U.S. patent number 3,680,544 [Application Number 05/070,658] was granted by the patent office on 1972-08-01 for transthoracic cannula-type device for cardiopulmonary resuscitation.
Invention is credited to James F. Conroy, James P. Shinnick.
United States Patent |
3,680,544 |
Shinnick , et al. |
August 1, 1972 |
TRANSTHORACIC CANNULA-TYPE DEVICE FOR CARDIOPULMONARY
RESUSCITATION
Abstract
A medical instrument, taking the general form of a flexible
catheter or cannula, combines a passage for intracardiac drugs with
an electrode or electrodes for applying an electrical stimulus to
the heart. Designed primarily for use in emergency cardiopulmonary
resuscitation procedures instituted in cases of cardiac arrest, the
instrument incorporates an expansible stop collar at its tip that
stabilizes its position following its penetration of the chest and
heart walls, and in particular prevents accidental withdrawal or
escape thereof. The stably positioned instrument affords the
opportunity for external cardiac heart massage without danger of
heart damage resulting from motion of the instrument that would
normally occur if an instrument of this type is not removed during
said external cardiac massage of the heart muscle.
Inventors: |
Shinnick; James P. (Maple
Shade, NJ), Conroy; James F. (Philadelphia, PA) |
Family
ID: |
22096614 |
Appl.
No.: |
05/070,658 |
Filed: |
September 9, 1970 |
Current U.S.
Class: |
600/581; 174/47;
604/21; 604/158; 604/915 |
Current CPC
Class: |
A61M
25/10 (20130101); A61B 10/00 (20130101); A61N
1/0587 (20130101) |
Current International
Class: |
A61M
25/10 (20060101); A61B 10/00 (20060101); A61N
1/05 (20060101); A61b 005/02 (); A61m 025/00 ();
A61n 001/34 () |
Field of
Search: |
;128/2R,2M,2.5D,2.5F,349R,172.1,303.1,303.11,303.13,344,348,347,349B |
References Cited
[Referenced By]
U.S. Patent Documents
Primary Examiner: Truluck; Dalton L.
Claims
We claim:
1. A transthoracic, cannula-type medical instrument for use in
cardiopulmonary resuscitation procedures comprising;
a. a flexible tubular member having normally closed valve means
therein and being provided with a tip adapted to be positioned
within the right ventricle of the heart muscle through the chest
wall of a patient and providing a channel having an opening for the
flow of liquid to the heart or for the removal of blood aliquots
therefrom:
b. stop means carried by said tubular member and located adjacent
said tip, said stop means being radially expandable outwardly with
respect to the axis of said tip into a position to engage the inner
surface of the endocardium and limit subsequent axial movement of
said tubular member;
c. means for applying an electrical stimulus to the heart muscle,
including electrodes exposed on the outer surface of said tubular
member;
d. said stop means and electrodes being so positioned with respect
to each other that when said stop means are moved outward into
contact with the inner surface of the endocardium, at least one of
said electrodes will be held in contact with the heart muscle.
2. A medical instrument as in claim 1 wherein said means for
applying an electrical stimulus further includes a path for an
electrical current extending from the electrode within the wall of
the tubular member and connectable remotely from the tip to a
source of electrical current.
3. A medical instrument as in claim 1 wherein said electrode is in
the form of a sleeve of electrically conductive material encircling
said tubular member.
4. A medical instrument as in claim 3, further including an
electrical lead embedded within and extending longitudinally of the
wall of said tubular member, said lead at one end being
electrically connected with said sleeve and at its other end being
electrically connectable to a source of electrical current.
5. A medical instrument as in claim 1, further including a check
valve within the tubular member to prevent backflow of said
fluids.
6. A medical instrument as in claim 1, wherein said valve means
includes a check valve in said member to prevent the backflow of
fluids from the heart muscle, and a branch tube providing an
auxiliary channel for liquids and connected with said member in
communication therewith between said tip and check valve.
7. A medical instrument as in claim 1 wherein said stop means
includes a hollow expansible element mounted upon said tip and
further includes a conduit for an expansion fluid that extends
within the wall of the tubular member in communication with the
expansible element and with a source of expansion fluid under
pressure, said means for applying an electrical stimulus including
a pair of leads connected between the respective electrodes and a
source of electrical current, said leads extending within the wall
of the tubular member in angularly spaced relation to said conduit
and to each other.
8. A medical instrument as in claim 7 wherein the expansible
element is in the form of an annular collar encircling the tip of
the tubular member and said electrodes are in the form of
cylindrical sleeves that extend about the tubular member and are
spaced longitudinally thereof from each other and from said collar.
Description
BACKGROUND OF THE INVENTION
1. Field of the Invention
The invention pertains to medical instruments of the cannula or
catheter type designed for transthoracic insertion into the heart
muscle through a previously inserted needle, and adapted following
insertion to serve as a channel for the administration of
intracardiac drugs, as a means for applying an electrical stimulus
to the heart, and as a means for obtaining venous blood samples for
analysis.
2. Description of the Prior Art
Applicants are aware of the following patents believed pertinent to
consideration of the invention:
Schipley 2,976,865 Schein et al. al. 3,078,850 Kilpatrick 3,087,486
Beebe et al 3,098,813 Chesebrough et al 3,313,293 Chardack
3,348,548 Khalil 3,359,974 Quinn 3,416,534 Ackermann 3,485,247
The prior art as represented by these patents contains at least
broad teaching for the concept of applying electrical stimuli and
drugs through a single instrument designed for transthoracic
insertion into the heart muscle. However, the patents fail to solve
a problem which becomes of particular concern in emergency
resuscitative situations. The problem results from the necessity of
external cardiac massage of the heart for the purpose of restarting
it, while the cannula remains in inserted position.
In recent years, there has been developed in hospitals an emergency
procedure designed to resuscitate a patient whose heart has failed.
Sometimes called a "Code 99," this procedure involves a coded call
put out over the intercommunication system, and responding
immediately to this call is a highly trained team of physicians,
nurses, and technicians. Wherever the members of the team may be in
the hospital, they converge immediately upon the room occupied by
the patient, and in a race against time, initiate cardiopulmonary
resuscitation of the patient, with each member of the team carrying
out his or her duties, in a combined effort that involves
considerable training, drill and the use of highly sophisticated
medical instruments.
One or more of the resuscitative procedures may prove successful in
restarting the stopped heart of the patient or in producing normal
beating of a heart that, for example, may be fibrillating or may
otherwise show imminent danger of full cardiac arrest. External
cardiac massage is always used, and often is sufficient to
resuscitate the patient. Or, the injection of adrenalin directly
into the heart may aid in the resuscitation effort. Or, the
application of electrical stimuli by such apparatus as a so-called
"pacemaker" may be helpful.
It is, of course, extremely critical that any or all of these
resuscitative methods be applied with an absolute minimum of delay.
Time is absolutely critical, and even the loss of a few seconds can
result in failure to resuscitate the patient or, in some instances,
serious brain damage, should the restoration of the heartbeat not
be obtained within a given, very short period of time.
The difficulty which we have noted arises from the fact that heart
massage cannot effectively be carried out while there remains in
the chest a rigidly constituted, transthoracically inserted cannula
or cardiac electrode.
This is by reason of the fact that the pressures exerted during
heart massage produce motions of the heart in respect to a cannula
or electrode, tending to drive instruments of this type too deeply
into the heart. Or, such motions may cause the opening resulting
from penetration of the heart wall by such instruments to be
enlarged extensively, or the instrument may be caused to escape or
come out of the right ventricle. In such an event, fluids flowing
through the cannula might flow into the pericardium, the
mediastinum, or the lung. Then again, the heart wall may become
torn by the instrument during the application of heart massage or
the instrument may be caused to alternately withdraw from and
re-penetrate the heart wall, repeatedly during the heart
massage.
Accordingly, instruments of this type are withdrawn before heart
massage is initiated, and if reinsertion is indicated, external
cardiac heart massage must be temporarily discontinued. One danger
here is that the transthoracic insertion, accomplished under
emergency conditions, may cause the instrument to strike a coronary
artery or the like, with fatal results. Obviously, reinsertion of
the instrument doubles the possibility of such an occurrence.
SUMMARY OF THE INVENTION
The present invention seeks to provide, in a single instrument, a
solution to the problems described above. To this end, we provide a
medical instrument which briefly may be said to consist of an
elongated, flexible tube adapted to provide a conduit for the
administration of intracardiac drugs or the like, or the withdrawal
of blood samples, and provided at its tip with an annular, radially
expandable collar. In close proximity to the collar, are axially
spaced, sleeve-like electrodes. An inflating tube for the collar,
and lead wires for the electrode are confined within and are
angularly spaced about the wall of the flexible tubular member
through which the intracardiac fluids pass into the heart. The
electrodes are so spaced relative to one another, and to the stop
collar, as to assure that both electrodes will impinge upon the
tissues of the wall of the heart muscle when the stop collar is
expanded. The stop collar, further is so located as to limit the
tubular member against withdrawal in an axial direction, as well as
against lateral displacement.
The instrument includes, at its outer end, a fitting adapted for
effecting the rapid connection thereof to a source of intracardiac
fluids to be applied. Further, in a preferred embodiment there is
provided an auxiliary tube, connected in communication with the
tubular member described above, said auxiliary tube being adapted
to provide a conduit for intracardiac fluids or withdrawal of blood
samples. In this way, the administration of a multiplicity of
intracardiac fluids is included within the capability of the
instrument. The main tubular member, but not the auxiliary tube, is
provided with a check valve, so arranged as to prevent backflow of
the administered drugs. The auxiliary tube, together with its check
valve, is located in advance of the check valve of the main tube,
that is, between the main tube check valve and the inserted tip of
the device.
The instrument constituting the present invention is particularly
designed for transthoracic insertion into the right ventricular
cavity by a procedure wherein there is first inserted a spinal
needle, which initially may be in communication with a syringe
usable to remove a blood sample, The removal of the syringe permits
insertion of the instrument constituting the present invention
directly through the needle into the right ventricle, after which
the needle is removed and the collar is inflated. Intracardiac
drugs and/or other fluid medications may then be administered, and
temporary cardiac pacing can be instituted if the situation so
dictates. Further, as indicated above, the application of heart
massage becomes permissible while the instrument remains
inserted.
BRIEF DESCRIPTION OF THE DRAWING
FIG. 1 is a longitudinal sectional view on an enlarged scale,
portions being broken away, of a medical instrument according to
the present invention;
FIG. 2 is a transverse sectional view on line 2--2 of FIG. 1;
FIG. 3 is a pictorial view illustrating the usage of the invention,
the invention being shown on a scale considerably smaller than that
of FIGS. 1 and 2; and
FIGS. 4-9 are views illustrating successively following steps in
the use of the invention, the dotted lines representing
fragmentarily the skin and heart of the patient.
DESCRIPTION OF THE PREFERRED EMBODIMENT
The reference numeral 10 designates generally a medical instrument
constructed according to the present invention. In a preferred
embodiment, the instrument comprises an elongated, flexible,
tubular member 12 which may be considered a main tube, formed of a
plastic material desirably of constant inner and outer diameter
from end to end thereof. The tubular member 12 is open at its tip
13, and at its opposite or outer end is sealably connected to a
fitting 14 adapted to permit connection of the tubular member to a
source of fluid drugs, medicaments, or other fluids to be directed
into the heart "H" of the patient to be resuscitated, through
channel 15 provided by the tubular member.
Within channel 15, at the outer inlet end 16 of the tubular member,
there is mounted a check valve 17. This has been illustrated by a
conventional symbol in the drawing, since the check valve can be
any of various known types already in use, and does not constitute
per se a part of the present invention.
At the tip end 13 of the tubular member 12, there is provided an
expandable collar 18, constituting a stop or abutment disposed upon
tip 13 for the purpose of stabilizing the position of the
instrument following transthoracic insertion thereof into the right
ventricular cavity of the heart.
The collar 18 in the illustrated example is an annular, hollow,
flexibly walled element the inside diameter of which is permanently
bonded or secured to the outer surface of the tip 13.
Communicating with the hollow interior 19 of the stop collar 18 is
a conduit 20 for expansion fluid to be directed to the hollow
interior 19 of the stop collar when the collar is to be expanded
following insertion into the heart. Conduit 20 extends from the
collar 18 within the wall of tubular member 12, to a location along
the length of the tubular member that would be disposed well
outwardly from the chest wall of the patient. At this point, the
conduit 20 is connected in communication with a flexible supply
line 21 into which a fluid may be injected for expanding the stop
collar 18.
The fluid could be air, pumped or otherwise directed into the
supply line 21, so as to inflate the stop collar 18. Or, the
pressure fluid could be a liquid similarly forced into the collar
for radially expanding the same. When the device is to be
withdrawn, the inflating medium is withdrawn from the collar
through line 21 to deflate the collar.
In close proximity to stop collar 18 and to each other are
sleeve-like electrodes 22, 24 formed of a suitable electrically
conductive material, extending about the tubular member 12 and
secured against axial displacement in respect to the tubular member
and each other in any suitable manner. Electrodes 22 are impinged
upon by electrical lead wires 26, 28 respectively which, as shown
in FIG. 2, are embedded within the wall of the tubular member 12
and are angularly spaced within said wall from each other and from
the conduit 20.
Lead wires 26, 28, extend longitudinally of and within the wall of
the tubular member, to a location intermediate the ends of the
tubular member, at which location they extend outwardly from said
member. At their outer extremities, the lead wires are secured to
plugs or jacks 30, 32 respectively constituting positive and
negative connecting means attachable to corresponding posts of a
source of electrical current.
In the preferred, illustrated embodiment, we also provide an
auxiliary tube 34, which is secured to the tubular member 12 at a
location between the check valve 17 and the tip 13, preferably a
location near the fitting 14. An orifice 38 provides communication
between the auxiliary tube and channel 15. The auxiliary tube 34
has a closure 37 which is permanently bonded to the wall of the
auxiliary tube, and which is formed of a self-sealing rubber or
equivalent material. A needle, now shown, may thus be inserted
through the closure to provide a conduit for additional drugs, or
to take blood samples. When the needle is withdrawn, the closure
instantly seals itself.
OPERATION
In use, and assuming the existence of an emergency in which cardiac
arrest has already occurred or is imminent, a syringe 40, having
plunger 42 is fitted with needle 44. The syringe and needle are
conventional devices, the needle being of the type typically
employed as a spinal needle. The needle is inserted through skin
"S" into the heart "H" as shown in FIG. 4. The insertion would be
into the right ventricular cavity, the needle passing directly
through the skin and endocardium, the preferred location of
application being the left sternal margin, fourth interspace.
During the insertion of the needle, a slight suction is maintained
within the needle and syringe barrel, after which, following full
insertion, plunger 42 is withdrawn to a greater extent as shown in
FIG. 5. This draws a quantity of blood into the barrel of the
syringe, as a blood sample and the syringe is now detached from the
needle as shown in FIG. 6, leaving a small globule of blood at the
outer end of the needle having the properties of a temporary
sealant against the admission of ambient air or other
contaminants.
Referring now to FIG. 7, the instrument 10 is now inserted, with
the stop collar deflated, through the needle 44 as shown in FIG.
7.
When the tubular member 12 has been positioned through the needle
44 to an extent disposing the tip 13 at the inner, beveled
extremity of the needle, the needle may be slightly withdrawn, as
shown in FIG. 8, to an extend exposing the stop collar. The stop
collar is positioned against the inner surface of the endocardium,
as shown in FIG. 8, at this stage of the operation, and is now
expanded as shown in FIG. 8 so as to provide a collar or abutment
limiting the tubular member 12 against axial displacement.
As shown in FIG. 9, the next step is to withdraw the needle 44
completely. The needle, as shown in FIG. 9 and also in FIG. 3, is
simply slid backwardly along the tubular member 12, to a
non-interfering position. Thereafter, intracardiac drugs and/or
other fluid medications may be administered by passage through the
tubular member 12. In FIG. 3, for example, the fitting 14 is
connected to a flask 46 through which fluids may be supplied. The
flask 46 has an outlet tube provided with the usual regulator 48.
If desired, other fluids can be simultaneously administered,
through a needle or syringe applied through the closure or
self-sealing valve 37 of auxiliary or branch tube 34.
The plugs or jacks 30, 32 are connected to corresponding posts of a
cardiac pulse generator 50, of conventional design.
It will be understood, of course, that although a detailed,
complete discussion of the various steps has been set forth above,
these steps may be varied under certain conditions. Further, in
practice the several steps shown in FIGS. 4-9 can be carried out by
a trained, skilled team in seconds, since all the necessary
apparatus will be maintained in a ready condition, awaiting a "Code
99" emergency.
In normal practice, before the insertion of the device, it would be
the usual procedure to apply external cardiac massage. A second
normal procedure would be to institute assisted ventilation, that
is, mechanical or human techniques are employed to "breathe" for
the patient. If, then, there is still no response to these initial
resuscitative measures, implantation of the instrument 10 is
effected in the manner described above, permitting intracardiac
injection of adrenalin or other fluid stimuli. Concurrently or
immediately following the injection of such fluids, electrical
stimuli may be employed, through the provision of the electrodes
22, 24. It may be observed, in this regard, that these electrodes
are so spaced from each other and from the stop collar 18 as to be
in impinging relation to the wall of the myocardium, when the stop
collar is in proper position against the heart wall.
Conventionally, rhythmic electrical pulses are supplied, and at the
same time, heart massage may be continued if desired. The invention
is so designed as to stabilize the positioning of the medical
instrument within the heart muscle, in such fashion as to assure to
the maximum extent against heart damage should it be desired to
apply massage procedures while the device is implanted. There is
always a danger when the needle 44 is inserted, of striking a
critical artery or vessel, and therefore, it is highly desirable
that there be only one insertion. By combining the cannula with the
electrode, this reduces the number of devices to be inserted. More
importantly, however, the stabilizing means incorporated in the
device eliminates the necessity of removing it should it be desired
to return to or continue heart massage. Should the device be
removed and then re-implanted, not only is valuable time lost, but
also, the danger of striking a critical blood vessel is obviously
multiplied by repeated implantation of the device.
It may also be desired to so form the wall of the tubular members
12 or 34, or both of them at selected locations along the length
thereof, as to permit the insertion of needles directly through the
material of the wall, as for example, in extracting fluids. The
material of the wall can be selected so as to provide a
self-sealing action when these needles are removed.
In some instances, the provision of self-sealing, tapping locations
on the tubular member 12 may eliminate the need for branch tubes or
the like, since any number of tubes can be connected to the main
tube 12 if this expedient is incorporated in the construction.
* * * * *