U.S. patent number RE36,460 [Application Number 09/070,795] was granted by the patent office on 1999-12-21 for method of providing circulation via lung expansion and deflation.
This patent grant is currently assigned to Life Science Holdings, Inc.. Invention is credited to Michael G. Federowicz, Robert M. Goldman, Ronald M. Klatz.
United States Patent |
RE36,460 |
Klatz , et al. |
December 21, 1999 |
Method of providing circulation via lung expansion and
deflation
Abstract
The invention discloses a method for providing circulation,
usually when it has substantially decreased or ceased, such as
during cardiac arrest. The method includes the steps of intubating
the airway of a patient, to provide access to the lungs. The air
and other material in the lungs is then evacuated. A liquid
breathing solution is then infused into the lungs, expanding the
lungs such that the lungs compress the heart and great vessels, to
generate cardiac outflow and ultimately circulation. A device that
performs this method is also disclosed.
Inventors: |
Klatz; Ronald M. (Chicago,
IL), Goldman; Robert M. (Chicago, IL), Federowicz;
Michael G. (Riverside, CA) |
Assignee: |
Life Science Holdings, Inc.
(Chicago, IL)
|
Family
ID: |
27535836 |
Appl.
No.: |
09/070,795 |
Filed: |
May 1, 1998 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
Issue Date |
|
|
383240 |
Feb 3, 1995 |
5584804 |
|
|
|
069916 |
Jun 1, 1993 |
5395314 |
|
|
|
886041 |
May 19, 1992 |
5234405 |
|
|
|
595387 |
Oct 10, 1990 |
5149321 |
|
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Reissue of: |
412135 |
Mar 28, 1995 |
05653685 |
Aug 5, 1997 |
|
|
Current U.S.
Class: |
604/26;
128/201.21; 604/24; 128/898; 604/518 |
Current CPC
Class: |
A61M
5/14 (20130101); A61M 16/0054 (20130101); A61M
60/268 (20210101); A01N 1/02 (20130101); A01N
1/0247 (20130101); A61B 16/00 (20130101); A61M
2202/0476 (20130101); A61M 60/40 (20210101); A61M
60/894 (20210101); A61B 2017/00969 (20130101); A61M
2210/0693 (20130101); A61M 60/00 (20210101); A61M
60/892 (20210101); A61M 60/113 (20210101) |
Current International
Class: |
A01N
1/02 (20060101); A61M 16/00 (20060101); A61B
16/00 (20060101); A61M 5/14 (20060101); A61M
1/10 (20060101); A61B 17/00 (20060101); A61M
037/00 () |
Field of
Search: |
;604/27-28,54,49,23-26,56 ;128/201.21,200.24,204.15,898 |
References Cited
[Referenced By]
U.S. Patent Documents
Other References
"Attempts at liquid Breathing, Technologies May Save Preemise,
Treat Illnesses", by Tim Friend, USA Today, May 31, 1994, p. 05D.
.
"Partial Liquid Ventilation Promising in Preemies With Severe RDS,"
by Calvin Pierce, Nov. 1994. .
"Cardiac Output During Liquid (Perfluorocarbon) Breathing in
Newborn Piglets", Scott E. Curtis, MD, Bradley P. Fuhrman, MD,
Donna F. Howland, BS, Maria DeFrancisis, BS Etsuro K. Motoyama, MD,
Official Journal of the Society of Critical Care Medicine, vol. 19,
No. 2, Feb. 1991, pp. 225-230. .
"The Effects of Liquid Ventilation of Cardiopulmonary Function in
Preterm Lambs", by Thomas H. Shaffer, Patricia R. Douglas, Corinne
A. Lowe, and Vinod K. Bhutani, Pediatric Research--An International
Journal of Clinical, Laboratory and Developmental Investigation,
vol. 17, No. 4, Apr. 1983, pp. 303-306. .
"Instrumentation For Measuring Cardiac Output by Direct Fick Method
During Liquid Ventilation", by E.M. Siveri, G.D. Moskowitz and T.H.
Shaffer, Undersea Biomedical Research, vol. 8, No. 2, Jun. 1981,
pp. 75-83. .
"Decompression Incidence in Air--And Liquid Breathing Hamsters", by
P.R. Lynch, J.S. Wilson, T.H. Shaffer, and N. Cohen, Undersea
Biomedical Research, vol. 10, No. 1, Mar. 1983, pp. 1-10. .
"Liquid Ventilation in Dogs: An Apparatus for Normobaric and
Hyperbaric Studies", by D. J. Harris, R.R. Coggin, J. Roby, M.
Frrxot, H. Turner, and P.B. Bennett, Journal of Applied Physiology,
vol. 54, No. 4, ISSN 0161-7588, Apr. 1983, pp. 1141-1148. .
"Easier Breathing in RDS", Medical Tribune, Jan. 11, 1990. .
Program and Abstracts for the 26.sup.th Educational and Scientific
Symposium, Official Journal of the Society of Critical Care
Mecicine, vol. 25/No. 1 (Suppl.) Jan. 1997..
|
Primary Examiner: McDermott; Corrine
Attorney, Agent or Firm: Oliff & Berridge, PLC
Parent Case Text
CROSS-REFERENCE TO RELATED APPLICATIONS
This application is a continuation in part of application Ser. No.
08/383,240, filed Feb. 3, 1995, now U.S. Pat. No. 5,584,804, which
is a continuation in part of application Ser. No. 08/069,916, filed
Jun. 1, 1993, now U.S. Pat. No. 5,395,314, which is a continuation
in part of application Ser. No. 07/886,041, filed May 19, 1992, now
U.S. Pat. No. 5,234,405, which is a divisional of application Ser.
No. 07/595,387, filed Oct. 10, 1990, now U.S. Pat. No. 5,149,321.
Claims
What is claimed is:
1. A method for providing circulation comprising:
establishing a pathway to the lungs of a patient suffering from
impaired cardiac outflow by placement of a tube in an airway of the
patient;
infusing a solution including oxygen carrying agents through the
tube into the lungs of the patient to expand the lungs in order to
compress the heart and great vessels a sufficient amount to
increase cardiac outflow.
2. The method of claim 1, additionally comprising evacuating the
lungs of air and other material prior to infusing the solution.
3. The method of claim 1, additionally comprising:
evacuating at least a portion of the solution from the lungs,
through the tube, to deflate the lungs in order to expand the heart
and great vessels; and
again infusing an amount of solution through the tube into the
lungs to again expand the lungs in order to compress the heart and
great vessels a sufficient amount to increase cardiac outflow.
4. The method of claim 1, wherein the oxygen carrying agents
include perfluorocarbons, hemoglobin based blood substitutes or
non-hemoglobin based blood substitutes.
5. The method of claim 1, wherein the solution is infused into the
lungs at at least normal body temperature of the patient.
6. The method of claim 1, wherein the patient suffers from cardiac
arrest caused by at least one of suffocation, drowning,
electrocution, loss of circulation, stroke, bodily injury,
poisoning and major trauma.
7. The method of claim 1, wherein the patient suffers from cardiac
arrest and application of the method begins when the patient is not
breathing.
8. The method of claim 1, wherein the solution additionally
includes free radical scavengers.
9. The method of claim 8, wherein the free radical scavengers
include antioxidants.
10. The method of claim 1, wherein the solution is infused into the
lungs at a temperature below normal body temperature of the
patient.
11. The method of claim 1, wherein the solution is infused into the
lungs at at least 80.degree. F.
12. A method for providing circulation comprising:
providing an apparatus including a pathway, a solution holder that
holds a solution including oxygen carrying agents, a pump
configured to force solution from the solution holder through the
pathway and a controller that controls infusion of the solution
from the solution holder through the pathway into the lungs of a
patient suffering from impaired cardiac outflow to expand the lungs
of the patient in order to compress the heart and great vessels a
sufficient amount to increase cardiac outflow;
using the apparatus to treat a patient suffering from impaired
cardiac outflow by placing the pathway in an airway of the patient
to establish a route to the lungs of the patient and infusing the
solution from the solution holder through the pathway into the
lungs of the patient to expand the lungs in order to compress the
heart and great vessels a sufficient amount to increase cardiac
outflow.
13. The method of claim 12, additionally comprising:
using the apparatus to evacuate the lungs of air and other material
prior to infusing the solution.
14. The method of claim 12, additionally comprising:
using the apparatus to evacuate at least a portion of the solution
from the lungs, through the pathway, to deflate the lungs in order
to expand the heart and great vessels and again infusing an amount
of solution through the tube into the lungs to again expand the
lungs in order to compress the heart and great vessels a sufficient
amount to increase cardiac outflow.
15. The method of claim 12, wherein the oxygen carrying agents
include perfluorocarbons, hemoglobin based blood substitutes or
non-hemoglobin based blood substitutes.
16. The method of claim 12, wherein the solution additionally
includes free radical scavengers.
17. The method of claim 12, wherein the free radical scavengers
include antioxidants.
18. The method of claim 12, wherein the solution is infused into
the lungs at a temperature below normal body temperature of the
patient.
19. The method of claim 12, wherein the solution is infused into
the lungs at at least 80.degree. F.
20. The method of claim 12, wherein the solution is infused into
the lungs at at least normal body temperature of the patient.
21. The method of claim 12, wherein the patient suffers from
cardiac arrest caused by at least one of suffocation, drowning,
elcetrocution, loss of circulation, stroke, bodily injury,
poisoning and major trauma.
22. The method of claim 12, wherein the patient suffers from
cardiac arrest and application of the method begins when the
patient is not breathing.
Description
FIELD OF THE INVENTION
This invention relates to an apparatus and method for treating
patients suffering from trauma, i.e., cardiac arrest. More
particularly, the present invention discloses an apparatus and
method for providing circulation for resuscitating the heart. The
method involves perfusing a liquid breathing solution including
substances such as artificial blood components into the respiratory
tract under positive and negative pressure, for the purpose of
creating circulation of blood through the circulatory system.
BACKGROUND OF THE INVENTION
During cardiac arrest, the heart ceases to pump blood.
Subsequently, there is no circulation, and the brain fails to
receive freshly oxygenated blood. Without a steady supply of
oxygenated blood, the brain will cease to function.
Current resuscitation techniques for cardiac arrest result in low
patient survival rates. In hospitals and clinics with advanced
cardiopulmonary resuscitation (CPR) and life support systems, the
survival rate is normally around 14%. Outside of hospital settings,
the survival rate is about 5%.
Among cardiac arrest victims overall, less than 10% survive
neurologically intact and without significant brain damage. The
other approximately 90% either die or sustain some neurologic
injury from ischemia, (i.e., lack of blood flow to the brain), or
anoxia (i.e., lack of oxygen to the brain). Such frequency of
neurologic injury occurs because after cardiac arrest, basic
cardiopulmonary resuscitation and advanced life support techniques,
such as CPR, closed heart cardiac chest massage, and electroshock
treatments, typically require fifteen to twenty minutes to regain
circulation from a failed heart. With conventional resuscitation
methods, irreversible neurologic damage begins soon after
circulation stops. Therefore, it is imperative to restart the heat
as soon as possible.
SUMMARY OF THE INVENTION
The present invention improves on the prior art by providing a
method for treating cardiac arrest, where circulation is resumed or
enhanced. The method includes the initial steps of intubating the
airway of a patient, to provide access to the lungs, and evacuating
air and other material in the lungs. A liquid breathing solution
(hereinafter "solution") is then infused into the lungs (via the
intubation), expanding the lungs such that the lungs compress the
heart and great vessels (aorta, aortic arch, vena cavx, pulmonary
artery, pulmonary vein, subclavian artery, subclavian vein), to
create cardiac outflow. In a subsequent step, some or substantially
all of the liquid breathing solution in the lungs may be evacuated
therefrom. This evacuation step allows the heart and great vessels
to expand, thereby increasing in volume. Upon the completion of the
evacuation step, additional solution may be infused into the lungs
such that they again expand, to compress the heart and great
vessels. These solution infusion and solution evacuation steps form
a cycle that can be repeated for as long as desired.
The present invention includes a device for evacuating the lungs of
air and other material, delivering the aforementioned liquid
breathing solution to the lungs, and evacuating the aforementioned
liquid breathing solution from the lungs. The device includes a
reservoir for holding liquid breathing solution, which communicates
with an oxygen tank, a heat exchanger and a valve controlled pump.
The device also includes a defoaming/filtration unit, along a
separate line, whose entry is controlled by a valve, for treating
spent solution, prior to its reentry into the pump. The pump is
capable of pumping in the reverse direction, to create suction for
evacuating air and other material from the lungs, as well as
evacuating spent liquid breathing solution, drawing it through the
defoaming unit into the pump, and returning the treated (defoamed
and/or filtered) solution to the reservoir (where it may be
replenished or reoxygenated). The pump also pumps in the forward
direction, to move solution from the reservoir out of the device,
where it is infused (pumped) into the lungs of the patient. The
forward pumping also moves waste material out of the device through
a waste conduit. The oxygen tank upon activation, releases oxygen
into the reservoir, oxygenating the liquid breathing solution
therein, and depending on the pressure, assists the pump to move
the solution out of the device. The movements of the pump and valve
are controlled by a logic control unit.
BRIEF DESCRIPTION OF THE DRAWINGS
For a more complete understanding of the invention, reference
should be made to the drawings wherein:
FIG. 1 is a front view of a first device used in performing the
invention illustrating the internal components;
FIG. 2 is a side view of the first device of FIG. 1 in use to treat
a patient;
FIG. 3 is a front view of a second device used in performing the
invention illustrating the internal components; and
FIG. 4 is a side view of the second device of FIG. 3 in use to
treat a patient.
DETAILED DESCRIPTION OF THE DRAWINGS
Referring to FIGS. 1 and 2, the device 20 of the invention is
semi-automatic. The device 20 includes an outer casing 22 with a
handle 23 and a window 24. The window 24 is located within a first
side 25 which has a greater width than length. The casing 22
includes an inner chamber 26. This inner chamber 26 contains
components which include a reservoir 30, an oxygen tank 34, a heat
exchanger 38, a pump 46, a logic control unit 50, and a power
source 54.
The reservoir 30 holds the liquid breathing solution (hereinafter
"solution"). The liquid breathing solution of this invention is a
fluid mixture of various components and is packaged in premixed,
premeasured canisters, for a single immediate use. These canisters
can be replenished (refilled) and exchanged for continued
application. The specific components are discussed below in
accordance with the methods of the invention. Preferably, this
reservoir 30 is adapted to hold up to ten liters of fluid contained
within replaceable canisters 32. The preferred canisters are clear
plastic bags, such that fluid depletion in the reservoir 30 can be
viewed through the window 24. However, these canisters can be rigid
containers, made of opaque materials, such as plastic, metal or the
like. These canisters 32 may be equipped with pressure relief
valves 33.
An oxygen tank 34, adjustable to various pressures, communicates
with reservoir 30 through a first conduit 35. Oxygen tank 34 is
sealed by a valve 36, which is opened once the device 20 is
activated. Tank 34 is preferably a cylinder ten inches tall by four
inches in diameter, containing oxygen pressurized to at least above
atmospheric pressure. Tank 34 could also hold gases such as carbon
dioxide, hydrogen or nitric oxide, and trace therapeutic
gasses.
A heat exchanger 38, capable of controlling the fluid's
temperature, surrounds reservoir 30. Preferably the heat exchanger
cools by undergoing an internal endothermic reaction, once a
charging valve 40 is opened when a charging handle 41 on the device
is activated. The exchanger contains Ammonium Nitrate and water,
which are initially separate. Upon activation, these chemicals
contact each other, reacting endothermically, causing the heat
exchanger to cool. Additionally, the heat exchanger's cooling can
be accomplished by carbon dioxide (dry ice), freon (or other
refrigerant gases) or a mechanical cooling device. Alternately, the
heat exchanger 38 may contain chemicals that create an exothermic
reaction for increasing the solution temperature above body
temperature (as high as 125 degrees fahrenheit) and/or an electric
heating element (powered by the logic control unit 50 and the
energy source 66), or other mechanical heating element.
A second conduit 44 extends from the reservoir and communicates
with a valve controlled pump 46 capable of pumping at various
rates, directions (forward and reverse) and modes, in communication
with a logic control unit 50. A filter (not shown) could be placed
along the second conduit to remove unwanted contaminants.
The second conduit 44 extends through the pump 46 and logic control
unit 50 through a two-way valve 51 and terminates in a side opening
52 on the device 20. This two-way valve 51 also controls flow of
solution through a third conduit 53 for treatment in a defoaming
and filtration unit 54 (hereinafter "defoaming unit") prior to
reentry into the reservoir 30. Preferably, this side opening 52 is
on the side 60 adjacent to the longitudinal side 25. Side opening
52 is capable of attaching to a tube 62, that connects to an
endotracheal tube 70 in a patient 72 (the patient 72 having been
intubated) at an adapter 78, such that solution can enter the
patient's airway and ultimately the lungs 74, in accordance with
the method of the invention.
The third conduit 53 extends from the two-way valve 51 to the valve
controlled pump 46 and extends to the reservoir 30. The defoaming
unit 54 is preferably along the third conduit 53, intermediate the
two-way valve 51 and the valve controlled pump 46. Alternately, the
defoaming unit 54 could be placed along the third conduit 53
intermediate the valve controlled pump 46 and the reservoir 30. The
valve controlled pump 46 draws the solution that was treated in the
defoaming unit 54, and pumps it into the reservoir 30, through the
third conduit 53. The defoaming unit 54 includes a defoamer, a
carbon dioxide scrubber and a filter(s). Suitable defoaming units
include those commercially available models such as the
ULTIPOR.RTM. blood filter EC3840 from Pall Biomedical Products
Corporation, East Hills. N.Y. 11548, in combinations of one or
more.
This valve controlled pump 46 may also control flow to a waste
conduit 63 that allows waste (fluids, gases, solids, including
solution, bodily fluids and tissue particulates, or other material)
to leave the device 20. Specifically, the waste exits the device
through a side waste opening 65.
The valve controlled pump 46 and the logic control unit 50 and two
way valve 51 are powered by an energy source 66. However, the
device is suitable for an electric adapter. A battery pack is the
preferred energy source 66.
The logic control unit 50 includes (not shown) an oxygen pressure
sensor, a fluid mass flow sensor, a fluid volume indicator and
regulator, a fluid pressure indicator and regulator, a fluid
temperature indicator and regulator, a fluid temperature indicator
with feedback to a mass sensor, and a timing device for estimating
the time the fluid in the reservoir will be depleted at a given
mass flow. The logic control unit 50 includes a microprocessor for
controlling the movements of the valve controlled pump 46 and the
two-way valve 51. However, the logic control unit 50 may be
manually overridden as the valve controlled pump 46 and two-way
valve 51 may be controlled manually. Measurements from the logic
control unit 50 are displayed on an LED or LCD digital display 56.
Digital display 56 preferably shows the temperature and flow rate
of the solution.
With respect to tube 62, high pressure respirator tubes, such as
those typically used in high pressure respirators or ventilators or
conventional heart-lung bypass pumps, are preferred. Additionally,
it is preferred that the adjacent side 60 also contain openings for
waste 65, for venting excess oxygen 68 and for oxygen intake 69.
This oxygen intake can be from the atmosphere or from adjunct
oxygen sources.
The device 20 is able to withdraw solution and waste from the
patient by running the valve controlled pump 46 in reverse. When
waste material is being removed, the two-way valve 51 opens the
second conduit 44, such that solution flows directly to the valve
controlled pump 46, where it pumps in the forward direction to move
the waste material out of the device 20 through the waste conduit
63. When spent solution is returned to the device 20 for treatment,
the two-way valve 51 closes the second conduit 44 and opens the
third conduit 53, such that spent solution is treated in the
defoaming unit 54, returned to the valve controlled pump 46, and
pumped to the reservoir 30, through the third conduit 53.
Solution is infused into the lungs as the two-way valve 51 opens
the second conduit 44, and closes the third conduit 53 (the valve
controlled pump 46 is such that the third conduit 53 as well as the
waste conduit 63 are closed). The oxygen tank valve 36 is opened
and pressurized oxygen is released from the oxygen tank 34 into
contact with the liquid breathing solution, thereby oxygenating it.
The heat exchanger 38 is activated by releasing the charging valves
40. Once activated, the oxygenated solution in the reservoir 30 is
cooled. This cooled solution moves through a second conduit 44,
forced by sufficient pressure from the oxygen tanks 34 or drawn by
sufficient pressure from the valve controlled pump 46 into the
logic control unit 50. The pump 46 within this logic control unit
50 further moves the chilled oxygenated solution through this
second conduit Solution then enters a tube 62, attached to an
opening 52 in device 20 whereby it is delivered to the endotracheal
tube 70 (as placed in a previously intubated or tracheotomized
patient 72) and ultimately to the lungs 74.
FIGS. 3 and 4 show a second device 100 of the invention. The device
100 is similar to the first device 20 disclosed above (in FIGS. 1
and 2) except that this device 100 includes two pumps. The first
valve controlled pump 46 is similar to that disclosed for the first
device 20 above, and the second valve controlled pump 102 receives
solution from a third conduit 104, that is fed solution through an
inflow tube 106 (inflow of solution to the device 100) extending
from the endotracheal tube 70 of the patient 72. The second valve
controlled pump 102 is controlled by the logic control unit 50 and
includes a separate series of inflow and outflow conduits.
This third conduit 104 originates at a side opening 107. (The first
and second conduits 35, 44 are similar to that disclosed for the
first device 20 above.) A two-way valve 108, controlled by the
logic control unit 50 (similar to that disclosed for the first
device 20 above), regulates solution flow to the third conduit 104.
A defoaming unit 110 is positioned along this third conduit 104
prior to its entering the second valve controlled pump 102. The
defoaming unit 110 may be any of those disclosed for use in the
first device 20 (FIGS. 1 and 2 above). This third conduit 104 then
exits the second valve controlled pump 102 and extends to the
reservoir 30. The defoaming unit 110 may alternately be placed
along this third conduit 104, intermediate the second valve
controlled pump 102 and the reservoir 30, if desired.
A fourth conduit 114 extends from the two-way valve 108 to the
second valve controlled pump 102. This fourth conduit 114 is
designed to carry waste, and solution (if necessary) to the second
valve controlled pump 102, where it is pumped through the waste
conduit 116 and out of the device 100 through the side waste
opening 118.
This device 100 forms a circular path for the solution, when it is
used to perform the method of the invention. The logic control unit
50 is such that its microprocessor controls and coordinates the
movements of the first and second valve controlled pumps 46, 102,
(pumps and valves therein) and the two-way valve 108 to move
solution into and out of the device 100 (and into and out of the
patient 72) along a circular path. The positioning of the two-way
valve 108 and second valve controlled pump 102 to move material or
solution to the waste conduit 116 and out of the device when
necessary, is also coordinated by the logic control unit 50. In
this device 100, the side opening 107 receives the inflow tube 106.
The side opening 107 communicates with the third conduit 104 that
carries the solution through the two-way valve 108, opened to the
flow path of the third conduit 104, such that the spent solution is
treated in the defoaming unit 110, moved to the second valve
controlled pump 102 and returned (by pumping) back to the reservoir
30.
Solution is infused into the lungs in a similar identical manner as
described above for the first device 20. The solution reaches the
patient 72 through an outflow tube 124 (outflow of solution from
the device 100), that connects with the device 100 at the side
opening 52, and that merges with the inflow tube 106 at a Y-shaped
end 126, joining the endotracheal tube 72 at an adapter 78. A valve
128 may be placed at the Y-shaped end 126 for the purpose of
increased control of directional flow of the solution such that
there is minimal mixing of fresh (oxygenated) solution and spent
solution in the inflow and outflow tubes 106, 124, and there is a
minimization of dead space, such that the patient 72 will inhale a
minimal amount of spent solution. The valve 128 is preferably a
pressure controlled valve, responsive to pressure created by the
directional flow of the solution. Alternately, the valve 128 may be
a mechanical, manually controlled or automatically controlled
valve, subject to the control of the microprocessor in the logic
control unit 50 (as connected by wires to the logic control unit
50). The only structural difference is that the second conduit 44
in this second device 100 lacks the two-way valve 51 (FIG. 1).
Both devices 20, 100 are relatively small. They are portable,
suitcase-like in appearance and suitable for field use, such as in
ambulances, battlefields, athletic fields, aircraft, marine
vehicles spacecraft, emergency treatment facilities, and the like.
They are lightweight and can be carried directly to the patient. In
one example of the device the outer casing measures forty inches by
twenty four inches by twenty inches and weighs approximately fifty
pounds. They are also suited for stationary, clinical use. Should a
clinical device be desired, the devices could be made larger and
modified accordingly for such use.
An alternative embodiment may have two or more reservoirs. These
additional reservoir(s) can be formed by dividing the reservoir
into multiple reservoirs or additional reserviors can be connected
to the reservoir of the device with an adapter mechanism.
Still additional alternative embodiments may use preoxygenated
solution in the reservoirs. Reservoirs containing preoxygenated
fluid solution eliminate the need for oxygen tanks as these devices
have sufficient power (enhanced electronics and powerful pumps),
capable of moving the solution from the reservoir in the device to
the lungs.
Another aspect of the invention comprises a method of treating
cardiac arrest, suffered typically from suffocation, drowning,
electrocution, losses of circulation, strokes, bodily injuries,
toxic (carbon monoxide, cyanide, etc.) poisoning, and associated
major trauma. Application of this method begins when a patient
suffering from cardiac arrest is no longer breathing.
The initial step involves instrumentizing the trachea of the
patient. This may be done by standard trachea intubation methods,
preferably achieved with an endotracheal tube or other equivalent
conduit. Alternately, an emergency tracheotomy (tracheostomy) may
be performed in the neck in order to reach the trachea. This is
typically achieved with a McSwain dart or other similar emergency
type instruments.
Once the trachea has been intubated or otherwise instrumentized
(such as by a tracheotomy), the tube 62 from the first device 20 or
dual tube unit 130 from the second device 100 is connected to the
endotracheal tube 70 by attachment with a adapter 78 or the
like.
With the first device 20, the valve controlled pump 46 is now
activated in reverse, such that the device automatically draws a
vacuum to evacuate the desired amount of air (usually 4 to 8
liters-substantially the entire capacity of the lungs of an adult
human) from the lungs. The material removed from the lungs during
this evacuation step is brought into the device 20, with the valve
in the pump 46 positioned such that this material enters the waste
conduit 63 and leaves the device through the side waste opening
65.
With the second device 100, the second valve controlled pump 102 is
initially activated with the two-way valve 108 opening the fourth
conduit 114, to evacuate the lungs. Once sufficient pressure is
drawn, the two-way valve 108 is closed as waste material is moved
(by pumping) to the waste conduit 116, and leaves the device 100
through side opening 120.
Once the lungs are evacuated, in the first device 20 (FIGS. 1 and
2), the valve controlled pump 46 is switched to the forward
direction. In the second device 100 (FIGS. 3 and 4), the first
valve controlled pump 46 is now activated. In both devices 20, 100,
the oxygen tank valves 36 are opened and pressurized oxygen is
released from the oxygen tanks 34 into contact with the liquid
breathing solution, thereby oxygenating it. The heat exchanger's 38
are activated by releasing the charging valves 40. Once activated,
the oxygenated solutions in the reservoirs are cooled. These cooled
liquid breathing solutions move through a second conduit 44, forced
by sufficient pressure from the oxygen tanks 34 or drawn by
sufficient pressure from the valve controlled pump 46 (first valve
controlled pump 46 in the second device) into the logic control
unit 50. The valve controlled pump 46 (first valve controlled pump
46 in the second device), within this logic control unit 50 further
moves the chilled oxygenated solution through this second conduit.
Solution then enters the respective tubes 62, (outflow tube) 124
attached to the side openings 52 in the devices 20, 100 whereby it
is delivered to the endotracheal tube 70 (as placed in a previously
intubated or tracheotomized patient 72) and ultimately to the lungs
74.
The solution is infused (pumped) to the lungs until it has replaced
substantially all of the air spaces and/or residual volumes of gas
therein, ultimately filling the lungs, such that they are expanded.
This expansion compresses the heart and great vessels (aorta,
aortic arch, vena cava, pulmonary artery, pulmonary vein,
subclavian artery, subclavian vein) within the thoracic cavity,
located between the lungs. Additionally, this expansion creates
increased intrathoracic pressure (positive pressure) with
sufficient force to compress the heart and great vessels, resulting
in cardiac outflow sufficient to provide circulation in the
body.
The solution is then evacuated from the lungs by suction created by
the pumps (the second valve controlled pump 102 in the second
device 100). Evacuating the lungs deflates them, reducing their
volume, thereby decreasing pressure on the heart and great vessels.
Additionally, this decrease in pressure creates decreased
intrathoracic pressure (negative pressure) which allows the heart
and great vessels to expand, resulting in the blood being drawn
back toward the heart, creating venous blood flow.
These solution infusion and evacuation steps form a cycle that can
be repeated as desired. This cycle is usually continued for as long
as necessary to create circulation.
For example, the solution may be delivered in a series of pulses
(pulsatile delivery). During pulsatile delivery, the valve
controlled pumps on the devices are controlled to pump in both the
forward and reverse directions. By pumping in both directions, the
lungs may be evacuated and infused with fluid in a cyclic manner.
Moreover, when solution is evacuated from the lungs, it can be
replenished (reoxygenated) in the reservoir and returned to the
lungs through the endotracheal tube (or equivalent instrumentation)
through subsequent pumping in a later cycle.
The number of cycles for the pumps could be determined by the
operator of the device. Optimal compression and expansion of the
heart and great vessels is based upon the volume and pressure
capacity of the lungs. Cardiac outflow, as a result of the
compression and expansion on the heart and great vessels, can then
be measured from biocompatible type sensors of blood pressure,
capillary blood flow, tissue oxygen, tissue carbon dioxide, tissue
pH, tissue lactic acid, blood oxygen, blood carbon dioxide, blood
pH, blood lactic acid, EKG, EEG, ultrasound determination of
cardiac wall measurement or heart chamber volume, pulse oximetry,
pulse carbon dioxide measurement, or the like.
For example, the pumps (in the first device, the valve controlled
pump, in the second device, the second pump) could first be brought
into reverse, either automatically or manually. This reversal would
involve a series of one or more pulses to extract a volume of air
approximately equal to the airspace of the lungs. The pump could
then deliver a solution in a present volume, at a present pressure,
or at a present flow rate, in accordance with any one or all of
these parameters, in a series of one or more pulses, to the lungs,
whereby the lungs are maximally expanded. This typically requires
approximately 4 to 8 liters for adult humans. Substantially the
entire solution volume (the volume infused) could then be evacuated
by the pumps (detailed above) operating in reverse. This solution
is then treated in the defoaming units and returned to the
reservoirs (where reoxygenation preferably occurs). Solution from
the reservoir is then infused (pumped) into the lungs to repeat the
cycle. This cycle can be continued for as long as desired, that is
typically until the patient's circulation and breathing are
restored.
An alternate method exists whereby once the lungs have initially
been filled with solution (approximately 4 to 8 liters, as
disclosed above) to a point where they are expanded (to compress
the heart and great vessels), a smaller volume of solution
(approximately 0.05 to 4.5 liters) is withdrawn and returned to the
reservoir to be replenished (reoxygenated). Upon withdrawal of this
smaller amount of solution, the lungs deflate (reduce in volume)
slightly, such that the heart and great vessels are subject to less
compression by the lungs, and thereby expand. Additional solution,
in amounts approximately equal to that withdrawn form the lungs,
would then be pumped into the lungs in pulses or a single stroke.
This additional amount of solution would be infused (pumped) into
the lungs at a sufficient pressure, to combine with and add to the
volume of solution already in the lungs, whereby the lungs would
again expand (increase in volume) to compress the heart and the
great vessels.
The cooled solution also serves to cool the entire blood volume, as
all blood circulates through the lungs by way of the great vessels
of the heart (pulmonary artery and pulmonary vein) contacting the
chilled solution which is pumped into the system by the device. The
cooled blood circulates through the body, thus lowering the
metabolism of the body, for the patient to survive neurologically
intact. Since the cooled blood circulates to the brain and other
organs, this method can be used for brain resuscitation and organ
preservation in live patients. This method can also be used for
organ preservation and total body cooling, as a method of achieving
hypothermia in brain-dead patients and cadavers.
Once the lungs have been fully infused with solution, additional
pumping of the heart, additional circulation of the solution, and
additional fluid return of solution from the lungs (into the
devices) may be desired. These additional actions may be achieved
by external compression devices such as mast-trouser-like pneumatic
or hydraulic compressive body garments (placeable any where along
the body) or chest hydraulic, pneumatic or mechanical type
percussion devices, or other equivalent devices. Additional
circulation may be achieved by pneumatic or mechanical devices that
impart rocking or thrusting motion to the body, thereby circulating
and stirring the solution in the lungs.
The method of the invention may also be used to provide circulation
in non-cardiac arrest situations. For example, it may be used to
enhance circulation for patients with congestive heart failure.
Also, it may be used to create circulation in patients suffering
from cardiac tamponade, electromechanical dissociation, lethal
cardiac arrythmia, or ineffective cardiac arrythmia. This method
can also be used for drug delivery, as the solution infused into
the lungs is absorbed into the lung tissues and other associated
tissues by capillary absorption or diffusion across the membranes
of the alveoli. These absorbed materials could then reach the
bloodstream when the lungs oxygenate the blood during
circulation.
For the methods of the invention, the liquid breathing solution is
temperature controlled and delivered to the lungs, tissues and
vasculature associated therewith, at temperatures at or below body
temperature. Preferably, the solution is cooled below body
temperature to approximately between forty and eighty degrees
fahrenheit, but nay be cooled as low as -10 degrees fahrenheit. At
temperatures below normal body temperature, the degenerative
metabolism of the organ(s) is slowed as the subsequent free radical
production (O.sub.2.sup.- or other free radicals) decreases. This
temperature-controlling step may alone allow up to an additional
eight hours of organ viability, without neurologic damage.
Alternately, the temperature controlling step may involve heating
the solution to achieve warming or rewarning, to achieve
hyperthermia or normothermia in the patient (or cadaver), for the
purpose of achieving specific metabolic or physiologic effects
and/or for the enhanced action and specific delivery of specific
drug therapies in the patient. As stated previously, delivery of
the chilled liquid breathing solution may be continuous or
pulsatile, cyclic or non-cyclic, depending upon the type of pumps,
logic control units and devices (disclosed above) in use for the
specific method.
Additional cooling is achieved by applying external cooling means
to the patient's head or chest area. The cooling means include a
bonnet containing ice cubes synthetic cooling packets and the like.
Alternately, cooling type wraps may be placed around the chest as
well as cooling means applied the head, neck and back, such as
those disclosed in U.S. Pat. No. 5,261,399 (Klatz et al.).
The solution is a mixture of various components suitable for
maintaining breathing as well as keeping the lungs and associated
tissues viable. Specifically, the solution is a fluid mixture that
may include components such as oxygen carrying agents,
antioxidants, barbiturates, carrier vehicles, physiologic buffers,
nutrients, heavy metal scavengers, cyto-protective agents,
ionotropic agents, electrolytes, metabolic mediators, anti-blood
coagulating agents, neuroprotective agents, anesthetic agents,
anti-inflamatories and other chemicals or combinations of
chemicals. These other chemicals are generally known to those
skilled in the art.
In the solution, oxygen carrying agents comprise about 0.00 to
99.99 percent by volume of this organ preservation solution. The
preferred solution includes 10.00 to 99.00 percent by volume of
oxygen carrying agents. Perfluorocarbons, hemoglobin based blood
substitutes, or non-hemoglobin based blood substitutes are the
preferred oxygen carrying agents, as they have an extremely high
oxygen capacity. When delivered to the lungs, in this oxygenation
step, these oxygen carrying agents may be supersaturated with
oxygen, either having been oxygenated in the fluid reservoir or
preoxygenated.
Antioxidants can be in the solution, in amounts up to 99.99 percent
by volume. Preferably, the solution includes 0.001 to 30.000
percent by volume of antioxidants. These antioxidants are the
preferred free radical scavengers. Once introduced into the
organ(s), these antioxidants compete with organ tissue proteins as
binding sites for the free radicals. Since a large portion of the
free radials complex with antioxidants, a substantial amount of
free radical damage is prevented since these same free radicals are
inactivated by the antioxidants and do not bind to or form
complexes with the proteins in the tissues of the lungs or other
organs. The preferred antioxidants include Vitamin A (plus other
carotenoids), Vitamin B, Vitamin C, Vitamin E, Selenium, Cysteine,
BET, BHA, Hydergine, Glutathione (reduced) and the like.
Barbiturates may be included in the solution in amounts up to 20.00
percent. Preferred barbiturates include Thiopental, Secobarbital
and Pentobarbital. Other commercially available barbiturates are
also permissible.
The solution may include up to 99.00 percent by volume of
components which act as carrier vehicles and diluents for the
oxygen carrying agents (e.g., perfluorocarbons, hemoglobin based
blood substitutes, and non-hemoglobin based blood substitutes) and
antioxidants (if present in the solution). Dimethylsulfoxide
(DMSO), Normosol.RTM. (Abbott Laboratories, North Chicago, Ill.),
Mannitol, HES, Dextran 40, colloids, and crystalloids are the
preferred carriers as they aid the above substances in traversing
tissue cell membranes.
Additionally, the solution may contain physiologic buffers, such as
HEPES (Monograph No. 4573, The Merk Index, Eleventh Edition) in
amounts up to 50.00 percent by volume, to maintain pH.
Nutrients are also provided in this solution, up to 30.00 percent
by volume. Glucose is one nutrient which is preferred.
The solution may also include up to 20.00 percent by volume heavy
metal scavengers or chelating agents. These heavy metal scavengers
or chelating agents would also serve to inhibit free radical
damage. Desferoxamine is one preferred heavy metal chelator.
Cytoprotective agents such as Calcium Channel Blockers (Ca.sup.++),
Magnesium Sulfate, Potassium Chloride, Potassium sulfate, Calcium
Chloride, THAM, and sodium phosphate dibasic, may also be present
in this organ preservation solution in amounts up to 10.00 percent
by volume. These cytoprotective agents, inhibit cell damage by
stabilizing the cell membrane.
Ionotropic agents, such as epinephrine and dopamine, may be present
in this solution up to 5.00 percent by volume.
Electrolytes, such as sodium chloride and magnesium chloride, may
be present in this solution up to 10.00 percent by volume.
Additional metabolic mediators such as MK-801 and glutamate
antagonists may also be in the solution up to 10.00 percent by
volume.
The solution may contain up to 10.00 percent by volume of heparin
or other suitable anti-blood coagulating agents to stop blood
clotting which may occur due to lack of blood flow during cardiac
arrest.
Neuroprotective agents may be in the solution in amounts up to 1.00
percent by volume. These neuroprotective agents may include
acetyl-L-carnitine, ACEA 1021 (CoCensys, Inc.), CERESTAT.RTM.
(Cambridge Neuroscience, Inc.), CPC 211, Freedox IV (tirlazed
mesylate), Lidoflazine, Phenyotoin (dilantin), adenosine, gamma
aminobutric acid, Lazeroids (The Upjohn Company, Kalamazoo. Mich.).
GM1 Gangliosides, PGE, NMDA receptor blocker, PGBx, Fluarizine,
Nicergoline, Nimodipine, Sabeluzole, Vincamine, Idebenome,
Piracetum, Vinpocetin, and 11-Bromide-Vincamine.
Anesthetic Agents such as Phenobarbital (and its analogs), valium
(and its analogs) and gamma hydroxy buterate (GEB) may be in the
solution in amounts up to 5.00 percent by volume.
Finally, the solution may contain up to 5.00 percent by volume
anti-inflamatories. These anti-inflamatories may include ibuprofen
and acetylsalicylic acid.
From the foregoing description, it is clear that those skilled in
the art could make changes in the described embodiments and methods
of the invention without departing from the broad inventive
concepts thereof. It is understood, therefore, that this invention
is not limited to the particular embodiments disclosed, but it is
intended to cover any modifications which are within the spirit and
scope of the claims.
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