapid
infusion device 60 has a battery pack 61, a bodily pressure
measurement flow regulator 62, a motor 63 with shaft 64, and a
motor 65 with shaft 67. A means, 66, to vary the resistance is
connected to battery pack 61, regulator 62, motor 65 and motor 63,
and can vary the speed of motors 63, 65, thereby varying the
rotational speed input to the single or multiple pump mechanism(s)
(not shown) which attaches to the shafts 64, 67.
[0049] FIG. 4 is a sectional view of one type of pump usable in an
embodiment of the present invention. Gear pump 80 is attachable to
shaft 16 of device 10 thereby driving pump means 82 and 83 and
imparting motion to fluid received from a reservoir through opening
81 and exiting through opening 84.
[0050] FIG. 5 is a sectional view of one type of pump usable in
another embodiment of the present invention wherein mechanism 100
is attachable to shaft 16 of device 10 thereby driving pump means
103 and 102 and imparting motion to a fluid from a reservoir
received through opening 101 and exiting through opening 104. As
can be seen the fluid goes through channels around the
circumference of pump means 102 and 103 and exits through opening
104.
[0051] FIG. 6 is a side view of a pump mechanism usable with the
present invention whereby shaft 122 is connected to shaft 16 of
unit 10, thereby driving gear 123 which imparts motion to fluid
received from a reservoir through opening 121 and exiting through
opening 124. Annular shoulders 125 provide secure attachment to
tubing or the like.
[0052] FIG. 7 is a typical IV arrangement 140 for hanging an IV bag
141 containing fluid which flows through tubing 143 to the rapid
infusion device 142 of the present invention. Device 142 is
attached to pole 147 by attachment means 146 and imparts motion to
the fluid from bag 141 and directs it through tubing 144 to a
patient. Device 142 may be powered by a battery or an external
power source through cord 145.
[0053] FIG. 8 is a sectional view showing an optional C.V.P.
monitoring system for the present invention. Pumping mechanism 160
contains a pressure probe 161 connected by a conduit 162 to the
outlet 165 of the pumping mechanism. Fluid enters the pumping
mechanism from a reservoir through inlet 164 whereby motion is
imparted to the fluid by the pumping mechanism gears 163. The fluid
pressure with the pump stopped is measured through conduit 165 and
tubing 162 which communicates with pressure probe 161.
[0054] FIG. 9 is a front view of the motor drive unit of one
embodiment of the present invention. Flow adjuster 176 variably
adjusts motive force to the drive unit resulting in fluid flow
rates to a patient from about 40 cc/hour to about 2.52 l/minute.
Switch 175 selects either AC or DC power to the unit. Plug 174
connects to an AC source where one is provided. Flow range
selection switch 173 adjusts the motive force to the drive unit
thereby providing for either high flow (500 cc/hour to 2.5
l/minute) and low flow, including maintenance flow, (40 cc/hour to
500 cc/hour). Switch 172 is a power on/off switch. Meter 171
indicates fluid flow when the unit is in operation. Housing 170
encases the unit. In one embodiment the removable portion (or unit)
can be either a plastic, metal, composite, or the like device with
the tubing therein. The plastic device is intended for disposal
after use and the tubing may be a permanent portion of the housing.
Another embodiment is more semi-permanent that may be attached to
the top of the motor drive unit allowing one to flip open the top
of the pump mechanism and replace the tubing, enabling anyone with
a minimum amount of training to operate the mechanism.
Advantageously the present invention encompasses different types of
pump attachments, semi-permanent, i.e. which may include a pumping
mechanism having a flip open top, i.e. the top can be opened and
the tubing as well as other parts of the mechanism that come into
contact with the fluid can be removed and replaced. This portion of
the top may be releasably attached by known means such as hinges,
snaps, latches, and the like.
[0055] Referring to FIG. 10, there is provided air detector
transmitter 180 and air detector receiver 182 or any other means
for determining the presence of air in the fluid before the fluid
is directed to a patient. Trough 181 is provided for a length of
tubing or a coupling device, preferably a leur-lock or other tubing
coupling means (not shown) including a portion through which flow,
temperature, etc. can be measured. Drive shaft coupler 183 mates
with coupler 222 (shown in FIG. 14) which is attached to top
housing 185. A flow probe or sensor determines the fluid flow rate
and may be ultrasonic or other known types of sensors.
[0056] FIG. 11 depicts IV tubing 190 having a male leur-lock
coupling device with connector 191.
[0057] FIG. 12 shows removable female leur-lock coupling 200 with
interchangeable leur-lock adaptor 201 having threads 202 which
screws into the unit 215 at lock receptacle 210 (shown in FIG. 13).
This allows easy replacement with apparatus of the same size as
that removed or with a different size, resulting in different flow
rates and capacities.
[0058] FIG. 13 shows a roller mechanism contained in housing 215
which has a threaded leur-lock receptacle 210 and indicates a fluid
flow direction of 211. Roller 212 compresses collapsible tube 213
against compression surface 214, thereby imparting motion to the
fluid within tube 213. Tube 213 which may be removable, disposable
and replaceable with another length of tube in one embodiment, may
be a permanent portion in another embodiment. Housing 215 is
removable and it and the components therein other than tube 213 are
reusable.
[0059] FIG. 14 shows bottom housing 220 having a connector 221 for
attachment to the base unit and motor drive shaft coupler 222 which
imparts motion to the pump mechanism. FIG. 14 shows detachable
housing 220, having connector 221 shown as a hexagonal friction
coupler, for attachment to the base unit and motor driver shaft
coupler 222. The hexagonal coupler frictionally locks it onto the
base unit and the teeth from the drive shaft (not shown) are
separate entities that interdigitate. The hexagonal coupler is a
fixed unit and may be made of molded plastic. Although the
preferred embodiment of attaching the roller pump to the base unit
is the described hexagonal friction coupling system, the present
invention is not limited to that embodiment since other coupling
means known in the art are included.
[0060] FIG. 15 is a sectional side view of the roller mechanism
shown in FIG. 13 and depicts housing 230 having drive coupler 233
in association with friction coupler 234 which imparts motion to
roller 231 about pivot point 232, thereby imparting motion to the
fluid.
[0061] FIG. 16 is a side view of the roller mechanism shown in FIG.
13 and depicts housing 242 showing fluid outflow receptacle 241 and
friction coupler 240 associated therewith.
[0062] FIG. 17 is a top view of one embodiment of the present
invention showing motor drive unit 251 and bubble detector 250 for
detecting air in the fluid before transmitting the fluid to a
patient, which is advantageously semi-permanent and can be
completely disposable or in which only the tubing and/or fluid
temperature adjustment means may be disposable.
[0063] FIG. 18 is a side view partly in section showing the present
invention having fluid temperature adjustment unit 261, depicted
with optional fluid cassette 262 having increased surface area to
impart desired temperature adjustment to the fluid, for heating or
cooling, and on-off switch 260 for controlling the unit. The pump
head contains releasably attached top 263, shown in side view,
which provides easy access to replace the disposable tubing in the
pump mechanism. Temperature adjustment unit 261 is adjacent to
fluid cassette 262. Optionally unit 261 may be contained within the
infusion device near fluid cassette 262. The fluid enters
temperature adjustment unit 261 from the pump mechanism, travels
through fluid channels, the temperature is adjusted to be within
set parameters, exits the unit and is transmitted to a patient. The
fluid channels may be formed within the unit, may be contained
within a removable portion such as a cassette insertable into the
unit, or may be contained in a separate unit and attached to the
pump mechanism fluid output tube.
[0064] FIG. 19 depicts the removable tubing apparatus,
advantageously useable with the semipermanent pump mechanism, which
can be completely disposable or in which only the tubing and/or the
fluid cassette may be disposable, which preferably is manufactured
of heat conducting material, showing cassette 273 having fluid
channels 270. Compressible tubing portion 272 is acted upon by the
roller pump to impart motion to the fluid within the tubing which
is held in place by guides 271. The present invention optionally
may include heat exchange means associated with the cassette and/or
separately with the tubing.
[0065] FIG. 20 depicts disposable head unit 280 in section showing
the action of the roller pump on a length of tubing. In this
embodiment unit 280 is capable of attachment to the top of the
infusion device shown in FIG. 18.
[0066] FIG. 21 is a top view in section of the motor drive unit
showing optional temperature adjustment heating coils 290 which may
be used instead of, or in addition to, the temperature adjustment
unit 261 shown in FIG. 18.
[0067] FIG. 22 is a bottom view in section of a disposable pump
head which comes in contact with the heating means of FIG. 21
showing optional fluid temperature adjustment channels 300,
preferably covered by a heat conductive material. This optional
unit may be employed instead of, or in addition to, the temperature
adjustment unit 261 shown in FIG. 18. The disposable pump head of
this embodiment is attachable to the top of the infusion device
shown in FIG. 18.
[0068] As indicated previously, the materials of construction of
the present invention are those normally used for medical
applications. In one embodiment of the present invention, the
apparatus is portable, thereby dictating small size and
lightweight. Where weight is a major factor, the housing and roller
pump mechanism are manufactured of a lightweight material.
Advantageously the housing and pump mechanism are comprised of a
plastic material.
[0069] Although the major use of the present invention is to infuse
quantities of blood into a patient, it can also be used to infuse
other fluids such as a dye into a vein or artery for imaging
purposes. The present invention can also be used as an irrigator,
to clean wounds during laparoscopic surgery and in regular surgical
procedures where any common irrigator is used.
[0070] Unlike standard or traditional methods of intravenous fluid
administration, the inventive rapid infusion system can provide
continuous total replacement of adult human blood volume through
any sort of hemorrhage, for an indefinite period of time and can
rapidly regulate fluid temperature with minimal increase in
resistance to flow, easily and rapidly administer massive
quantities of blood to a single patient during a single operation,
administer physiologic fluid maintained at a predetermined
temperature at flow rates in excess of 2.5 l per minute, and permit
simultaneous display and control of fluid temperature, flow rate,
line pressure, and total volume of physiologic fluid administered.
The present invention allows for two ways to achieve the wide flow
ranges listed, including, but not limited to: by changing the pump
gears and by changing the pump motor. These changes may be
accomplished automatically by switching means activated by various
fluid and/or bodily sensors. The system also is portable and able
to be quickly and easily used in an emergency situation or by
emergency personnel in the field. The blood delivered by the system
can include clotting factors and can infuse an infinite amount of
blood over an indefinite period of time based on the pump mechanism
employed, the tubing sizes, etc., employed. The system can also
include a heating apparatus which imparts heat to the fluid flowing
through a tube or through a channel within the apparatus, thereby
controlling the fluid temperature.
[0071] If desired the present invention can consist of multiple
pumps infusing blood or the like to a patient through multiple
catheters, thereby providing such fluids in volumes to the patient
which are far in excess of that possible by present infusers.
[0072] While the invention has been described in its preferred
embodiment, it is to be understood that the words which have been
used are words of description rather than limitation and that
changes may be made within the purview of the appended claims
without departing from the scope or spirit of the invention.
* * * * *