U.S. patent application number 09/925291 was filed with the patent office on 2002-06-06 for cardiac resuscitation device for percutaneous direct cardiac massage.
Invention is credited to Zadini, Filiberto P., Zadini, Giorgio C..
Application Number | 20020068848 09/925291 |
Document ID | / |
Family ID | 27379034 |
Filed Date | 2002-06-06 |
United States Patent
Application |
20020068848 |
Kind Code |
A1 |
Zadini, Filiberto P. ; et
al. |
June 6, 2002 |
Cardiac resuscitation device for percutaneous direct cardiac
massage
Abstract
An apparatus and method for cardiac resuscitation wherein the
apparatus has an expandable member carried by a rigid stem and
placeable inside the chest cavity adjacent to the heart by the tip
end of the stem to effect pumping of the heart by applying and
releasing pressure to the expandable member via a rigid stem from
outside the chest cavity through the chest wall so as to
alternately compress and decompress the heart and further includes
numerous safety mechanisms to prevent injuries to the intrathoracic
organs and mishaps. Compression and decompression may be achieved
by moving the expanded expandable member toward the heart and away
from it, or by alternatively expanding and contracting said
expandable member to effect pumping of the heart.
Inventors: |
Zadini, Filiberto P.; (North
Hills, CA) ; Zadini, Giorgio C.; (Camarillo,
CA) |
Correspondence
Address: |
TOWNSEND AND TOWNSEND AND CREW, LLP
TWO EMBARCADERO CENTER
EIGHTH FLOOR
SAN FRANCISCO
CA
94111-3834
US
|
Family ID: |
27379034 |
Appl. No.: |
09/925291 |
Filed: |
August 8, 2001 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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09925291 |
Aug 8, 2001 |
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09428139 |
Oct 26, 1999 |
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09428139 |
Oct 26, 1999 |
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08555985 |
Nov 13, 1995 |
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08555985 |
Nov 13, 1995 |
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08100573 |
Jul 30, 1993 |
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08100573 |
Jul 30, 1993 |
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07924301 |
Aug 3, 1992 |
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Current U.S.
Class: |
600/16 |
Current CPC
Class: |
A61M 60/40 20210101;
A61B 17/3494 20130101; A61M 60/268 20210101; A61M 60/122 20210101;
A61B 17/0218 20130101; A61M 60/857 20210101; A61B 2017/320044
20130101; A61B 17/0281 20130101; A61B 2017/00557 20130101 |
Class at
Publication: |
600/16 |
International
Class: |
A61N 001/362 |
Claims
What is claimed is:
1. A method of direct cardiac massage, said method comprising:
advancing a cardiac massage device in a posterior direction through
a small thoracotomy in a patient's chest wall to engage a heart
surface; and compressing the heart surface using the cardiac
massage device.
2. A method as in claim 1, further comprising expanding an
expandable member on the cardiac massage device after the
expandable member has advanced through the chest wall.
3. A method as in claim 2, wherein the expandable member is moved
to alternately compress the heart against the thoracic spine and
release such compression to effect pumping of the heart.
4. A method as in claim 2, wherein the expandable member is
alternately inflated and deflated to compress and decompress the
heart against the thoracic spine to effect pumping of the
heart.
5. A method for direct cardiac massage, said method comprising:
advancing a cardiac massage device through an intercostal space to
engage a heart surface; and compressing the heart surface using the
cardiac massage device.
6. A method as in claim 5, further comprising expanding an
expandable member on the cardiac massage device after the
expandable member has advanced through the chest wall.
7. A method as in claim 6, wherein the expandable member is moved
to alternately compress the heart against the thoracic spine and
release such compression to effect pumping of the heart.
8. A method as in claim 6, wherein the expandable member is
alternately inflated and deflated to compress and decompress the
heart against the thoracic spine to effect pumping of the
heart.
9. A method for direct cardiac massage, said method comprising:
advancing a cardiac massage device through the trigonum sine pleura
of a patient's chest wall to engage a heart surface; and
compressing the heart using the cardiac massage device.
10. A method as in claim 9, further comprising expanding an
expandable member on the cardiac massage device after the
expandable member has advanced through the chest wall.
11. A method as in claim 10, wherein the expandable member is moved
to alternately compress the heart against the thoracic spine and
release such compression to effect pumping of the heart.
12. A method as in claim 10, wherein the expandable member is
alternately inflated and deflated to compress and decompress the
heart against the thoracic spine to effect pumping of the heart.
Description
CROSS REFERENCES TO RELATED APPLICATIONS
[0001] This Application is a continuation of 09/428,139, filed Oct.
26, 1999, which is a continuation of application Ser. No.
08/555,985, now U.S. Pat. No. 5,931,850 which is a
continuation-in-part of co-pending patent application Ser. No.
08/100,573, filed on Jul. 30, 1993, now abandoned, which is a
continuation-in-part of co-pending application Ser. No. 07/924,301
filed on Aug. 3, 1992, now U.S. Pat. No. 5,466,221. The subject
mater of this application may be related to the subject matter of
U.S. application Ser. No. 09/287,231 filed on Apr. 6, 1999. The
full disclosures of each of these applications are incorporated
herein by reference.
BACKGROUND OF THE INVENTION
[0002] 1. Field of the Invention
[0003] This invention relates to methods and apparatus for
cardiopulmonary resuscitation and is particularly directed to
improved methods and apparatus for performing direct heart
massage.
[0004] 2. Description of the Background Art
[0005] In order to resuscitate a patient victim of a cardiac
arrest, it is necessary to provide an adequate artificial
circulation of oxygenated blood to the vital organs by
reestablishing the pumping function of the heart at values as close
as possible to the physiological prearrest condition. Such a
cardiac pumping function must be instituted at the earliest
possible stage. It is documented that a cardiac arrest results in
irreversible brain death if a sufficient blood flow is not
reestablished within a critical period of time from the moment of
the cardiac arrest. Such a period of time is measured ranging
between four and six minutes.
[0006] In order to reestablish the pumping function of the heart,
two methods of cardiopulmonary resuscitation have been used
heretofore: external or closed cardiac massage, and internal or
open cardiac massage. Closed cardiac massage consists of applying
pressure on the anterior chest wall and alternately releasing such
pressure. In the vast majority of cases, closed chest compressions
produce a severe low flow state, Raymond E. Jackson: Basic
Cardiopulmonary Resuscitation; Emergency Medicine, American College
of Emergency Physicians. Open chest cardiopulmonary, resuscitation
improves hemodynamics, resuscitation and the chance of surviving
cardiac arrest.
[0007] Cerebral blood flow achieved with open chest techniques has
been shown to be near normal physiological values. There are
several case reports of patients who have been resuscitated with
direct cardiac massage when attempts with closed chest
cardiopulmonary resuscitation have been unsuccessful, Advanced
Cardiac Life Support Textbook, American Heart Association, page 42.
However, few physicians today are skilled in the technique of
direct cardiac massage. Since most cardiac arrests occur outside of
a hospital and since most patients cannot be brought to a facility
where a thoracotomy and direct cardiac massage can be performed in
less that 15 minutes of total arrest time, the applicability of
direct cardiac massage has been limited ACLS textbook, page 42. In
addition to that, this technique is often characterized by many
physicians as a rather grossly traumatic procedure, often seen as a
desperate terminal attempt to resuscitate an arrested heart.
[0008] The aforementioned drawbacks of the two prior art techniques
of heart massage have been recognized by Prisk and Johnson, who
proposed a new method and apparatus for which they obtained a
patent, U.S. Pat. No. 3,496,932, issued Feb. 24, 1970. The method
and apparatus described by Prisk and Johnson includes an inflatable
bladder, insertable through the subxyphoideal region into a space
between the sternum and the heart via a trocar-cannula assembly. In
order to accommodate the inflatable bladder and its stem, the sharp
three-sided tip of the trocar must have a comparably large
diameter, as illustrated in FIG. 4 of the Prisk and Johnson patent.
However, the larger the sharp three-sided trocar tip, the more
likely are injuries to the heart, coronaries or surrounding organs.
In addition to the risk inherent in the size of the sharp tip of
the trocar, the blind advancement of a trocar with a sharp tip in
the thoracic cavity has been proposed by Prisk and Johnson. Such
blind advancement carries extremely high risk of puncturing and/or
lacerating the heart, coronary vessels or the surrounding
structures, with devastating consequences. Prisk and Johnson's
proposed position of blindly inserting the trocar between the
sternum and the pericardial sac is, indeed, an extremely risky
procedure; this space being very narrow, while it is virtually
impossible to insert the trocar into the other designated position,
i.e., within the pericardial sac, this space being only virtual,
since the visceral and parietal pericardium are in contact,
separated only by a thin film of pericardial fluid. Furthermore,
the device proposed by Prisk and Johnson lacks any mechanism for
locating the position of the sharp tip of the trocar and lacks any
safety mechanisms to prevent or avoid injuries, such as puncturing
of the heart or coronary vessels. Moreover, an inflatable bladder
with a laterally flexible stem, as proposed by Prisk and Johnson,
lacks the required stability for maintaining its central position
to effectively compress the heart. Also, the proposed
inflatable-deflatable bladder has no guidance, thus lacking the
ability to properly impress direction of the compressions toward
the vertebral column, allowing the heart to be displaced during the
phase of compression laterally to the column, and not maintaining
the heart in position between the vertebral column and the sternum,
as required for effective pumping and resulting in ineffective
compression of the heart. Given the individual variability in the
size and depth of the thoracic cage, the device of Prisk and
Johnson is inadequate in that it has no means to adapt to the
various depths of the thoracic cavity and ignores the variability
in the distance between the sternum and the vertebral column.
Finally, the method of insertion of the Prisk and Johnson bladder
is a multistep manual procedure, which is necessarily
time-consuming and conflicts with the need for a rapid institution
of cardiopulmonary resuscitation.
[0009] Buckman and Badellino in their PCT Application No. PCT/US
93/06886 with international filing date Jul. 20, 1993, describe a
plunger-like apparatus for intrathoracic direct substernal heart
massage comprising a heart contacting member having a surface which
is at least partially concave for contacting the heart and handle
means attached to the heart for manually manipulating the
apparatus.
[0010] With regard to the critical issue of entering the chest
cavity to use their plunger-like device, in a way that prevents
injuries to the intrathoracic organs, and is more practical than a
traditional thoracotomy. Buckman and Badellino disclose a "small
thoracotomy" which they describe as a fall thickness incision by
sharp dissection, from side to side of the chest wall, of a width
ranging from about three and a half inch to about one inch.
[0011] Although a thoracotomy of such a reduced size is indeed an
improvement over a traditional thoracotomy, because it is more
expedite, still it is not the solution to the problem of entering
the chest cavity safely to introduce means for heart compression on
a patient with cardiac arrest. Buckman's reduced thoracotomy still
cannot prevent the occurrence of pneumothorax, i.e., the collapsing
of the lungs. As a matter of fact, with the incision size required
by the sizes of the devices as described by Buckman and with the
incision sizes actually disclosed by Buckman, pneumothorax is an
unavoidable occurrence associated with Buckman's devices.
Pneumothorax is obviously a non-acceptable complication in a
patient in cardiac arrest who has a critical need for oxygen. A
pneumothorax requires the placement of a chest tube to re-expand
the lungs, which is another invasive surgical procedure, and adds
problems to problems and morbidity to morbidity, and which cannot
be practically performed for instance on the field at the site of a
cardiac arrest if the cardiac arrest, as most of them do, has
occurred outside a hospital setting.
[0012] In reality, in prior art, such as in Prisk's invention, an
incision of one inch or so is required, and possibly the
introduction of the inflatable-deflatable balloon by Prisk may even
require a smaller incision than the incisions disclosed by Buckman
and Badellino. With that regard, the device proposed by Buckman and
Badellino hardly seems to offer a real advantage or be an
improvement over Prisk. Yet quite an emphasis is placed in the
minimized dimension of the surgical incision required to pass
Buckman's device into the chest cavity, to the extent that the
procedure of chest massage is named by Buckman and Badellino as
minimally invasive.
[0013] On the contrary, the drawbacks of even a small thoracotomy
such as the one proposed by Buckman, which still causes
pneumothorax, are completely overcome with this invention, which
resolves the problem of introducing a heart massaging member into
the chest cavity without causing pneumothorax. The width of passage
through the chest wall needed to insert the heart massaging members
disclosed in parent application Ser. No. 07/921,301 by Zadini et
al. in application Ser. No. 08/100,573 by Zadini et al. and in this
present Application can be much smaller than the sizes reported by
Buckman and Badellino. Due to the very small width of the passage
through the chest wall the devices disclosed in parent application
Ser. No. 07/921,301 by Zadini et al., application Ser. No.
08/100,573 by Zadini et al., and in this present Application can
take advantage of a location for entry into the chest cavity in the
left parasternal region in a skin area corresponding to the
intrathoracic anatomical area designated "sine pleura." The choice
of the area "sine pleura" prevents precisely the insurgence of
pneumothorax, i.e., collapsing of the lung, which inevitably occurs
every time the pleural cavity is inadvertedly entered. With regard
to the occurrence of pneumothorax, due to the fact that the area
"sine pleura" is a substantially restrictive area, the choice of
such area is only meaningful if the opening passage through the
chest wall is significantly small, such as it can be achieved with
all the embodiments described in parent application Ser. No.
07/921,301 by Zadini et al., application Ser. No. 08/100,573 by
Zadini et al., and in this present Application. Being the width of
the area "sine pleura" such a small area, only the Zadini's devices
can enter the chest safely without causing collapsing of the
lungs.
[0014] With regard to another critical issue, i.e., the problem of
avoiding injuries to other intrathoracic organs besides the pleural
cavity and the lungs, when entering the chest cavity, such as the
heart, which is laying just beneath the anterior chest wall,
Buckman's disclosed method of entry into the chest cavity is of an
entry by sharp dissection with sham surgical instruments. No
different from Prisk's entry by sharp dissection with a trocar.
[0015] In particular, Prisk, page 2, lines 68-69, discloses "a
trocar and cannula assembly" which "are used as tools to expedite
the placement of the bladder within the chest." Prisk's bladder is
equivalent to Buckman's plunger-like heart massaging member. Such
tools for the placement of the bladder within the chest are
precisely the equivalent of the Buckman's "sharp surgical
instrument." Buckman's device, no differently from and no better
than Prisk's device, is inserted into the chest after a passage is
opened through the chest wall and entry by sharp dissection into
the chest cavity is carried out by the sharp tip or edge of a
surgical instrument such as a surgical blade, as clearly and
unequivocally is repeatedly disclosed by Buckman in the
specification and also in his claims. For instance, page 1, line 8,
"a heart massager which is introduced through a relatively small
surgical incision made in the chest wall;" page 8, lines 30, 31,
and page 9, lines 1 and 2, "The instant invention is related to
massagers and a particular method for their usage that allows each
massager to be inserted through a small surgical opening made in
the chest wall, so as to allow to directly contact the
antero-lateral surface of the human heart;" page 9, lines 30, 31,
and page 10, lines 1 through 4, "In its operation and in general
manner, the massager is inserted into the left chest via small
surgical incision. The massager has a heart contacting member that
is subcutaneously inserted through the incision and into the
interior of the chest so that the now substernal massager may be
placed on the anterior and lateral surface of the ventricular
chambers of the heart." Page 6, lines 19 through 20, "surgically
separating the intercostal space inserting the heart massages
through the intercostal space, etc." Page 27, lines "after a
surgical incision is made a sharp surgical instrument is used to
provide sharp dissection preferably in the fourth intercostal
space, thereby allowing for the entrance of the finger of the
operator which is used to locate, by finger palpation, the apex
region of the heart."
[0016] Therefore the first entry into the chest cavity, in front of
the underlying heart, is of a sharp tip or of a razor-like blade of
a surgical knife, and is no different from the sharp, razor-like
tip of the Prisk trocar. The chances of injuring the underlying
heart, which is in contact with the anterior chest wall are still
there either that the razor-like blade of a surgical knife is used
or a sharply tipped trocar is used.
[0017] Notwithstanding the fact that Buckman's entry into the chest
is by sharp dissection, no less and no better than Prisk's, Buckman
and Badellino at page 3, lines 23-24 of their application seem to
favorably compare their method of inserting the device into the
chest cavity over Prisk's method by stating: "it is desired that
the heart massager not only be devoid of a pointed tip, etc." There
seems to be suggested that, unlikely Buckman's heart massaging
member which is devoid of a pointed tip, Prisk's heart massaging
member does have pointed tips, etc. However, Prisk's heart
massaging member, being an inflatable-deflatable bladder has no
pointed tips nor sharp edges at all.
[0018] In particular Prisk's balloon is "devoid of any sharp tip
that may unnecessarily and inadvertedly damage body elements" no
more and no less than Buckman's and Badellino's heart massaging
member.
[0019] Buckman and Badellino do not disclose an entry by blunt
dissection into the chest cavity but only of inserting a blunt
heart massaging member, or more precisely, of inserting a heart
contacting member devoid of pointed tips or sharp edges, through a
passage already opened through the chest wall by sharp means.
[0020] However the absence of any pointed tips or share edges in
heart massaging members is no novelty. In fact other heart
contacting members for cardiac massage as well, such as all the
well-known Direct Mechanical Ventricular Assisting Devices
described by Anstadt, and many others, are indeed devoid of any
sharp tips or sharp edges and are inserted into the chest cavity
devoid of any sharp tips and sharp edges after a thoracotomy, i.e.,
after a full thickness incision of the chest wall carried out by
sharp instruments, which is precisely the method used also by
Buckman and Badellino, G.L. Anstadt et al., Trans. Amer. Soc.
ArtifInt. Organs, Vol. XII. 1966; Mark P. Anstadt et al., Chest,
1991 Vol. 100; Mark W. Wolcott et al., Surgery, 1960 Vol. 48 No. 5;
Theodor Kolobow et al., Trans. Amer. Soc. Artif Int. Organs, Vol.
XI. 1965; W. Rassman et al., Journal of Thoracic and Cardiovascular
Surgery, 1968. Vol. 56. No. 6; David Goldfarb, Prog. Cardiovase.
Dis., 1969, Vol. 12. No. 3; W. J. Kola, Progress in Cardiovascular
Diseases, 1969, Vol. XII. No. 3; Peter Schiff et al., Trans. Amer.
Soc. Artif Int. Organs, Vol. XV, 1969; W. Rassman et al., and Peter
Schiff et al., R. Bartlett et al., Ann. Emerg. Med., 13 Part 2
1984; M. Anstadt et al., Resuscitation, 21, 1991; P. Safar et al.,
Am. J. Emerg. Med. 8, 1990. As far as Prisk is concerned, Prisk
teaches precisely to introduce into the chest cavity, through a
passage already opened by sharp means, such as his trocar is, his
heart massaging member which includes a flexible tube with a closed
round distal end and a deflated bladder around the tube. Prisk
therefore teaches to enter the chest cavity by the means of sharp
dissection then to introduce a heart massaging member which is
devoid of any sharp tips or sharp edges. That is precisely the
method disclosed by Buckman.
[0021] With regard to the further advancement of the heart
contacting member within the chest cavity into the substernal
region between sternum and heart, after entry into the chest cavity
is accomplished with sharp means, it is quite obvious that no sharp
means is needed after a passage has been opened through a wall
delimiting the chest cavity. No sharp means is needed to advance
further into the chest cavity, because the chest cavity where the
heart massaging member has to be placed, i.e., the substernal
space, is devoid of any structure that needs to be cut through.
Therefore, not having to cut through anything, it is obvious that a
heart massaging member be devoid of any pointed tips or sharp edges
in its transit within the chest cavity. Furthermore the heart
massaging member does not have to travel within the chest cavity
because the heart is just there, in contact with the internal
surface of the thoracic cavity.
[0022] Therefore, besides the fact that inserting a heart
contacting member being "devoid of sharp tip that may unnecessarily
and inadvertedly damage body elements," as disclosed by Buckman is
not at all, as it will be shown, the problem that needs to be
resolved, the introduction into the chest cavity of a heart
contacting member which is "devoid of share tip that may
unnecessarily and inadvertedly damage body elements" is not novel
over Prisk's invention itself and over others' prior art such as
the Direct Mechanical Ventricular Actuation Devices of Anstadt and
others.
[0023] No matter how blunt or how well devoid of sharp tips and
edges is the heart massaging member inserted for the purpose of
direct cardiac compression, it is precisely the problem of first
entry, i.e., of opening the way to access the chest cavity by means
of a safe method, which constitutes the main unresolved problem by
the prior art, and which Buckinan and Badellino fail to resolve. In
Buckman and Badellino it is the cutting blade which cuts the
deepest layer of the chest wall, that surfaces and makes first its
access into the chest cavity. No matter how small can the
penetration be into the chest cavity of such a sharp blade or tip,
and how carefully can be carried out by the operator, still the
entry into a chest cavity in Buckman and Badellino is not an entry
by blunt dissection. Indeed the heart massager of Buckman and
Badellino is and can only and solely be inserted after a full
thickness incision is made through the chest wall including the
last layer of tissue lining the chest cavity.
[0024] Buckman and Badellino do not disclose in their application
any means for blunt dissection, nor entry by blunt dissection. In
fact they call for "sharp dissection" provided by a "sharp surgical
instrument" after a first surgical incision of the skin is made.
Nowhere in their specification is disclosed entry into the chest
cavity either by a blunt instrument opening its way into the chest
cavity or by a digital blunt dissection. Entrance of the finger of
the operator is allowed only after a sharp dissection of the chest
wall by a sharp surgical instrument is carried out, and is used for
the purpose of locating the apex of the heart.
[0025] The main issue of a safe entry is not to make a skin
incision to pass the superficial layer represented by the skin and
or the subcutaneous tissue, but to avoid a sharp surgical
dissection of the chest wall, because the sharp dissection of the
chest wall may inadvertedly lead to cutting injuries of
intrathoracic organs. Particularly, what has to be avoided is a
sharp dissection which separates the deepest final layer of chest
wall so as to avoid accessing the chest cavity and entering with a
sharp surgical instrument into the chest cavity.
[0026] All the embodiments disclosed in Buckman and Badellino
preclude the possibility that their devices are advanced and/or
entered into the chest cavity by blunt dissection through the chest
wall because they are too wide to allow blunt dissection. More
specifically, such dimensions are just less than about three inches
for the device of FIGS. 1-8, page 12, lines 25-26, and just less
than about one inch for the device of FIGS. 9-11, page 12, line 30.
In fact, at page 20, lines 10-11, it is acknowledged that this
umbrella-like embodiment is inserted through the chest wall by a
surgical incision of less than about one inch.
[0027] The key issue is not so much to insert into the chest cavity
a heart massager devoid of any sharp tips, which is not novel over
Prisk, but is to introduce a massager of said characteristics via a
safely made entry into the chest cavity via blunt means, not by
potentially highly risky means such as a pointed tip or a
razor-like surgical blade. In view of the obviously critical status
of a patient in a cardiac arrest and the need for performing
urgently and safely, Buckman's device does not represent any
advantage over Prisk's device. Buckman's device is only an
alternative way of pumping the heart. The claimed advantage by
Buckman of performing a minimally invasive by a small surgical
incision is already present in Prisk and therefore not novel over
Prisk.
[0028] If direct cardiac massage can be of any practical utility
and be performed by paramedics in the field, at the site where
cardiac arrests occur, the specific issue of entry into the chest
cavity safely and expeditiously is the main issue to be resolved,
and this problem is indeed resolved with this invention.
[0029] By disclosing means and methods of entering the chest cavity
by blunt dissection, this invention resolves the key problem of
implementing direct cardiac massage without causing pneumothorax,
or other injuries to the intrathoracic organs including the
heart.
[0030] Thus, none of the prior art methods and apparatus for
cardiac pulmonary resuscitation have been entirely satisfactory. A
device having features for safe entry into the chest such as a
blunt entry into the chest for the purpose of direct cardiac
compression and a method of inserting a heart massager into the
chest after a safe entry such as a blunt entry into the chest has
never been described in any prior art and is subject matter of this
invention.
SUMMARY OF THE INVENTION
[0031] The disadvantages of the device of Prisk and Johnson, as
well as those of closed and open cardiac massage, are overcome with
the present invention and an improved method and apparatus for
performing cardiopulmonary resuscitation is provided which permits
direct cardiac massage without the risks inherent in massive
opening of the thoracic cavity, as required in performing a
thoracotomy.
[0032] It is a general object of our invention to provide a method
and apparatus for cardiac massage which combines the hemodynamic
effectiveness of direct heart massage with the rapidity of
institution of closed heart massage, thus satisfying the two
fundamental conditions required to restitute a human being to life
and intact mental functions. Special attention was paid to the
construction of a device which offers a satisfactory degree of
safety in every phase of its operation. A safe device positively
effects its effectiveness and its rapidity of application and,
therefore, its usefulness.
[0033] More specifically, it is a main object of this invention to
provide a heart assisting device which is hemodynamically effective
in providing coronary arteries, cerebral arteries and systemic
circulation with sufficient blood flow. In order to achieve
hemodynamic effectiveness, the method of the present invention
calls for insertion through the chest wall, in a designated area in
front of the heart, of an expandable member such as an inflatable
balloon via a blunt stem. The expandable member, fixed to the
intrathoracic end of the blunt stem, is inserted via a rigid stem
with a blunt tip through the thickness of the chest wall into the
chest cavity adjacent to the heart.
[0034] In a first type of embodiments, the expandable member is
then expanded, and while it is maintained expanded, a mechanical
force is then periodically applied to the extrathoracic end of the
stem, causing the expandable member to alternately compress the
heart against the thoracic spine and releasing such compression to
effect pumping of the heart and generate artificial
circulation.
[0035] In a second type of embodiments, the expandable member is
alternatively inflated and deflated to alternatively compress and
decompress the heart against the thoracic spine, to generate
artificial circulation.
[0036] The stem also serves the purpose of guiding the direction of
the expandable member as it moves in the first type of embodiments
and as it expands and contracts in the second type of embodiments.
We are convinced that the device of the present invention grants
hemodynamic effectiveness because the direction of compression is
guided and the depth of compression and rate of pumping are
adjustable.
[0037] It is also an object of the present invention to make the
installation of a heart assisting device inside the chest cavity an
extremely rapid operation. To accomplish such rapid installation,
the device is constructed in such a way that its implementation
does not require specialized medical knowledge and, consequently,
the device of the present invention may be applied by semi-skilled
persons, such as paramedic personnel and the like. This will
ultimately effect its rapidity of installation and, hence, its
usefulness. Moreover, the device of the present invention can
safely be applied not only in a hospital by physicians but also in
the field, at the site of the cardiac arrest, out of the hospital
setting. This feature of rapid and easy installation is achieved by
applying the device to an easily accessible and easily identifiable
designated area either on the anterior chest wall or on the
subxyphoideal region, by the use of a small gauge stem and by the
automation of most of the operations of the device, except those
controlling the depth and rate of compression, which are preferably
left to the discretion of the operator of the device to permit such
variations as are desirable to obtain optimal blood flow.
[0038] The device performs the cardiopulmonary resuscitation
through a small hole in the chest wall, i.e., a thoracostomy, not
through the highly traumatic thoracotomy. Furthermore, no
pneumothorax is caused by the device and no chest tube placement is
required, thus avoiding the high morbidity of both thoracotomy and
chest tube placement.
[0039] An additional object of the present invention is to
construct a device which is as safe as possible in every phase of
its operation. Such safety is achieved by a number of features,
such as:
[0040] 1) Use of a disposable sterile unit as that part of the
device which will enter the chest cavity to prevent transmission of
infections.
[0041] 2) Use of a bluntly tipped stem to prevent accidental
punctures.
[0042] 3) Use of an inserting mechanism for the inflatable
expandable member which grants controlled insertion of the tip of
the stem into the chest cavity through the chest wall.
[0043] 4) Use of an inserting mechanism for the inflatable
expandable member which grants control and preservation of the
angle of insertion of the stem so that the inflatable expandable
member is properly directed in front of the heart to ensure that
compression of the heart is directed against the thoracic
spine.
[0044] 5) Use of a feature which grants automatic arrest of the
stem advancement into the chest wall, as soon as the tip of the
stem has entered the chest cavity, to prevent possible damage to
the heart during the insertion of the stem.
[0045] 6) Use of an automatic and rapid sequence of preparatory
steps leading to the inflation of the expandable member in front of
the heart.
[0046] In general the automation of the preparatory steps should be
regarded as a features provided for the purpose of safety, besides
rapidity of implementation, because such automation tends to
eliminate the possibility of afflicting the operation with human
errors, a calamitous inconvenience, but the most likely to occur in
a highly rushed situation, such as a cardiac resuscitation
attempt.
[0047] It is also an object of the present invention to provide an
alternative method of safe insertion of an expandable member within
the chest cavity, an automatically intervening alternative, in case
of malfunctioning of part of the device, arranging for arrest of
the operations, easy and rapid extraction of the defective device,
and untroubled reinsertion of a replacement device.
[0048] These and other objects and features of the present
invention will be apparent from the following detailed description,
taken with reference to the figures of the accompanying
drawings.
BRIEF DESCRIPTION OF THE DRAWINGS
[0049] FIG. 1 is a front view of a cardiac pump embodying the
present invention.
[0050] FIG. 2 is tridimensional view of the lever-double rack
mechanism of advancement, shown in front view in FIG. 1.
[0051] FIG. 3 is a vertical section through the cardiac pump of
FIG. 1, showing the cardiac pump is its normal rest position.
[0052] FIG. 4 is an enlarged detail view of the central portion of
FIG. 3.
[0053] FIG. 5 is a tridimensional representation of a portion of
the stem member of the cardiac pump of FIG. 1.
[0054] FIG. 6 is an enlarged vertical section of the lower tip of
the cardiac pump of FIG. 1.
[0055] FIG. 7 is a view, similar to that of FIG. 4, showing the
cardiac pump of FIG. 1 in its second stage of operation.
[0056] FIG. 8 is a view, similar to that of FIG. 3, showing the
stem tip of the cardiac pump of FIG. 1 at the instant it enters the
patient's chest cavity.
[0057] FIG. 9 is a view similar to that of FIG. 3 showing the stem
tip of the cardiac pump of FIG. 1 with the expandable member fully
inflated prior to compression of the heart.
[0058] FIG. 10 is a view similar to that of FIG. 9 in a further
stage showing the actual the compression of the heart against the
vertebral column.
[0059] FIG. 11 is a vertical section of an alternative form of the
cardiac pump.
[0060] FIG. 12 is a vertical section of another alternative form of
the cardiac pump.
[0061] FIG. 13 is a vertical section through the handle portion of
the cardiac pump of FIG. 12.
[0062] FIG. 14 shows a top view of the lever of the device of FIG.
12.
[0063] FIG. 15 is a vertical section of a further alternative form
of the cardiac pump.
[0064] FIG. 16 is an enlarged detail view of the mid-portion of the
cardiac pump of FIG. 15.
[0065] FIG. 17 is an enlarged vertical section through the stem tip
of the cardiac pump of FIG. 15.
[0066] FIG. 18 shows a vertical section of an alternative form of
the device as it is prior to use.
[0067] FIG. 19 is a vertical section of device of FIG. 18 showing
the stem tip of the cardiac pump of FIG. 18 at the instant it
enters the patient's chest cavity.
[0068] FIG. 20 is a view similar to that of FIG. 19 with the
expandable member of the device within the chest cavity after the
initial inflation at completion of preparation stages prior to the
actual pumping of the heart.
[0069] FIG. 21 shows the device of FIG. 18 with the expandable
member fully inflated and the heart consequently fully compressed
against the vertebral column.
[0070] FIG. 22 is a vertical section through an alternative form of
the device of FIG. 18 as it is prior to use.
[0071] FIG. 23 is a vertical section of the lower segment of the
body of the device shown in FIG. 18.
[0072] FIG. 24 is a vertical section of yet an alternative form of
the device of FIG. 18 shown as it is prior to use.
[0073] FIG. 25 is a vertical section of yet an alternative form of
the device of FIG. 18 shown as it is prior to use.
[0074] FIG. 26 is a vertical section of the device of FIG. 25 after
arming.
[0075] FIG. 27 is a vertical section of the device of FIG. 25 after
penetration of blunt tip into chest cavity.
[0076] FIG. 28 is a cross-sectional view of an alternative form of
the device of FIG. 1 shown after stem tip penetration of the chest
cavity.
[0077] FIG. 29 is a cross-sectional view of the device of FIG. 28
shown after full expansion of the expandable member.
[0078] FIG. 30 is a cross-sectional view of an alternative form of
the device of FIG. 1.
[0079] FIG. 31 is a cross-sectional view of the device of FIG. 30
shown after full expansion of the expandable member and at an early
stage of compression of the heart.
[0080] FIG. 32 is a cross-sectional view of the device of FIG. 30
shown after full expansion of the expandable member accomplishing
full compression of the heart.
[0081] FIG. 33 is a cross-sectional view of an alternative form of
the device of FIG. 1 shown after stem tip penetration of the chest
cavity.
[0082] FIG. 34 is a detail of FIG. 33, precisely of the fully
expanded expanding member viewed from below.
[0083] FIG. 35 is a cross-sectional view of a detail of an
alternative form of the device of FIG. 24.
[0084] FIG. 36 is a cross-sectional view of a detail of FIG. 35
showing the device at an early stage of operation.
[0085] FIG. 37 is a cross-sectional view of a detail of FIG. 35
showing the device at a subsequent early stage of operation.
DESCRIPTION OF THE SPECIFIC EMBODIMENTS
[0086] All the embodiments encompassed in the following
specifications share the common features of placing an expandable
member inside the chest cavity through a small opening, a small
thoracostomy, "not a thoracotomy," in the chest wall in a position
adjacent to the heart. Such a placement is carried out in a safe,
controlled, largely automatized and expedite fashion by a bluntly
tipped member of the device, with minimum invasiveness, and
virtually with no possibility of injury to intrathoracic organs and
without causing pneumothorax and without requiring chest tubes
which are unavoidable in any thoracotomy of whichever size. These
features are absolutely critical to the implementation of a device
that has to perform not only in the controlled environment of
emergency departments and operated by physicians, but also and
especially on the field where the cardiac arrest occurs, outside
the hospital, where this device can be operated by paramedics and
the like.
[0087] Restating that all the embodiments share the common
denominator of features described above, two distinct types of
embodiments have been described on the basis of mechanism of
pumping the heart. In one type, type A, the pumping of the heart is
accomplished by positioning said expandable member adjacent to the
heart, expanding said expandable member, then by displacing said
member forward and backward to compress and decompress the heart
against the vertebral column by alternatively applying and
releasing pressure on a rigid stem connected to said expandable
member.
[0088] In the other type, type B, of embodiments, the pumping of
the heart is accomplished by positioning said expandable member
adjacent to the heart, then inflating and deflating said expandable
member to compress and decompress the heart.
[0089] All the embodiments can be inserted into the chest cavity
via means of blunt dissection separately constructed from the
actual heart compressing device, although it is preferable to
incorporate the means for blunt dissection and the means for
performing the heart massage. The blunt dissection can also be
accomplished by the method of digital dissection by the operator
after a slight skin incision.
TYPE A EMBODIMENTS
[0090] Embodiment I
[0091] In that form of the present invention chosen for purposes of
illustration in FIGS. 1-10, a percutaneous cardiac pump, indicated
generally at 1, is shown with the actuating mechanism shown in the
normal rest position. As best seen in FIG. 3, the cardiac pump 1 is
composed of three main components, each of generally cylindrical
shape and essentially coaxially mounted: an outer, generally
cylindrical, component or support case, indicated generally at 2;
an inner, generally cylindrical, component or stem member, or main
unit, or stem unit, indicated generally at 100; and an intermediate
member, also of generally cylindrical shape, indicated generally at
300, interposed between the stem member 100 and the support case
2.
[0092] The support case 2 is hollow and is of generally tubular,
cylindrical shape having an open proximal end 3, a body 4 and a
distal end 5, including a narrow neck 6, and a flat, circular base
7. The base 7 is preferably formed of transparent material to
enable the operator to better visualize the actual position of the
pump 1 on the anterior chest of the patient. Also, base 7 is formed
with a central opening 31 to allow passage therethrough of stem 102
of the stem member 100, as seen in FIGS. 1 and 3 and more fully
described below. The body 4 of the support case 2 has a
longitudinal slit 9 extending from its proximal end 11 to a distal
end 13, as best seen in FIG. 1 and FIG. 2.
[0093] As best seen in FIG. 2, two parallel ears 15 are attached to
the body 4 of the support case 2 and protrude outwardly adjacent
each side of the slit 9. Ear 15, located on the right side in FIG.
2, is drawn transparent for the purpose of showing the parts
located between the ears. Lever 17, with dogs 19 and 21, is
interposed between the ears 15 and is pivotally secured to the ears
15 by suitable means, such as pin 23, to form a fulcrum for the
lever 17. A double rack 301 is mounted on the intermediate member
300 and projects through the slit 9 for engagement by dogs 19 and
21 of the lever 17. Dog 21 is pivotally secured to lever 17 by pin
31, while dog 19 with its tail 34 is pivotally secured to ears 15
via pin 30. Displacing rod 32, which protrudes from one end of pin
31, seats on tail 34 of dog 19.
[0094] The intermediate member 300 as seen in FIG. 3 is generally
tubular and is interposed between the support case 2 and the stem
member 100. As noted above, the double rack 301, represented in
FIGS. 1, 2, and 3, is mounted on the intermediate unit 300, as best
seen in FIG. 3, and projects through slit 9 of the support case 2,
as best seen in FIGS. 1 and 2. As best seen in FIG. 2, the double
rack 301 comprises a first rack 310, having teeth 8 oriented
downward, and a second rack 311, having teeth 11 oriented upward.
The intermediate member 300 has a slit 309, seen on the right side
of FIG. 3. In the starting or rest position, the lower end of the
slit 309 is positioned slightly above and in line with pin 260 of
the stem member 100. Intermediate member 300 is locked to the stem
member 100, in the rest position, by balls 305 which seat in
receptacles 307 of the intermediate unit 300 and are partly engaged
in holes 144 of stem member 100. The inner, generally cylindrical,
component or stem member 100 is mounted essentially coaxially
within (located centrally within the support member 2 and) the just
described intermediate member 300.
[0095] Stem member 100 is a rigid hollow cylinder composed of three
parts: handle 111, body 113 and stem 102. As noted above, stem 102
protrudes from the distal end 115 of body 113 and projects through
opening 31 in the base 7 of the support member 2. At the upper end
of the stem member 100 is a generally T-shaped handle 111, having a
transverse bar 145 mounted on the upper end of an elongated,
cylindrical gas-filled or fluid-filled bottle 129. Interposed
between base 95 of gas container 129 and bottom wall 94 of cavity
146 formed within handle 145 is spring or resilient means 90. Tooth
91 projecting from side wall or gas container 129 engages
longitudinal slit 93 of side wall of cavity 146. Said tooth allows
vertical but non-rotatory movement of handle bar 145 in respect to
gas container 129 and in respect of the device when gas container
129 is locked to it. The bottle 129 carries an externally threaded
portion, as seen at 133 in FIG. 3, and contains a quantity of
compressed gas such as air, or fluid under pressure, which is
retained within bottle 129 by a suitable seal 135 mounted in nozzle
131 of the bottle 129. The body 113 comprises five chambers 117,
119, 121, 123 and 125. As best seen in FIG. 3, chamber 117 is
located adjacent the upper end of the body 113 and has an open end
127 which receives the nozzle 131 of the air bottle 129 and has a
diaphragm 118 defining the boundary between chamber 117 and chamber
119. Chamber 117 also has an internally threaded portion 139, which
is matable with the external threads 133 of the air bottle 129.
Also within chamber 117, a hollow needle 140, having a needle tip
141, is mounted on the diaphragm 118, as by gasket 143. As best
seen in FIG. 4, chamber 119 extends between diaphragm 118, at its
upper end, and diaphragm 120, at its lower end. Within the chamber
119, is a pin 180 having a pin shaft 182 projecting laterally from
pin head 184, which is slidably mounted within a cylindrical pin
case 188 and is urged by suitable means, such as spring 186 mounted
within the pin case 188, to project through opening 25 of the
support case 2, when the cardiac pump 1 is in the rest position. As
best seen in FIG. 4, the pin shaft 182 projects, in air-tight
manner, through window 185 of side wall 147 of chamber 119.
Diaphragm 118 is formed with a central opening 142 which
communicates with the interior of hollow needle 141. Also within
chamber 119, below the pin case 188, a shutter 190 is mounted for
lateral sliding movement through window 183 of the stem member 100
and window 27 of the support case 2. Shutter 190 has a downwardly
and inwardly slanted outer end 192 and is provided with an opening
191 located eccentrically and extending vertically through the
shutter 190. In the rest position, shutter 190 covers and seals
opening 199 of lower diaphragm 120, while uncovering opening 197 of
diaphragm 120. Within chamber 121, as best seen in FIG. 4, the
opening 199 is connected to inlet 202 of pressure valve 200, while
opening 197 communicates with inlet 198 of shut-off valve 210.
Pressure valve 200 also has an outlet 204. Shut-off valve 210 also
has an outlet 208 and contains a shutter 211, which controls
passage of air through the outlet 208 and which is movable through
opening 212 of shut-off valve 210 to project into slit 9 of the
support case 2 above the upper end of the double rack 301.
Diaphragm 122, as best seen in FIGS. 4 and 5, defines the boundary
between chamber 121, above, and chamber 123, below, and is formed
with opening 209, communicating with outlet 208 of shut-off valve
210, and with openings 201 and 219. Opening 201 is connected to
pipe 216, which communicates with chamber 123, but projects above
diaphragm 122, into space 243 below the pressure valve 200, and is
connected to exit pipe 217, which exits through opening 227 of side
wall 205 of chamber 121. Chamber 123 is defined by upper diaphragm
122 and lower diaphragm 124 and is best understood from FIGS. 3, 4
and 5. As shown, a pipe 226 extends completely through chamber 123,
between opening 209 in upper diaphragm 122 and opening 251 in lower
diaphragm 124. Pipe 220 extends downward from opening 219 of upper
diaphragm 122, parallel to pipe 216, and terminates at plate 206,
which defines the upper end of piston chamber 233. A transverse
opening 222 communicates the interior of pipe 216 with that of pipe
220. Similarly, transverse pipe 224 communicates the interior of
pipe 216 with that of pipe 226. Below the transverse pipe 224, pipe
216 has a second transverse opening 237 communicating with the
interior of pipe 220 and an additional transverse opening 238 which
opens to into chamber 121. The piston chamber 233 is enclosed by a
cylindrical wall 249 and has a piston 230 slidably retained
therein. Piston 230 has a piston head 231 and a piston shaft 232,
which extends slidably into the lower end of pipe 216. As seen in
FIG. 4, a spring 218 is located within pipe 216, above the end of
piston shaft 232, and bears against the end of piston shaft 232 to
urge the piston 230 downward to seat against annular retainer 244.
The piston shaft 232 is formed with a transverse opening 234 which,
in the rest position, is aligned with opening 237 of pipe 220 and
with transverse pipe 224, which communicates with pipe 226. Piston
230 is also formed with an annular recess 241, which seats piston
ring 240. Also, the cylindrical wall 249 of the piston chamber 233
has an annular recess 242, formed adjacent the upper end thereof,
which serves to receive piston ring 240 to releasably lock the
piston 230 in its upper position, as more fully described below,
and has a lateral opening 235 communicating with the exterior of
the cardiac pump 1 above recess 242. Below piston 230, space 245
separates the lower surface 223 of piston 230 from lower diaphragm
124 of chamber 123. As noted above, diaphragm 124 has an opening
251, which receives pipe 226, and has a central opening 250 which
communicates with the expanded proximal end 253 of pipe 252 in
subjacent chamber 125. Chamber 125 extends between diaphragm 124,
at the upper end, and the open lower end 115 of body 113 of the
stem member 100. Within the expanded upper end 253 of pipe 252 is a
pin case 263, containing a pin 261, having a pin head 262, and
having a spring 264 mounted within the pin case 263, behind the pin
head 262, to normally urge the pin 261 laterally outward to project
through opening 260 on the wall of the stem member 100 pressing
against the wall of the intermediate member 300, just below slit
309 of intermediate member 300.
[0096] Pipe 252 extends downwardly within chamber 125 and
terminates at the level of flange 275, which serves as a seat for
piston 270. Piston 270 is sliceable mounted about pipe 252 and, in
the rest position, is located to close transverse openings 254 of
pipe 252. Piston 270 is formed with an annular recess 271 with a
subjacent annular receptacle 272. In the rest position, balls 305
sit in window 144 of stem member 100 and are retained between
receptacle 272 of piston 270 and receptacle 307 of the intermediate
member 300 to releasably lock the stem member 100 to the
intermediate member 300. Spring 276 is seated on flange 278 and
serves to normally urge the piston 270 upward to cause receptacle
272 to retain the balls 305 in their "locked" position. As best
seen in FIG. 3, a large spring 230 is located within the lower end
of the support case 2 and bears against the lower end 115 of the
stem member 100 to urge the stem member 100 upward. As seen in
FIGS. 3 and 6, an elongates hollow stem 102 extends downward from
the lower end 115 of the stem member 110 and exits through opening
31 of the flat base 7 of the support case 2 to support a blunt end
104 of spheroid shape having a circular groove 103 which contains
an expandable member such as balloon 105, which is folded when the
cardiac pump 1 is in its rest position.
[0097] The stem end, or stem tip, 104 is blunt in order to avoid
injuries such as puncture wounds and lacerations to the
intrathoracic organs. The relatively small size of the stem end
meets little resistance from the chest wall structures that it has
to transpass in order to reach the chest cavity, once a skin
incision is done, as it will be described below. Stem 102
communicates with the interior of stem end 104 through opening 101
and communicates with balloon 105 through openings 106 within
groove 103. Stem end 104 has a blunt end 108 and is generally in
the form of a hollow dome, FIG. 6 also diagrammatically shows the
anterior thoracic wall 107, with the skin incised at 109, together
with the underlying chest cavity 110 containing the heart 69.
[0098] Description of the Operation of Embodiment I
[0099] To apply the cardiac pump 1, the operator makes a small
incision 109 in the patient's skin adjacent the 4th or 5th
intercostal space along the left sternal border of the patient or
in the subxyphoideal region.
[0100] The skin incision is carried out with a suitable surgical
instrument such a lancet, or surgical knife, preferably provided
with an arrest: to prevent deep penetration. After appropriate
sterilization, the cardiac pump 1 is placed on the patient's chest
with the tip 104 of stem 102 inserted into the incision 109. When
this is done, the stem tip 104 will be partially buried under the
patient's skin within the thoracic wall 107, but will not have
entered the chest cavity 110, and base 7 of the support case 2 will
be seated on the appropriate area of the chest wall 107. Next, the
operator rotates handle bar 145, causing threads 133 of the air
bottle 129 to engage threads 139 of upper chamber 117 of the stem
member 100, and drawing the adapter 131 of the air bottle 129
toward needle 141 until the needle tip 140 of needle 141 enters the
adapter 131 and pierces seal 135, as seen in FIG. 7, allowing the
compressed air contained within the air bottle 129 to flow through
needle 141 and opening 142 in diaphragm 118 into chamber 119 of the
stem member 100. The operator continues to screw the handle 145
until a tight seal is obtained by the adapter edges 130 pressing
firmly against gasket 143. As the compressed air enters chamber
119, the air pressure will bear against pin head 184 of pin 180,
driving pin 180 medially against spring 186 to remove pin shaft 182
from projecting through window 25 of support case 2 and, thus,
unlocking the main unit 100 from the support case 2.
[0101] If the air pressure is insufficient, or if a leak allows the
air to escape, pin shaft 182 of pin 180 will not disengage from
window 25 and the stem member 100 will remain locked to the support
case 2, thereby preventing further operation of the cardiac pump 1.
If the air pressure is adequate to actuate pin 180 and, hence, to
unlock the stem member 100 from the support case 2, the operator
will grab the device at level of the proximal end of the support
case, and, while exercising down pressure upon the handle of the
stem member, he will repeatedly press lever 17, causing the dogs 19
and 21 to act on the racks 311 and 310, respectively, and to
displace the double rack 301 downward.
[0102] More precisely, a displacement of handle 18 of lever 17
toward double rack 301 will cause a downward movement of dog 2
pivoted on pin 31 of arm 16 of lever 17: the downward movement of
dog 21 which is engaged in rack 310, with upwardly oriented teeth,
will result in a downward displacement of rack 310. While arm 16 of
lever 17 moves downward, pin 32, protruding from one end of pin 31
will displace tail 34 of dog 19 toward rack 311, releasing dog 19
from rack 311, with downwardly oriented teeth, just before downward
movement of rack 310 is initiated, and locking rack 311 immediately
after downward advancement of rack 310. Downward advancement of
rack 310 in turn will carry intermediate member 300 and stem member
100 downward, due to the interlocking performed by balls 305
sitting in windows 144 of the stem member 100 and in receptacle 307
of intermediate member 300. Balls 305 are retained in windows 144
and receptacle 307 by the annular receptacles 272 of piston 270,
which is urged to its upward position by spring 275 acting between
flange 278 of the stem member 100 and the lower surface 275 of
piston 270.
[0103] As it can be understood from FIG. 7, after the intermediate
member 300 and stem member 100 are advanced a predetermined the
length with respect to the support case 2, preferably about 1/2
centimeter, by the operator acting on the lever 17, shutter 190
will be displaced medially, due to the edge 28 of window 27 bearing
against the slanted end 192 of shutter 190. This displacement of
shutter 190 will permit the compressed air to enter pressure valve
200 by passing through opening 199 of diaphragm 120 and inlet 202
of the pressure valve 200. The compressed air will exit, through
outlet 204 of pressure valve 200, at a preestablished pressure and
will travel through opening 219 of diaphragm 122 connected pipe
220, opening 237, window 234 of piston shaft 232, then into chamber
123, opening 250 of diaphragm 124, expanded end 253 of pipe 252,
through pipe 252, space 247 below piston 270, through the elongated
hollow stem 102 and opening 101 into tip 104 and will attempt to
pass through openings 106 to inflate balloon 105. However, balloon
105 will be presented from inflating due to the inextensibility of
the surrounding chest wall structure 107. As a result, the air
pressure within the pathway, just described, will quickly reach
equilibrium with the pressure at outlet 204 of the pressure valve
200. As this occurs, the air pressure within this pathway will act
upon the lower surface 223 of piston 230 and will force piston 230
to move upward, against the urging of spring 218, until piston ring
240 becomes seated in annular recess 242 of piston chamber 233,
locking piston 230 against further upward movement and aligning
opening 234 of the piston shaft 232 with window 222 of pipes 216
and 220. This movement of piston 230 and piston shaft 232 will
close opening 237 and, hence, will force the compressed air from
pressure valve 200 to flow through lateral pipe 224, vertical pipe
226, opening 251 of diaphragm 124 and into space 246 above piston
270. At this point, the air pressure in space 246, above piston
270, and in space 247, below piston 270 will be equal.
Consequently, piston 270 will be urged into its upward position by
the action of spring 276. Moreover, pressure valve 200 serves to
regulate the air pressure below the pressure valve 200 and to
assure that the air pressure in balloon 105 and in the various
pathways between the balloon 105 and pressure valve 200 is less
than the air pressure within the air bottle 129. This is a second
safety feature and assures that the air pressure within the balloon
105 will be insufficient to cause disruption of the chest wall
structure 107. The automatic arming of the cardiac pump 1 is now
completed, within a few seconds of initiation of the operation, and
the cardiac pump 1 is ready for further operation.
[0104] In the next stage of the operation, the operator continues
actuating lever 17, causing further advancement of the stem tip 104
through the chest wall structure 107 toward the chest cavity 110.
As seen in FIG. 8, the instant that the stem tip 104 passes out of
the chest wall structure 107 into the chest cavity 110, the balloon
105 will expand, due to the fact that the balloon 105 is no longer
enclosed by the chest wall structure 107 and the compressed air
within the stem 102 is able to pass through openings 106 into the
balloon 105. The expansion of the balloon 105 will result in a
pressure drop within space 247, below piston 270. Because piston
230 has been forced to its upward position, as described above, air
can no longer flow through opening 234 of piston 230 to re-supply
space 247. Consequently, the air pressure in space 246, above
piston 270, will exceed the air pressure in space 247, below,
piston 270, and will drive piston 270 downward, against the urging
of spring 276. As piston 270 is driven downward toward flange 278,
it will expose windows 254 of pipe 252, permitting air form space
246, above piston 270, to pass into pipe 252 and, thus, through
stem 102 to further inflate the balloon 105.
[0105] The forward movement of the piston 270 also causes balls 305
to be transferred from the recesses 272 into the larger recess 271
of piston 270, which allows the balls 305 to disengage from windows
144 of the stem member 100 and, thus, unlocks the stem member 100
from the intermediate member 300, which prevents lever 17 and
double rack 301 from causing any further advancement of the tip 104
into the chest cavity 110. Simultaneous with the unlocking of the
stem member 100 from the intermediate member 300, spring 280 acts
between the distal end 5 of the support case 2 and the lower end
115 of the stem member 100, forcing the stem member 100 to move
upward relatively to support case 2 and to intermediate member 300,
which, at this stage, are interlocked one to the other.
Intermediate member is locked, at this stage, to support case 2,
being prevented to slide upward relatively to support case 2 by dog
21, said dog 21 being anchored to support case 2 and engaged to
rack 310 of intermediate member 300. As a consequence of the upward
movement of the stem member 100 in respect to the intermediate
member 300, pin 261, which is part of, and is anchored to, stem
member 100, will align with opening, or slit, 309 formed in
intermediate member 300. When pin 261, which is constantly urged
outwardly by compression spring 264, aligns with opening 309 of
intermediate member 300, being no longer retained in its retracted
position by the wall of the intermediate member 300, pin 261 will
promptly engage in said opening 309, by gaining access to it. By
gaining access to slit 309 of intermediate member 300, pin 261,
which continues being urged outwardly by spring 264, will project
against the vertical series of holes, or openings, 29 formed in the
wall of support case 2, said vertical series of openings being so
located to face the vertical slit 309 of the intermediate member.
Stem member 100 will continue to move upward in respect to
intermediate member 300 and support case 2 in response to action of
spring 280, until its pin 261, after gaining access into slit 309
of intermediate member 300 and being forced to press against the
wall of the support case 2 by spring 264, finally engages into the
first available hole of the series of holes 29 formed in the wall
of the support case 2 in correspondence of vertical slit 309 of
intermediate member 300. As soon as pin 261 of stem member 100
engages into one of said holes 29 of support case 2, stem member
100 will stop its upward movement, and will lock to support case 2.
Of course, although the above sequence is descriptively time
consuming, it should require just a fraction of a second or so to
complete as a device operation.
[0106] This serves to prevent accidental advancement of the stem
104 of the stem member 100 prior to full inflation of the balloon
105. Also, the unlocking of the stem member 100 from the
intermediate member 300 renders lever 17 ineffective, which
provides a tactile indication to the operator that the stem member
100 has been unlocked from the intermediate member 300 and is now
locked to the support case 2. In response to this tactile signal,
the operator presses the shutter 211 of the shut-off valve 210
inwardly to allow high pressure air from air bottle 129 to pass
through outlet 208 of the shut-off valve 210 and through stem 102
and tip 104 to produce full inflation of the balloon 105, thus
bypassing the pathway of pressure valve 200.
[0107] The balloon fully inflated will assume a cup or dome shape
in order to embrace the heart. This high pressure air will also
flow into the expanded end 253 of pipe 252 and will bear against
the head 262 of pin 261, driving pin 261 inward, against the urging
of spring 264, to cause pin 261 to withdraw from opening 29 of the
support case 2 and, hence, unlocking the stem member 100 from the
support case 2 to permit the pumping operation.
[0108] As shown in FIGS. 9 and 10, to perform the pumping
operation, the operator alternately applies downward pressure to
the handle 145 and releases such pressure. Since the stem member
100 is now unlocked from both the intermediate member 300 and from
the support case 2, downward pressure on the handle 145 will be
carried through the stem member 100 and will be applied through
stem 102 to the balloon 105, causing the balloon 105 to be pressed
against the heart 11 and, as pressure is applied to the balloon
105, to compress the heart 11 against the thoracic spine 13.
Contraction of spring 90 will prevent injury to the heart if
excessive pressure is applied after full compression of the heart
against the thoracic spine. Furthermore, since the handle 145 and
tip 104 are both integral parts of the stem member 100, the
operator receives tactile signals through the structure of the stem
member 100 from which, with experience, he can determine the
location of the balloon 105 with respect to the heart 11 and the
direction and effect of the pressure applied thereto. If the
balloon 105 during the pumping operation deflates accidentally, the
pressure surrounding pin head 262 will fall allowing spring 264 to
urge pin 261 to engage one of the openings 29 of support member 2,
thus arresting the pumping operation and signaling to the operator
that the handle has to be unscrewed from the device to let the
balloon to deflate completely and thus the entire device to be
removed and replaced.
[0109] When the resuscitation operation has been completed, the
operator unscrews and removes the air bottle 129, which allows the
balloon 105 to deflate and permits the stem tip 104 and balloon 105
to be easily withdrawn from the chest cavity 110.
[0110] Embodiment II
[0111] FIG. 11 shows an alternative form, indicated generally at
500 of the cardiac pump 1 of FIGS. 1-10. The cardiac pump 500 of
FIG. 11 differs from cardiac pump 1 of FIGS. 1-10 mainly in the
structure and function of the stem unit generally indicated at 501,
as it will be outlined below. The support case 2 and intermediate
member 300 are basically the same as those of the cardiac pump 1 of
FIGS. 1-10 and the same numbers have been used to identify the
corresponding components thereof. The stem member 501 of the
cardiac pump 500 is composed of three parts: handle 111, body 513,
and stem 502, projecting from the distal end 515 of the body 513.
Handle 111 is identical to handle of the cardiac pump 1 of FIGS.
1-10.
[0112] The body 513 of stem member 501 of cardiac pump 500 is
divided into four chambers: an upper chamber 517, a second chamber
519, a third chamber 521, and a lower chamber 525. The upper
chamber 517 is identical to chamber 117 of FIGS. 1-10. As such it
has an open upper end 127 to receive the compressed air bottle 129.
The lower end of chamber 517 is defined by diaphragm 518, which is
also identical to diaphragm 118 of the cardiac pump 1 of FIGS.
1-10. The second chamber 519 extends between diaphragm 518 and
diaphragm 520, which is substantially identical to diaphragm 120 of
the cardiac pump 1 of FIGS. 1-10, but has only a single central
opening 400. Chamber 519 is basically the same as chamber 119 of
FIGS. 1-10 and includes pin 180 and related structures as described
in cardiac pump 100 of FIGS. 1-10. Shutter 190 of FIGS. 1-10 is no
longer present in cardiac pump 500.
[0113] Chamber 521 extends between diaphragm 520 and lower
diaphragm 524 and is enclosed by side walls 402. Chamber 521 is
composed of two adjoining compartments; upper compartment 401 and
lower compartment 403. The upper end of side wall 402 is connected
by annular flange 441 to the side walls 406 of body 513. Within the
upper compartment 401, is a pin case 414 containing a pin 408,
having a pin shaft 410 projecting laterally from a pin head 412 and
urged outwardly of the pin case 414 by suitable means, such as
spring 418, to cause the pin shaft 410 to project outwardly to
engage in opening 417 of stem member 501. Pin shaft 410 is retained
from further projecting outwardly by upper edge 314 of the wall of
intermediate member 300. Pin case 414 also has a window 416
communicating with compartment 401.
[0114] A pipe 430 extends axially through compartment 403 of
chamber 521 and connects to opening 432, located centrally of
diaphragm 524, and the closed upper end 436 of stem 502 is slidably
mounted within and concentric with the pipe 430. Inner stem 502
extends downwardly through opening 432 of diaphragm 524 and
continues, through lower chamber 525, and passes through opening
550 in the distal end 515 of chamber 525 to reach stem tip 526
continuing in its convex apex 504 of stem tip 526. Inner stem 502
is encircled by outer stem 552 which projects from distal end 515
of chamber 525 of stem member 501 and exits through opening 31 of
flat base 7 of support case 2 to continue in tip base 503 of tip
526.
[0115] Inner stem 502 is slidably mounted within outer stem
552.
[0116] Adjacent its upper end 436, stem 502 is provided with
windows 438, while pipe 430 is formed with windows 440, which are
normally out of alignment with the windows 438 of stem 502, but
which, when aligned, as described hereinafter, allow gas or fluid
flow between compartment 403 and the interior of the stem 502. A
spring 442 is located between the side wall 402 of compartment 403
and the side wall 406 of body 513, between flange 441 and the upper
surface of piston 470. In passing through chamber 525, stem 502
extends axially through piston 470 and is secured to the piston 470
for movement therewith. Piston 470 is formed with an annular recess
471, having an annular extension 472. In the rest position, balls
305 are seated in extension 472 of piston 470 and project through
opening 144 in wall 406 of the body 513 of the stem member 501 to
seat in receptacle 307 of the intermediate member 300 to releasably
lock the stem member 501 to the intermediate member 300. Also, ball
446 seats in an annular recess 460, at the lower end of piston 470,
and projects through opening 461 in wall 406 of the body 513 of
stem member 501 to seat in window 380 of the intermediate member
300 to prevent downward movement of the piston 470 and, hence, of
stem 502.
[0117] The stem tip 526 has the same overall shape of stem tip 104
of the cardiac pump 1 of FIGS. 1-10, however it is structurally and
functionally different. Stem tip 526 is composed of tip base 503
which, as outlined above, is in continuity with outer stem 552 and
a convex apex 504 which, as outlined above, is in continuity with
inner stem 502. Between edges 505 of tip base 503 and edge 507 of
convex apex 504 is contained folded expandable member such as
balloon 506. Also, the lower end of inner stem 502 is formed with
windows 510 which allow air to pass out of inner stem 502 to
inflate the balloon 506, when appropriate. The support case 2 is
formed with a receptacle 473, located adjacent the lower end 550 of
the body-513 of the stem member 501 when the cardiac pump 500 is in
the rest position, for receiving the ball 446, as described
hereinafter.
[0118] Description of the Operation of Embodiment II
[0119] In operation, the cardiac pump 500 of FIG. 11 is placed
within skin incision 109, in the same manner as cardiac pump 1 of
FIGS. 1-10, with stem tip 526 partially buried under the patient's
skin. Compressed air bottle 129 is, then, screwed into chamber 517,
causing penetration of seal 135 by needle tip 141 of needle 140,
and allowing air to pass through opening 400 into chambers 519 and
521. The air pressure in chamber 519 will result in lateral
withdrawal of pin 180, against the urging of spring 186, unlocking
the stem member 501 and intermediate member 300 from support case 2
for downward movement with respect to the support case 2, due to
the action of lever 17 and the double rack 301, in the same manner
as described above with respect to cardiac pump 1 of FIGS.
1-10.
[0120] When lever 17 and the double rack 301 have advanced the stem
member 501 and intermediate member 300 by a predetermined distance,
preferably approximately 1/2 centimeter, ball 446 will enter
receptacle 40 of the support case 2, releasing piston 470 for
downward movement by spring 442. However, such downward movement is
prevented, at this time, since the tip apex 504 is engaging the
inextensible structure of the chest wall 107 and, thus, serves to
prevent downward movement of stem 502 and piston 470. Continued
operation of lever 17 on the double rack 301 will, eventually,
cause the stem tip 526 to penetrate into the chest cavity 110,
whereupon downward movement of the stem tip 526 is no longer
impeded by the structure of the chest wall 107. The instant such
penetration of the chest cavity 110 occurs, spring 442 will drive
piston 470 and stem 502 downward, causing windows 438 of stem 502
to align with windows 440 of pipe 430 and allowing air to pass from
chamber 521, through stem 502 and windows 510 to inflate the
balloon 506. The downward movement of piston 470 also allows balls
305 to be moved out of extension 472 of piston 470, to enter recess
471 of piston 470 and to disengage from receptacle 307 of the
intermediate member 300 and, thus, to unlock the stem member 501
from the intermediate member 300. However, prior to full inflation
of the balloon 506, pin shaft 410 of pin 408 will be urged by
spring 418 to project through longitudinal slit above edge 314 of
the intermediate member 300 into one of the openings 29 of the
support case 2 to prevent forward movement of the stem member 501.
When the balloon 506 is fully inflated, the air pressure in chamber
521 will rise, causing pin head 412 to drive pin 408 inwardly,
against the urging of spring 418, withdrawing pin shaft 410 through
slit above edge 314 of the intermediate member 300, out of opening
29 of support case 2, to fully release the stem member 501 for the
pumping operation, which is performed in the manner described above
with respect to the cardiac pump 1 of FIGS. 1-10. In case balloon
506 during the pumping operation deflates accidentally, pressure
surrounding pin head 412 of pin 408 will fall, allowing spring 418
to urge pin 408 outwardly to engage one of the openings 29 of
support member 2. When the resuscitation operation has been
completed, the operator unscrews and removes the air bottle 129,
which allows the balloon 506 to deflate and permits the stem tip
526 and balloon 506 to be easily withdrawn from the chest cavity
110.
[0121] Embodiment III
[0122] FIGS. 12, 13, and 14, show a further alternative form,
indicated generally at 600, of the cardiac pump 1 of FIGS. 1-10,
having a support case 800, which is similar to the support case 2
of the cardiac pump 1 of FIGS. 1-10; a stem member 601, and an
intermediate member 700. The stem member 601 as shown in FIG. 13,
comprises a handle 111, a body 613 and a stem 602 projecting from
end 615 of body 613. Handle is mounted atop a compressed air bottle
129, which is threadedly attached to the upper end of a generally
cylindrical body 613 of stem member 601. Handle 111, as shown in
FIG. 14, is identical in structure and function to handle 111
described for the device shown in FIG. 1 to 10 and to handle of
device shown in FIG. 11. Body 613 is divided into upper chamber 617
and lower chamber 621. Chamber 617 is identical to chamber 517 of
the cardiac pump 500 of FIG. 11. Diaphragm 618 separates chambers
617 and 621 and has a central opening 142, surrounded by hollow
needle 140 which has pointed end 141 and is identical with hollow
needle 140 of the cardiac pump 1 of FIGS. 1-10. Chamber 621 extends
between diaphragm 618 and the distal end 615 of the body 613, while
hollow stem 602 communicates with end 615 of the body 613 and
projects through the base 7 of the support case 800 to communicate
with stem tip 104, which is identical with the stem tip 104 of the
cardiac pump 1 of FIGS. 1-10. Within chamber 621 is a pin case 607
having a window 608 and containing a pin 605 which projects through
opening 670 of the wall of body 613 and is formed with a head 606
that is normally urged laterally outward by a spring 609 contained
within the pin case 607. However, the action of spring 609 causes
the pin head 606 to bear against ball 610, which is seated in
receptacle 671 of the pin case 607 and prevents outward movement of
the pin 605 until the ball 610 is released as described
hereinafter. The exterior of the body 613 is provided with a male
threaded portion 603 which mates with the female threaded portion
641 of the intermediate member 700. The intermediate member 700 is
interposed between the stem member 601 and the support case 800 and
is of generally cylindrical shape, with the female threaded portion
641 located approximately midway of the length of the intermediate
member 700, and has an annular rack 742 extending about the
exterior of the middle of the intermediate member 700, provided
with a plurality of outwardly projecting teeth 744. The support
case 800 has a generally hollow, cylindrical body 801 encircling
the intermediate member 700 and the stem member 601 and the upper
portion of the body 801 of support case 800 is provided with a
vertical row of small openings 870 for receiving the pin 605 of the
stem member 601.
[0123] Lever 854 encircles with its expanded head 857 support
member 800 at its midportion and is held in that midportion by the
presence of two annular rails 898 and 899.
[0124] Lever 854 carries a dog support 858 to which a dog 851 is
pivotally secured via a pin 856 and is provided with dog arrest 859
for dog 851. Dog 851 projects through opening 853 of support member
800 and reaches for ratcheting engagement the teeth 744 of the
annular rack 742 mounted on the intermediate member 700. The
support case 800 also carries a pin 860 mounted externally of
support member 800 by a flexible arm 862, which is secured to
support member 800 by a button 863 and extends downwardly from the
button 863 to allow the pin 860 to project through opening 864 of
support case 800 to engage annular recess 865 of the intermediate
member 700. A handle 866 projects outwardly from the pin 860 to
permit manual actuation of the pin 860.
[0125] Description of the Operation of Embodiment III
[0126] In use, the cardiac pump 600 of FIGS. 12, 13, and 14, and
10, is placed on the patient's chest either on the anterior chest
wall in the fourth or fifth intercostal space or in the
subxyphoideal region within skin incision 109, in the manner
described above with respect to the cardiac pump 1 of FIGS. 1-10,
with the stem tip 104 partially buried within the chest wall
structure 107.
[0127] The operator then ratchets the lever 854 laterally, while
keeping the base 7 of the support case 601 pressing steadily
against the patient's chest. This action causes dog 851 to drive
the teeth 744 on rack 742 to rotate the intermediate member 700.
Since the operator is preventing rotation of the stem member 800,
by his grip on handle 145, and since intermediate member 700 is
prevented from advancing, by pin 860 projecting through opening 864
and engaging annular recess 865 of the intermediate member 700, the
rotation of the intermediate member 700 will cause threads 641 to
interact with threads 603 of the stem member 600 to force the stem
member 601 to advance the stem tip 104 through the chest wall
structure 107 until the stem tip 104 penetrates the chest cavity
110. The gradual and controlled slow advancement will finally
result in penetration of the stem tip 104 into the chest cavity
110. Once the passage of a relatively broad stem end 104 is
completed and relatively narrow stem 602 is engaged in the chest
hole formed by stem end 104, the operator will have an immediate
tactile signal of front and side clearance of the stem 602 in the
hole formed in the chest wall. Upon receipt of this signal, the
operator will cease to actuate the lever 854 and will screw in the
air bottle 129, causing needle point 141 of needle 140 to rupture
the seal 135 and allowing compressed air from the air bottle 129 to
inflate the balloon 105. As the balloon 105 reaches full inflation,
the air pressure within the stem member 601 will increase and will
drive pin 605 inward, against the action of spring 609, allowing
ball 610 to be released from receptacle 612 thus freeing pin 605.
The operator will then unlock the intermediate member 700 from the
support case 800 by pulling handle 864 of pin 860 to disengage pin
860 from the annular recess 865 of the intermediate member 700 to
permit the operator to commence the cardiac pumping by alternately
pressing and releasing the handle bar 145 of handle 111. If the
balloon 105 should become deflated during the pumping operation,
the air pressure within the stem member 601 will fall, allowing
spring 609 to urge freed pin 605 laterally outward to project
through one of the openings 870 of the support case 800 to lock the
stem member 601 to the support case 800 and, hence, to prevent
further pumping and possible damage to the heart 69.
[0128] Embodiment IV
[0129] FIGS. 15, 16, and 17, show another alternative form,
indicated generally at 900, of the cardiac pump 1 of FIGS. 1-10.
The stem member 901 of cardiac pump 900 is different from those
previously described, although the support case 800 and
intermediate member 700 are identical with those of the cardiac
pump 600 of FIGS. 12-14. The stem member 901 is composed of handle
111, body 913 and stem 992, having a stem tip 994. Body 913 of stem
member 901 of pump 900 is divided into three chambers: upper
chamber 917, central chamber 919 and lower chamber 907.
[0130] Upper chamber 917 is identical to chamber 517 of the cardiac
pump 500 of FIG. 11. Diaphragm 918 separates chambers 917 and 919
and has a central opening 142, surrounded by hollow needle 140 with
pointed end 141, identical to the one described in the embodiment
of FIGS. 1-10.
[0131] Chamber 919 contains a pin 180 and a shutter 190, which are
identical to the corresponding components of the cardiac pump 1 of
FIGS. 1-10, and has a diaphragm 920 formed with a central opening
199, which is normally blocked by shutter 190, and separating the
central chamber 919 from the lower chamber 907. Lower chamber 907
contain a cylindrical vacuum chamber 910, which is mounted axially
within chamber 907 by a pair of support arms 912 extending between
the vacuum chamber 910 and the body 913 of the stem member 901, as
best seen in FIG. 16. A sealing cylinder 914 encircles the middle
of the vacuum chamber 910 and is normally urged upward by spring
902, bearing against flange 903, which projects radially outward
from the vacuum chamber 910. Another flange 926 projects radially
inward from the body 913 of the stem member 901 to limit downward
movement of the sealing cylinder 914.
[0132] The sealing cylinder 914 is formed with an inwardly facing
annular recess 916. In the rest position of the pump 900, balls 918
are seated in recess 916 and in windows 920 of vacuum chamber 910.
The locking piston 924 is axially slideable within the vacuum
chamber 910 and carries a sealing cap 930 at its lower end with an
annular recess 928 formed immediately above the sealing cap 930.
Lower end of chamber 907 of stem member 913 projects in outer stem
992 which slides through hole 31 of flat base 7 of support case 800
to reach stem end 994 firmly supporting both hollow convex apex 995
and solid base 912 of stem end 994.
[0133] Inner stem 932 projects from distal end 942 of vacuum
chamber 910 and extends concentrically inside hollow outer stem
992, downward to reach and communicate with hollow convex apex
995.
[0134] Hollow convex apex 995 has a solid inner wall 996 and an
outer wall 997 separated by a space 998 therebetween. Inner stem
932 penetrates inner wall 996 and communicates the space 998 with
the lower end 942 of the vacuum chamber 910 within the body 913 of
the stem member 901. The outer wall 997 is formed with a plurality
of openings 999. Finally, a balloon 1000 is mounted between the
adjacent edges of the concave base 912 and the convex apex 995 and
windows 980 are formed in the lower portion of outer stem 992
communicating the interior of the balloon 105 with the interior of
body 913 of the stem member 901. Lever 854 with annexed structure
and pin 860 with annexed structure are the same as the one
described for FIG. 12 to 14.
[0135] Description of the Operation of Embodiment IV
[0136] In use, the compressed air bottle 129 is screwed into upper
chamber 917, causing needle point 141 of needle 140 to rupture the
seal 135 and allowing compressed air from the air bottle 129 to
enter chamber 919 and to displace pin 180 inward, unlocking the
stem member 901 from the support case 800. The operator then
ratchets lever 854, as described for cardiac pump 600 of FIG.
12-14, causing advancement of the stem member 901 with respect to
the support case 800, until shutter 190 is displaced inward by body
801 of the support case 800, causing air to pass through opening
199 into chamber 907 surrounding the vacuum chamber 910. This air
pressure drives the sealing cylinder 914 downward, against the
urging of spring 902, and allowing balls 941 to move out of the
annular recess 927 to unlock piston 924 from the vacuum chamber
910. However, spring 934 is unable, at this time, to move piston
924 upward, since such action will cause the sealing cap 930,
carried by the lower end of piston 924 to create a vacuum within
the vacuum chamber 910 below piston 924, since the chest wall
structure 107 prevents air from entering stem tip 994 and passing
through inner stem 932 into the vacuum chamber 910. This vacuum
will resist the upward urging of spring 934. However, as soon as
the stem tip 994 enters the chest cavity 110, air from within the
chest cavity 110 can enter stem tip 994 and flow through inner stem
932 to relieve this vacuum and to allow spring 934 to move piston
924 to its upward position, wherein balls 918 can pass into the
annular recess 928, adjacent the lower end of piston 924, to unlock
sealing cylinder 914 from piston 924. Upon disengagement of sealing
cylinder 914 from piston 924, sealing cylinder 914 will be forced
downward by compressed air already present in chamber 907 against
the action of spring 902 which urges sealing cylinder upward.
Compressed air, by displacing sealing cylinder 914 downward will
bypass the sealing cylinder 914 and will flow through outer stem
992 and windows 980 of stem end 994 to inflate the balloon 1000.
The operator may then apply periodic pressure to the handle bar 145
to perform the pumping operation. If the balloon 1000 should
accidentally deflate during the pumping operation, the air pressure
within the stem member 901 will fall, allowing spring 186 to urge
pin 180 laterally outward to project through one of the openings
870 of the support case 800 to lock the stem member 901 to the
support case 800 and, hence, to prevent further pumping and
possible damage to the heart 69.
[0137] Embodiment V
[0138] FIGS. 28 and 29 show vet an alternative form of device 1 of
FIG. 1. As shown in FIG. 28, which is a cross-sectional view of the
device, the device generally indicated at 1250 is composed of three
main components: stem member 1252, expandable member 1254 and
pneumatic container 1256. Stem member 1252 is composed of upper
segment or rod 1262, intermediate stem segment 1258 and lower stem
segment 1260. Stem member 1252 is provided proximally with handle
1206. Within handle recess 1207 of handle 1206 is slidably mounted
proximal end 1205 of upper stem segment or rod 1262. Proximal end
1205 of rod 1262 is of general cylindrical shape as upper segment
stem or rod 1262 but of larger diameter. Spring or resilient means
1208 urges stem member 1252 downward. Circular lid or arrest 1209
in handle 1206 does not permit exit of stem member 1252 from handle
1206 by engaging proximal end 1205 of upper stem segment 1262.
[0139] Externally and concentric to the upper portion of upper stem
segment or rod 1262 of stem member 1252 is mounted external arrest
cylinder 1270. External arrest cylinder 1270 is provided with
arrest tab 1272. Flexible arm 1273 of arrest tab 1272 is fastened
to external arrest cylinder 1270 via pin 1274. External arrest
cylinder 1270 has arrest lid 1407 engaging flange 1276 of
intermediate stem segment 1258 to prevent exit of upper stem
segment 1262 from intermediate stem segment 1258.
[0140] Arrest tab 1272 has the function of disabling the
advancement of rod 1258 in case of malfunction or the device during
the cardiac compression as it will be explained below. Also, when
stem member 1252 is advanced into the chest cavity by downward
pressure on handle 1206 arrest tab 1272 will not permit upward
displacement of intermediate stem segment 1258 via tooth 1271
engaging circular arrest or flange 1276 of upper portion 1263 of
intermediate stem segment 1258 through opening 1285 of external
arrest cylinder 1270 as it will be apparent from the description
below.
[0141] Intermediate stem segment 1258 is of general cylindrical
hollow shape. It receives in its upper portion 1263 rod 1262
airtightly slideable in it, while its lower portion 1264 is
slideable within hollow lower stem segment 1260. Pneumatic
container or bottle 1256 is connected with intermediate stem
segment 1258 via conduit 1277. Pneumatic bottle or container 1256,
contains compressed air or suitable gas as CO.sub.2. Conduit 1277
is in open communication with hollow intermediate stem member 1258
via opening 1299 and is airtightly sealed via sealing membrane
1278. Perforating screw 1279 is housed in recess 1280 of pneumatic
container 1256, said perforating screw having thread 1281 mating
with corresponding thread 1282 on recess 1280 of pneumatic
container 1256, screw tip 1283 being in contact with sealing
membrane 1278. Screw 1279 has handle 1284. Screw tip 1283 has holes
1246 to allow passage of air after screw 1279 has penetrated
membrane 1278. Pneumatic container or bottle 1256 is housed within
housing 1247. Handle 1248 projects outwardly from housing 1247 for
easy handling by the operator. Distal end 1286 of intermediate stem
segment 1258 is engaged as above mentioned in a slideable fashion
within hollow lower stem segment 1260. Expandable member 1254,
firmly connected to distal end 1286 of intermediate stem member
1258, comprises inflatable member 1288 and support ribs 1216
preferably, although not necessarily made of resilient material
such as steel. All support ribs 1216 are connected at their
respective proximal ends 1225 to distal end 1286 of intermediate
stem segment 1258. Inflatable member or balloon 1288 of expandable
member 1254 is connected and in flow communication with
intermediate stem segment 1258 via opening 1292.
[0142] Stem tip or distal end 1261 of stem member 1252 is firmly
connected to distal end 1287 of hollow lower stem segment 1260 of
stem member 1252 and is of greater width than contiguous lower stem
segment 1260. Stem tip 1261 is of general spheroid or ovoid shape
or of elliptic cross-section. Stem tip 1261 is composed of two
parts: proximal part 1234 shaped as an inverted cup firmly attached
as above described to distal end 1287 of lower stem segment 1260 of
stem member 1252, and distal part or convex apex 1235 having
circular edge 1236 adapted to fit together with circular edge 1237
of circular opening 1238 of proximal part 1234 of stem tip 1261 to
form together the above mentioned spheroid shaped stem tip 1261.
Convex apex 1235 is firmly attached to base or inferior surface
1291 of inflatable member or balloon 1288 described below. Support
ribs 1216 are firmly attached to superior surface 1290 of
inflatable member 1288 and approximately equidistantly spaced.
Superior surface 1290 of balloon 1288 interconnects therefore
continuous ribs 1216 in a web fashion. Balloon 1288 of expandable
member 1261 is preferably made of substantially inextensible and
airtight material. However balloon 1288 can also be made of
stretchable, compliant airtight material. Apex 1235 of stem tip
1261, as above described, is firmly attached to base or inferior
surface 1291 of balloon 1288. Inflatable member or balloon 1288 of
expandable member 1254 is connected and in flow communication with
intermediate stem segment 1258 via opening 1292.
[0143] Stem tip or distal end 1261 of stem member 1252 is firmly
connected to distal end 1287 of hollow lower stem segment 1260 of
stem member 1252 and is of greater width than contiguous lower stem
segment 1260. Stem tip 1261 is of general spheroid or ovoid shape
or of elliptic cross-section. Stem tip 1261 is composed of two
parts: proximal part 1234 shaped as an inverted cup firmly attached
as above described to distal end 1287 of lower stem segment 1260 of
stem member 1252, and distal part or convex apex 1235 having
circular edge 1236 adapted to fit together with circular edge 1237
of circular opening 1238 of proximal part 1234 of stem tip 1261 to
form together the above mentioned spheroid shaped stem tip 1261.
Convex apex 1235 is firmly attached to base or inferior surface
1291 of inflatable member or balloon 1288 described below. Support
ribs 1216 are firmly attached to superior surface 1290 of
inflatable member 1288 and approximately equidistantly spaced.
Superior surface 1290 of balloon 1288 interconnects therefore
continuous ribs 1216 in a web fashion. Balloon 1288 of expandable
member 1261 is preferably made of substantially inextensible and
airtight material. However balloon 1288 can also be made of
stretchable, compliant airtight material. Apex 1235 of stem tip
1261 .as above described, is firmly attached to base or inferior
surface 1291 of balloon 1288. Base 1291 of balloon 1288 provides in
use the contact surface with the heart when expandable member 1254
is expanded.
[0144] As shown in FIG. 28, when expandable member 1254 is in a
contracted status, balloon 1288 and support ribs 1216 are retained
in their entire length within lower stem segment 1260. Support ribs
1216 are forced to bunch together very close one to another against
their resiliency which urge them to diverge outwardly one from
another in correspondence of their distal segments. Balloon 1288 is
contracted or folded within hollow lower stem segment 1262 along
with ribs 1216.
[0145] Locking means 1401 is fastened to intermediate segment 1258
of stem member 1252 via pin 1402 and provided with resilient arm
1406 having a slant contact surface 1405 for facilitating
engagement of flange 1404 of lower stem segment 1260 in recess 1403
of locking means 1401, as it will be apparent from the description
below.
[0146] In use, as shown in FIG. 28, hollow stem tip 1261 is
inserted into the skin preferably in the left parasternal region in
a skin area corresponding to the intrathoracic anatomical area
designated "sine pleura," after a small skin incision is made to
allow entry of distal tip 1261 of stem member 1252 into the
subcutaneous tissue.
[0147] Stem member 1252 is further advanced through the thickness
of chest wall 107 by means for blunt dissection until entry of stem
end or tip 1261 is gained into chest cavity 110. Arrest tab 1272
will not allow downward displacement of upper stem member segment
or rod 1262 as a result of engagement of tooth 1271 with circular
arrest or flange 1276 of intermediate member segment 1258. Being
distal end 1261 of stem member 1252 of a greater width than distal
contiguous segment 1287 of hollow lower stem segment 1260, distal
end or stem tip 1261 of stem member 1252 allows an operator of the
device, upon penetration of distal stem end or tip 1261 into the
chest cavity 110, to tactily sense entry of the distal stem end or
stem tip 1261 into the chest cavity by the sudden fall of
resistance to forward and sideways movement of said distal stem end
1261, said resistance to forward and sideways movements being
encountered during passage of said stem tip 1261 through chest wall
107. When the operator has ascertained penetration of distal end
1261 of stem member 1252 into chest cavity 110, he or she advances
slideable intermediate stem member 1258 relatively to the hollow
lower stem segment 1260 by holding still hollow lower stem segment
1260 relatively to the patient with one hand, and acting upon
handle 1248 with his or her other hand so as to move intermediate
stem segment 1258 downwardly relatively to lower stem segment 1260,
toward chest cavity 110. Intermediate stem member 1258 therefore
will be advanced to a full advanced position, i.e., until conduit
1277 of container 1256 will engage flange 1404 of proximal end 1296
of lower stem segment 1260. Upon full advancement of intermediate
stem member 1258 into lower stem segment 1260, locking means 1401
will lock stem intermediate member 1258 to lower stem segment 1260
via engagement of recess 1403 with flange 1404.
[0148] Being distal end 1286 of intermediate stem member 1258
connected to proximal ends 1225 of ribs 1216, the forward movement
of intermediate stem member 1258 will result with ejection and exit
of ribs 1216 through opening 1238 of proximal part 1234 of stem tip
1261. Upon ejection of distal segments of support ribs 1215 from
the stem tip 1261, support ribs 1216 will diverge one from another,
due, as already described, to their outward resiliency. Such an
outward expansion of ribs 1216 begins with the distal segments of
the ribs and proceeds with contiguous segments. The outward
resiliency is a critically important feature in placing an
expandable member into the chest cavity, because it allows
self-expansion of the expandable member very early upon entry of
the blunt stem tip 1261 and by such a feature it prevents the need
for displacement of the anterior wall of the heart when the
expandable member is still contracted, having to advance by its
entire antero-posterior length before opening up to expand in order
to exit first from the chest wall. Advancement of a contracted
expandable member toward the heart until its passage through the
chest wall is completed, or almost completed, is dangerous and
risky and should be avoided by any device because the heart is in
contact with the chest wall and, as a matter of fact, the external
lining of the heart, i.e., its pericardium is attached to the inner
aspect of the chest wall via sterno-pericardial ligaments. The
presence of the sterno-pericardial ligaments adds the requirement
of additional pressure to be exerted upon the heart with a
contracted expandable member and requires an antero-posterior
displacement of the anterior wall of the heart approximately equal
to the radius of the heart contacting surface of the expanded
expandable member if the ribs are not made outwardly resilient.
[0149] The operator will screw in perforating screw 1279 which will
perforate, via screw tip 1283, sealing membrane 1278 allowing
passage of compressed air or gas from pneumatic container 1256 into
inflatable member 1288 via conduit 1277 along hollow intermediate
stem segment 1258. Inflatable member 1288 will fully expand, and,
by expanding, will provide, via its inferior surface or base 1291,
a contact surface to heart 69 for the purpose of direct compression
of the heart. Indeed, in order to compress-decompress the heart,
the operator will press downward on handle 1206 which in turn will
displace downward intermediate member 1258 via rod 1262. Fully
expanded balloon or inflatable member 1288 will compress heart 69
while ribs 1216 will provide balloon 1288 with lateral and
posterior support so as to require a reduced expanding pressure
within the inflatable member 1288 allowing a softer contact with
the external surface of the heart. In case of accidental
perforation of balloon 1288 at any stage of the operation pressure
within hollow intermediate stem segment 1258 will drop disabling
advancement of rod 1262 no longer upwardly held by compressed air
or gas. This is a very important safety feature which can also be
applied to all types of embodiments A.
[0150] Embodiment VI
[0151] Embodiment VI has numerous similarities and numerous parts
which are identical to device 1250 of FIG. 28 and 29. Reference
numbers illustrating the same parts have been therefore maintained.
FIGS. 30, 31, and 32, show an embodiment, indicated generally at
1200, of the cardiac pump 1 of FIG. 1 to 10. The device includes a
different type of expandable member carried by the blunt stem tip
of a stem member.
[0152] As shown in FIG. 30, the device, generally indicated at
1200, is composed of two main components, stem member 1202 and
expandable member 1204. Stem member 1202, of general cylindrical
shape, comprises hollow stem 1203 having a proximal end 1205 and a
distal end or stem tip 1201. Proximal end 1205 of stem member 1202,
of general cylindrical shape as hollow stem 1203 but of larger
diameter, is mounted in slideable fashion within recess 1207 of
handle 1206. Spring or resilient means 1208 urges downward stem
member 1202 Circular lid or arrest 1209 in handle 1206 does not
permit exit of stem member 1202 from handle 1206. Within hollow
stem 1203 is slidably mounted rod 1210. Proximal end 1231 of
expandable member 1204 is firmly attached to distal end 1218 of rod
1210 in a folded or contracted status prior to use. Hollow stem
1203 is formed with longitudinal slit 1213 for handle arm 1212 of
handle 1211, longitudinal slit 1213 having proximal end 1219 and
distal end 1220. Locking means or tab 1245 having flexible arm 1229
is fastened via pin 1243 to hollow stem 1203 with tooth 1245'
engaging opening 1242 in hollow stem 1203.
[0153] Stem end or tip 1201, firmly attached to distal segment 1233
of hollow stem 1203 of stem member 1202 is of greater width than
continuous distal segment 1233. Stem tip 1202 is of general
spheroid, elliptical cross-section or ovoid shape. Stem tip 1201 is
composed of two parts: proximal cart 1234 shaped as an inverted cup
and firmly attached as above described to hollow stem 1203 of stem
member 1202, and distal part or convex apex 1235 with circular edge
1236 of apex 1235 adapted to fit together with circular edge 1237
of circular opening 1238 of proximal cup 1234 to form together the
above mentioned spheroid shaped stem tip 1201. Convex apex 1235 is
firmly attached to base membrane 1223 as it will be apparent from
the description below. As for embodiment V of FIG. 28 and 29,
expandable member 1204 comprises a body formed with a number of
ribs 1216, made of resilient material such as steel. All ribs 1216
are connected at their respective proximal ends 1225 to distal end
1218 of a rod 1210, slideable, as already described, within hollow
stem 1203 of stem member 1202. Proximal end 1219 of slit 1213 of
hollow stem 1203 arrests upward displacement of rod 1210 via
engagement of arm 1212 of handle 1211 with proximal end 1219 of
slit 1213. Arrest of rod 1210 prevents that distal ends 1215 of
ribs 1216, connected to rod 1210, lose their alignment with stem
tip 1201 by moving backward, i.e., proximally in respect to hollow
stem 1203.
[0154] Contiguous ribs 1216 are interconnected via webs 1222, of
grossly triangular shape as seen in FIGS., 31 and 32 and made of
fabrics or plastic or other suitable material substantially
inextensible. A base sheet or membrane 1223 also made of fabrics or
plastic or other suitable substantially inextensible material is
attached to distal blunt ends 1215 of ribs 1216 and to distal or
outer margin or edge 1221 of webs 1222 to form a base for contact
with heart 69 when expandable member 1204 is fully expanded. As
shown in FIG. 29, when expandable member 1204 is in a contracted
status, all ribs 1216 are retained in their entire length within
hollow stem 1202 and forced to bunch together very close one to
another, against their resiliency which urges them to diverge
outwardly one from another in correspondence of their distal
segments.
[0155] In use, as shown in FIG. 30, as for all the devices
previously described, hollow stem tip 1201 is inserted into the
skin preferably in the left parasternal region in a skin area in
correspondence of the anatomical area designated "sine pleura,"
after a small skin incision is made to allow entry of distal tip
1201 of stem member 1202 into the subcutaneous tissue.
[0156] Stem member 1202 is further advanced by blunt dissection
through the thickness of chest wall 107 until entry is gained into
chest cavity 110 by blunt dissection. Being distal end 1201 of
hollow stem 1203 of a greater width than distal contiguous segment
1233 of hollow stem 1203 distal end or stem tip 1201 of stem member
1202 allows an operator of the device, upon entry of distal stem
end or blunt tip 1201 into the chest cavity 110, to tactily sense
entry of the blunt distal stem end 1201 into the chest cavity by
the sudden fall of resistance to forward and sideways movement of
said distal stem end 1201 said resistance to forward and sideways
movements being present during passage of said stem tip 1201
through chest wall 107.
[0157] When the operator has ascertained penetration of distal end
1201 of stem member 1202 into chest cavity 110, he or she advances
slideable rod 1210 relatively to hollow stem 1203 by holding still,
relatively to the patient, with one hand, hollow stem 1203 by its
distal segment, and acting upon handle 1211 with his or her other
hand so as to move rod 1210 downwardly, toward chest cavity 110.
Rod handle 1211 will be advanced to a fully advanced position, i
e., until handle arm 1212 of handle 1211 will engage distal end
1220 of slit 1213 of hollow stem 1203. Being distal end 1213 of rod
1210 connected to proximal ends 1225 of ribs 1216, the downward
movement or rod 1210 will result with election end exit of ribs
1216 through opening 1238 of proximal part, or cup, of stem tip
1201. Upon ejection of distal segments 1215 of ribs 1216 from stem
tip 1201 ribs 1216 will diverge outwardly one from another due, as
already described, as a result of their resiliency. Webs 1222, of
fabrics or plastic or other suitable material, will retain ribs
1216 from diverging beyond a desired decree of divergence. Ribs
1216 and webs 1222, upon full expansion, will form a bell-shaped
member with base sheet 1223 facing heart 69, and top surface 1227
facing stem 1203. Base membrane 1223, being attached to distal ends
1215 of ribs 1216 and to distal webs margins 1221 of webs 1222,
form a substantially inextensible base for contact with heart 69
when expandable member 1204 is fully expanded. Releasable locking
means 1245 will lock rod 1210 via entry of tooth 1245' into opening
1242 of stem member 1202 in a fully advanced position by engaging
proximal end 1217 of slideable rod 1210, for the time of
compression and decompression of the heart. The operator as shown
in FIG. 30 will compress and decompress hearth 69 by pressing on
handle 1206. Contraction of spring or resilient means 1208 will
prevent injuries to the heart if excessive pressure is applied
after compression of the heart against the thoracic spine. When the
resuscitation operation has been completed the operator will unlock
rod 1210 via disengaging tooth 1245' from proximal end 1217 of rod
1210. He or she then will retract rod 1210 by pulling up handle
1211. Expandable member 1204 will contract and will fold within
hollow stem 1203 permitting so the extraction of stem tip 1201 and
the penetrated segment of stem 1203 from chest cavity 110.
[0158] Embodiment VII
[0159] FIGS. 33 and 34 show vet an alternative form of device 1 of
FIG. 1 to 10. FIG. 33 is a cross-sectional view of the device
generally indicated at 1300. Device 1300 is composed of two main
components stem member 1302 and expandable member 1304. Stem member
1302 is composed of proximal end 1303, shaft 1305 and stem end
1306. Stem shaft 1305 is composed of three concentric cylindrical
stems, outer 1308, intermediate 1309 and inner 1310. Stem member
1302 is provided proximally with handle 1206 in all similar to the
two previously described device 1200 and 1250. Within handle 1206
recess 1207 of handle 1206 is slidably mounted proximal end 1205 of
upper stem member segment 1310. Proximal end 1205 of upper stem
segment 1310 is of general cylindrical shape as upper segment of
stem member 1302 but of larger diameter. Spring or resilient means
1208 urges downward stem member 1302. Circular lid or arrest 1209
in handle 1206 does not permit the exit of stem member 1302 from
handle 1206 via engaging proximal end 1205 of upper stem member
segment 1307.
[0160] Outer stem 1308 and intermediate stem 1309 of shaft 1305 of
stem member 1302 are hollow while inner stem 1310 can be either
solid or hollow. Handle wheels 1313, 1314, 1315, are respectively
connected to each of the three cylindrical stems, outer 1308,
intermediate 1309, and inner 1310. Each handle wheel 1313, 1314,
1315, is formed with respective seating 1316, 1317, 1318, for
locking means or pin 1319. While seating 1318 of inner stem 1310 is
visible in FIG. 33, seating 1316 and 1317 cannot be visualized
because not aligned with seating 1318 with the device at rest prior
to expansion of expandable member 1304 as it can be better
understood from the description below. Locking means 1319 composed
of pin 1320 and arm or handle 1321 engaged within seating 1318.
[0161] Expandable member 1304 is composed of three or more
identical bluntly tipped rods 1330, 1331, 1332, connected by
membrane 1343, as seen in FIG. 34. Blunt rods 1330, 1331, 1332, are
firmly attached to, or in continuity respectively with stem ends
1330' 1331' 1332' of outer stem 1308, intermediate stem 1309 and
inner stem 1310, being positioned at an angle preferably obtuse, in
order to facilitate the insertion of expandable member 1304 into
chest cavity 110 by the operator as it will be apparent from the
description of the operation. Rods 1330, 1331, 1332, remain
superimposedly overlapped until expansion of the expandable member
is actuated by the operator. Rods 1330, 1331, 1332, have blunt ends
1342 for the purpose of blunt dissection of the chest wall and for
avoiding injuries to the intrathoracic organs upon chest cavity
penetration. In order to facilitate penetration by blunt dissection
through the chest wall, rods 1330, 1331, and 1332, may be curved
outwardly in continuity with the stem, with convexity facing the
chest cavity so as to enter the chest cavity almost parallel to the
anterior wall of the heart.
[0162] In operation, as shown in FIG. 30, the operator after making
a superficial incision in the skin as for all the devices
previously described, in the left parasternal region in a skin area
in correspondence of the anatomical area designated "sine pleura,"
the operator inserts blunt ends 1342 of rods 1330, 1331, 1332, of
expandable member 1304 into the subcutaneous tissue and advances
them by means of blunt dissection through to the thickness of the
chest wall. Blunt dissection of the chest wall will be carried out
with rods 1330, 1331, and 1332, with an approach nearly
perpendicular to the anterior chest wall until occurred blunt
penetration of blunt ends 1342 of rods 1330, 1331, 1332, into the
chest cavity occurs. During penetration through the chest wall,
stem member 1302 will therefore be tilted from its initial
perpendicular position relatively to the anterior chest wall. As
soon as the operator senses the occurred penetration into the chest
cavity by blunts ends 1342, he or she will gradually reposition
stem member 1302 to reach a right angle in respect to the anterior
chest wall while gradually advancing blunted tips of rods 1330,
1331, and 1332, inside the chest cavity along a plane which is
substantially parallel to the anterior wall of the heart and is in
close proximity of the inner aspect of the anterior chest wall.
Once rods 1330, 1331, and 1332, are fully entered into the chest
cavity and consequently stem member 1302 is repositioned
approximately perpendicularly in respect to the anterior chest
wall, the operator will rotate sequentially handle wheels 1313,
1314, 1315, in order to space distal ends of rods 1330, 1331, and
1332, and fully expand expandable member 1304 as shown in FIG. 34
which is a view from below of the fully expanded expandable member.
Indeed rods 1330, 1331, 1332, being sideways rotated will distend
connecting membrane 1343. Locking means 1319 will be inserted in
corresponding aligned seating 1316, 1317, 1318, locking respective
rods 1330, 1331, 1332, in a fully outwardly expanded position by
locking wheels 1313, 1314, and 1315, all together. As for the
device previously described, compression of the heart will be
accomplished by downward pressure on handle 1206. Membrane 1343,
fully distended by spread rods 1330, 1331, 1332, will provide an
adequate contact surface area for the purpose of compressing the
heart.
[0163] The device will be easily removed by extracting pin 1320
from seatings 1315, 1316, and 1317, and by rotating rods 1330,
1331, 1332, to their original position, by acting upon wheels 1313,
1314, 1315, so as to contract expandable member 1343 and allow its
extraction from chest cavity 107.
[0164] All the disclosed expandable member may have a number of
different shapes, and the heart compressing surface of the
expandable member may also have a number of shapes to adapt to the
surface of the heart, including a concave shape, flat, convex and
can also be deformable for such adaptation to the heart.
[0165] Obviously, numerous other variations and modifications can
be made without departing from the spirit of the present invention.
Therefore, it should be clearly understood that the forms of the
present invention described above and shown in the figures of the
accompanying drawing are illustrative only and are not intended to
limit the scope of the present invention.
TYPE A EMBODIMENTS
[0166] FIGS. 18 to 25 illustrate a group of devices which, while
retaining the same mechanisms of gaining entry into the chest
cavity in front of the heart, differ in the way of compressing and
decompressing the arrested heart. All the devices of type B share
with the previously described devices of type A, a most important
feature: safe entry of a stem provided with a blunt tip carrying an
expandable member into the thoracic cavity. By entering the chest
cavity with a blunt tip, following gradual and controlled
advancement of such a blunt tip through the chest wall, with
largely automatized provisions for the instantaneous arrest of
advancement immediately upon entry into chest cavity by the blunt
tip the underlying intrathoracic structures are exposed to no risk
of injuries deriving from the insertion of the expandable member
into the chest cavity. To the contrary, entry into the thoracic
cavity with any pointed, sharp tipped device carries the potential
and the probability, regardless of any precautionary measures, for
resulting in high incidence of major and fatal injuries to the
underlying structure, above all the heart, including coronary
arteries and myocardium, defeating so the purpose of successful
resuscitation.
[0167] Device 1002 of FIGS. 18 to 21 is an alternative form of
device 1 represented in FIGS. 1 to 10. Device 1002 retains the same
safety mechanisms of gaining entry into the chest cavity in front
of the heart as device 1 of FIG. 1 to 10, including the blunt
penetrating tip, while it differs in the way of compressing and
decompressing the arrested heart.
[0168] Device 1002 is basically similar to device 1 of FIGS. 1 to
10 with few structural differences. The corresponding parts have
retained the same numbers.
[0169] Device 1002, as shown in FIGS. 18 and 19, is composed of
four main components: support member generally indicated at 1004,
stem member or stem unit generally indicated at 1006, an
intermediate member generally indicated at 300, and an
inflating-deflating means or device generally indicated at
1008.
[0170] The support member 1004 is the same as support member 2
except that, as better shown in FIGS. 18 and 19, it has, at its
surface, on its distal segment 5, slit 1010, in order to permit the
insertion of distal end 1012 of hose 1014 of inflating-deflating
device 1008 on window 1016 of stem 102 of stem unit 1006.
[0171] Stem member or unit member 1006 is basically similar to stem
or unit member 100 of FIG. 1 to 10 with few important
differences.
[0172] Handle 111 of FIG. 1 with T bar 145 is no longer
present.
[0173] Shut-off valve 210 (better) illustrated in FIG. 3 and 4, is
no longer present.
[0174] Opening 197, shown in FIG. 4 in diaphragm 120 and opening
209 (FIG. 4) in diaphragm 122 are no longer present.
[0175] As shown in FIGS. 18 and 19, stem 102 is connected to hose
1004 of inflating-deflating means 1008. Three ways shut off valve
1018 is located at the connection between distal end 1012 of hose
1014 and stem 1002.
[0176] Expandable member or balloon 1020, contained in position of
rest within circular groove 103 of stem end 104 as for the device
of FIG. 1 to 17 is of larger size when fully expanded than balloon
105. Intermediate member 300 is identical to intermediate member
300 of device of FIGS. 1 to 10, thereof same numbers have been used
for same parts.
[0177] Inflating-deflating means or device 1008 is generally
cylindrical in shape with top wall 1022 bottom wall 1024 and
lateral pleated walls 1026. Resilient member or spring 1028 is
contained within device 1008 to maintain its lateral wall 1026
distended in its resting position.
[0178] It is obvious that manually operated inflating-deflating
device 1008 may be substituted by a power operated
inflating-deflating device.
[0179] Description of the Operation of Embodiment I
[0180] The device is placed on the anterior chest in the same way
as the correspondent device of FIGS. 1 to 10, and the following
operations are exactly the same as the ones described for the
previous device of FIGS. 1 to 10, with few important functional
differences.
[0181] After chest wall penetration and complete passage of blunt
stem end 104 through chest wall 107, balloon 1020 will
automatically inflate via the same mechanism described for device
of FIGS. 1 to 10, as shown in FIGS. 19 and 20.
[0182] During advancement of stem 102 through chest wall, distal
end 1012 of hose 1014, connected to stem 102, will be able to slide
within slit 1010 of support member 1004.
[0183] As in correspondent device of FIGS. 1 to 10, lever 17 and
intermediate member 300 will automatically disengage from stem unit
1006 upon penetration of blunt stem end 104 into chest cavity,
signaling to the operator, by said disengagement, that penetration
has occurred into the chest cavity.
[0184] The disengagement of the stem member 1006 from intermediate
member 300 results in a sudden upward displacement of stem unit
1006 in respect to support case 1004 due to the action of spring
280. Said upward displacement of stem unit 1006 is however minimal,
being limited by engagement of pin 261 into the most distally
located hole 29 formed in the side wall of support case 1004. Pin
261 is allowed to engage to hole 29 because is no longer retained
in its retracted position by side wall of intermediate member 300,
which, contrary to stem unit 1006, is prevented from sliding upward
in respect to support case 1004 by dog 21 of lever 17 that is
anchored to support case 1004. Pin 261 therefore blocks the
advancement of blunt stem end 104 with its balloon 1020 in respect
to support case 1004 to a distance automatically determined by the
device and selected for that specific chest wall thickness that
stem 102 of stem unit 1004 penetrates at that particular time.
[0185] This automatic arrest of blunt stem end 104 of stem 102 of
stem member or unit 1006 is an important safety feature required to
prevent that inadverted advancement of stem tip 104 with deflated
balloon 1020 might result in damage to the heart, despite bluntness
of stem end 104. In device of FIGS. 1 to 10 the locking of stem
unit 100 to support case 2 by pin 261 is released by the act of
opening the shut of T-valve 180 and consequent entering of high
pressure gas into the system with resulting full inflation of
balloon 105 and sufficient pressure upon the head 262 of pin 261 to
withdraw pin 261 from engagement into hole 29 of support case 2, to
allow advancement and then withdrawal of stem unit 100 in respect
to support case 2 to effect pumping of the heart. On the contrary,
in device of FIGS. 18 to 21, pin 261 is required to remain engaged
to hole 29 of support case 1004 to keep stem unit 1006 locked to
support case 1004, consequently no high pressure gas will enter the
system so that pin 261 is not withdrawn and disengaged from support
case 1004.
[0186] After automatic disengagement of lever 17 and intermediate
member 300 from stem unit 1006, and automatic locking of stem unit
1006 to support case 1004, the operator, made aware of the occurred
penetration into chest cavity, will act on three ways shut off
valve 1018, opening the passage between hose 1014 and stem 102 and
closing passage between stem 102 and chamber 125.
[0187] At this point, the operator is ready to perform the cardiac
compression-decompression. The operator, by pressing upon top wall
1022 of inflating-deflating device 1008, inflates balloon 1020, as
shown in FIG. 21.
[0188] Inflation of balloon 1020 will result in its expansion and
compression of the heart between the thoracic spine and the balloon
1020 itself, as shown in FIG. 21.
[0189] By releasing pressure upon top wall 1022 of
inflating-deflating device 1008, the operator will deflate balloon
1020. Deflation of balloon 1020 will result in its contraction and,
consequently, in the decompression of the heart.
[0190] By alternatively pressing upon inflating-deflating device
1008 and releasing such pressure, the operator will alternatively
compress and decompress the heart.
[0191] Being stem tip 104 indirectly locked to support member 1006
as a consequence of actuation of pin 261, as described above, upon
entry of stem tip 104 into the chest cavity while stem tip 104 is
still adjacent to the inner surface of chest wall 107, and being
support case 1006 impeded to advance toward the chest cavity by its
base 7, stem tip 104 is prevented to advance toward the chest
cavity and, at the same time, after the initial expansion of
expandable member 1020, is prevented as well to withdraw from the
chest cavity by the expandable member expanded within the chest
cavity. Stem tip 104 remains, consequently, firmly anchored to its
position in contact with inner surface of chest wall 107.
[0192] With the predicament that no definite type of expandable
member, with regard to its geometric and physical properties, is to
be considered critical, or even significant or relevant for the
successful implementation of cardiac massage with any of the
devices described as type B in this disclosure, except for its
property of being expandable so to be passed through the chest wall
while still in a contracted state into the chest cavity where it
can be expanded, a description is made below of a sample of
possible expandable member, as represented in FIGS. 20 and 21, with
the assertion that by no means the expandable member described
below is to be considered as the only embodiment conceived in this
disclosure. Other embodiments have been considered, differing from
the one described below by shape, by site of attachment to the stem
tip, by progression of expansion and by other properties. Being
expandable member 1020 secured to stem tip 104, and, as just stated
above, being stem tip 104 firmly anchored to its position in
contact with inner surface of chest wall 107, expansion of said
expandable member 1020 as it is represented in FIGS. 20 and 21 and
exclusively for the purpose of illustration, will rather occur
anteriorly in direction of the chest cavity and will not occur
posteriorly toward chest wall 107. Also, anterior expansion of the
expandable member 1020 will not occur, in this particular
embodiment, in correspondence of its center where expandable member
1020 is attached to blunt stem tip 104, with resulting anterior
umbilication of the expanded member in correspondence of blunt stem
tip 104. This umbilication of the expanded expandable member 1020
in correspondence of blunt stem tip 104 prevents blunt stem tip 104
from ever coming to contact with the heart during the
compression-decompressio- n cycle, safeguarding the heart from
possible occurrence of blunt injuries. Umbilication of the
expandable member both in systolic and diastolic phase also tends
to shape the anterior surface of the expandable member 1020 to a
configuration generally and approximately resembling a cup with the
periphery of expandable member 1020 more protruded toward the chest
cavity than its central area. By such a configuration, expandable
member 1020, when adjacent to the heart, will embraces it, and, by
being secured to stem tip 104, which in turn is firmly anchored to
the inner aspect of the chest wall in a designated area adjacent to
the heart where the pleura is absent, it will be able to guide the
heart by directing it, during the phase of compression, toward the
thoracic spine.
[0193] Embodiment II
[0194] FIGS. 22 and 23 show an alternative form, generally
indicated at 1050, of device 500 illustrated in FIG. 11.
[0195] Device 1050 retains the same safety mechanisms of gaining
entry into the chest cavity in front of the heart as device 500 of
FIG. 11, including the blunt penetrating tip, while it differs in
the way of compressing and decompressing the arrested heart.
[0196] Structure of device 1050 is therefore similar to device 500,
except for the following differences. Corresponding parts have
maintained the same numbering.
[0197] Device 1050, as shown in FIG. 22, is composed of four main
components: support member generally indicated at 1052, stem member
or unit generally indicated at 1054, an intermediate member
generally indicated at 300, and an inflating-deflating means or
device generally indicated at 1008.
[0198] The support member 1052 is the same as support member 2 of
FIG. 11 except that, as shown in FIG. 22, it is closed by top wall
1053. It also has, at its surface, on its distal segment 5, slit
1010, in order to permit the insertion of distal end 1012 of hose
1014 of inflating-deflating device 1008 on window 1016 of outer
stem 552 of stem member 1054 as it will be described below.
[0199] Stem member or unit member 1054 is structurally similar to
stem member 501 of FIG. 11, but devoid of many of its
components.
[0200] In particular gas-fluids container 129 with its handle 111,
the entire chamber 517 with its side walls and all its content,
diaphragm 518, chamber 519 with its side walls and all its content,
including pin 180 are no longer present.
[0201] Central opening 400 in diaphragm 518 is no longer
present.
[0202] Chamber 521 is devoid of pipe 430 and inner stem 502.
[0203] Opening 432 in diaphragm 524 is preserved.
[0204] Inner stem 502 which was slidably mounted within piston 470
of FIG. 11 is no longer present and is replaced by solid rod
1060.
[0205] Outer stem 552 is connected to hose 1014 of
inflating-deflating means 1008 at window 1016. Three ways shut off
valve 1018 is located at the connection between hose end 1012 of
hose 1014 and outer stem 552.
[0206] As shown in FIG. 23, in a segment of outer stem 552 proximal
to insertion of hose 1014, a cylinder 1012 is slidably mounted
within outer stem 552 and around rod 1060, said cylinder having a
cone shaped proximal end 1162 and a distal end 1152 for the seating
of compression spring 1160 acting from flange 1156.
[0207] Expandable member or balloon 1062, contained in position of
rest between convex tip base 503 and convex apex 507 of stem end or
tip 526 as for the device of FIG. 11 is of larger size when fully
expanded than balloon 506.
[0208] Intermediate member 300 is identical to intermediate member
of device of FIG. 11, thereof same numbers have been used for same
parts.
[0209] Inflating-deflating means or device 1008 with connected hose
1014 and shut off valve 1018 it is the same device of FIGS. 18 to
21 and same numbering has been maintained.
[0210] Description of the Operation of Embodiment II
[0211] Device 1050 is placed on the chest in the same way as the
previous device, and the following steps are exactly the same as
the ones described for the previous device 500 of FIG. 11, with few
important functional differences.
[0212] After chest wall penetration and complete passage of blunt
stem end or tip 526 through chest wall 107, lever 17 is felt by the
operator to disengage from stem unit 1054 and no further
advancement of stem tip 526 will occur within the chest cavity. The
operator will act on three ways shut off valve 1018 opening the
passage between hose 1014 and outer stem 552 and closing passage
between outer stem 552 and chamber 525. Cylinder 1150, located
proximally to insertion of hose 1014 to outer stem 552, will
prevent retrograde pathway of gas or fluid contained within device
1008, so that the content of device 1008 can flow to and from
expandable member 1062. At this point, the operator is ready to
perform the cardiac compression-decompression. The operator, by
pressing upon top wall 1022 of inflating-deflating device 1008
inflates balloon 1062, as shown for the device 1002 in FIG. 21.
[0213] Inflation of balloon 1062 will result in its expansion and
compression of the heart between the thoracic spine and the balloon
1062 itself, as shown for the device 1002 in FIG. 21.
[0214] By releasing pressure upon top wall 1022 of
inflating-deflating device 1008, the operator will deflate balloon
1062. Deflation of balloon 1062 will result in its contraction and,
consequently, in the decompression of the heart, as shown for
device 1002 in FIG. 20.
[0215] By alternatively pressing upon inflating-deflating device
1062 and releasing such pressure, the operator will alternatively
compress and decompress the heart.
[0216] Embodiment III
[0217] FIG. 24 shows an alternative form, generally indicated at
1070, of device 600 illustrated in FIG. 12.
[0218] Device 1070 retains the same safety mechanisms of gaining
entry into the chest cavity in front of the heart as device 600 of
FIG. 12, including the blunt penetrating tip, while it differs in
the way of compressing and decompressing the arrested heart.
[0219] Structure of device 1070 is therefore similar to device 600,
except for the following differences.
[0220] Corresponding parts have maintained the same numbering.
[0221] Device 1070, as shown in FIG. 24, is composed of four main
components: support member generally indicated at 1072, stem member
or unit generally indicated at 1074, an intermediate member
generally indicated at 700 and an inflating-deflating means or
device generally indicated at 1008.
[0222] The support member 1072 is the same as support member or
case 800 of device 600 of FIG. 12, except that, as shown in FIG.
24, it is closed at its top by top wall 1073. It also has, at its
surface, on its distal portion slit 1076, in order to permit the
insertion of distal end 1012 of hose 1014 of inflating-deflating
device 1008 on window 1016 of stem 602 of stem unit or member 1074.
Pin 1020 substitutes pin 860 of FIG. 12. It is composed of head
1082 and arm 1084.
[0223] Pin 1080 substitutes pin 860 of device 600 of FIG. 12. Pin
1080 is secured to support case 1072 through opening 864 to engage
in annular recess 865 of intermediate member 700. Arm 862 of pin
860 described in FIG. 12 for manual displacement is no longer
present.
[0224] Stem member or unit 1074 is structurally similar to stem or
unit member 601 of FIG. 12, but devoid of some of its
components.
[0225] In particular gas-fluids container 129 with its handle 111,
the entire chamber 617 with its side walls and all its content,
opening 142 in diaphragm 618, and pin 605 in chamber 621 are no
longer present.
[0226] Stem member 1074 is closed at its proximal end by top wall
1075.
[0227] As for the device 1002 described in FIGS. 18 to 21 and
device 1050 described in FIGS. 22 and 23, distal portion 1012 of
hose 1014 of inflating-deflating means 1008 is connected to
correspondent stem 602 at window 1016. Three ways shut off valve
1018 located at connection between distal portion 1012 of hose 1014
and stem 602 is the same structurally and functionally to the one
described for the devices 1002 of FIGS. 18 to 21.
[0228] Expandable member or balloon 1088, contained in position of
rest within circular groove 103 of stem end 102 is, when expanded,
of larger size than balloon 105 of device 600 of FIG. 12.
Intermediate member 700 is identical to intermediate member 700 of
device of FIG. 12, thereof same numbers have been used for same
parts.
[0229] Inflating-deflating means or device 1008 is the same one
structurally and functionally described for devices 1002 and 1050
respectively of FIG. 18 and FIG. 22.
[0230] Description of the Operation of Embodiment III
[0231] Device 1070 is placed on the chest in the same way as device
600, and the following operations are exactly the same as the
operations described for device 600 of FIG. 12, with few important
functional differences.
[0232] After chest wall penetration and complete passage of stem
end or tip 108 through chest wall 107, the operator will tactually
sense a sudden looseness of the device engaged in the chest wall,
due to the side clearance of the stem 602 in respect to the
surrounding chest wall tissue just penetrated by stem end 108 of
much larger diameter than stem 602, as already described for device
600 of FIG. 12.
[0233] Upon tactually sensing the completed penetration of stem end
or tip 108 into the chest cavity, the operator will act on three
ways shut off valve 1018, opening the passage between hose 1014 and
stem 602 and closing passage between stem 602 and chamber 125.
[0234] At this point, the operator is ready to perform the cardiac
compression-decompression. As for devices 1002 and 1050, the
operator, by pressing upon top wall 1022 of inflating-deflating
device 1088, inflates balloon or expandable member 1088 as shown
for device 1002 of FIG. 21. Inflation of balloon 1088 will result
in its expansion and compression of the heart between the thoracic
spine and the balloon 1080 itself, as shown for device 1002 of FIG.
21.
[0235] By releasing pressure upon top wall 1022 of
inflating-deflating device 1008, the operator will deflate balloon
1088. Deflation of balloon 1088 will result in its contraction and,
consequently, in the decompression of the heart.
[0236] By alternatively pressing upon inflating-deflating device
1008 and releasing such pressure, the operator will alternatively
compress and decompress the heart.
[0237] Embodiment IV
[0238] FIG. 25 shows an alternative form, generally indicated at
1100, of device 900 illustrated in FIGS. 15 to 17.
[0239] Device 1100 retains the same safety mechanisms of gaining
entry into the chest cavity in front of the heart as device 900 of
FIGS. 15 to 17, including the blunt penetrating tip, while it
differs in the way of compressing and decompressing the arrested
heart.
[0240] Device 1100, while maintaining some of the characteristics
of device 900 of FIGS. 15 to 17, has some important structural
differences. Corresponding parts have maintained the same
numbering. Device 1100, as shown in FIG. 25, is composed of four
main components: support member generally indicated at 1102, stem
member or stem unit generally indicated at 1104, an intermediate
member generally indicated at 700, and an inflating-deflating means
or device generally indicated at 1008.
[0241] The support member 1102, of generally cylindrical hollow
shape is the same as support member 800 of device 900 of FIGS. 15
to 17, except for the differences outlined below. As shown in FIG.
25, support member 1102 is closed is at its proximal end by top
wall 1103. Opening 1105 is formed in top wall 1103. Sight chamber
1122 is mounted atop top wall 1103, surrounding opening 1105 of top
wall 1103 of support member 1102 and upper segment of rod 1109
exiting through opening 1105.
[0242] A coaxially positioned hollow cylinder 1106 is circularly
connected with its upper rim 1107 to the inner surface of top wall
1103 of support case 1102 while is open at its distal end 1104.
Side wall 1108 of cylinder 1106 is interposed between an inner
cylinder 1110, corresponding in some respects to cylinder or vacuum
chamber 910 of device 900 of FIGS. 15 to 17, and an outer cylinder
1113 with cylindrical side wall 1112.
[0243] Distal end 1114 of hollow cylinder 1106 reaches a level
distal to location of balls 941 described below.
[0244] Support member 1102 has, at its surface, on its distal
segment 6, a slit 1010, in order to permit the insertion of distal
end 1012 of hose 1014 of inflating-deflating device 1008 on window
1016 of outer stem 992 of stem unit 1104.
[0245] Pin 1120 substitutes pin 860 of device 900 of FIGS. 15 and
16. Pin 1120 is secured to support case 1102 through opening 864 to
engage in annular recess 865 of intermediate member 700. Arm 866 of
pin 860 described in FIGS. 15 and 16 for manual displacement is no
longer present. Tubular guide 1146, projecting from the inner
surface of top wall 1103, surrounds in a slideable fashion rod 1109
which stems out, as it will be described below, from upper face of
piston 924. Intermediate member 700 is identical to intermediate
member 700 of device of FIG. 12, thereof same numbers have been
used for same parts. Lever 854 and annexed structures are identical
to the same lever described for the device of FIGS. 15 and 16.
[0246] Stem member or unit member 1104 is structurally similar to
stem member 901 of FIGS. 15 to 1 7, but devoid of some of its
components, while some components are modified or added.
[0247] In particular gas-fluids container 129 with its handle 111,
the entire chamber 917 with its side walls and all its content,
diaphragm 918, the entire chamber 919 with its side walls and with
all its content including pin 180 and shutter 190 and diaphragm 920
are no longer present.
[0248] Annular recesses 1121 and 1122 formed in the inside aspect
of side wall of body 913 of stem unit 901 of device 900 of FIGS. 15
to 17 are no longer present.
[0249] Slideable sealing cylinder 914, spring 902, balls 918 and
windows 920 formed in cylinder 910 are no longer present. Proximal
support arm 912 of cylinder 910 are also removed. Stem member or
stem unit 1104 is of general cylindrical shape, being its upper
segment composed of two coaxially positioned cylinders, outer
cylinder 1113 and inner cylinder 1110, which grossly corresponds to
vacuum chamber or cylinder 910 of FIGS. 15 and 16. Coaxially
positioned inner cylinder 1110 and cylindrical side wall 1112 of
outer cylinder 1113 are connected one to the other at their distal
end by anterior segment 1144 of stem member 1104. Said inner
cylinder 1110 and said cylindrical side wall 1112 of outer cylinder
1113 are separated in their proximal segment by space 1140. As
mentioned above, inner cylinder 1110 and cylindrical side wall 1112
of outer cylinder 1113 of stem member 1104 are slidably mounted on
side wall 1108 of hollow cylinder 1106 of support member 1102,
which, by occupying space 1140, is interposed between the two.
Distal end 1114 of hollow cylinder 1106 extends beyond the location
of balls 941 when the device is its starting position. Anterior
segment 1144 of stem member 1104 contains chamber 1142 which is
posteriorly in continuity with chamber 1126 of cylinder 1110 and
anteriorly communicates with the inside of stem 992. Within
contiguous chambers 1126 and 1142 is slidably mounted piston 924,
being 1130 its anterior segment and 1128 its posterior segment.
Compression spring 1136 is mounted between face 1132 of posterior
piston segment 1128 and flange 1134 of solid anterior segment 1144
of stem member 1104. Rod 1109 stems out of posterior face 925 of
piston 924 projecting posteriorly. Rod 1109 exits through center
opening of top wall 923 of chamber 1126 and continuing through
tubular guide 1146 up to sight chamber 1122. Sealing cap 930 is
mounted atop distal end of anterior piston segment 1130 to maintain
air tightness. Balls 941 seat in recess 927 of piston 924 and are
engaged in windows 939 of side wall of cylinder 1110 and are
impeded to exit from recess 927 by side walls 1108 of cylinder
1106. Thread 603, mounted at the Outer surface of stem member 1104
as for the device of FIG. 15 and 16, is matable to correspondent
thread of intermediate member 700. Outer stem 992 is connected to
distal end 1012 of hose 1014 of inflating-deflating means 1008 at
window 1016. Three ways shut off valve 1018 is located at the
connection between hose end 1012 of hose 1014 and outer stem
992.
[0250] Expandable member or balloon 1124, interposed and connected
to hollow convex apex 995 and solid base 912 of stem end or tip 994
is of larger size when fully expanded than balloon 1000 of
correspondent device 900 of FIGS. 15 to 17.
[0251] Inflating-deflating means or device 1008 with connected hose
1014 and shut off valve 1018 is the same device of FIGS. 18 to 21
and same numbering has been maintained.
[0252] Description of the Operation of Embodiment IV
[0253] Device 1100 is placed on the chest in the same way as device
900, the operator then ratchets lever 854, as described for cardiac
pump 900 of FIGS. 15 to 17, causing advancement of the stem member
901 with respect to the support case 1102 into the thickness of the
chest wall. Upon a preestablished advancement of the stem member by
approximately 1 centimeter within the chest wall so that stem tip
994 is well buried inside the chest wall, to seal openings 999 from
air entry, balls 941 which seat in annular recess 927 of piston 924
and are engaged in windows 939 of cylinder 1110 which is carried
forward jointly to the stem unit 1104 to which is anchored by
distal supports 920, will align with distal end 1114 of hollow
cylinder 1106 which, as described above, protrudes from the top
wall 1103 of support case 1102 and is connected to it.
[0254] With downward displacement of stem unit 1104 and
consequently of inner cylinder 1110, which is part of it, in
respect to side wall 1108 of cylinder 1106, balls 941, carried
within window 939 of walls of inner cylinder 1110, will gradually
advance to align first with level of distal end or edge 1114 of
side wall 1108 of cylinder 1106, then, by moving further downward,
said balls will pass the level of the distal edge 1114. As soon as
balls 941 pass the level of edge 1114 of side wall 1108 of cylinder
1106, they will no longer be retained, within annular recess 927 of
piston 924 and window 939 of inner cylinder 1110, by distal end
1114 of hollow cylinder 1006. Exit of balls 941 from their seating
in annular recess 927 of piston 924 though window 939 of inner
cylinder 1110 into space 1120 will be accelerated by compressed
compression spring 1136, which, by urging piston 924 upwardly, will
force dislodgment of said balls 941 out of their seat in annular
recess 927 of piston 924, being said balls 941, as described above,
no longer forced to be retained in their seat by side wall 1108 of
cylinder 1106.
[0255] Upon dislodgment of locking balls 941 from annular recess
927 of piston 924, piston will no longer be retained in its
starting advanced position, and compressed compression spring 1136,
which urges piston 924 upwardly, will be able to upwardly displace
piston 924. However, being the interior of cylinder 1110, and, more
specifically, being anterior chamber 1142 in open flow
communication with openings 999 of stem tip 994 via stem 992, and
being said openings sealed by tissues burying being stem tip 994
within the thickness of the chest wall, piston 924, which
airtightly slides within cylinder 1110, will create a vacuum in
chamber 1142 when upwardly displaced. Said vacuum will oppose to
full withdrawal of piston 924 urged by spring 1136, resulting in a
partial upward displacement of piston 924. From this moment on,
piston 924 will be unimpeded to move further upward upon vanishing
of the vacuum present in chamber 1142 in front of piston 924.
Vanishing of vacuum in chamber 1142 in front of piston 924 will
occur upon gaining access to the chest cavity by stem tip 994. Upon
gaining access to the chest cavity, openings 999 of stem tip 994
will lose the sealing put up by the tissue layers of the chest
wall, and, being said openings 999 of stem tip 994 in flow
communication with chamber 1142, will place said chamber 1142 in
flow communication with the chest cavity, with resulting vanishing
of the vacuum in chamber 1142.
[0256] The sequence resulting in readiness by piston 924 to move
upward upon vanishing of the vacuum in front of it is an arming
operation, which is made possible in an automatic fashion, by the
presence of hollow cylinder 1106.
[0257] Access into the chest cavity by stem tip 994 will be
signaled to the operator by the full upward displacement of piston
924. Upon occurred penetration into chest cavity of stem tip 994
and consequent vanishing of vacuum in chamber 1142, piston 924, as
described above, will be allowed to fully displace upward. Full
upward displacement of piston 924 will be revealed to the operator
for instance by upward displacement of rod 1109 which, being fixed
to posterior end 925 of piston 924 and by exiting inner or vacuum
cylinder 1110 through the center opening formed in top wall 923 of
cylinder 1110, then exiting through opening 1105 of top wall 1103
of intermediate member 1102, will move upward, jointly with said
piston.
[0258] As soon as the operator of the device will be made aware of
the occurred penetration into the chest cavity by the upward
displacement of rod 1109 and piston 924, the operator will act on
three ways shut off valve 1108, opening the passage between hose
1104 and outer stem 992 and closing passage between stem 992 and
chamber 907.
[0259] At this point, the operator is ready to perform the cardiac
compression-decompression. The operator, by pressing upon top wall
1022 of inflating-deflating device 1008, inflates balloon 1124, as
for the device 1002 shown in FIG. 21.
[0260] Inflation of balloon 1124 will result in its expansion and
compression of the heart between the thoracic spine and the balloon
1124 itself, as previously shown in FIG. 21. By releasing pressure
upon top wall 1022 of inflating-deflating device 1008, the operator
will deflate balloon 1124.
[0261] Embodiment V
[0262] FIG. 35 shows a cross-sectional view of a detail of an
alternative form of device 1070 of FIG. 24. The device, generally
indicated at 1500, is basically the same as device 1070 of FIG. 24,
except for few important differences, such as stem end 1502. Stem
tip 1502 is composed of two parts: proximal part 1504 shaped as an
inverted cup firmly attached to distal end 1506 of stem 602 of stem
member 1074, and distal part or convex apex 1506. Convex apex 1506
is firmly attached to inner hollow stem 1508 which is slideable in
airtight fashion within hollow stem 602 and has proximal opening
1522. Convex apex has circular edge 1510 adapted to fit together
with circular edge 1512 of circular opening 1514 of proximal cart
1504 of stem tip 1502 to form together a spheroidly-shaped stem tip
1502. Inner hollow stem 1508 has at least one distal opening 1516
within stem end 1502 in flow communication with expandable member
or balloon 1520 partially or fully contained in a contracted status
within stem end 1502. Hollow inner stem 1502 also provides lateral
stability to expandable member 1520 upon expansion of balloon 1520
in operation and also provides the device with means of direction
totally lacking in the cited Prisk reference, and allow the
operator to have full control on the direction to be given to the
expandable member in respect to the position of the heart.
[0263] The device is operated as device 1070 of FIG. 24. After a
small superficial incision is made, which could be as small as one
centimeter in length, to allow that the blunt end of the device
wins the skin resistance, in a location preferably in the left
parasternal region in a skin area corresponding to the
intrathoracic anatomical area designated "sine pleura," the blunt
tip of the device is engaged in the skin incision and advanced by
blunt dissection through the thickness of the chest wall as for
device 1070 of FIG. 24. The choice of the area sine pleura prevents
the insurgence of pneumothorax, i.e., collapsing of the lung, which
inevitably occurs every time the pleural cavity is inadvertedly
entered. With regard to the occurrence of pneumothorax, due to the
fact that the area "sine pleura" is a substantially restricted
area, the choice of such area is only meaningful if the opening
passage through the chest wall is significantly small, such as it
can be achieved with all the embodiments described in this
invention. Being the width of this area in the order of less than
two centimeter, it is critical that the heart contacting pumping
member which has to be passed through the chest wall to enter the
chest cavity is contracted to a comparably small size, i.e., less
than 2 centimeter or 1.5 centimeter.
[0264] Blunt stem end 1502 is further advanced through the
thickness of chest wall 107 by blunt dissection until it enters the
chest cavity by blunt dissection.
[0265] Upon entry into the chest cavity the operator will be alert
of the occurred entry of stem end 1502 as for device 1070 of FIG.
24. Balloon 1520 will be inflated by the operator acting upon
pneumatic source or inflating-deflating device 1070 of FIG. 24, not
shown in FIG. 35, as described for device 1070 of FIG. 24. Air or
suitable gas such as CO.sub.2 will flow into hollow inner stem
through opening 1522 and will exit through distal opening 1516 to
enter balloon 1520 resulting in its inflation. As balloon 1520
begins to inflate, as seen in FIG. 36, hollow inner stem 1508,
being slideable within hollow stem 1508, will be dragged forward
with convex apex 1506 to which is firmly attached, being convex
apex 1516 of stem end or tip 1502 being firmly attached to the
heart contacting surface. Although the depth of advancement of
hollow inner stem 1508 can be variable depending upon the
individual anatomical variabilities, and the balloon may not be
required to be fully inflated before it achieves the goal of
compressing the heart, the presence of the guiding or inner hollow
stem 1508 will guarantee that the balloon inflates only toward the
direction given by the operator. This offer the advantage of using
one size balloon for all individual to achieve identical results in
terms or compression results. Due to the capability offered by this
device to aim the balloon precisely toward the heart and overcoming
therefore even the slightest individual anatomical differences
regarding position, the compression results can be optimized by
monitoring blood pressure and pulse of the patient having cardiac
compression decompression.
[0266] The compression pressure exerted upon the heart can be
quantified to absolute precision with proper instruments so that no
incidents due to excess of compression pressure can occur. As above
described it should also be emphasized that guiding stem 1508 only
moves passively dragged by the inflating heart contacting member,
therefore it never constitutes a threat for injuring the heart in
the event the balloon accidentally deflates.
[0267] The above disclosed slideable guiding stem can be applied to
all embodiments where the heart contacting member is an inflatable
deflatable type.
[0268] The guiding stem can also be used for stabilization of the
expandable member of all types of embodiments of type A and to
retract the center or umbilical area of the expandable member of
such embodiments.
[0269] FIG. 37 shows balloon or expandable member or
inflatable-deflatable member 1520 inflated to the required pressure
to achieve cardiac compression.
[0270] Balloon 1520 can be made of polyethylene or suitable
material used for angioplasty. It is preferable that the balloon be
made of non compliant or substantially non compliant material,
however it can also be made of stretchable material if stretchable
material can achieve the same results. The preferred general shape
of balloon 1520 is grossly cylindrical. The diameter of the
cylinder should be adequate to offer a sufficient area of contact
with the heart to result with heart compression. The surface
contacting the heart is deformable to adapt to the anatomy of the
anterior aspect of the heart to perfectly mate with the anterior
aspect of the heart. Due to the guidance of guiding stem 1508,
there is no need to give any particular shape to the heart
contacting surface of the heart compressing member to prevent that
the heart compressing member accidentally misses the heart, because
the guiding stem assures that the heart compressing member is
properly positioned on the heart.
* * * * *