Surgery – Internal organ support or sling
Reexamination Certificate
2000-02-25
2002-05-14
Lacyk, John P. (Department: 3736)
Surgery
Internal organ support or sling
C600S016000
Reexamination Certificate
active
06387042
ABSTRACT:
FIELD OF THE INVENTION
This invention relates to an apparatus devised to aid the heart in its contractile function.
The object of the invention consists in an apparatus to treat cardiac insufficiency through a system similar to the physiologic way, improving heart emptying, allowing to initially and, in further controls, regulate contractility and distention parameters as well as cavity filling and emptying times fitting the mechanics to the heart electric activity and keeping a physiologic way because the apparatus aids the heart in its own operation working in a similar way to the systolic contraction of the physiologic ventricular and atrial musculature.
The apparatus of the invention allows to improve the contraction of heart cavities in global dilatations (in the typical case of dilated cardiomyopathy) as well as the contraction of segmentary dilatations, so also asynergies, dyssynergies, aneurysms and zonal dilatations of many cardiopathies can be prevented.
BACKGROUND OF THE INVENTION
Cardiac insufficiency in its concept of incapacity for the heart to meet its blood pumping function is a frequent state to which one can be lead by several causes and mechanisms.
It is the cause of physical impairment, functional incapacity and a situation of illness in many thousands of persons, and it is the mechanism which leads a great number of patients to death.
Many attempts have been made to try to overcome or to relieve cardiac insufficiency, and during last years, the advances are considerably great because of the always better knowledge of the heart physiologic and pathologic mechanisms as well as those of the rest of the organs and systems which are involved in its operation, as well as the progress of diagnostic and therapeutic techniques in their pharmacologic, mechanic and electric features.
All of it leads to an important advance in the treatment of cardiopathies with subsequent improvement of survival, quality of life and in the relief or disappearance of the symptoms and complications to which cardiac patients are exposed.
However, the field in which advances have still to be made is very large. The evolution of the cardiac insufficiency is attenuated with drugs and final failure is significantly delayed compared with former times, but still we are not capable to prevent it nor to provide the myocardium with the lost strength when it reaches a certain degree of dilatation and diminution of its contractile capacity.
It is so to such extent that, during last decades a number of heart transplantation units have been developed to provide with a new heart from somebody else patients whose prognosis was unfortunate because the rest of the medical possibilities were exhausted to stop the evolution towards definite failure in a weakened heart.
Artificial hearts have been also developed which include a pumping system in the apparatus itself. But said artificial hearts, because of the haemolysis they produce and other important medical drawbacks and high economic costs, up to now, are not long lasting and in many cases they are applied temporarily while the patient is waiting for a heart transplantation.
The Revista Española de Cardiología, vol. 51, pages 23-30, July 1998, publishes an article by Dr. Francisco Torrent Guasp, where a contention prosthesis is disclosed which consists in a stiff or malleable non extensile ring which carries out a contention task in the ventricle two basal thirds, narrowing the ventricular mass. Said contention prosthesis would limit a further heart dilatation but would not allow to regulate the diastolic volume nor would make further modifications possible and it wouldn't improve systolic emptying. Said article includes a description and illustration of the ventricular mechanics in the function of which four main ventricle motions are distinguished: narrowing, shortening, lengthening and enlarging (
FIG. 3
, page 522).
Patent U.S. Pat. No. 5,383,840 discloses a biocompatible device for ventricular aid and arrhythmia control including a compressing assembly which comprises a band for wrapping the heart perimeter and means to more or less closely fit the band around the external walls of the ventricular cavities during predetermined periods of time so that a pressure is applied to said ventricles which is approx. transversal to the lengthwise axis thereof, of an adjustable value, in synchronism with the systolic cycles of said cardiac cavities, in addition to the cavity walls narrowing-shortening and said means allowing further loosening and dilatation of said walls chronologically with the cardiac cycle.
Said patent discloses in details other systems of the state of the art applied to same aim among which the patent U.S. Pat. No. 4,304,225 is referred to which also discloses a pressure band.
Other documents of the state of the art relative to the object of this invention are disclosed in patent U.S. Pat. No. 4,448,190 which includes a wrapping associated to pumping means to closely fit or loosen an organ such as the aorta or the ventricles while a series of electrical impulses are sent in synchronism. Another similar device appears disclosed in patent U.S. Pat. No. 5,131,905.
In all these backgrounds the devices compress the heart transversally, as if a manual massage was performed. This way of compressing, in spite of being effective, is different of the physiologic behaviour in the systolic contraction of the ventricular muscle, which expels the blood from the apex to the base of the ventricles.
On the other hand, none of mentioned backgrounds foresees means for applying a contractile treatment similar to that of the atria and to allow treating simultaneously or separately atria and ventricles.
DESCRIPTION OF THE INVENTION
Unlike mentioned backgrounds, the invention proposes an apparatus aiding physiologic systolic and diastolic dynamics of the heart cavities which we will call SPES (system for pressing electrosyncronically) for aiding the heart in its contractile function.
The apparatus consists in a stable structure or wrapping, acting as a receptacle, having a contour similar to that of the ventricles, approximately cone-shaped, and which surrounds/sheathes them, the mouthpiece of which includes a first stiff ring which the same as a distal tip of the structure, distal from the ring and on which the heart apex will be arranged, is fixed to the body skeleton (ribs) for example with flexible tension members or semi-stiff members having the suitable texture which guarantee its relative locking.
Coupled to said first stiff ring, there exists a second stiff ring, having a slightly smaller diameter, guided with possibility to concentrically revolvingly slide, a driving device having been provided fixed to the external ring and with a toothed member geared with a peripheral toothed profile of the external wall of the internal ring, so that when said motor acts the internal ring is revolvingly moved, sliding driven on the external ring which remains fixed.
An approximately cone-shaped bag of flexible fabric, similar to the ventricular contour is connected by its mouthpiece to the rotating internal ring, above described, and its vertex is internally joined to the distal tip of the external stiff wrapping.
By means of said arrangement, said flexible internal bag remains in contact with the pericardium which wraps the ventricles, containing the heart within it and in turn surrounded by said stiff structure integral with the external ring in such a way that the apparatus squeezes the internal bag when the internal ring rotates.
That is to say, the behaviour of the apparatus which is proposed acts according to the heart physiology of systolic contraction of the ventricular musculature, carrying out an emptying upward the aortic and pulmonary valves, which results particularly effective for systolic emptying as emptying direction is the same as that of the myocardium at the systole.
The structure, surface and distribution of said bag fibres will be selected so that they allow to apply different pressures on one or the other ventricle.
The apparatus includ
Garrison David L.
Garrison & Assoc. PS
Lacyk John P.
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