WO2001049236A2

WO2001049236A2 - Method and system for treating cardiac arrest

Info

Publication number: WO2001049236A2
Application number: PCT/US2001/000058
Authority: WO
Inventors: Jack W. Lasersohn; William J. Worthen; Scott M. Evans; Suzanne C. Winter; David P. Balding
Original assignee: Alsius Corporation
Priority date: 2000-01-04
Filing date: 2001-01-03
Publication date: 2001-07-12
Also published as: US6516224B2; WO2001049236A9; AU2754201A; US6393320B2; US6405080B1; US20010047191A1; US20010047192A1; WO2001049236A3; US20010049545A1

Abstract

A method for treating cardiac arrest includes defibrillating the patient and/or ventilating the patient and/or administering a cardiac arrest drug such as epinephrine to resuscitate the patient, and then cooling the patient's body temperature using one or more cooling catheters (51, 52) placed in the central venous system and/or particularly cooling the patient's brain temperature using a catheter in the aortic arch or carotid artery.

Description

METHOD AND SYSTEM FOR TREATING CARDIAC ARREST

FIELD OF THE INVENTION

The present invention relates to methods and systems for treating cardiac arrest.

BACKGROUND

It has been discovered that the medical outcome for a patient suffering from

severe brain trauma or from ischemia caused by stroke or heart attack is improved if the

patient is cooled below normal body temperature (about 37°C). As understood by the

present invention, the medical outcome for many such patients might be significantly

improved if the patients were to be mildly or moderately cooled to 32°C-36°C relatively

quickly for a short period e.g., 1-2 hours, after an ischemic insult. And if desirable, the

patient's body temperature can be maintain at about 32°C-36°C for approximately 12-72

hours. It is believed that such cooling improves cardiac arrest patient outcomes by

improving the mortality rate, in that many organs can benefit from the cooling, and by

improving the neurological outcome for those patients that survive.

Systems and methods have been disclosed that propose cooling blood flowing to

the brain through the carotid artery. An example of such systems and methods is

disclosed in U.S. pat. app. serial no. 09/063,984, filed April 21, 1998, owned by the present assignee and incorporated herein by reference. In the referenced application,

various catheters are disclosed which can be advanced into a patient's carotid artery and

through which coolant can be pumped in a closed circuit, to remove heat from the blood in the carotid artery and thereby cool the brain. The referenced devices have the

advantage over other methods of cooling (e.g., wrapping patients in cold blankets) of

being controllable, relatively easy to use, and of being capable of rapidly cooling and

maintaining blood temperature at a desired set point.

As recognized in U.S. pat. app. serial no. 09/133,813, filed August 13, 1998,

owned by the present assignee and incorporated herein by reference, the above-mentioned

advantages in treating ischemia by cooling can also be realized by cooling the patient's

entire body, i.e., by inducing systemic hypothermia. The advantage of systemic

hypothermia is that, as recognized by the present assignee, to induce systemic

hypothermia a cooling catheter or other cooling device need not be advanced into the

blood supply of the brain, but rather can be easily and quickly placed into the relatively

large vena cava of the central venous system. Moreover, since many patients already are

intubated with central venous catheters for other clinically approved purposes anyway,

providing a central venous catheter that can also cool the blood requires no additional

surgical procedures for those patients. A cooling central venous catheter is disclosed in

the present assignee's U.S. patent applications serial nos. 09/253,109, filed February 19,

1999 and 09/305,613, filed May 5, 1999, both of which are incorporated herein by

reference. The present invention understands that the above-mentioned benefits of

hypothermia might be particularly suited for treating cardiac arrest. This is because

outcomes for cardiac arrest patients currently are very poor, even when the patients can be

resuscitated, since brain damage occurs as a result of the global ischemia caused by lack

of blood flow before resuscitation. The severity of such brain damage, as understood

herein, can potentially be alleviated by hypothermia.

SUMMARY OF THE INVENTION

A kit for lowering a patient's temperature includes a first catheter that has at least

one fluid circulation passageway connectable to a source of coolant. In accordance with

the present invention, the first catheter is configured for placement in a patient's vena

cava via a groin entry point. Also, a second catheter has at least one fluid circulation

passageway connectable to a source of coolant. As set forth below, the second catheter is

configured for placement in a patient's circulatory system via a neck entry point.

In one aspect, a bolus of cold saline solution is introduced into the brain of the

patient through a third catheter to lower the brain temperature quickly. In one

embodiment, the third catheter is advanced into the patient's aortic arch. In another

embodiment, the third catheter is advanced into the patient's carotid artery. In a preferred

embodiment, the temperature of the cold saline solution can range from 0 to 37 degrees

celsius; although other temperature ranges will be understood by those skilled in the art.

The cold saline solution is released into the brain area through the drug delivery port of the third catheter. This third catheter (included in the kit) may also include at least one

fluid circulation passageway connectable to a similar source of coolant as the first and

second catheters. Alternatives to saline solution will be understood by those skilled in the

art. Similarly, the third catheter may be advanced into other arteries that supply the brain

with blood, such as, but not limited to, the brachiocephalic artery, the basilar artery, etc.;

or the third catheter may be advanced into the various cerebral arteries that are connected to the carotid artery such as, but not limited to, the middle cerebral artery (MCA), the

internal cerebral artery (ICA), the anterior cerebral artery (ACA), etc.

In a preferred embodiment, the kit can include the source of coolant. Preferably,

the source of coolant includes at least one thermal electric cooler (TEC) for heating or

cooling coolant such that coolant is returned to the catheter to heat or cool the catheter.

The kit can be incorporated in system that includes a ventilation system, and/or a

defibrillator system, and/or a component containing a drug selected from the group

consisting of: epinephrine, buffers, antiarrhythmics, and atropine.

In another aspect, a method for treating cardiac arrest in a patient includes

defibrillating the patient, and lowering the patient's temperature using at least one

catheter placed in the venous system of the patient.

In still another aspect, a method for treating cardiac arrest using hypothermia

includes resuscitating the patient and inducing hypothermia in the patient.

In yet another aspect, a system for treating cardiac arrest in a patient includes at least one cooling catheter that is advanceable into the central venous system of the

patient. The system further includes one or more of: a defibrillator, a ventilator, and a

cardiac arrest drug delivery device engageable with the patient.

In yet another aspect, a system for treating cardiac arrest in a patient includes at

least one catheter that may be introduced into the aortic arch or into the carotid artery of

the patient and that can deliver a bolus of cold saline solution into the patient's brain to

lower the brain temperature quickly. The system further includes at least one other

catheter that may be advanced into the central venous system of the patient. This central

venous catheter is situated in a heat exchange relationship with the patient's blood supply

using coolant which is circulated between the central venous catheter and an external

coolant source in a closed loop. The system may also include one or more of: a

defibrillator, a ventilator and a cardiac arrest drug delivery device engageable with the

patient.

In yet another aspect, the catheter (that may be introduced into the aortic arch or

into the carotid artery of the patient for delivery of a bolus of cold saline solution) is also

a heat exchange catheter which can circulate coolant between the blood supply of the

patient's brain and an external coolant source in a closed loop either to continue to lower

the brain temperature or to maintain the brain temperature at a given threshold as

determined by the patient's caretaker.

The details of the present invention, both as to its structure and operation, can best be understood in reference to the accompanying drawings, in which like reference

numerals refer to like parts, and in which:

BRIEF DESCRIPTION OF THE DRAWINGS

Figure 1 is a schematic view of the cooling system using the first cooling catheter;

Figure 2 is a schematic view of the cooling system using the second cooling

catheter;

Figure 3 is a flow chart of the present invention for treating cardiac arrest in a

patient; and

Figure 4 is a flow chart of the steps for cardiopulmonary resuscitation (CPR).

Figure 5 is a schematic view of the cooling system using the third cooling catheter.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT

Referring initially to Figure 1, a therapeutic system, generally designated 10, is

shown for treating cardiac arrest in a patient 12. As shown, the system 10 includes a

cooling system 14 that can be a water-bath system such as the system disclosed in the

present assignee's U.S. patent application serial no. 09/220,897 filed December 28, 1998

and incorporated herein by reference, or a cooling system including at least one thermal

electric cooler (TEC) 16, as disclosed in the present assignee's U.S. patent application

serial no. 09/260,950, filed March 2, 1999 and incorporated herein by reference. In any

case, the cooling system 14 can be considered a source of coolant, preferably sterile saline, for the catheters of the present invention.

As set forth in these applications, the cooling system 14 can include a heat

exchanger, a pump, and, if desired, a controller. Preferably, the pump is a peristaltic

pump, but other types of positive displacement pumps, such as but not limited to piston

pumps and gear pumps, or even centrifugal pumps, can be used. A peristaltic pump is

preferred in the present implementation because it can pump coolant without directly

contacting the coolant, but instead simply by squeezing a tube through which the coolant

flows. In this way, the pump is reusable, and only the present catheters and portions of

the system 10 coming in direct contact with the coolant need be made disposable to

render an advantageously disposable and sterile coolant delivery system. The controller

controls the rate at which coolant is pumped by the pump and, if desired, the rate at which

heat is added or subtracted from the coolant. The controller can be implemented by a

software-executing processor or by discrete logic circuits or other electronic circuitry

device to establish a desired patient temperature by appropriately controlling the pump

and/or heat exchanger in response to a temperature signal derived from a sensor in the

patient 12.

As shown in Figure 1 , a first cooling catheter 18 can communicate with the

cooling system 14 via coolant supply and return lines 20, 22. The coolant lines 20, 22

can be IN lines or tubes or other suitable fluid conduits, such as metal (steel) tubes.

When the coolant lines 20, 22 are plastic tubes, they can be connected to the catheter 18

and the cooling system 14 by suitable connecting structure, such as Luer fittings, interference fits, solvent bonding, heat staking, ultrasonic welding, and the like.

The first cooling catheter 18 includes a heat exchange region 24. The heat

exchange region 24 can be established by one or more hollow fibers, as disclosed in the

above-referenced U.S. patent application serial no. 09/133,813. Alternatively, the heat

exchange region 24 can include one or more cooling membranes such as balloons as

disclosed in the above-referenced U.S. patent application serial nos. 09/253,109 and

09/305,613. For example, the heat exchange region 24 of the first catheter 18 can be

established by four axially staggered balloons, each ten millimeters in diameter when

inflated with coolant.

In any case, as set forth in the referenced applications, coolant is circulated in a

closed fluid communication loop between the heat exchange region 24 and cooling

system 14 to remove heat from the patient 12. As set forth in greater detail below, the

first catheter 18 is advanced (preferably through an introducer sheath) into the vena cava

of the patient 12 through a groin entry point 26 to establish hypothermia in the patient 12.

Preferably, the catheter 18 is advanced either through the saphenous vein or femoral vein

in accordance with the method described below.

In addition to or in lieu of the first catheter 18, a second cooling catheter 28

(Figure 2) which is configured for use as a central venous catheter can be advanced into

the central venous system of the patient through a neck entry point 29. The second

catheter 28 can be embodied by the catheter disclosed in the above-referenced patent

application serial nos. 09/253,109 and 09/305,613. Accordingly, the second catheter 28 can communicate with the cooling system 14 via coolant supply and return lines 30, 32.

Also, the second catheter 28 can communicate with one or more central venous

components 34, such as IN infusion devices, drug delivery syringes for infusing

epinephrine, blood withdrawal devices, and so on.

As disclosed in the referenced applications, the second catheter 28 includes a heat

exchange region 36 that can be established by one or more membranes such as balloons, although it could be established by hollow fibers in the manner of the catheter 18, but on

a smaller scale. The catheter 28 can be advanced into the superior vena cava through the

jugular vein or subclavian vein to cool the patient 12 by means of coolant circulating in a

closed loop between the cooling system 14 and the balloon 36. As mentioned above, the

second catheter 28 can also be used to undertake conventional central venous catheter

functions.

Referring back to Figure 1 , in addition to the cooling components discussed

above, the system 10 can include a heart defibrillator system 38 that can be engaged with

the patient 12 by means of one or more defibrillator connecting lines 40 with associated

engaging paddles/electrodes 41. Moreover, the system 10 can include a ventilation

system 42 that ventilates the patient 12 by means of an endotracheal tube 44 or other

equivalent device such as a ventilating mask.

The process of the present invention can be appreciated in reference to Figure 3.

Commencing at block 46, basic life support algorithms are undertaken on a patient

suffering from cardiac arrest. The basic life support activities can include one or more of the cardiopulmonary resuscitation (CPR) acts discussed below in reference to Figure 4.

At block 48, in an attempt to quickly start the patient's heart beating again,

particularly in the absence of a defibrillator, a precordial thump can be administered to

the patient's chest. In addition, or if and when the defibrillator system 38 becomes

available, at block 50 the defibrillator is engaged with the patient and the patient is

defibrillated to start the patient's heart beating.

After initial defibrillation, the patient's heart rhythm is assessed at block 52. At

decision diamond 54 it is determined in accordance with cardiac arrest resuscitation

standards whether the patient exhibits ventricular fibrillation (NF) or ventricular

tachycardia (NT). NF is defined as a pulseless, chaotic, disorganized rhythm

characterized by an undulating irregular pattern that varies in size and shape with a

ventricular waveform greater than 150 beats per minute. If no NFNT is detected,

indicating that the patient's heart is beating normally, some or all of the CPR acts shown

in Figure 4 are administered as necessary at block 56 for, e.g., up to three minutes.

If, on the other hand, it is determined at decision diamond 56 that the patient

exhibits NFNT, the patient is defibrillated up to, e.g., three times at block 58. In one

preferred embodiment, defibrillation energy levels are 200 J (2 J/kg) for the first shock,

200J-300J (2-4 J/kg) for the second shock, and 360J (4J/kg) for the third and subsequent

shocks (weight-based dosages are pediatric recommendations). CPR is then administered

at block 60 for up to, e.g., one minute.

In one embodiment, hypothermia is induced into the patient's brain at block 61 in the form of a bolus of cold saline solution introduced into the aortic arch or into the

carotid artery. Also, the bolus of cold saline may be introduced directly to one or more of

the cerebral arteries connected to the carotid artery, such as, but not limited to, the MCA,

the ICA, the ACA, etc. via one or more catheters. In another aspect, the catheter (in

addition to delivering a bolus of cold saline) is also a heat exchange catheter through

which coolant can be pumped in a closed circuit to remove heat from the blood supplied

to the brain and thereby maintain the brain temperature at a desired level or further lower

the brain temperature. It is to be understood that the step shown in block 61 can be

undertaken at other convenient times, including before defibrillation and CPR or

concurrently therewith, and after block 62 when therapeutic hypothermia is induced into

the patient's circulatory system or concurrently therewith.

In accordance with the present invention, after defibrillation and CPR, moderate

hypothermia is induced in the patient at block 62 to alleviate the results of global

ischemia arising from cardiac arrest. It is to be understood that the step shown at block

62 can be undertaken at other convenient times including before defibrillation and CPR

or concurrently therewith. In any case, the patient's temperature is lowered below normal

body temperature, and as low as 32 C, by advancing one or both of the catheters 18, 28

into the patient 12 and then circulating coolant through the catheter 18, 28.

In one embodiment of the present method, the first catheter 18 is initially

advanced into the vena cava through the groin to cool the patient while resuscitation personnel require access to the neck for intubation and for establishing rapid IN access.

When CPR is complete, the second catheter 28 can be advanced into the vena cava

through the relatively less septic neck, and if desired the first catheter 18 can be removed

from the relatively more septic groin area. It is to be understood that while this is one

preferred sequence of the order of steps for inducing hypothermia in a cardiac arrest

patient, other sequences can be used. For example, the first catheter 18 can be used

exclusively to the second catheter 28, the second catheter 28 can be used exclusively to

the first catheter 18, or both catheters 18, 28 can be used together simultaneously.

In one embodiment, a third catheter 48 is advanced into the aortic arch or into the

carotid artery. As shown in Figure 5, a bolus of cold saline solution 54 is introduced

through the drug delivery port 49 of the third catheter 48 to lower the brain temperature

quickly. In another embodiment, the third catheter 48 (in addition to delivering a bolus of

cold saline) is also a heat exchange catheter through which coolant can be pumped in a

closed circuit to remove heat from the blood supplied to the patient's brain and thereby

maintain the brain temperature at a desired level or further lower the brain temperature.

The third catheter 48 can be embodied by the catheter disclosed in the above-referenced

patent application Serial Νos. 09/253,109 and 09/305,613. As shown in Figure 5, the

third catheter 48 communicates with a cooling system 50 via coolant supply and return

lines 51, 52. Also, the third catheter 48 can communicate with one or more delivery

components 53, such as delivery of a bolus of saline, drug delivery, etc. The third

catheter 48 can be used exclusively with the first catheter 18, exclusively with the second catheter 28 or with both the first and second catheters either in series or simultaneously.

Figure 4 shows that CPR can include but need not be limited to checking defibrillator

electrode/paddle engagement on the patient at block 64. Also, CPR can include establishing

endotracheal access with the ET tube 44 at block 66 and then ventilating the patient using the

ventilation system 42. If tracheal intubation is not possible, a laryngeal mask airway or

Combitube can be used as alternatives.

Moreover, at block 68 intravenous (IN) access can be established using one of the

catheters 18, 28 or another catheter such as a Swan-Ganz catheter, and then cardiac arrest

drugs such as epinephrine can be administered. If IN access is not attainable, epinephrine

can be administered via the ET tube 44 using at least twice the intravascular dosage of at

least 1 mg (O.Olmg/kg) every 3 minutes.

At block 70 other drugs can be considered for administration including buffers,

antiarrhythmics, and atropine, and the installation of a pacemaker can also be undertaken.

Any causes that can be corrected (such as, e.g., blocked airways) are corrected at block 72.

While the particular METHOD AND APPARATUS FOR ESTABLISHING AND

MAINTAINING THERAPEUTIC HYPOTHERMIA as herein shown and described in

detail is fully capable of attaining the above-described objects of the invention, it is to be

understood that it is the presently preferred embodiment of the present invention and is

thus representative of the subject matter which is broadly contemplated by the present

invention, that the scope of the present invention fully encompasses other embodiments which may become obvious to those skilled in the art, and that the scope of the present

invention is accordingly to be limited by nothing other than the appended claims, in

which reference to an element in the singular is not intended to mean "one and only one"

unless explicitly so stated, but rather "one or more". All structural and functional

equivalents to the elements of the above-described preferred embodiment that are known

or later come to be known to those of ordinary skill in the art are expressly incorporated

herein by reference and are intended to be encompassed by the present claims. Moreover,

it is not necessary for a device or method to address each and every problem sought to be

solved by the present invention, for it to be encompassed by the present claims.

Furthermore, no element, component, or method step in the present disclosure is intended

to be dedicated to the public regardless of whether the element, component, or method

step is explicitly recited in the claims. No claim element herein is to be construed under

the provisions of 35 U.S.C. §112, sixth paragraph, unless the element is expressly recited

using the phrase "means for".

Claims

What is claimed is:

1. A kit, comprising:

a first catheter having at least one fluid circulation passageway

connectable to a first source of coolant, the first catheter being configured for placement

in a patient's central venous system; and

a second catheter being configured for at least partial placement in said

patient's aortic arch, said second catheter comprising a fluid dispensing component

connectable to at least one bolus of saline solution.

2. The kit of Claim 1 wherein said first catheter is configured for placement

in said patient's vena cava system through a groin entry point.

3. The kit of Claim 1 wherein said second catheter is configured for

advancement through said patient's aortic arch for placement in said patient's carotid

artery.

4. The kit of Claim 1 wherein said second catheter further comprises at least

one fluid circulation passageway connectable to said first source of coolant

5. The kit of Claim 1 wherein said second catheter further comprises at least

one fluid circulation passageway connectable to a second source of coolant

6. The kit of Claim 1 further comprising a third catheter having at least one

fluid circulation passageway connectable to said first source of coolant, the third catheter

being configured for placement in said patient's circulatory system via a neck point.

7. The kit of Claim 1 further comprising a third catheter having at least one

fluid circulation passageway connectable to a source of coolant different from said first source of coolant, the third catheter being configured for placement in said patient's

circulatory system via a neck point.

8. The kit of Claim 1 further comprising at least one ventilation system.

9. The kit of Claim 1 further comprising at least one defibrillator system.

10. The kit of Claim 1 further comprising at least one component containing a

drug selected from the group consisting of epinephrine, buffers, antiarrhythmics, and

atropine.

11. A method for treating cardiac arrest in a patient, comprising the acts of:

lowering said patient's temperature using a first catheter placed in the central venous

system of said patient, said first catheter including a fluid circulation passageway connectable to a source of coolant; and introducing a bolus of saline solution into said

patient's arterial system.

12. The method of Claim 11, further comprising the act of defibrillating said

patient.

13. The method of Claim 11 , further comprising the act of administering a

precordial thump to said patient.

14. The method of Claim 11, further comprising the act of ventilating said

patient.

15. The method of Claim 11 , further comprising the act of administering one

or more of: epinephrine, buffers, antiarrhythmics, or atropine to said patient.

16. The method of Claim 11 wherein said bolus of saline solution is

introduced through a second catheter.

17. A method for treating cardiac arrest in a patient, comprising the acts of:

system of said patient, said first catheter including a first fluid circulation passageway connectable to a source of coolant; and using a second catheter placed in said patient's aortic arch to introduce a bolus of saline solution into said patient's aortic arch, wherein

said second catheter includes a second fluid circulation passageway connectable to said

source of coolant.

18. A method for treating cardiac arrest in a patient, comprising the acts of:

system of said patient, said first catheter including a first fluid circulation passageway

connectable to a first source of coolant; and using a second catheter placed in said

patient's aortic arch to introduce a bolus of saline solution into said patient's aortic arch,

wherein said second catheter includes a second fluid circulation passageway connectable

to a second source of coolant.

19. A method for treating cardiac arrest in a patient, comprising the acts of:

system of said patient, said first catheter including a fluid circulation passageway

connectable to a source of coolant; and using a second catheter placed in said patient's

carotid artery to introduce a bolus of saline solution into said patient's carotid artery.

20. The method of Claim 19, further comprising the act of defibrillating said

patient.

21. The method of Claim 19, further comprising the act of administering a

precordial thump to said patient.

22. The method of Claim 19, further comprising the act of ventilating said

patient.

23. The method of Claim 19 further comprising the act of administering one or

more of: epinephrine, buffers, antiarrhythmics, and atropine to said patient.

24. A method for treating cardiac arrest in a patient, comprising the acts of:

carotid artery to introduce a bolus of saline solution into said patient's carotid artery,

to said source of coolant.

25. A method for treating cardiac arrest in a patient, comprising the acts of:

system of said patient, said first catheter including a first fluid circulation passageway connectable to a first source of coolant; and using a second catheter placed in said

patient's carotid artery to introduce a bolus of saline solution into said patient's carotid

artery, wherein said second catheter includes a second fluid circulation passageway

connectable to a second source of coolant.

26. A method for treating cardiac arrest in a patient using hypothermia,

comprising the acts of: resuscitating said patient;

inducing hypothermia by circulating coolant through a first catheter

positioned in said patient's central venous system; and

lowering said patient's brain temperature by introducing a bolus of saline

solution into said patient's arterial system using a second catheter positioned in said

patient's aortic arch.

27. A method for treating cardiac arrest in a patient using hypothermia,

comprising the acts of:

resuscitating said patient;

inducing hypothermia by circulating coolant through a first catheter

positioned in said patient's central venous system; and

lowering said patient's brain temperature by introducing a bolus of saline

solution into said patient's arterial system using a second catheter positioned in said patient's carotid artery.

28. A system for treating cardiac arrest in a patient comprising:

at least one of: a defibrillator, a ventilator and a cardiac arrest drug

delivery device engageable with said patient;

at least one cooling catheter advanceable into said patient's central venous

system; and a fluid dispensing catheter advanceable into said patient's aortic arch for

delivery of at least one bolus of saline solution into said patient's aortic arch.

29. The system of Claim 28 wherein said fluid dispensing catheter further

comprises at least one fluid circulation passageway connectable to a source of coolant.

30. A system for treating cardiac arrest in a patient comprising:

at least one of: a defibrillator, a ventilator and a cardiac arrest drug

delivery device engageable with said patient;

at least one cooling catheter advanceable into said patient's central venous

system; and

a fluid dispensing catheter advanceable into said patient's carotid artery for

delivery of at least one bolus of saline solution into said patient's carotid artery.

31. The system of Claim 30 wherein said fluid dispensing catheter further