Cardiac resuscitation device for percutaneous direct cardiac massage

Abstract

An apparatus and method for cardiac resuscitation wherein the apparatus has an expandable member carried by a rigid stem and placeable inside the chest cavity adjacent to the heart by the tip end of the stem to effect pumping of the heart by applying and releasing pressure to the expandable member via a rigid stem from outside the chest cavity through the chest wall so as to alternately compress and decompress the heart and further includes numerous safety mechanisms to prevent injuries to the intrathoracic organs and mishaps. Compression and decompression may be achieved by moving the expanded expandable member toward the heart and away from it, or by alternatively expanding and contracting said expandable member to effect pumping of the heart.

Description

[0001] This Application is a continuation of 09 / 428,139, filed Oct. 26, 1999, which is a continuation of application Ser. No. 08 / 555,985, now U.S. Pat. No. 5,931,850 which is a continuation-in-part of co-pending patent application Ser. No. 08 / 100,573, filed on Jul. 30, 1993, now abandoned, which is a continuation-in-part of co-pending application Ser. No. 07 / 924,301 filed on Aug. 3, 1992, now U.S. Pat. No. 5,466,221. The subject mater of this application may be related to the subject matter of U.S. application Ser. No. 09 / 287,231 filed on Apr. 6, 1999. The full disclosures of each of these applications are incorporated herein by reference.[0002] 1. Field of the Invention[0003] This invention relates to methods and apparatus for cardiopulmonary resuscitation and is particularly directed to improved methods and apparatus for performing direct heart massage.[0004] 2. Description of the Background Art[0005] In order to resuscitate a patient victim of a cardiac arrest, it is necessary to...

AI Technical Summary

Problems solved by technology

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.

However, few physicians today are skilled in the technique of direct cardiac massage.

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.

However, the larger the sharp three-sided trocar tip, the more likely are injuries to the heart, coronaries or surrounding organs.

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.

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.

With that regard, the device proposed by Buckman and Badellino hardly seems to offer a real advantage or be an improvement over Prisk.

However the absence of any pointed tips or share edges in heart massaging members is no novelty.

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.

Buckman and Badellino do not disclose in their application any means for blunt dissection, nor entry by blunt dissection.

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.

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.

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.

Thus, none of the prior art methods and apparatus for cardiac pulmonary resuscitation have been entirely satisfactory.

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