US20020068848A1 - Cardiac resuscitation device for percutaneous direct cardiac massage - Google Patents
Cardiac resuscitation device for percutaneous direct cardiac massage Download PDFInfo
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- US20020068848A1 US20020068848A1 US09/925,291 US92529101A US2002068848A1 US 20020068848 A1 US20020068848 A1 US 20020068848A1 US 92529101 A US92529101 A US 92529101A US 2002068848 A1 US2002068848 A1 US 2002068848A1
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- stem
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/34—Trocars; Puncturing needles
- A61B17/3494—Trocars; Puncturing needles with safety means for protection against accidental cutting or pricking, e.g. limiting insertion depth, pressure sensors
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/02—Surgical instruments, devices or methods, e.g. tourniquets for holding wounds open; Tractors
- A61B17/0218—Surgical instruments, devices or methods, e.g. tourniquets for holding wounds open; Tractors for minimally invasive surgery
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
- A61M60/20—Type thereof
- A61M60/295—Balloon pumps for circulatory assistance
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
- A61M60/40—Details relating to driving
- A61M60/497—Details relating to driving for balloon pumps for circulatory assistance
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/02—Surgical instruments, devices or methods, e.g. tourniquets for holding wounds open; Tractors
- A61B17/0281—Abdominal wall lifters
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B2017/00535—Surgical instruments, devices or methods, e.g. tourniquets pneumatically or hydraulically operated
- A61B2017/00557—Surgical instruments, devices or methods, e.g. tourniquets pneumatically or hydraulically operated inflatable
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/32—Surgical cutting instruments
- A61B2017/320044—Blunt dissectors
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.
Description
- 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.
- 1. Field of the Invention
- This invention relates to methods and apparatus for cardiopulmonary resuscitation and is particularly directed to improved methods and apparatus for performing direct heart massage.
- 2. Description of the Background Art
- 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.
- 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.
- 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. - 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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 page 9,lines page 9,lines 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.” - 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.
- 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. - 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.
- 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.
- 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. - 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.
- 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.
- 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.
- 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.
- 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.
- 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. - 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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:
- 1) Use of a disposable sterile unit as that part of the device which will enter the chest cavity to prevent transmission of infections.
- 2) Use of a bluntly tipped stem to prevent accidental punctures.
- 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.
- 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.
- 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.
- 6) Use of an automatic and rapid sequence of preparatory steps leading to the inflation of the expandable member in front of the heart.
- 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.
- 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.
- 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.
- FIG. 1 is a front view of a cardiac pump embodying the present invention.
- FIG. 2 is tridimensional view of the lever-double rack mechanism of advancement, shown in front view in FIG. 1.
- FIG. 3 is a vertical section through the cardiac pump of FIG. 1, showing the cardiac pump is its normal rest position.
- FIG. 4 is an enlarged detail view of the central portion of FIG. 3.
- FIG. 5 is a tridimensional representation of a portion of the stem member of the cardiac pump of FIG. 1.
- FIG. 6 is an enlarged vertical section of the lower tip of the cardiac pump of FIG. 1.
- FIG. 7 is a view, similar to that of FIG. 4, showing the cardiac pump of FIG. 1 in its second stage of operation.
- 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.
- 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.
- 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.
- FIG. 11 is a vertical section of an alternative form of the cardiac pump.
- FIG. 12 is a vertical section of another alternative form of the cardiac pump.
- FIG. 13 is a vertical section through the handle portion of the cardiac pump of FIG. 12.
- FIG. 14 shows a top view of the lever of the device of FIG. 12.
- FIG. 15 is a vertical section of a further alternative form of the cardiac pump.
- FIG. 16 is an enlarged detail view of the mid-portion of the cardiac pump of FIG. 15.
- FIG. 17 is an enlarged vertical section through the stem tip of the cardiac pump of FIG. 15.
- FIG. 18 shows a vertical section of an alternative form of the device as it is prior to use.
- 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.
- 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.
- FIG. 21 shows the device of FIG. 18 with the expandable member fully inflated and the heart consequently fully compressed against the vertebral column.
- FIG. 22 is a vertical section through an alternative form of the device of FIG. 18 as it is prior to use.
- FIG. 23 is a vertical section of the lower segment of the body of the device shown in FIG. 18.
- FIG. 24 is a vertical section of yet an alternative form of the device of FIG. 18 shown as it is prior to use.
- FIG. 25 is a vertical section of yet an alternative form of the device of FIG. 18 shown as it is prior to use.
- FIG. 26 is a vertical section of the device of FIG. 25 after arming.
- FIG. 27 is a vertical section of the device of FIG. 25 after penetration of blunt tip into chest cavity.
- 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.
- FIG. 29 is a cross-sectional view of the device of FIG. 28 shown after full expansion of the expandable member.
- FIG. 30 is a cross-sectional view of an alternative form of the device of FIG. 1.
- 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.
- 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.
- 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.
- FIG. 34 is a detail of FIG. 33, precisely of the fully expanded expanding member viewed from below.
- FIG. 35 is a cross-sectional view of a detail of an alternative form of the device of FIG. 24.
- FIG. 36 is a cross-sectional view of a detail of FIG. 35 showing the device at an early stage of operation.
- FIG. 37 is a cross-sectional view of a detail of FIG. 35 showing the device at a subsequent early stage of operation.
- 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.
- 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.
- 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.
- 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.
- Embodiment I
- 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 thestem member 100 and thesupport case 2. - The
support case 2 is hollow and is of generally tubular, cylindrical shape having an openproximal end 3, abody 4 and adistal end 5, including anarrow neck 6, and a flat,circular base 7. Thebase 7 is preferably formed of transparent material to enable the operator to better visualize the actual position of thepump 1 on the anterior chest of the patient. Also,base 7 is formed with acentral opening 31 to allow passage therethrough ofstem 102 of thestem member 100, as seen in FIGS. 1 and 3 and more fully described below. Thebody 4 of thesupport case 2 has alongitudinal slit 9 extending from itsproximal end 11 to adistal end 13, as best seen in FIG. 1 and FIG. 2. - As best seen in FIG. 2, two
parallel ears 15 are attached to thebody 4 of thesupport case 2 and protrude outwardly adjacent each side of theslit 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, withdogs ears 15 and is pivotally secured to theears 15 by suitable means, such aspin 23, to form a fulcrum for thelever 17. Adouble rack 301 is mounted on theintermediate member 300 and projects through theslit 9 for engagement bydogs lever 17.Dog 21 is pivotally secured to lever 17 bypin 31, whiledog 19 with itstail 34 is pivotally secured toears 15 viapin 30. Displacingrod 32, which protrudes from one end ofpin 31, seats ontail 34 ofdog 19. - The
intermediate member 300 as seen in FIG. 3 is generally tubular and is interposed between thesupport case 2 and thestem member 100. As noted above, thedouble rack 301, represented in FIGS. 1, 2, and 3, is mounted on theintermediate unit 300, as best seen in FIG. 3, and projects throughslit 9 of thesupport case 2, as best seen in FIGS. 1 and 2. As best seen in FIG. 2, thedouble rack 301 comprises afirst rack 310, having teeth 8 oriented downward, and asecond rack 311, havingteeth 11 oriented upward. Theintermediate member 300 has aslit 309, seen on the right side of FIG. 3. In the starting or rest position, the lower end of theslit 309 is positioned slightly above and in line withpin 260 of thestem member 100.Intermediate member 300 is locked to thestem member 100, in the rest position, byballs 305 which seat inreceptacles 307 of theintermediate unit 300 and are partly engaged inholes 144 ofstem member 100. The inner, generally cylindrical, component or stemmember 100 is mounted essentially coaxially within (located centrally within thesupport member 2 and) the just describedintermediate member 300. -
Stem member 100 is a rigid hollow cylinder composed of three parts: handle 111,body 113 andstem 102. As noted above, stem 102 protrudes from thedistal end 115 ofbody 113 and projects throughopening 31 in thebase 7 of thesupport member 2. At the upper end of thestem member 100 is a generally T-shapedhandle 111, having atransverse bar 145 mounted on the upper end of an elongated, cylindrical gas-filled or fluid-filledbottle 129. Interposed betweenbase 95 ofgas container 129 andbottom wall 94 ofcavity 146 formed withinhandle 145 is spring or resilient means 90. Tooth 91 projecting from side wall orgas container 129 engages longitudinal slit 93 of side wall ofcavity 146. Said tooth allows vertical but non-rotatory movement ofhandle bar 145 in respect togas container 129 and in respect of the device whengas container 129 is locked to it. Thebottle 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 withinbottle 129 by asuitable seal 135 mounted innozzle 131 of thebottle 129. Thebody 113 comprises fivechambers chamber 117 is located adjacent the upper end of thebody 113 and has anopen end 127 which receives thenozzle 131 of theair bottle 129 and has adiaphragm 118 defining the boundary betweenchamber 117 andchamber 119.Chamber 117 also has an internally threadedportion 139, which is matable with theexternal threads 133 of theair bottle 129. Also withinchamber 117, ahollow needle 140, having aneedle tip 141, is mounted on thediaphragm 118, as bygasket 143. As best seen in FIG. 4,chamber 119 extends betweendiaphragm 118, at its upper end, anddiaphragm 120, at its lower end. Within thechamber 119, is apin 180 having apin shaft 182 projecting laterally frompin head 184, which is slidably mounted within acylindrical pin case 188 and is urged by suitable means, such asspring 186 mounted within thepin case 188, to project through opening 25 of thesupport case 2, when thecardiac pump 1 is in the rest position. As best seen in FIG. 4, thepin shaft 182 projects, in air-tight manner, throughwindow 185 ofside wall 147 ofchamber 119.Diaphragm 118 is formed with acentral opening 142 which communicates with the interior ofhollow needle 141. Also withinchamber 119, below thepin case 188, ashutter 190 is mounted for lateral sliding movement throughwindow 183 of thestem member 100 andwindow 27 of thesupport case 2.Shutter 190 has a downwardly and inwardly slantedouter end 192 and is provided with anopening 191 located eccentrically and extending vertically through theshutter 190. In the rest position, shutter 190 covers and seals opening 199 oflower diaphragm 120, while uncoveringopening 197 ofdiaphragm 120. Withinchamber 121, as best seen in FIG. 4, theopening 199 is connected toinlet 202 ofpressure valve 200, while opening 197 communicates withinlet 198 of shut-offvalve 210.Pressure valve 200 also has anoutlet 204. Shut-offvalve 210 also has anoutlet 208 and contains ashutter 211, which controls passage of air through theoutlet 208 and which is movable throughopening 212 of shut-offvalve 210 to project intoslit 9 of thesupport case 2 above the upper end of thedouble rack 301.Diaphragm 122, as best seen in FIGS. 4 and 5, defines the boundary betweenchamber 121, above, andchamber 123, below, and is formed withopening 209, communicating withoutlet 208 of shut-offvalve 210, and withopenings Opening 201 is connected topipe 216, which communicates withchamber 123, but projects abovediaphragm 122, intospace 243 below thepressure valve 200, and is connected to exitpipe 217, which exits through opening 227 ofside wall 205 ofchamber 121.Chamber 123 is defined byupper diaphragm 122 andlower diaphragm 124 and is best understood from FIGS. 3, 4 and 5. As shown, apipe 226 extends completely throughchamber 123, betweenopening 209 inupper diaphragm 122 andopening 251 inlower diaphragm 124.Pipe 220 extends downward from opening 219 ofupper diaphragm 122, parallel topipe 216, and terminates atplate 206, which defines the upper end ofpiston chamber 233. Atransverse opening 222 communicates the interior ofpipe 216 with that ofpipe 220. Similarly,transverse pipe 224 communicates the interior ofpipe 216 with that ofpipe 226. Below thetransverse pipe 224,pipe 216 has a secondtransverse opening 237 communicating with the interior ofpipe 220 and an additionaltransverse opening 238 which opens to intochamber 121. Thepiston chamber 233 is enclosed by acylindrical wall 249 and has apiston 230 slidably retained therein.Piston 230 has apiston head 231 and apiston shaft 232, which extends slidably into the lower end ofpipe 216. As seen in FIG. 4, aspring 218 is located withinpipe 216, above the end ofpiston shaft 232, and bears against the end ofpiston shaft 232 to urge thepiston 230 downward to seat againstannular retainer 244. Thepiston shaft 232 is formed with atransverse opening 234 which, in the rest position, is aligned with opening 237 ofpipe 220 and withtransverse pipe 224, which communicates withpipe 226.Piston 230 is also formed with anannular recess 241, which seatspiston ring 240. Also, thecylindrical wall 249 of thepiston chamber 233 has anannular recess 242, formed adjacent the upper end thereof, which serves to receivepiston ring 240 to releasably lock thepiston 230 in its upper position, as more fully described below, and has alateral opening 235 communicating with the exterior of thecardiac pump 1 aboverecess 242. Belowpiston 230,space 245 separates thelower surface 223 ofpiston 230 fromlower diaphragm 124 ofchamber 123. As noted above,diaphragm 124 has anopening 251, which receivespipe 226, and has acentral opening 250 which communicates with the expandedproximal end 253 ofpipe 252 insubjacent chamber 125.Chamber 125 extends betweendiaphragm 124, at the upper end, and the openlower end 115 ofbody 113 of thestem member 100. Within the expandedupper end 253 ofpipe 252 is apin case 263, containing apin 261, having apin head 262, and having aspring 264 mounted within thepin case 263, behind thepin head 262, to normally urge thepin 261 laterally outward to project through opening 260 on the wall of thestem member 100 pressing against the wall of theintermediate member 300, just below slit 309 ofintermediate member 300. -
Pipe 252 extends downwardly withinchamber 125 and terminates at the level offlange 275, which serves as a seat forpiston 270.Piston 270 is sliceable mounted aboutpipe 252 and, in the rest position, is located to closetransverse openings 254 ofpipe 252.Piston 270 is formed with anannular recess 271 with a subjacentannular receptacle 272. In the rest position,balls 305 sit inwindow 144 ofstem member 100 and are retained betweenreceptacle 272 ofpiston 270 andreceptacle 307 of theintermediate member 300 to releasably lock thestem member 100 to theintermediate member 300.Spring 276 is seated onflange 278 and serves to normally urge thepiston 270 upward to causereceptacle 272 to retain theballs 305 in their “locked” position. As best seen in FIG. 3, alarge spring 230 is located within the lower end of thesupport case 2 and bears against thelower end 115 of thestem member 100 to urge thestem member 100 upward. As seen in FIGS. 3 and 6, an elongateshollow stem 102 extends downward from thelower end 115 of thestem member 110 and exits through opening 31 of theflat base 7 of thesupport case 2 to support ablunt end 104 of spheroid shape having acircular groove 103 which contains an expandable member such asballoon 105, which is folded when thecardiac pump 1 is in its rest position. - 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 ofstem end 104 throughopening 101 and communicates withballoon 105 throughopenings 106 withingroove 103.Stem end 104 has ablunt end 108 and is generally in the form of a hollow dome, FIG. 6 also diagrammatically shows the anteriorthoracic wall 107, with the skin incised at 109, together with theunderlying chest cavity 110 containing theheart 69. - Description of the Operation of Embodiment I
- To apply the
cardiac pump 1, the operator makes asmall 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. - 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 thetip 104 ofstem 102 inserted into theincision 109. When this is done, thestem tip 104 will be partially buried under the patient's skin within thethoracic wall 107, but will not have entered thechest cavity 110, andbase 7 of thesupport case 2 will be seated on the appropriate area of thechest wall 107. Next, the operator rotateshandle bar 145, causingthreads 133 of theair bottle 129 to engagethreads 139 ofupper chamber 117 of thestem member 100, and drawing theadapter 131 of theair bottle 129 towardneedle 141 until theneedle tip 140 ofneedle 141 enters theadapter 131 and piercesseal 135, as seen in FIG. 7, allowing the compressed air contained within theair bottle 129 to flow throughneedle 141 andopening 142 indiaphragm 118 intochamber 119 of thestem member 100. The operator continues to screw thehandle 145 until a tight seal is obtained by the adapter edges 130 pressing firmly againstgasket 143. As the compressed air enterschamber 119, the air pressure will bear againstpin head 184 ofpin 180, drivingpin 180 medially againstspring 186 to removepin shaft 182 from projecting throughwindow 25 ofsupport case 2 and, thus, unlocking themain unit 100 from thesupport case 2. - If the air pressure is insufficient, or if a leak allows the air to escape,
pin shaft 182 ofpin 180 will not disengage fromwindow 25 and thestem member 100 will remain locked to thesupport case 2, thereby preventing further operation of thecardiac pump 1. If the air pressure is adequate to actuatepin 180 and, hence, to unlock thestem member 100 from thesupport 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 presslever 17, causing thedogs racks double rack 301 downward. - More precisely, a displacement of
handle 18 oflever 17 towarddouble rack 301 will cause a downward movement ofdog 2 pivoted onpin 31 ofarm 16 of lever 17: the downward movement ofdog 21 which is engaged inrack 310, with upwardly oriented teeth, will result in a downward displacement ofrack 310. Whilearm 16 oflever 17 moves downward,pin 32, protruding from one end ofpin 31 will displacetail 34 ofdog 19 towardrack 311, releasingdog 19 fromrack 311, with downwardly oriented teeth, just before downward movement ofrack 310 is initiated, andlocking rack 311 immediately after downward advancement ofrack 310. Downward advancement ofrack 310 in turn will carryintermediate member 300 and stemmember 100 downward, due to the interlocking performed byballs 305 sitting inwindows 144 of thestem member 100 and inreceptacle 307 ofintermediate member 300.Balls 305 are retained inwindows 144 andreceptacle 307 by theannular receptacles 272 ofpiston 270, which is urged to its upward position byspring 275 acting betweenflange 278 of thestem member 100 and thelower surface 275 ofpiston 270. - As it can be understood from FIG. 7, after the
intermediate member 300 and stemmember 100 are advanced a predetermined the length with respect to thesupport case 2, preferably about ½ centimeter, by the operator acting on thelever 17,shutter 190 will be displaced medially, due to theedge 28 ofwindow 27 bearing against theslanted end 192 ofshutter 190. This displacement ofshutter 190 will permit the compressed air to enterpressure valve 200 by passing throughopening 199 ofdiaphragm 120 andinlet 202 of thepressure valve 200. The compressed air will exit, throughoutlet 204 ofpressure valve 200, at a preestablished pressure and will travel through opening 219 ofdiaphragm 122connected pipe 220, opening 237,window 234 ofpiston shaft 232, then intochamber 123, opening 250 ofdiaphragm 124, expandedend 253 ofpipe 252, throughpipe 252,space 247 belowpiston 270, through the elongatedhollow stem 102 andopening 101 intotip 104 and will attempt to pass throughopenings 106 to inflateballoon 105. However,balloon 105 will be presented from inflating due to the inextensibility of the surroundingchest wall structure 107. As a result, the air pressure within the pathway, just described, will quickly reach equilibrium with the pressure atoutlet 204 of thepressure valve 200. As this occurs, the air pressure within this pathway will act upon thelower surface 223 ofpiston 230 and will forcepiston 230 to move upward, against the urging ofspring 218, untilpiston ring 240 becomes seated inannular recess 242 ofpiston chamber 233, lockingpiston 230 against further upward movement and aligningopening 234 of thepiston shaft 232 withwindow 222 ofpipes piston 230 andpiston shaft 232 will close opening 237 and, hence, will force the compressed air frompressure valve 200 to flow throughlateral pipe 224,vertical pipe 226, opening 251 ofdiaphragm 124 and intospace 246 abovepiston 270. At this point, the air pressure inspace 246, abovepiston 270, and inspace 247, belowpiston 270 will be equal. Consequently,piston 270 will be urged into its upward position by the action ofspring 276. Moreover,pressure valve 200 serves to regulate the air pressure below thepressure valve 200 and to assure that the air pressure inballoon 105 and in the various pathways between theballoon 105 andpressure valve 200 is less than the air pressure within theair bottle 129. This is a second safety feature and assures that the air pressure within theballoon 105 will be insufficient to cause disruption of thechest wall structure 107. The automatic arming of thecardiac pump 1 is now completed, within a few seconds of initiation of the operation, and thecardiac pump 1 is ready for further operation. - In the next stage of the operation, the operator continues actuating
lever 17, causing further advancement of thestem tip 104 through thechest wall structure 107 toward thechest cavity 110. As seen in FIG. 8, the instant that thestem tip 104 passes out of thechest wall structure 107 into thechest cavity 110, theballoon 105 will expand, due to the fact that theballoon 105 is no longer enclosed by thechest wall structure 107 and the compressed air within thestem 102 is able to pass throughopenings 106 into theballoon 105. The expansion of theballoon 105 will result in a pressure drop withinspace 247, belowpiston 270. Becausepiston 230 has been forced to its upward position, as described above, air can no longer flow through opening 234 ofpiston 230 to re-supplyspace 247. Consequently, the air pressure inspace 246, abovepiston 270, will exceed the air pressure inspace 247, below,piston 270, and will drivepiston 270 downward, against the urging ofspring 276. Aspiston 270 is driven downward towardflange 278, it will exposewindows 254 ofpipe 252, permittingair form space 246, abovepiston 270, to pass intopipe 252 and, thus, throughstem 102 to further inflate theballoon 105. - The forward movement of the
piston 270 also causesballs 305 to be transferred from therecesses 272 into thelarger recess 271 ofpiston 270, which allows theballs 305 to disengage fromwindows 144 of thestem member 100 and, thus, unlocks thestem member 100 from theintermediate member 300, which preventslever 17 anddouble rack 301 from causing any further advancement of thetip 104 into thechest cavity 110. Simultaneous with the unlocking of thestem member 100 from theintermediate member 300,spring 280 acts between thedistal end 5 of thesupport case 2 and thelower end 115 of thestem member 100, forcing thestem member 100 to move upward relatively to supportcase 2 and tointermediate member 300, which, at this stage, are interlocked one to the other. Intermediate member is locked, at this stage, to supportcase 2, being prevented to slide upward relatively to supportcase 2 bydog 21, saiddog 21 being anchored to supportcase 2 and engaged to rack 310 ofintermediate member 300. As a consequence of the upward movement of thestem member 100 in respect to theintermediate member 300,pin 261, which is part of, and is anchored to, stemmember 100, will align with opening, or slit, 309 formed inintermediate member 300. Whenpin 261, which is constantly urged outwardly bycompression spring 264, aligns with opening 309 ofintermediate member 300, being no longer retained in its retracted position by the wall of theintermediate member 300,pin 261 will promptly engage in saidopening 309, by gaining access to it. By gaining access toslit 309 ofintermediate member 300,pin 261, which continues being urged outwardly byspring 264, will project against the vertical series of holes, or openings, 29 formed in the wall ofsupport case 2, said vertical series of openings being so located to face thevertical slit 309 of the intermediate member.Stem member 100 will continue to move upward in respect tointermediate member 300 andsupport case 2 in response to action ofspring 280, until itspin 261, after gaining access intoslit 309 ofintermediate member 300 and being forced to press against the wall of thesupport case 2 byspring 264, finally engages into the first available hole of the series ofholes 29 formed in the wall of thesupport case 2 in correspondence ofvertical slit 309 ofintermediate member 300. As soon aspin 261 ofstem member 100 engages into one of saidholes 29 ofsupport case 2,stem member 100 will stop its upward movement, and will lock to supportcase 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. - This serves to prevent accidental advancement of the
stem 104 of thestem member 100 prior to full inflation of theballoon 105. Also, the unlocking of thestem member 100 from theintermediate member 300 renderslever 17 ineffective, which provides a tactile indication to the operator that thestem member 100 has been unlocked from theintermediate member 300 and is now locked to thesupport case 2. In response to this tactile signal, the operator presses theshutter 211 of the shut-offvalve 210 inwardly to allow high pressure air fromair bottle 129 to pass throughoutlet 208 of the shut-offvalve 210 and throughstem 102 andtip 104 to produce full inflation of theballoon 105, thus bypassing the pathway ofpressure valve 200. - 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 ofpipe 252 and will bear against thehead 262 ofpin 261, drivingpin 261 inward, against the urging ofspring 264, to causepin 261 to withdraw from opening 29 of thesupport case 2 and, hence, unlocking thestem member 100 from thesupport case 2 to permit the pumping operation. - 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 thestem member 100 is now unlocked from both theintermediate member 300 and from thesupport case 2, downward pressure on thehandle 145 will be carried through thestem member 100 and will be applied throughstem 102 to theballoon 105, causing theballoon 105 to be pressed against theheart 11 and, as pressure is applied to theballoon 105, to compress theheart 11 against thethoracic 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 thehandle 145 andtip 104 are both integral parts of thestem member 100, the operator receives tactile signals through the structure of thestem member 100 from which, with experience, he can determine the location of theballoon 105 with respect to theheart 11 and the direction and effect of the pressure applied thereto. If theballoon 105 during the pumping operation deflates accidentally, the pressure surroundingpin head 262 will fall allowingspring 264 to urgepin 261 to engage one of theopenings 29 ofsupport 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. - When the resuscitation operation has been completed, the operator unscrews and removes the
air bottle 129, which allows theballoon 105 to deflate and permits thestem tip 104 andballoon 105 to be easily withdrawn from thechest cavity 110. - Embodiment II
- FIG. 11 shows an alternative form, indicated generally at500 of the
cardiac pump 1 of FIGS. 1-10. Thecardiac pump 500 of FIG. 11 differs fromcardiac 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. Thesupport case 2 andintermediate member 300 are basically the same as those of thecardiac pump 1 of FIGS. 1-10 and the same numbers have been used to identify the corresponding components thereof. Thestem member 501 of thecardiac pump 500 is composed of three parts: handle 111,body 513, and stem 502, projecting from thedistal end 515 of thebody 513. Handle 111 is identical to handle of thecardiac pump 1 of FIGS. 1-10. - The
body 513 ofstem member 501 ofcardiac pump 500 is divided into four chambers: anupper chamber 517, asecond chamber 519, athird chamber 521, and alower chamber 525. Theupper chamber 517 is identical tochamber 117 of FIGS. 1-10. As such it has an openupper end 127 to receive thecompressed air bottle 129. The lower end ofchamber 517 is defined by diaphragm 518, which is also identical to diaphragm 118 of thecardiac pump 1 of FIGS. 1-10. Thesecond chamber 519 extends between diaphragm 518 anddiaphragm 520, which is substantially identical to diaphragm 120 of thecardiac pump 1 of FIGS. 1-10, but has only a singlecentral opening 400.Chamber 519 is basically the same aschamber 119 of FIGS. 1-10 and includespin 180 and related structures as described incardiac pump 100 of FIGS. 1-10. Shutter 190 of FIGS. 1-10 is no longer present incardiac pump 500. -
Chamber 521 extends betweendiaphragm 520 andlower diaphragm 524 and is enclosed byside walls 402.Chamber 521 is composed of two adjoining compartments;upper compartment 401 andlower compartment 403. The upper end ofside wall 402 is connected byannular flange 441 to theside walls 406 ofbody 513. Within theupper compartment 401, is apin case 414 containing apin 408, having apin shaft 410 projecting laterally from apin head 412 and urged outwardly of thepin case 414 by suitable means, such asspring 418, to cause thepin shaft 410 to project outwardly to engage in opening 417 ofstem member 501.Pin shaft 410 is retained from further projecting outwardly by upper edge 314 of the wall ofintermediate member 300.Pin case 414 also has awindow 416 communicating withcompartment 401. - A
pipe 430 extends axially throughcompartment 403 ofchamber 521 and connects to opening 432, located centrally ofdiaphragm 524, and the closedupper end 436 ofstem 502 is slidably mounted within and concentric with thepipe 430.Inner stem 502 extends downwardly throughopening 432 ofdiaphragm 524 and continues, throughlower chamber 525, and passes throughopening 550 in thedistal end 515 ofchamber 525 to reachstem tip 526 continuing in itsconvex apex 504 ofstem tip 526.Inner stem 502 is encircled byouter stem 552 which projects fromdistal end 515 ofchamber 525 ofstem member 501 and exits through opening 31 offlat base 7 ofsupport case 2 to continue intip base 503 oftip 526. -
Inner stem 502 is slidably mounted withinouter stem 552. - Adjacent its
upper end 436,stem 502 is provided withwindows 438, whilepipe 430 is formed withwindows 440, which are normally out of alignment with thewindows 438 ofstem 502, but which, when aligned, as described hereinafter, allow gas or fluid flow betweencompartment 403 and the interior of thestem 502. Aspring 442 is located between theside wall 402 ofcompartment 403 and theside wall 406 ofbody 513, betweenflange 441 and the upper surface ofpiston 470. In passing throughchamber 525,stem 502 extends axially throughpiston 470 and is secured to thepiston 470 for movement therewith.Piston 470 is formed with anannular recess 471, having anannular extension 472. In the rest position,balls 305 are seated inextension 472 ofpiston 470 and project throughopening 144 inwall 406 of thebody 513 of thestem member 501 to seat inreceptacle 307 of theintermediate member 300 to releasably lock thestem member 501 to theintermediate member 300. Also,ball 446 seats in anannular recess 460, at the lower end ofpiston 470, and projects throughopening 461 inwall 406 of thebody 513 ofstem member 501 to seat inwindow 380 of theintermediate member 300 to prevent downward movement of thepiston 470 and, hence, ofstem 502. - The
stem tip 526 has the same overall shape ofstem tip 104 of thecardiac pump 1 of FIGS. 1-10, however it is structurally and functionally different.Stem tip 526 is composed oftip base 503 which, as outlined above, is in continuity withouter stem 552 and aconvex apex 504 which, as outlined above, is in continuity withinner stem 502. Betweenedges 505 oftip base 503 and edge 507 ofconvex apex 504 is contained folded expandable member such asballoon 506. Also, the lower end ofinner stem 502 is formed withwindows 510 which allow air to pass out ofinner stem 502 to inflate theballoon 506, when appropriate. Thesupport case 2 is formed with a receptacle 473, located adjacent thelower end 550 of the body-513 of thestem member 501 when thecardiac pump 500 is in the rest position, for receiving theball 446, as described hereinafter. - Description of the Operation of Embodiment II
- In operation, the
cardiac pump 500 of FIG. 11 is placed withinskin incision 109, in the same manner ascardiac pump 1 of FIGS. 1-10, withstem tip 526 partially buried under the patient's skin.Compressed air bottle 129 is, then, screwed intochamber 517, causing penetration ofseal 135 byneedle tip 141 ofneedle 140, and allowing air to pass through opening 400 intochambers chamber 519 will result in lateral withdrawal ofpin 180, against the urging ofspring 186, unlocking thestem member 501 andintermediate member 300 fromsupport case 2 for downward movement with respect to thesupport case 2, due to the action oflever 17 and thedouble rack 301, in the same manner as described above with respect tocardiac pump 1 of FIGS. 1-10. - When
lever 17 and thedouble rack 301 have advanced thestem member 501 andintermediate member 300 by a predetermined distance, preferably approximately ½ centimeter,ball 446 will enterreceptacle 40 of thesupport case 2, releasingpiston 470 for downward movement byspring 442. However, such downward movement is prevented, at this time, since thetip apex 504 is engaging the inextensible structure of thechest wall 107 and, thus, serves to prevent downward movement ofstem 502 andpiston 470. Continued operation oflever 17 on thedouble rack 301 will, eventually, cause thestem tip 526 to penetrate into thechest cavity 110, whereupon downward movement of thestem tip 526 is no longer impeded by the structure of thechest wall 107. The instant such penetration of thechest cavity 110 occurs,spring 442 will drivepiston 470 and stem 502 downward, causingwindows 438 ofstem 502 to align withwindows 440 ofpipe 430 and allowing air to pass fromchamber 521, throughstem 502 andwindows 510 to inflate theballoon 506. The downward movement ofpiston 470 also allowsballs 305 to be moved out ofextension 472 ofpiston 470, to enterrecess 471 ofpiston 470 and to disengage fromreceptacle 307 of theintermediate member 300 and, thus, to unlock thestem member 501 from theintermediate member 300. However, prior to full inflation of theballoon 506,pin shaft 410 ofpin 408 will be urged byspring 418 to project through longitudinal slit above edge 314 of theintermediate member 300 into one of theopenings 29 of thesupport case 2 to prevent forward movement of thestem member 501. When theballoon 506 is fully inflated, the air pressure inchamber 521 will rise, causingpin head 412 to drivepin 408 inwardly, against the urging ofspring 418, withdrawingpin shaft 410 through slit above edge 314 of theintermediate member 300, out of opening 29 ofsupport case 2, to fully release thestem member 501 for the pumping operation, which is performed in the manner described above with respect to thecardiac pump 1 of FIGS. 1-10. Incase balloon 506 during the pumping operation deflates accidentally, pressure surroundingpin head 412 ofpin 408 will fall, allowingspring 418 to urgepin 408 outwardly to engage one of theopenings 29 ofsupport member 2. When the resuscitation operation has been completed, the operator unscrews and removes theair bottle 129, which allows theballoon 506 to deflate and permits thestem tip 526 andballoon 506 to be easily withdrawn from thechest cavity 110. - Embodiment III
- FIGS. 12, 13, and14, show a further alternative form, indicated generally at 600, of the
cardiac pump 1 of FIGS. 1-10, having asupport case 800, which is similar to thesupport case 2 of thecardiac pump 1 of FIGS. 1-10; astem member 601, and anintermediate member 700. Thestem member 601 as shown in FIG. 13, comprises ahandle 111, abody 613 and astem 602 projecting fromend 615 ofbody 613. Handle is mounted atop acompressed air bottle 129, which is threadedly attached to the upper end of a generallycylindrical body 613 ofstem 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 intoupper chamber 617 andlower chamber 621.Chamber 617 is identical tochamber 517 of thecardiac pump 500 of FIG. 11.Diaphragm 618 separateschambers central opening 142, surrounded byhollow needle 140 which has pointedend 141 and is identical withhollow needle 140 of thecardiac pump 1 of FIGS. 1-10.Chamber 621 extends betweendiaphragm 618 and thedistal end 615 of thebody 613, whilehollow stem 602 communicates withend 615 of thebody 613 and projects through thebase 7 of thesupport case 800 to communicate withstem tip 104, which is identical with thestem tip 104 of thecardiac pump 1 of FIGS. 1-10. Withinchamber 621 is apin case 607 having a window 608 and containing apin 605 which projects throughopening 670 of the wall ofbody 613 and is formed with ahead 606 that is normally urged laterally outward by aspring 609 contained within thepin case 607. However, the action ofspring 609 causes thepin head 606 to bear againstball 610, which is seated inreceptacle 671 of thepin case 607 and prevents outward movement of thepin 605 until theball 610 is released as described hereinafter. The exterior of thebody 613 is provided with a male threadedportion 603 which mates with the female threadedportion 641 of theintermediate member 700. Theintermediate member 700 is interposed between thestem member 601 and thesupport case 800 and is of generally cylindrical shape, with the female threadedportion 641 located approximately midway of the length of theintermediate member 700, and has anannular rack 742 extending about the exterior of the middle of theintermediate member 700, provided with a plurality of outwardly projectingteeth 744. Thesupport case 800 has a generally hollow,cylindrical body 801 encircling theintermediate member 700 and thestem member 601 and the upper portion of thebody 801 ofsupport case 800 is provided with a vertical row ofsmall openings 870 for receiving thepin 605 of thestem member 601. -
Lever 854 encircles with its expandedhead 857support member 800 at its midportion and is held in that midportion by the presence of twoannular rails -
Lever 854 carries adog support 858 to which adog 851 is pivotally secured via apin 856 and is provided withdog arrest 859 fordog 851.Dog 851 projects through opening 853 ofsupport member 800 and reaches for ratcheting engagement theteeth 744 of theannular rack 742 mounted on theintermediate member 700. Thesupport case 800 also carries apin 860 mounted externally ofsupport member 800 by aflexible arm 862, which is secured to supportmember 800 by abutton 863 and extends downwardly from thebutton 863 to allow thepin 860 to project through opening 864 ofsupport case 800 to engageannular recess 865 of theintermediate member 700. Ahandle 866 projects outwardly from thepin 860 to permit manual actuation of thepin 860. - Description of the Operation of Embodiment III
- 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 withinskin incision 109, in the manner described above with respect to thecardiac pump 1 of FIGS. 1-10, with thestem tip 104 partially buried within thechest wall structure 107. - The operator then ratchets the
lever 854 laterally, while keeping thebase 7 of thesupport case 601 pressing steadily against the patient's chest. This action causesdog 851 to drive theteeth 744 onrack 742 to rotate theintermediate member 700. Since the operator is preventing rotation of thestem member 800, by his grip onhandle 145, and sinceintermediate member 700 is prevented from advancing, bypin 860 projecting throughopening 864 and engagingannular recess 865 of theintermediate member 700, the rotation of theintermediate member 700 will causethreads 641 to interact withthreads 603 of thestem member 600 to force thestem member 601 to advance thestem tip 104 through thechest wall structure 107 until thestem tip 104 penetrates thechest cavity 110. The gradual and controlled slow advancement will finally result in penetration of thestem tip 104 into thechest cavity 110. Once the passage of a relativelybroad stem end 104 is completed and relativelynarrow stem 602 is engaged in the chest hole formed bystem end 104, the operator will have an immediate tactile signal of front and side clearance of thestem 602 in the hole formed in the chest wall. Upon receipt of this signal, the operator will cease to actuate thelever 854 and will screw in theair bottle 129, causingneedle point 141 ofneedle 140 to rupture theseal 135 and allowing compressed air from theair bottle 129 to inflate theballoon 105. As theballoon 105 reaches full inflation, the air pressure within thestem member 601 will increase and will drivepin 605 inward, against the action ofspring 609, allowingball 610 to be released fromreceptacle 612 thus freeingpin 605. The operator will then unlock theintermediate member 700 from thesupport case 800 by pullinghandle 864 ofpin 860 to disengagepin 860 from theannular recess 865 of theintermediate member 700 to permit the operator to commence the cardiac pumping by alternately pressing and releasing thehandle bar 145 ofhandle 111. If theballoon 105 should become deflated during the pumping operation, the air pressure within thestem member 601 will fall, allowingspring 609 to urge freedpin 605 laterally outward to project through one of theopenings 870 of thesupport case 800 to lock thestem member 601 to thesupport case 800 and, hence, to prevent further pumping and possible damage to theheart 69. - Embodiment IV
- FIGS. 15, 16, and17, show another alternative form, indicated generally at 900, of the
cardiac pump 1 of FIGS. 1-10. Thestem member 901 ofcardiac pump 900 is different from those previously described, although thesupport case 800 andintermediate member 700 are identical with those of thecardiac pump 600 of FIGS. 12-14. Thestem member 901 is composed ofhandle 111,body 913 and stem 992, having astem tip 994.Body 913 ofstem member 901 ofpump 900 is divided into three chambers: upper chamber 917,central chamber 919 andlower chamber 907. - Upper chamber917 is identical to
chamber 517 of thecardiac pump 500 of FIG. 11.Diaphragm 918 separateschambers 917 and 919 and has acentral opening 142, surrounded byhollow needle 140 withpointed end 141, identical to the one described in the embodiment of FIGS. 1-10. -
Chamber 919 contains apin 180 and ashutter 190, which are identical to the corresponding components of thecardiac pump 1 of FIGS. 1-10, and has adiaphragm 920 formed with acentral opening 199, which is normally blocked byshutter 190, and separating thecentral chamber 919 from thelower chamber 907.Lower chamber 907 contain acylindrical vacuum chamber 910, which is mounted axially withinchamber 907 by a pair ofsupport arms 912 extending between thevacuum chamber 910 and thebody 913 of thestem member 901, as best seen in FIG. 16. A sealingcylinder 914 encircles the middle of thevacuum chamber 910 and is normally urged upward byspring 902, bearing againstflange 903, which projects radially outward from thevacuum chamber 910. Another flange 926 projects radially inward from thebody 913 of thestem member 901 to limit downward movement of thesealing cylinder 914. - The
sealing cylinder 914 is formed with an inwardly facingannular recess 916. In the rest position of thepump 900,balls 918 are seated inrecess 916 and inwindows 920 ofvacuum chamber 910. Thelocking piston 924 is axially slideable within thevacuum chamber 910 and carries asealing cap 930 at its lower end with anannular recess 928 formed immediately above the sealingcap 930. Lower end ofchamber 907 ofstem member 913 projects inouter stem 992 which slides throughhole 31 offlat base 7 ofsupport case 800 to reach stem end 994 firmly supporting both hollowconvex apex 995 andsolid base 912 ofstem end 994. -
Inner stem 932 projects fromdistal end 942 ofvacuum chamber 910 and extends concentrically inside hollowouter stem 992, downward to reach and communicate with hollowconvex apex 995. - Hollow
convex apex 995 has a solidinner wall 996 and anouter wall 997 separated by aspace 998 therebetween.Inner stem 932 penetratesinner wall 996 and communicates thespace 998 with thelower end 942 of thevacuum chamber 910 within thebody 913 of thestem member 901. Theouter wall 997 is formed with a plurality ofopenings 999. Finally, aballoon 1000 is mounted between the adjacent edges of theconcave base 912 and theconvex apex 995 andwindows 980 are formed in the lower portion ofouter stem 992 communicating the interior of theballoon 105 with the interior ofbody 913 of thestem 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. - Description of the Operation of Embodiment IV
- In use, the
compressed air bottle 129 is screwed into upper chamber 917, causingneedle point 141 ofneedle 140 to rupture theseal 135 and allowing compressed air from theair bottle 129 to enterchamber 919 and to displacepin 180 inward, unlocking thestem member 901 from thesupport case 800. The operator then ratchetslever 854, as described forcardiac pump 600 of FIG. 12-14, causing advancement of thestem member 901 with respect to thesupport case 800, untilshutter 190 is displaced inward bybody 801 of thesupport case 800, causing air to pass through opening 199 intochamber 907 surrounding thevacuum chamber 910. This air pressure drives thesealing cylinder 914 downward, against the urging ofspring 902, and allowingballs 941 to move out of theannular recess 927 to unlockpiston 924 from thevacuum chamber 910. However,spring 934 is unable, at this time, to movepiston 924 upward, since such action will cause thesealing cap 930, carried by the lower end ofpiston 924 to create a vacuum within thevacuum chamber 910 belowpiston 924, since thechest wall structure 107 prevents air from enteringstem tip 994 and passing throughinner stem 932 into thevacuum chamber 910. This vacuum will resist the upward urging ofspring 934. However, as soon as thestem tip 994 enters thechest cavity 110, air from within thechest cavity 110 can enterstem tip 994 and flow throughinner stem 932 to relieve this vacuum and to allowspring 934 to movepiston 924 to its upward position, whereinballs 918 can pass into theannular recess 928, adjacent the lower end ofpiston 924, to unlock sealingcylinder 914 frompiston 924. Upon disengagement of sealingcylinder 914 frompiston 924, sealingcylinder 914 will be forced downward by compressed air already present inchamber 907 against the action ofspring 902 which urges sealing cylinder upward. Compressed air, by displacing sealingcylinder 914 downward will bypass thesealing cylinder 914 and will flow throughouter stem 992 andwindows 980 ofstem end 994 to inflate theballoon 1000. The operator may then apply periodic pressure to thehandle bar 145 to perform the pumping operation. If theballoon 1000 should accidentally deflate during the pumping operation, the air pressure within thestem member 901 will fall, allowingspring 186 to urgepin 180 laterally outward to project through one of theopenings 870 of thesupport case 800 to lock thestem member 901 to thesupport case 800 and, hence, to prevent further pumping and possible damage to theheart 69. - Embodiment V
- 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 andpneumatic container 1256.Stem member 1252 is composed of upper segment orrod 1262,intermediate stem segment 1258 andlower stem segment 1260.Stem member 1252 is provided proximally withhandle 1206. Withinhandle recess 1207 ofhandle 1206 is slidably mountedproximal end 1205 of upper stem segment orrod 1262.Proximal end 1205 ofrod 1262 is of general cylindrical shape as upper segment stem orrod 1262 but of larger diameter. Spring orresilient means 1208 urges stemmember 1252 downward. Circular lid orarrest 1209 inhandle 1206 does not permit exit ofstem member 1252 fromhandle 1206 by engagingproximal end 1205 ofupper stem segment 1262. - Externally and concentric to the upper portion of upper stem segment or
rod 1262 ofstem member 1252 is mountedexternal arrest cylinder 1270.External arrest cylinder 1270 is provided witharrest tab 1272.Flexible arm 1273 ofarrest tab 1272 is fastened toexternal arrest cylinder 1270 viapin 1274.External arrest cylinder 1270 hasarrest lid 1407 engagingflange 1276 ofintermediate stem segment 1258 to prevent exit ofupper stem segment 1262 fromintermediate stem segment 1258. -
Arrest tab 1272 has the function of disabling the advancement ofrod 1258 in case of malfunction or the device during the cardiac compression as it will be explained below. Also, whenstem member 1252 is advanced into the chest cavity by downward pressure onhandle 1206arrest tab 1272 will not permit upward displacement ofintermediate stem segment 1258 viatooth 1271 engaging circular arrest orflange 1276 ofupper portion 1263 ofintermediate stem segment 1258 through opening 1285 ofexternal arrest cylinder 1270 as it will be apparent from the description below. -
Intermediate stem segment 1258 is of general cylindrical hollow shape. It receives in itsupper portion 1263rod 1262 airtightly slideable in it, while itslower portion 1264 is slideable within hollowlower stem segment 1260. Pneumatic container orbottle 1256 is connected withintermediate stem segment 1258 viaconduit 1277. Pneumatic bottle orcontainer 1256, contains compressed air or suitable gas as CO2.Conduit 1277 is in open communication with hollowintermediate stem member 1258 viaopening 1299 and is airtightly sealed via sealingmembrane 1278.Perforating screw 1279 is housed inrecess 1280 ofpneumatic container 1256, said perforatingscrew having thread 1281 mating withcorresponding thread 1282 onrecess 1280 ofpneumatic container 1256,screw tip 1283 being in contact with sealingmembrane 1278.Screw 1279 hashandle 1284.Screw tip 1283 hasholes 1246 to allow passage of air afterscrew 1279 has penetratedmembrane 1278. Pneumatic container orbottle 1256 is housed withinhousing 1247. Handle 1248 projects outwardly fromhousing 1247 for easy handling by the operator.Distal end 1286 ofintermediate stem segment 1258 is engaged as above mentioned in a slideable fashion within hollowlower stem segment 1260.Expandable member 1254, firmly connected todistal end 1286 ofintermediate stem member 1258, comprisesinflatable member 1288 andsupport ribs 1216 preferably, although not necessarily made of resilient material such as steel. Allsupport ribs 1216 are connected at their respective proximal ends 1225 todistal end 1286 ofintermediate stem segment 1258. Inflatable member orballoon 1288 ofexpandable member 1254 is connected and in flow communication withintermediate stem segment 1258 viaopening 1292. - Stem tip or
distal end 1261 ofstem member 1252 is firmly connected todistal end 1287 of hollowlower stem segment 1260 ofstem member 1252 and is of greater width than contiguouslower 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 todistal end 1287 oflower stem segment 1260 ofstem member 1252, and distal part or convex apex 1235 havingcircular edge 1236 adapted to fit together withcircular edge 1237 ofcircular opening 1238 ofproximal part 1234 ofstem tip 1261 to form together the above mentioned spheroid shapedstem tip 1261.Convex apex 1235 is firmly attached to base orinferior surface 1291 of inflatable member orballoon 1288 described below.Support ribs 1216 are firmly attached tosuperior surface 1290 ofinflatable member 1288 and approximately equidistantly spaced.Superior surface 1290 ofballoon 1288 interconnects thereforecontinuous ribs 1216 in a web fashion.Balloon 1288 ofexpandable member 1261 is preferably made of substantially inextensible and airtight material. Howeverballoon 1288 can also be made of stretchable, compliant airtight material.Apex 1235 ofstem tip 1261, as above described, is firmly attached to base orinferior surface 1291 ofballoon 1288. Inflatable member orballoon 1288 ofexpandable member 1254 is connected and in flow communication withintermediate stem segment 1258 viaopening 1292. - Stem tip or
distal end 1261 ofstem member 1252 is firmly connected todistal end 1287 of hollowlower stem segment 1260 ofstem member 1252 and is of greater width than contiguouslower 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 todistal end 1287 oflower stem segment 1260 ofstem member 1252, and distal part or convex apex 1235 havingcircular edge 1236 adapted to fit together withcircular edge 1237 ofcircular opening 1238 ofproximal part 1234 ofstem tip 1261 to form together the above mentioned spheroid shapedstem tip 1261.Convex apex 1235 is firmly attached to base orinferior surface 1291 of inflatable member orballoon 1288 described below.Support ribs 1216 are firmly attached tosuperior surface 1290 ofinflatable member 1288 and approximately equidistantly spaced.Superior surface 1290 ofballoon 1288 interconnects thereforecontinuous ribs 1216 in a web fashion.Balloon 1288 ofexpandable member 1261 is preferably made of substantially inextensible and airtight material. Howeverballoon 1288 can also be made of stretchable, compliant airtight material.Apex 1235 ofstem tip 1261 .as above described, is firmly attached to base orinferior surface 1291 ofballoon 1288.Base 1291 ofballoon 1288 provides in use the contact surface with the heart whenexpandable member 1254 is expanded. - As shown in FIG. 28, when
expandable member 1254 is in a contracted status,balloon 1288 andsupport ribs 1216 are retained in their entire length withinlower 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 hollowlower stem segment 1262 along withribs 1216. - Locking means1401 is fastened to
intermediate segment 1258 ofstem member 1252 viapin 1402 and provided withresilient arm 1406 having aslant contact surface 1405 for facilitating engagement offlange 1404 oflower stem segment 1260 inrecess 1403 of locking means 1401, as it will be apparent from the description below. - 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 ofdistal tip 1261 ofstem member 1252 into the subcutaneous tissue. -
Stem member 1252 is further advanced through the thickness ofchest wall 107 by means for blunt dissection until entry of stem end ortip 1261 is gained intochest cavity 110.Arrest tab 1272 will not allow downward displacement of upper stem member segment orrod 1262 as a result of engagement oftooth 1271 with circular arrest orflange 1276 ofintermediate member segment 1258. Beingdistal end 1261 ofstem member 1252 of a greater width than distalcontiguous segment 1287 of hollowlower stem segment 1260, distal end or stemtip 1261 ofstem member 1252 allows an operator of the device, upon penetration of distal stem end ortip 1261 into thechest cavity 110, to tactily sense entry of the distal stem end or stemtip 1261 into the chest cavity by the sudden fall of resistance to forward and sideways movement of saiddistal stem end 1261, said resistance to forward and sideways movements being encountered during passage of saidstem tip 1261 throughchest wall 107. When the operator has ascertained penetration ofdistal end 1261 ofstem member 1252 intochest cavity 110, he or she advances slideableintermediate stem member 1258 relatively to the hollowlower stem segment 1260 by holding still hollowlower stem segment 1260 relatively to the patient with one hand, and acting uponhandle 1248 with his or her other hand so as to moveintermediate stem segment 1258 downwardly relatively tolower stem segment 1260, towardchest cavity 110.Intermediate stem member 1258 therefore will be advanced to a full advanced position, i.e., untilconduit 1277 ofcontainer 1256 will engageflange 1404 ofproximal end 1296 oflower stem segment 1260. Upon full advancement ofintermediate stem member 1258 intolower stem segment 1260, locking means 1401 will lock stemintermediate member 1258 tolower stem segment 1260 via engagement ofrecess 1403 withflange 1404. - Being
distal end 1286 ofintermediate stem member 1258 connected toproximal ends 1225 ofribs 1216, the forward movement ofintermediate stem member 1258 will result with ejection and exit ofribs 1216 through opening 1238 ofproximal part 1234 ofstem tip 1261. Upon ejection of distal segments ofsupport ribs 1215 from thestem tip 1261,support ribs 1216 will diverge one from another, due, as already described, to their outward resiliency. Such an outward expansion ofribs 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 theblunt 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. - The operator will screw in perforating
screw 1279 which will perforate, viascrew tip 1283, sealingmembrane 1278 allowing passage of compressed air or gas frompneumatic container 1256 intoinflatable member 1288 viaconduit 1277 along hollowintermediate stem segment 1258.Inflatable member 1288 will fully expand, and, by expanding, will provide, via its inferior surface orbase 1291, a contact surface toheart 69 for the purpose of direct compression of the heart. Indeed, in order to compress-decompress the heart, the operator will press downward onhandle 1206 which in turn will displace downwardintermediate member 1258 viarod 1262. Fully expanded balloon orinflatable member 1288 will compressheart 69 whileribs 1216 will provideballoon 1288 with lateral and posterior support so as to require a reduced expanding pressure within theinflatable member 1288 allowing a softer contact with the external surface of the heart. In case of accidental perforation ofballoon 1288 at any stage of the operation pressure within hollowintermediate stem segment 1258 will drop disabling advancement ofrod 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. - Embodiment VI
- 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 thecardiac 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. - As shown in FIG. 30, the device, generally indicated at1200, is composed of two main components,
stem member 1202 andexpandable member 1204.Stem member 1202, of general cylindrical shape, compriseshollow stem 1203 having aproximal end 1205 and a distal end or stemtip 1201.Proximal end 1205 ofstem member 1202, of general cylindrical shape ashollow stem 1203 but of larger diameter, is mounted in slideable fashion withinrecess 1207 ofhandle 1206. Spring orresilient means 1208 urgesdownward stem member 1202 Circular lid orarrest 1209 inhandle 1206 does not permit exit ofstem member 1202 fromhandle 1206. Withinhollow stem 1203 is slidably mountedrod 1210.Proximal end 1231 ofexpandable member 1204 is firmly attached todistal end 1218 ofrod 1210 in a folded or contracted status prior to use.Hollow stem 1203 is formed withlongitudinal slit 1213 forhandle arm 1212 ofhandle 1211,longitudinal slit 1213 havingproximal end 1219 anddistal end 1220. Locking means ortab 1245 havingflexible arm 1229 is fastened viapin 1243 tohollow stem 1203 withtooth 1245′ engagingopening 1242 inhollow stem 1203. - Stem end or
tip 1201, firmly attached todistal segment 1233 ofhollow stem 1203 ofstem member 1202 is of greater width than continuousdistal 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 tohollow stem 1203 ofstem member 1202, and distal part or convex apex 1235 withcircular edge 1236 of apex 1235 adapted to fit together withcircular edge 1237 ofcircular opening 1238 ofproximal cup 1234 to form together the above mentioned spheroid shapedstem tip 1201.Convex apex 1235 is firmly attached tobase 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 ofribs 1216, made of resilient material such as steel. Allribs 1216 are connected at their respective proximal ends 1225 todistal end 1218 of arod 1210, slideable, as already described, withinhollow stem 1203 ofstem member 1202.Proximal end 1219 ofslit 1213 ofhollow stem 1203 arrests upward displacement ofrod 1210 via engagement ofarm 1212 ofhandle 1211 withproximal end 1219 ofslit 1213. Arrest ofrod 1210 prevents that distal ends 1215 ofribs 1216, connected torod 1210, lose their alignment withstem tip 1201 by moving backward, i.e., proximally in respect tohollow stem 1203. -
Contiguous ribs 1216 are interconnected viawebs 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 ormembrane 1223 also made of fabrics or plastic or other suitable substantially inextensible material is attached to distalblunt ends 1215 ofribs 1216 and to distal or outer margin oredge 1221 ofwebs 1222 to form a base for contact withheart 69 whenexpandable member 1204 is fully expanded. As shown in FIG. 29, whenexpandable member 1204 is in a contracted status, allribs 1216 are retained in their entire length withinhollow 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. - 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 ofdistal tip 1201 ofstem member 1202 into the subcutaneous tissue. -
Stem member 1202 is further advanced by blunt dissection through the thickness ofchest wall 107 until entry is gained intochest cavity 110 by blunt dissection. Beingdistal end 1201 ofhollow stem 1203 of a greater width than distalcontiguous segment 1233 ofhollow stem 1203 distal end or stemtip 1201 ofstem member 1202 allows an operator of the device, upon entry of distal stem end orblunt tip 1201 into thechest cavity 110, to tactily sense entry of the bluntdistal stem end 1201 into the chest cavity by the sudden fall of resistance to forward and sideways movement of saiddistal stem end 1201 said resistance to forward and sideways movements being present during passage of saidstem tip 1201 throughchest wall 107. - When the operator has ascertained penetration of
distal end 1201 ofstem member 1202 intochest cavity 110, he or she advancesslideable rod 1210 relatively tohollow stem 1203 by holding still, relatively to the patient, with one hand,hollow stem 1203 by its distal segment, and acting uponhandle 1211 with his or her other hand so as to moverod 1210 downwardly, towardchest cavity 110. Rod handle 1211 will be advanced to a fully advanced position, i e., untilhandle arm 1212 ofhandle 1211 will engagedistal end 1220 ofslit 1213 ofhollow stem 1203. Beingdistal end 1213 ofrod 1210 connected toproximal ends 1225 ofribs 1216, the downward movement orrod 1210 will result with election end exit ofribs 1216 through opening 1238 of proximal part, or cup, ofstem tip 1201. Upon ejection ofdistal segments 1215 ofribs 1216 fromstem tip 1201ribs 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 retainribs 1216 from diverging beyond a desired decree of divergence.Ribs 1216 andwebs 1222, upon full expansion, will form a bell-shaped member withbase sheet 1223 facingheart 69, andtop surface 1227 facingstem 1203.Base membrane 1223, being attached todistal ends 1215 ofribs 1216 and todistal webs margins 1221 ofwebs 1222, form a substantially inextensible base for contact withheart 69 whenexpandable member 1204 is fully expanded. Releasable locking means 1245 will lockrod 1210 via entry oftooth 1245′ intoopening 1242 ofstem member 1202 in a fully advanced position by engagingproximal end 1217 ofslideable rod 1210, for the time of compression and decompression of the heart. The operator as shown in FIG. 30 will compress and decompresshearth 69 by pressing onhandle 1206. Contraction of spring orresilient 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 unlockrod 1210 via disengagingtooth 1245′ fromproximal end 1217 ofrod 1210. He or she then will retractrod 1210 by pulling uphandle 1211.Expandable member 1204 will contract and will fold withinhollow stem 1203 permitting so the extraction ofstem tip 1201 and the penetrated segment ofstem 1203 fromchest cavity 110. - Embodiment VII
- 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 stemmember 1302 andexpandable member 1304.Stem member 1302 is composed ofproximal end 1303,shaft 1305 and stemend 1306.Stem shaft 1305 is composed of three concentric cylindrical stems, outer 1308, intermediate 1309 and inner 1310.Stem member 1302 is provided proximally withhandle 1206 in all similar to the two previously describeddevice handle 1206recess 1207 ofhandle 1206 is slidably mountedproximal end 1205 of upperstem member segment 1310.Proximal end 1205 ofupper stem segment 1310 is of general cylindrical shape as upper segment ofstem member 1302 but of larger diameter. Spring orresilient means 1208 urgesdownward stem member 1302. Circular lid orarrest 1209 inhandle 1206 does not permit the exit ofstem member 1302 fromhandle 1206 via engagingproximal end 1205 of upperstem member segment 1307. -
Outer stem 1308 andintermediate stem 1309 ofshaft 1305 ofstem member 1302 are hollow whileinner stem 1310 can be either solid or hollow. Handlewheels handle wheel respective seating pin 1319. Whileseating 1318 ofinner stem 1310 is visible in FIG. 33,seating seating 1318 with the device at rest prior to expansion ofexpandable member 1304 as it can be better understood from the description below. Locking means 1319 composed ofpin 1320 and arm or handle 1321 engaged withinseating 1318. -
Expandable member 1304 is composed of three or more identical bluntly tippedrods membrane 1343, as seen in FIG. 34.Blunt rods outer stem 1308,intermediate stem 1309 andinner stem 1310, being positioned at an angle preferably obtuse, in order to facilitate the insertion ofexpandable member 1304 intochest cavity 110 by the operator as it will be apparent from the description of the operation.Rods Rods 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 - 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 ofrods 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 withrods blunt ends 1342 ofrods 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 repositionstem member 1302 to reach a right angle in respect to the anterior chest wall while gradually advancing blunted tips ofrods rods member 1302 is repositioned approximately perpendicularly in respect to the anterior chest wall, the operator will rotate sequentiallyhandle wheels rods expandable member 1304 as shown in FIG. 34 which is a view from below of the fully expanded expandable member. Indeedrods membrane 1343. Locking means 1319 will be inserted in corresponding alignedseating respective rods wheels handle 1206.Membrane 1343, fully distended byspread rods - The device will be easily removed by extracting
pin 1320 fromseatings rods wheels expandable member 1343 and allow its extraction fromchest cavity 107. - 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.
- 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.
- 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.
-
Device 1002 of FIGS. 18 to 21 is an alternative form ofdevice 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 asdevice 1 of FIG. 1 to 10, including the blunt penetrating tip, while it differs in the way of compressing and decompressing the arrested heart. -
Device 1002 is basically similar todevice 1 of FIGS. 1 to 10 with few structural differences. The corresponding parts have retained the same numbers. -
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. - The
support member 1004 is the same assupport member 2 except that, as better shown in FIGS. 18 and 19, it has, at its surface, on itsdistal segment 5, slit 1010, in order to permit the insertion ofdistal end 1012 ofhose 1014 of inflating-deflatingdevice 1008 onwindow 1016 ofstem 102 ofstem unit 1006. - Stem member or
unit member 1006 is basically similar to stem orunit member 100 of FIG. 1 to 10 with few important differences. - Handle111 of FIG. 1 with
T bar 145 is no longer present. - Shut-off valve210 (better) illustrated in FIG. 3 and 4, is no longer present.
-
Opening 197, shown in FIG. 4 indiaphragm 120 and opening 209 (FIG. 4) indiaphragm 122 are no longer present. - As shown in FIGS. 18 and 19, stem102 is connected to
hose 1004 of inflating-deflatingmeans 1008. Three ways shut offvalve 1018 is located at the connection betweendistal end 1012 ofhose 1014 andstem 1002. - Expandable member or balloon1020, contained in position of rest within
circular groove 103 ofstem end 104 as for the device of FIG. 1 to 17 is of larger size when fully expanded thanballoon 105.Intermediate member 300 is identical tointermediate member 300 of device of FIGS. 1 to 10, thereof same numbers have been used for same parts. - Inflating-deflating means or
device 1008 is generally cylindrical in shape withtop wall 1022bottom wall 1024 and lateralpleated walls 1026. Resilient member orspring 1028 is contained withindevice 1008 to maintain itslateral wall 1026 distended in its resting position. - It is obvious that manually operated inflating-deflating
device 1008 may be substituted by a power operated inflating-deflating device. - Description of the Operation of Embodiment I
- 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.
- After chest wall penetration and complete passage of
blunt stem end 104 throughchest 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. - During advancement of
stem 102 through chest wall,distal end 1012 ofhose 1014, connected to stem 102, will be able to slide withinslit 1010 ofsupport member 1004. - As in correspondent device of FIGS.1 to 10,
lever 17 andintermediate member 300 will automatically disengage fromstem unit 1006 upon penetration ofblunt stem end 104 into chest cavity, signaling to the operator, by said disengagement, that penetration has occurred into the chest cavity. - The disengagement of the
stem member 1006 fromintermediate member 300 results in a sudden upward displacement ofstem unit 1006 in respect to supportcase 1004 due to the action ofspring 280. Said upward displacement ofstem unit 1006 is however minimal, being limited by engagement ofpin 261 into the most distally locatedhole 29 formed in the side wall ofsupport case 1004.Pin 261 is allowed to engage tohole 29 because is no longer retained in its retracted position by side wall ofintermediate member 300, which, contrary tostem unit 1006, is prevented from sliding upward in respect to supportcase 1004 bydog 21 oflever 17 that is anchored to supportcase 1004.Pin 261 therefore blocks the advancement ofblunt stem end 104 with its balloon 1020 in respect to supportcase 1004 to a distance automatically determined by the device and selected for that specific chest wall thickness that stem 102 ofstem unit 1004 penetrates at that particular time. - This automatic arrest of
blunt stem end 104 ofstem 102 of stem member orunit 1006 is an important safety feature required to prevent that inadverted advancement ofstem tip 104 with deflated balloon 1020 might result in damage to the heart, despite bluntness ofstem end 104. In device of FIGS. 1 to 10 the locking ofstem unit 100 to supportcase 2 bypin 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 ofballoon 105 and sufficient pressure upon thehead 262 ofpin 261 to withdrawpin 261 from engagement intohole 29 ofsupport case 2, to allow advancement and then withdrawal ofstem unit 100 in respect to supportcase 2 to effect pumping of the heart. On the contrary, in device of FIGS. 18 to 21,pin 261 is required to remain engaged tohole 29 ofsupport case 1004 to keepstem unit 1006 locked to supportcase 1004, consequently no high pressure gas will enter the system so thatpin 261 is not withdrawn and disengaged fromsupport case 1004. - After automatic disengagement of
lever 17 andintermediate member 300 fromstem unit 1006, and automatic locking ofstem unit 1006 to supportcase 1004, the operator, made aware of the occurred penetration into chest cavity, will act on three ways shut offvalve 1018, opening the passage betweenhose 1014 and stem 102 and closing passage betweenstem 102 andchamber 125. - At this point, the operator is ready to perform the cardiac compression-decompression. The operator, by pressing upon
top wall 1022 of inflating-deflatingdevice 1008, inflates balloon 1020, as shown in FIG. 21. - Inflation of balloon1020 will result in its expansion and compression of the heart between the thoracic spine and the balloon 1020 itself, as shown in FIG. 21.
- By releasing pressure upon
top wall 1022 of inflating-deflatingdevice 1008, the operator will deflate balloon 1020. Deflation of balloon 1020 will result in its contraction and, consequently, in the decompression of the heart. - By alternatively pressing upon inflating-deflating
device 1008 and releasing such pressure, the operator will alternatively compress and decompress the heart. - Being
stem tip 104 indirectly locked to supportmember 1006 as a consequence of actuation ofpin 261, as described above, upon entry ofstem tip 104 into the chest cavity whilestem tip 104 is still adjacent to the inner surface ofchest wall 107, and beingsupport case 1006 impeded to advance toward the chest cavity by itsbase 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 ofchest wall 107. - 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 member1020 secured to stem
tip 104, and, as just stated above, beingstem tip 104 firmly anchored to its position in contact with inner surface ofchest 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 towardchest 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 toblunt stem tip 104, with resulting anterior umbilication of the expanded member in correspondence ofblunt stem tip 104. This umbilication of the expanded expandable member 1020 in correspondence ofblunt stem tip 104 preventsblunt stem tip 104 from ever coming to contact with the heart during the compression-decompression 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 stemtip 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. - Embodiment II
- FIGS. 22 and 23 show an alternative form, generally indicated at1050, of
device 500 illustrated in FIG. 11. -
Device 1050 retains the same safety mechanisms of gaining entry into the chest cavity in front of the heart asdevice 500 of FIG. 11, including the blunt penetrating tip, while it differs in the way of compressing and decompressing the arrested heart. - Structure of
device 1050 is therefore similar todevice 500, except for the following differences. Corresponding parts have maintained the same numbering. -
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. - The
support member 1052 is the same assupport member 2 of FIG. 11 except that, as shown in FIG. 22, it is closed bytop wall 1053. It also has, at its surface, on itsdistal segment 5, slit 1010, in order to permit the insertion ofdistal end 1012 ofhose 1014 of inflating-deflatingdevice 1008 onwindow 1016 ofouter stem 552 ofstem member 1054 as it will be described below. - Stem member or
unit member 1054 is structurally similar to stemmember 501 of FIG. 11, but devoid of many of its components. - In particular gas-
fluids container 129 with itshandle 111, theentire chamber 517 with its side walls and all its content, diaphragm 518,chamber 519 with its side walls and all its content, includingpin 180 are no longer present. - Central opening400 in diaphragm 518 is no longer present.
-
Chamber 521 is devoid ofpipe 430 andinner stem 502. -
Opening 432 indiaphragm 524 is preserved. -
Inner stem 502 which was slidably mounted withinpiston 470 of FIG. 11 is no longer present and is replaced bysolid rod 1060. -
Outer stem 552 is connected tohose 1014 of inflating-deflatingmeans 1008 atwindow 1016. Three ways shut offvalve 1018 is located at the connection betweenhose end 1012 ofhose 1014 andouter stem 552. - As shown in FIG. 23, in a segment of
outer stem 552 proximal to insertion ofhose 1014, acylinder 1012 is slidably mounted withinouter stem 552 and aroundrod 1060, said cylinder having a cone shapedproximal end 1162 and adistal end 1152 for the seating ofcompression spring 1160 acting fromflange 1156. - Expandable member or
balloon 1062, contained in position of rest betweenconvex tip base 503 andconvex apex 507 of stem end or tip 526 as for the device of FIG. 11 is of larger size when fully expanded thanballoon 506. -
Intermediate member 300 is identical to intermediate member of device of FIG. 11, thereof same numbers have been used for same parts. - Inflating-deflating means or
device 1008 with connectedhose 1014 and shut offvalve 1018 it is the same device of FIGS. 18 to 21 and same numbering has been maintained. - Description of the Operation of Embodiment II
-
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 theprevious device 500 of FIG. 11, with few important functional differences. - After chest wall penetration and complete passage of blunt stem end or
tip 526 throughchest wall 107,lever 17 is felt by the operator to disengage fromstem unit 1054 and no further advancement ofstem tip 526 will occur within the chest cavity. The operator will act on three ways shut offvalve 1018 opening the passage betweenhose 1014 andouter stem 552 and closing passage betweenouter stem 552 andchamber 525.Cylinder 1150, located proximally to insertion ofhose 1014 toouter stem 552, will prevent retrograde pathway of gas or fluid contained withindevice 1008, so that the content ofdevice 1008 can flow to and fromexpandable member 1062. At this point, the operator is ready to perform the cardiac compression-decompression. The operator, by pressing upontop wall 1022 of inflating-deflatingdevice 1008 inflatesballoon 1062, as shown for thedevice 1002 in FIG. 21. - Inflation of
balloon 1062 will result in its expansion and compression of the heart between the thoracic spine and theballoon 1062 itself, as shown for thedevice 1002 in FIG. 21. - By releasing pressure upon
top wall 1022 of inflating-deflatingdevice 1008, the operator will deflateballoon 1062. Deflation ofballoon 1062 will result in its contraction and, consequently, in the decompression of the heart, as shown fordevice 1002 in FIG. 20. - By alternatively pressing upon inflating-deflating
device 1062 and releasing such pressure, the operator will alternatively compress and decompress the heart. - Embodiment III
- FIG. 24 shows an alternative form, generally indicated at1070, of
device 600 illustrated in FIG. 12. -
Device 1070 retains the same safety mechanisms of gaining entry into the chest cavity in front of the heart asdevice 600 of FIG. 12, including the blunt penetrating tip, while it differs in the way of compressing and decompressing the arrested heart. - Structure of
device 1070 is therefore similar todevice 600, except for the following differences. - Corresponding parts have maintained the same numbering.
-
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. - The
support member 1072 is the same as support member orcase 800 ofdevice 600 of FIG. 12, except that, as shown in FIG. 24, it is closed at its top bytop wall 1073. It also has, at its surface, on its distal portion slit 1076, in order to permit the insertion ofdistal end 1012 ofhose 1014 of inflating-deflatingdevice 1008 onwindow 1016 ofstem 602 of stem unit ormember 1074. Pin 1020 substitutes pin 860 of FIG. 12. It is composed of head 1082 and arm 1084. -
Pin 1080 substitutes pin 860 ofdevice 600 of FIG. 12.Pin 1080 is secured to supportcase 1072 throughopening 864 to engage inannular recess 865 ofintermediate member 700.Arm 862 ofpin 860 described in FIG. 12 for manual displacement is no longer present. - Stem member or
unit 1074 is structurally similar to stem orunit member 601 of FIG. 12, but devoid of some of its components. - In particular gas-
fluids container 129 with itshandle 111, theentire chamber 617 with its side walls and all its content, opening 142 indiaphragm 618, and pin 605 inchamber 621 are no longer present. -
Stem member 1074 is closed at its proximal end bytop wall 1075. - As for the
device 1002 described in FIGS. 18 to 21 anddevice 1050 described in FIGS. 22 and 23,distal portion 1012 ofhose 1014 of inflating-deflatingmeans 1008 is connected tocorrespondent stem 602 atwindow 1016. Three ways shut offvalve 1018 located at connection betweendistal portion 1012 ofhose 1014 and stem 602 is the same structurally and functionally to the one described for thedevices 1002 of FIGS. 18 to 21. - Expandable member or
balloon 1088, contained in position of rest withincircular groove 103 ofstem end 102 is, when expanded, of larger size thanballoon 105 ofdevice 600 of FIG. 12.Intermediate member 700 is identical tointermediate member 700 of device of FIG. 12, thereof same numbers have been used for same parts. - Inflating-deflating means or
device 1008 is the same one structurally and functionally described fordevices - Description of the Operation of Embodiment III
-
Device 1070 is placed on the chest in the same way asdevice 600, and the following operations are exactly the same as the operations described fordevice 600 of FIG. 12, with few important functional differences. - After chest wall penetration and complete passage of stem end or
tip 108 throughchest wall 107, the operator will tactually sense a sudden looseness of the device engaged in the chest wall, due to the side clearance of thestem 602 in respect to the surrounding chest wall tissue just penetrated bystem end 108 of much larger diameter thanstem 602, as already described fordevice 600 of FIG. 12. - Upon tactually sensing the completed penetration of stem end or
tip 108 into the chest cavity, the operator will act on three ways shut offvalve 1018, opening the passage betweenhose 1014 and stem 602 and closing passage betweenstem 602 andchamber 125. - At this point, the operator is ready to perform the cardiac compression-decompression. As for
devices top wall 1022 of inflating-deflatingdevice 1088, inflates balloon orexpandable member 1088 as shown fordevice 1002 of FIG. 21. Inflation ofballoon 1088 will result in its expansion and compression of the heart between the thoracic spine and theballoon 1080 itself, as shown fordevice 1002 of FIG. 21. - By releasing pressure upon
top wall 1022 of inflating-deflatingdevice 1008, the operator will deflateballoon 1088. Deflation ofballoon 1088 will result in its contraction and, consequently, in the decompression of the heart. - By alternatively pressing upon inflating-deflating
device 1008 and releasing such pressure, the operator will alternatively compress and decompress the heart. - Embodiment IV
- FIG. 25 shows an alternative form, generally indicated at1100, of
device 900 illustrated in FIGS. 15 to 17. -
Device 1100 retains the same safety mechanisms of gaining entry into the chest cavity in front of the heart asdevice 900 of FIGS. 15 to 17, including the blunt penetrating tip, while it differs in the way of compressing and decompressing the arrested heart. -
Device 1100, while maintaining some of the characteristics ofdevice 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. - The
support member 1102, of generally cylindrical hollow shape is the same assupport member 800 ofdevice 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 bytop wall 1103.Opening 1105 is formed intop wall 1103.Sight chamber 1122 is mounted atoptop wall 1103, surrounding opening 1105 oftop wall 1103 ofsupport member 1102 and upper segment ofrod 1109 exiting throughopening 1105. - A coaxially positioned
hollow cylinder 1106 is circularly connected with itsupper rim 1107 to the inner surface oftop wall 1103 ofsupport case 1102 while is open at itsdistal end 1104.Side wall 1108 ofcylinder 1106 is interposed between aninner cylinder 1110, corresponding in some respects to cylinder orvacuum chamber 910 ofdevice 900 of FIGS. 15 to 17, and anouter cylinder 1113 withcylindrical side wall 1112. -
Distal end 1114 ofhollow cylinder 1106 reaches a level distal to location ofballs 941 described below. -
Support member 1102 has, at its surface, on itsdistal segment 6, aslit 1010, in order to permit the insertion ofdistal end 1012 ofhose 1014 of inflating-deflatingdevice 1008 onwindow 1016 ofouter stem 992 ofstem unit 1104. -
Pin 1120 substitutes pin 860 ofdevice 900 of FIGS. 15 and 16.Pin 1120 is secured to supportcase 1102 throughopening 864 to engage inannular recess 865 ofintermediate member 700.Arm 866 ofpin 860 described in FIGS. 15 and 16 for manual displacement is no longer present.Tubular guide 1146, projecting from the inner surface oftop wall 1103, surrounds in aslideable fashion rod 1109 which stems out, as it will be described below, from upper face ofpiston 924.Intermediate member 700 is identical tointermediate 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. - Stem member or
unit member 1104 is structurally similar to stemmember 901 of FIGS. 15 to 1 7, but devoid of some of its components, while some components are modified or added. - In particular gas-
fluids container 129 with itshandle 111, the entire chamber 917 with its side walls and all its content,diaphragm 918, theentire chamber 919 with its side walls and with all itscontent including pin 180 andshutter 190 anddiaphragm 920 are no longer present. - Annular recesses1121 and 1122 formed in the inside aspect of side wall of
body 913 ofstem unit 901 ofdevice 900 of FIGS. 15 to 17 are no longer present. -
Slideable sealing cylinder 914,spring 902,balls 918 andwindows 920 formed incylinder 910 are no longer present.Proximal support arm 912 ofcylinder 910 are also removed. Stem member orstem unit 1104 is of general cylindrical shape, being its upper segment composed of two coaxially positioned cylinders,outer cylinder 1113 andinner cylinder 1110, which grossly corresponds to vacuum chamber orcylinder 910 of FIGS. 15 and 16. Coaxially positionedinner cylinder 1110 andcylindrical side wall 1112 ofouter cylinder 1113 are connected one to the other at their distal end byanterior segment 1144 ofstem member 1104. Saidinner cylinder 1110 and saidcylindrical side wall 1112 ofouter cylinder 1113 are separated in their proximal segment byspace 1140. As mentioned above,inner cylinder 1110 andcylindrical side wall 1112 ofouter cylinder 1113 ofstem member 1104 are slidably mounted onside wall 1108 ofhollow cylinder 1106 ofsupport member 1102, which, by occupyingspace 1140, is interposed between the two.Distal end 1114 ofhollow cylinder 1106 extends beyond the location ofballs 941 when the device is its starting position.Anterior segment 1144 ofstem member 1104 containschamber 1142 which is posteriorly in continuity withchamber 1126 ofcylinder 1110 and anteriorly communicates with the inside ofstem 992. Withincontiguous chambers piston 924, being 1130 its anterior segment and 1128 its posterior segment.Compression spring 1136 is mounted betweenface 1132 ofposterior piston segment 1128 andflange 1134 of solidanterior segment 1144 ofstem member 1104.Rod 1109 stems out ofposterior face 925 ofpiston 924 projecting posteriorly.Rod 1109 exits through center opening oftop wall 923 ofchamber 1126 and continuing throughtubular guide 1146 up tosight chamber 1122.Sealing cap 930 is mounted atop distal end ofanterior piston segment 1130 to maintain air tightness.Balls 941 seat inrecess 927 ofpiston 924 and are engaged inwindows 939 of side wall ofcylinder 1110 and are impeded to exit fromrecess 927 byside walls 1108 ofcylinder 1106.Thread 603, mounted at the Outer surface ofstem member 1104 as for the device of FIG. 15 and 16, is matable to correspondent thread ofintermediate member 700.Outer stem 992 is connected todistal end 1012 ofhose 1014 of inflating-deflatingmeans 1008 atwindow 1016. Three ways shut offvalve 1018 is located at the connection betweenhose end 1012 ofhose 1014 andouter stem 992. - Expandable member or
balloon 1124, interposed and connected to hollowconvex apex 995 andsolid base 912 of stem end ortip 994 is of larger size when fully expanded thanballoon 1000 ofcorrespondent device 900 of FIGS. 15 to 17. - Inflating-deflating means or
device 1008 with connectedhose 1014 and shut offvalve 1018 is the same device of FIGS. 18 to 21 and same numbering has been maintained. - Description of the Operation of Embodiment IV
-
Device 1100 is placed on the chest in the same way asdevice 900, the operator then ratchetslever 854, as described forcardiac pump 900 of FIGS. 15 to 17, causing advancement of thestem member 901 with respect to thesupport 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 thatstem tip 994 is well buried inside the chest wall, to sealopenings 999 from air entry,balls 941 which seat inannular recess 927 ofpiston 924 and are engaged inwindows 939 ofcylinder 1110 which is carried forward jointly to thestem unit 1104 to which is anchored bydistal supports 920, will align withdistal end 1114 ofhollow cylinder 1106 which, as described above, protrudes from thetop wall 1103 ofsupport case 1102 and is connected to it. - With downward displacement of
stem unit 1104 and consequently ofinner cylinder 1110, which is part of it, in respect toside wall 1108 ofcylinder 1106,balls 941, carried withinwindow 939 of walls ofinner cylinder 1110, will gradually advance to align first with level of distal end oredge 1114 ofside wall 1108 ofcylinder 1106, then, by moving further downward, said balls will pass the level of thedistal edge 1114. As soon asballs 941 pass the level ofedge 1114 ofside wall 1108 ofcylinder 1106, they will no longer be retained, withinannular recess 927 ofpiston 924 andwindow 939 ofinner cylinder 1110, bydistal end 1114 ofhollow cylinder 1006. Exit ofballs 941 from their seating inannular recess 927 ofpiston 924 thoughwindow 939 ofinner cylinder 1110 intospace 1120 will be accelerated bycompressed compression spring 1136, which, by urgingpiston 924 upwardly, will force dislodgment of saidballs 941 out of their seat inannular recess 927 ofpiston 924, being saidballs 941, as described above, no longer forced to be retained in their seat byside wall 1108 ofcylinder 1106. - Upon dislodgment of locking
balls 941 fromannular recess 927 ofpiston 924, piston will no longer be retained in its starting advanced position, andcompressed compression spring 1136, which urgespiston 924 upwardly, will be able to upwardly displacepiston 924. However, being the interior ofcylinder 1110, and, more specifically, beinganterior chamber 1142 in open flow communication withopenings 999 ofstem tip 994 viastem 992, and being said openings sealed by tissues burying beingstem tip 994 within the thickness of the chest wall,piston 924, which airtightly slides withincylinder 1110, will create a vacuum inchamber 1142 when upwardly displaced. Said vacuum will oppose to full withdrawal ofpiston 924 urged byspring 1136, resulting in a partial upward displacement ofpiston 924. From this moment on,piston 924 will be unimpeded to move further upward upon vanishing of the vacuum present inchamber 1142 in front ofpiston 924. Vanishing of vacuum inchamber 1142 in front ofpiston 924 will occur upon gaining access to the chest cavity bystem tip 994. Upon gaining access to the chest cavity,openings 999 ofstem tip 994 will lose the sealing put up by the tissue layers of the chest wall, and, being saidopenings 999 ofstem tip 994 in flow communication withchamber 1142, will place saidchamber 1142 in flow communication with the chest cavity, with resulting vanishing of the vacuum inchamber 1142. - 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 ofhollow cylinder 1106. - Access into the chest cavity by
stem tip 994 will be signaled to the operator by the full upward displacement ofpiston 924. Upon occurred penetration into chest cavity ofstem tip 994 and consequent vanishing of vacuum inchamber 1142,piston 924, as described above, will be allowed to fully displace upward. Full upward displacement ofpiston 924 will be revealed to the operator for instance by upward displacement ofrod 1109 which, being fixed toposterior end 925 ofpiston 924 and by exiting inner orvacuum cylinder 1110 through the center opening formed intop wall 923 ofcylinder 1110, then exiting throughopening 1105 oftop wall 1103 ofintermediate member 1102, will move upward, jointly with said piston. - 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 andpiston 924, the operator will act on three ways shut offvalve 1108, opening the passage betweenhose 1104 andouter stem 992 and closing passage betweenstem 992 andchamber 907. - At this point, the operator is ready to perform the cardiac compression-decompression. The operator, by pressing upon
top wall 1022 of inflating-deflatingdevice 1008, inflatesballoon 1124, as for thedevice 1002 shown in FIG. 21. - Inflation of
balloon 1124 will result in its expansion and compression of the heart between the thoracic spine and theballoon 1124 itself, as previously shown in FIG. 21. By releasing pressure upontop wall 1022 of inflating-deflatingdevice 1008, the operator will deflateballoon 1124. - Embodiment V
- 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 asdevice 1070 of FIG. 24, except for few important differences, such asstem end 1502.Stem tip 1502 is composed of two parts:proximal part 1504 shaped as an inverted cup firmly attached todistal end 1506 ofstem 602 ofstem member 1074, and distal part orconvex apex 1506.Convex apex 1506 is firmly attached to innerhollow stem 1508 which is slideable in airtight fashion withinhollow stem 602 and hasproximal opening 1522. Convex apex has circular edge 1510 adapted to fit together withcircular edge 1512 ofcircular opening 1514 ofproximal cart 1504 ofstem tip 1502 to form together a spheroidly-shapedstem tip 1502. Innerhollow stem 1508 has at least onedistal opening 1516 withinstem end 1502 in flow communication with expandable member orballoon 1520 partially or fully contained in a contracted status withinstem end 1502. Hollowinner stem 1502 also provides lateral stability toexpandable member 1520 upon expansion ofballoon 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. - 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 fordevice 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. -
Blunt stem end 1502 is further advanced through the thickness ofchest wall 107 by blunt dissection until it enters the chest cavity by blunt dissection. - Upon entry into the chest cavity the operator will be alert of the occurred entry of
stem end 1502 as fordevice 1070 of FIG. 24.Balloon 1520 will be inflated by the operator acting upon pneumatic source or inflating-deflatingdevice 1070 of FIG. 24, not shown in FIG. 35, as described fordevice 1070 of FIG. 24. Air or suitable gas such as CO2 will flow into hollow inner stem throughopening 1522 and will exit throughdistal opening 1516 to enterballoon 1520 resulting in its inflation. Asballoon 1520 begins to inflate, as seen in FIG. 36, hollowinner stem 1508, being slideable withinhollow stem 1508, will be dragged forward with convex apex 1506 to which is firmly attached, beingconvex apex 1516 of stem end ortip 1502 being firmly attached to the heart contacting surface. Although the depth of advancement of hollowinner 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 innerhollow 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. - 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. - The above disclosed slideable guiding stem can be applied to all embodiments where the heart contacting member is an inflatable deflatable type.
- 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.
- FIG. 37 shows balloon or expandable member or inflatable-
deflatable member 1520 inflated to the required pressure to achieve cardiac compression. -
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 ofballoon 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 guidingstem 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.
Claims (12)
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.
Priority Applications (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US09/925,291 US20020068848A1 (en) | 1992-08-03 | 2001-08-08 | Cardiac resuscitation device for percutaneous direct cardiac massage |
Applications Claiming Priority (5)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US07/924,301 US5466221A (en) | 1992-08-03 | 1992-08-03 | Percutaneous cardiac pump for cardiopulmonary resuscitation |
US10057393A | 1993-07-30 | 1993-07-30 | |
US08/555,985 US5931850A (en) | 1992-08-03 | 1995-11-13 | (Percutaneous cardiac pump for cardiopulmonary resuscitation) cardiac resuscitation device for percutaneous direct cardiac massage |
US09/428,139 US6296653B1 (en) | 1992-08-03 | 1999-10-26 | Cardiac resuscitation device for percutaneous direct cardiac massage |
US09/925,291 US20020068848A1 (en) | 1992-08-03 | 2001-08-08 | Cardiac resuscitation device for percutaneous direct cardiac massage |
Related Parent Applications (1)
Application Number | Title | Priority Date | Filing Date |
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US09/428,139 Continuation US6296653B1 (en) | 1992-08-03 | 1999-10-26 | Cardiac resuscitation device for percutaneous direct cardiac massage |
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US20020068848A1 true US20020068848A1 (en) | 2002-06-06 |
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US08/555,985 Expired - Fee Related US5931850A (en) | 1992-08-03 | 1995-11-13 | (Percutaneous cardiac pump for cardiopulmonary resuscitation) cardiac resuscitation device for percutaneous direct cardiac massage |
US09/428,139 Expired - Fee Related US6296653B1 (en) | 1992-08-03 | 1999-10-26 | Cardiac resuscitation device for percutaneous direct cardiac massage |
US09/925,291 Abandoned US20020068848A1 (en) | 1992-08-03 | 2001-08-08 | Cardiac resuscitation device for percutaneous direct cardiac massage |
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Application Number | Title | Priority Date | Filing Date |
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US08/555,985 Expired - Fee Related US5931850A (en) | 1992-08-03 | 1995-11-13 | (Percutaneous cardiac pump for cardiopulmonary resuscitation) cardiac resuscitation device for percutaneous direct cardiac massage |
US09/428,139 Expired - Fee Related US6296653B1 (en) | 1992-08-03 | 1999-10-26 | Cardiac resuscitation device for percutaneous direct cardiac massage |
Country Status (1)
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US (3) | US5931850A (en) |
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US11654275B2 (en) | 2019-07-22 | 2023-05-23 | Shifamed Holdings, Llc | Intravascular blood pumps with struts and methods of use and manufacture |
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US11964145B2 (en) | 2019-07-12 | 2024-04-23 | Shifamed Holdings, Llc | Intravascular blood pumps and methods of manufacture and use |
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US5931850A (en) | 1999-08-03 |
US6296653B1 (en) | 2001-10-02 |
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Legal Events
Date | Code | Title | Description |
---|---|---|---|
STCB | Information on status: application discontinuation |
Free format text: ABANDONED -- FAILURE TO RESPOND TO AN OFFICE ACTION |