U.S. patent application number 11/285123 was filed with the patent office on 2006-04-13 for apparatus and method for out-of-hospital thrombolytic therapy.
Invention is credited to Victor I. Chornenky, Ali Jaafar.
Application Number | 20060079860 11/285123 |
Document ID | / |
Family ID | 32851363 |
Filed Date | 2006-04-13 |
United States Patent
Application |
20060079860 |
Kind Code |
A1 |
Chornenky; Victor I. ; et
al. |
April 13, 2006 |
Apparatus and method for out-of-hospital thrombolytic therapy
Abstract
This invention provides an apparatus and method for emergency
administration or self-administration of thrombolytic therapy in
early stage of a heart attack. The apparatus includes a needle
injector for making a venipuncture, a battery operated micro cooler
for maintaining low temperature environment for vials with
lyophilized thrombolytic and adjuvant drugs, a container with a
diluent for reconstitution of the lyophilized drugs, a programmable
infusion pump, and a microprocessor for controlling the process of
infusion and recording the data. As the system is activated, said
container becomes fluidly communicable with the infusion pump and
vials with drugs in the cooler. Designed for autonomous execution
of several schedules of infusion, it also can be controlled
remotely by a qualified operator via an Internet interface.
Inventors: |
Chornenky; Victor I.;
(Minnetonka, MN) ; Jaafar; Ali; (Eden Prairie,
MN) |
Correspondence
Address: |
OFFICES OF CRAIG GREGERSEN
P.O. BOX 386353
10032 QUEBEC AVENUE SOUTH
BLOOMINGTON
MN
55438
US
|
Family ID: |
32851363 |
Appl. No.: |
11/285123 |
Filed: |
November 22, 2005 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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10750503 |
Dec 31, 2003 |
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11285123 |
Nov 22, 2005 |
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09849051 |
May 7, 2001 |
6699230 |
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10750503 |
Dec 31, 2003 |
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Current U.S.
Class: |
604/508 |
Current CPC
Class: |
A61M 5/44 20130101; A61M
5/1452 20130101; A61M 5/14244 20130101; A61M 2205/3584 20130101;
A61M 2205/8206 20130101; A61M 39/223 20130101; A61M 5/1407
20130101; A61J 3/002 20130101; A61M 2205/50 20130101; A61M
2205/3553 20130101; A61M 5/172 20130101; A61M 5/1456 20130101; A61M
2005/1402 20130101; A61M 2205/3606 20130101 |
Class at
Publication: |
604/508 |
International
Class: |
A61M 31/00 20060101
A61M031/00 |
Claims
1. An apparatus for out-of-hospital thrombolytic therapy
comprising: a. a library of medication in liquid or lyophilized
form including a thrombolytic agent, adjuvant drugs for supportive
care during heart attack and a diluent for reconstitution of drugs;
b. an intravenous needle providing an access to the patient's
circulatory system; c. a battery operated infusion pump with a set
of conduits, on-off and multi-port valves fluidly communicable with
the intravenous needle, the source of a diluent, and the vials with
drugs in the library; d. a battery operated micro cooler adapted
for keeping the medication library at reduced temperatures for
preservation of their potency over a several year period; e. a
microprocessor based control unit with a stored set of programs,
designed to control operation of the infusion pump and valves to
provide the priming of the system, drug reconstitution, and
preprogrammed intravenous infusion of the thrombolytic agent and
supportive drugs.
2. An apparatus for out-of-hospital thrombolytic therapy according
to claim 1, wherein said control unit is adapted for remote
programming via the Internet, by a local operator, or by the
patient.
3. An apparatus for out-of-hospital thrombolytic therapy according
to claim 1, which is portable.
4. An apparatus for out-of-hospital thrombolytic therapy according
to claim 1, wherein the temperature in the medication library is
kept below 5.degree. C.
5. An apparatus for out-of-hospital thrombolytic therapy according
to claim 1, wherein the thrombolytic agent and the schedule of
infusion are preselected by a physician for the patient
individually.
6. An apparatus for out-of-hospital thrombolytic therapy
comprising: a. a thrombolytic agent in lyophilized form and a
diluent for its reconstitution; b. an intravenous needle providing
an access to the patient's circulatory system; c. an infusion pump
or syringe; d. a battery operated micro cooler adapted for keeping
the thrombolytic agent at reduced temperatures for preservation of
its potency over a several year period.
7. A method of out-of-hospital thrombolytic therapy comprising:
providing an apparatus including: a library of medication in liquid
or lyophilized form including a thrombolytic agent, adjuvant drugs
for supportive care during heart attack and a diluent for
reconstitution of drugs; an intravenous needle providing an access
to the patient's circulatory system; a battery operated infusion
pump with a set of conduits, on-off and multi-port valves fluidly
communicable with the intravenous needle, the source of a diluent,
and the vials with drugs in the library; a battery operated micro
cooler adapted for keeping the medication library at reduced
temperatures for preservation of their potency over a several year
period; a microprocessor based control unit with a stored set of
programs, designed to control operation of the infusion pump and
valves to provide the priming of the system, drug reconstitution,
and preprogrammed intravenous infusion of the thrombolytic agent
and supportive drugs; keeping said apparatus in stand by state
continuously for long period of time until it is needed; activating
the apparatus after onset of the symptoms of a heart attack, with
the heart attack diagnosis confirmed or not confirmed by a
physician; gaining an intravenous access to the patient's
circulatory system by puncturing a vein with an intravenous needle
provided with apparatus; and starting treatment.
Description
[0001] This application is a continuation of U.S. patent
application Ser. No. 10/750,503, which is a continuation of U.S.
patent application Ser. No. 09/849,051.
FIELD OF THE INVENTION
[0002] This invention relates to medical devices and more
particularly to devices and methods for thrombolytic therapy of
coronary arteries for patients experiencing an early stage of acute
myocardial infarction.
BACKGROUND OF THE INVENTION
[0003] Acute myocardial infarction is a major cause of mortality
and morbidity in an atherosclerosis--prone contemporary society.
Each year approximately 1.5 million Americans suffer a myocardial
infarction, and more than 400,000 individuals will likely die from
it this year. Few life threatening diseases are as common as acute
myocardial infarction. Myocardial infarction is the morphologic
manifestation of irreversible cell death in an area of the heart
that is caused by a prolonged, and often abrupt, mismatch between
the supply of the oxygen and nutrients in the blood and the
metabolic needs of the myocardial cells. The most common cause of
this condition is the sudden interruption of blood flow in a
coronary artery by an occlusive thrombus formed in an area with
atherosclerotic disease. A myocardial infarction is an evolving,
dynamic event. A coronary occlusion results in ischemia that is
initially reversible, but over time becomes irreversible. Necrosis
of myocardium, or cardiac muscle, begins 20 to 30 minutes after
total occlusion of the vessel. This "wave front of necrosis"
proceeds through the ischemic part of the myocardium and is
complete within 4-6 hours of occlusion. Later a scar is formed over
the necrotic part of the myocardium. The area of myocardium
affected by infarction does not contribute any more to the overall
pumping function of the heart.
[0004] To successfully salvage the myocardium, the blood flow
though the occluded artery must be restored before the myocardium
cells have been irreversibly destroyed. Restoration of the blood
flow, or reperfusion, is more successful at the early stage of
evolving infarction. Prompt therapy can make the difference between
heart muscle death or salvage.
[0005] The most common method of reperfusion heart muscle during a
myocardial infarction is the use of medications that dissolve
thrombi--thrombolytic agents. Thrombolytic agents, including
streptokinase, urokinase, anisteplase, and tissue plasminogen
activator (tPA) are extremely efficient in preventing disability
and the death among people having heart attacks. About 80 percent
of people having a heart attack who receive a thrombolytic agent
within 2 hours of the onset of symptoms have reperfusion.
Successful reperfusion reduces the size of the myocardial
infarction and helps preserve the overall pumping function of the
heart.
[0006] There are several compelling reasons to start the
thrombolytic therapy as early as possible. Probably, the best time
for it is approximately 20-30 minutes after onset of symptoms, when
no irreversible damage to the myocardium has been done yet. At this
time the polymerization of fibrin in thrombus is still in progress
and the thrombus is soft and easier to dissolve. This is because at
this stage it is more permeable for the thrombolytic agents. The
major mechanism of thrombolysis of totally occlusive thrombi is
dragging the blood plasma with a thrombolytic agent in it through
the body of thrombus by the blood pressure differential before and
after the thrombus. Thus, early started thrombolytic therapy allows
facilitates the faster dissolution of the thrombus. It is important
also that for lysis of a very fresh thrombus that all thrombolytic
agents are equally efficient. The tPA agent is about 10 times more
expensive than streptokinase, but there is no difference in the
time of dissolving of fresh thrombi.
[0007] Thus, very early thrombolytic therapy promises a complete
salvage of the myocardium with the preservation of the overall
pumping function of the heart, and it can be performed with a cost
effective choice of thrombolytic drug. Mortality and morbidity of
the patients suffering a myocardial infarction can be drastically
reduced.
[0008] Whether or not thrombolytic treatment is undertaken or
successful, additional treatment is usually required. Nitroglycerin
is given either under the tongue or by vein to reduce symptoms by
decreasing the heart's demand for oxygen and by improving the blood
flow through coronary arteries as much as possible. Heart attacks
can be very painful, so narcotics such as morphine are given when
necessary. Medications such as beta-adrenergic blocking agents may
be helpful for reducing pain and enhancing survival.
Beta-adrenergic blockers make the heart beat more slowly and less
forcefully, so it requires less oxygen. Blood clots can re-form in
the coronary artery at the sites where thrombolysis has already
dissolved the original blood clot. Thrombolytic drugs dissolve
blood clots that already formed; anticoagulants prevent new blood
clots from developing. A similar function is performed by
antiplatelet medication like aspirin, which can be administered
orally or intravenously.
[0009] Both thrombolytic therapy and supportive care are available
in emergency rooms in hospitals. A lot of effort has been spent to
provide the treatment as soon as possible. Nevertheless, the
shortest time that passes before the treatment starts is still
about two hours. At this time some damage to the myocardium is
already done, and the treatment strategy is to minimize it and
relieve the symptoms associated with this damage.
[0010] In many countries a special emergency mobile care paramedic
unit has been introduced for cardiac patients with suspected
myocardial infarction. With this "out-of-hospital" approach
thrombolytic therapy can be delivered faster than in hospital
emergency rooms. It is very promising way of improving cardiac
care. The drawback of this approach is that the diagnosis and
overall management of the patients by paramedics is not of the
quality provided by highly qualified physicians in the emergency
rooms in hospitals.
[0011] It is desirable that the emergency care be selected,
prescribed and managed by the patient's personal cardiologist, who
is familiar with the patient's cardiac history and general state of
health.
[0012] It is desirable also to develop a method to provide a
multiple medication therapy for cardiac patients suffering from a
heart attack in its earliest stage, in the first 20-30 minutes
after the onset of the symptoms. Such an early start would make
real a new treatment strategy, the fundamental objective of which
is the complete salvage of the myocardium and the preservation of
100% of its pumping function, rather than reducing to minimum the
damage made in the first 2 hours.
[0013] There have been many known devices and methods for
intravenous infusion of drugs, particularly drugs in a dry form, or
lyophilized drugs, ready for reconstitution to liquid state before
the usage. As an example, U.S. Pat. No. 5,024,657, assigned to
Baxter International, and many others in U.S. class 604/85. This
device is intended for hospital use by a qualified nurse or
physician. It is not automated and can't be used by a person with
little or no medical training.
[0014] It should be mentioned that a great number of contemporary
drugs loose their activity within months of storage at room
temperature. It is especially true for the protein based drugs,
including thrombolytic agents. The system in accordance with the
referred patent does not have a cooler and thus does not warrant
the long-term efficiency of the drugs. It can not be held in a
stand by state for a long period of time.
[0015] Another example of prior art can be U.S. Pat. No. 5,609,572,
issued to Volker Lang. In this patent a modular cassette infusion
system for multiple infusions and automatic administration of
medicaments is described. For infusion control the system utilizes
a microprocessor, which has fixed program and manual programming
steps and is compatible with the infusion equipment. It
substantially reduces the work to be performed by nursing staff.
The device described in this patent requires manual reconstitution
of dry drugs and does not allow keeping the drug potent and ready
for a long time. To operate the system and to make an intravenous
(IV) puncture by a standard needle carrier a professional nurse is
required. The system is not adapted for self-administration of
thrombolytic therapy.
[0016] An IV needle carrier assembly is described in U.S. Pat. No.
4,170,993. It includes a delta-shaped base plate and IV needle
carrier--receiving barrel, secured to the base plate. An adhesion
tape affixed to the base plate anchors the plate to the skin of the
patient. The needle can be moved in two positions, rearward and
forward. In the latter position it is placed for puncturing the
vein. After establishing an IV access the base is affixed by the
adhesion tape for the assembly to retain its place on the skin.
This IV needle assembly is intended to be used by a medical
professional and is not adapted to gaining an IV access by a
patient himself.
SUMMARY OF THE INVENTION
[0017] An object of the present invention is to provide an
apparatus and method for intravenous infusion of thrombolytic
agents and supportive medication as early as 20-30 minutes after
the onset of the heart attack symptoms.
[0018] Another object of the present invention is to provide an
apparatus capable of being in a stand-by position continuously for
several years.
[0019] Yet another object of the invention is to provide numerous
standard schedules of delivery of medications, enabling a
cardiologist to select an appropriate care for covering the needs
of different patients.
[0020] Another object of the present invention is, in case of
inability to promptly contact a personal cardiologist or other
qualified physician, to provide a cardiac patient with an option to
self-diagnose an acute myocardial infarction and self-administer
the thrombolytic therapy.
[0021] Another object of the present invention is to provide a
simple and easy to use needle carrier adapted for gaining IV access
by a patient himself or another person without special advanced
medical training.
[0022] Yet another object of the invention is to provide a low
temperature environment for the library of medications ensuring
preservation of their potency for several years.
[0023] Yet another object of the present invention is to provide a
library of medication for thrombolytic therapy and supportive care
for the treatment of a heart attack. Provided medication can be in
a lyophilized or liquid form.
[0024] Another object of present invention is to provide to a
personal cardiologist or other qualified physician remote access to
the control of the apparatus via the Internet or other information
network.
[0025] Another object of the present invention is to provide an
apparatus for IV infusion, that is highly automated and, after
activation, does not require any intervention of an operator.
[0026] Still another object is to make the system portable and
battery powered, so it can be maintained in a stand by state at a
residence, in a car, in an aircraft, or in the field.
[0027] The fore mentioned objects are achieved by the present
invention, which provides an apparatus and method for emergency
treatment of a myocardial infarction. The apparatus comprises a
library of medications, a highly automated infusion pump,
controlled by a microprocessor, an intravenous needle, providing an
access to the patient's circulatory system, a set of valves and
conduits, providing fluid communication between the pump, the
needle, the medications vials and a bag of solvent used for
reconstitution of the lyophilized medications. These medications
are placed into a sterile compartment, in which temperature is
reduced to 4 C. or lower. This temperature guarantees protein
thrombolytic drug stability during 3-5 years if the cooler is not
off more than 1-3 months total.
[0028] The invention is intended to be used in the out-of-hospital
settings like a residence, a car, a passenger aircraft, a hotel, a
nursing home and the like.
[0029] This invention provides an opportunity to a patient himself
to start the thrombolytic therapy right after the onset of cardiac
pain, only 20-30 minutes after an occlusion in coronaries had been
diagnosed (independently by the patient him/herself or after a
consultation with a physician). To activate the system and start
the therapy the patient should perform very simple operations with
a highly automated infusion system. First, after activation the
system reconstitutes the lyophilized drugs and primes itself by
venting the air to avoid an air embolism. When the system is ready
for infusion, it sends a message to the operator and waits for a
command to start infusion. At that time the patient should gain an
IV access by puncturing a vein on his/her wrist, thereby fluidly
connecting the infusion apparatus with the patient's circulatory
system. As soon as the access to the patient's vein is established,
the thrombolytic and concomitant therapy can be started at any
moment. As the treatment starts the system uses as a default a
predetermined infusion schedule, preselected by a personal
physician of the patient. The state of the patient during infusion
can be evaluated by a physician via a phone line though
conversation, or other diagnostic means like ECG with an Internet
interface, capable of sending data to the physician. The system can
be stopped at any moment and, depending on the state of the
patient, the infusion schedule can be changed via the Internet by a
qualified physician or by the operator (patient) directly. With the
thrombolytic and supportive therapy in progress all efforts should
be undertaken to transport the patient to an emergency room in a
hospital, where the patient can be treated further by qualified
cardiologists. The information about all medications infused into
the patient's circulatory system, and the schedules of their
infusion are stored in the data acquisition system of the apparatus
and are available for the qualified personnel in the emergency room
of the hospital.
[0030] This invention is intended to be used by well-informed
patients experiencing an early stage of a heart attack. Individuals
who already had a heart attack, are good candidates for using the
apparatus. The term well-informed patients means that these
patients not only are familiar with the basics of the
cardiovascular disease but also were instructed in details by their
personal cardiologist how to use this apparatus, how to communicate
with the physician during the onset of a heart attack, what
symptoms are important for the correct diagnosis or self-diagnosis
of his/her conditions, if by some reasons the contacts with a
cardiologist are impossible. In this case the patient must rely
upon his/her own judgments and an automated infusion of drugs which
will be performed according to the schedules preselected by the
patient's physician.
[0031] The present invention provides thrombolytic therapy for
cardiac patients at the earliest stage of a heart attack, before
any necrosis of myocardium or other irreversible changes occur.
Right after an occlusion of a coronary artery has happened, the
thrombus is weak and is easier to dissolve. It requires less time
and amount of thrombolytic agent for restoring patency of the
occluded artery and thus results in lower chances of bleeding
complications, the major side effect of thrombolytic therapy. In
addition, at the early stage of thrombosis, there is no significant
difference in efficiency between different thrombolytic drugs (SK
or t-PA). So, an early thrombus can be efficiently dissolved by a
cheaper streptokinase (SK), cost of which is about 10% of that of
t-PA. The overall value of the present invention is provided by the
ability of early TT to completely salvage patient's myocardium,
resulting in significantly lower morbidity and mortality.
[0032] The present invention is designated for use by emergency
personal with limited or no medical training in nursing homes,
passenger aircrafts and the like, and by well-informed high heart
attack risk cardiac patients. The intended individual users should
be cautiously screened by a qualified cardiologist before
prescribing them an opportunity to buy a system and
self-administering the thrombolytic drugs. Before activating the
system and starting TT individual users have to diagnose a coronary
artery occlusion relying upon their symptoms. The pain of an acute
MI typically lasts for at least 30 min, it is unrelenting and does
not respond to nitroglycerin. Pain that is not relieved by
nitroglycerin or nifedipine challenge (ruling out coronary
vasospasm) would indicate occlusive thrombus instead of unstable
angina.
[0033] The objects, features, and advantages of the present
invention are evident for those skilled in the art from the
following description of a preferred embodiment of the invention
with reference to the accompanying drawings.
BRIEF DESCRIPTION OF THE DRAWING
[0034] FIG. 1 is an apparatus for out-of-hospital thrombolytic and
supportive therapy.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT
[0035] The present invention is schematically shown in the FIG. 1.
A needle carrier 1, which includes an IV needle 2, is fluidly
connected via a conduit 4 to an outlet 7 of a syringe 9.
Hydrophilic filter 5 prevents accidentally trapped air bubbles from
entering the patient circulation. One-way valve 6 separates the
needle conduit 4 from a conduit star junction 8, connected to the
syringe outlet 7. The valve 6 has two positions: "on", which allows
the liquid from the syringe outlet 7 to flow to the infusion needle
2 under appropriately applied pressure, and "off", which completely
shuts the passage. In the "off" position the valve 6 prevents blood
from the patient's vein from entering the conduit 4 and farther
into the syringe when vacuum is in the syringe.
[0036] Another one-way "on-off" valve 13 controls the passage of
fluid from a saline diluent reservoir 14 via a conduit 12 to the
conduit star 8. It also has two positions: in "on" position the
conduit 12 is open and when vacuum is applied saline can be sucked
into the syringe outlet 7. In the "off" position the conduit 12 is
shut off, and the fluid communication between the saline reservoir
14 and the syringe is blocked.
[0037] Conduit star 8, which fluidly connects the syringe outlet 7,
infusion needle 2 and the saline reservoir 14, is also connected to
a conduit 11, leading to a multi-port selection valve 15. The
multi-port valve 15 is designed to separately communicate the
conduit 11 with a needle set 16. The needles are adapted to further
communicate with drug vials from a medication library 17. By demand
of the control unit 3 the multi-port valve 15 may connect the
syringe to a selected drug vial. The drug library 17 is disposed in
a hermetic sterile department of a cooler 18, preferably, a
thermoelectric cooler. A needle set 16 is secured in an engaging
mechanism 19. A thermally insulating wall 20 is removed or
punctured through by the needles during activation of the
system.
[0038] When the system is activated, the engaging mechanism 19
moves the needle set along a rail 21, a part of engaging mechanism
19, forcing all needles to prick all rubber caps of multiple vials
simultaneously and thus ensuring fluid communication of the conduit
11 with the drug library 17. The needle set is propelled along the
rail 21 by hand or automatically by an electro motor, not shown in
FIG. 1. The syringe 9 is the main part of an automated IV pump 22,
which also includes an electric motor 23 and a worm mechanism 24,
transforming rotational motion of the motor into a translational
push-pull motion of the piston 25 in the syringe 9. The
programmable control unit 3 of the system controls "on-off"
positions of the valves 6, 10, 13, 15, the longitudinal position of
the piston 25 in the syringe 9, and the speed of its motion,
defining the intravenous infusion rate.
[0039] The control unit has several standard programs for priming
the system, reconstitution of the drugs, preparing predetermined
concentrations of drugs in saline solution, and their delivery in
predetermined amounts and rates into the patient circulation. The
control unit 17 can be reprogrammed remotely by a physician via the
a modem connection such as through a phone line or the Internet.
For this purpose an Internet interface 26 with a phone connector 27
is provided. Additionally, with advancing wireless technology, such
remote programming could be accomplished through the use of
wireless communication devices. A battery with recharging circuitry
is provided, which can be powered by any of standard voltages: 110,
220, 12 V.
[0040] It will be obvious to those skilled in the art that many
modifications may be made within the scope of the present invention
without departing from the spirit of thereof, and the invention
includes all such modifications.
[0041] The present invention having thus been described, other
modifications, alterations, or substitutions may now suggest
themselves to those skilled in the art, all of which are within the
spirit and the scope of the present invention. It is therefore
intended that the present invention be limited only by the scope of
the attached claims below.
* * * * *