Surgery – Cardiac augmentation
Reexamination Certificate
1998-06-17
2001-03-27
Evanisko, George R. (Department: 3762)
Surgery
Cardiac augmentation
C623S003210
Reexamination Certificate
active
06206820
ABSTRACT:
BACKGROUND AND SUMMARY OF THE INVENTION
This application claims the priority of German patent document 195 38 796.1, filed Oct. 18, 1995 and PCT patent document PCT/DE96/01978 filed Oct. 17, 1996, the disclosures of which are expressly incorporated by reference herein.
The present relates to a device for supporting cardiac function having elastic filling chambers which exert mechanical pressure and act selectively on the left ventricle region. The chambers can be filled with a medium and evacuated via connection lines.
When the heart fails to pump, the problem is a muscle weakness of the left cardiac chamber, such that insufficient blood volume can be expelled from the heart into the main aorta, and maintaining circulation is no longer ensured. The causes of this pumping failure of the cardiac muscle are varied. For instance, after heart surgery, viruses, deficient coronary circulation including pump failure can lead to loss of cardiac function.
To support cardiac activity mechanically during or following surgery, a number of devices are known. By way of illustration, German patent document DE-33 07 211 A1 discloses a device that can be implemented for supporting the activity of the myocardium. This device is composed of a rigid-walled container housing surrounding at least partially the ventricular region of the myocardium. Pump chambers, which directly deform the cardiac wall at the corresponding sites, are provided on the interior side of the container housing. However, this known device has the drawback that the pressure propagation on certain ventricle regions continues within the organ to such an extent that cardiac regions on the opposite side corresponding to the pressure exerting centers are pressed against the rigid container wall, thereby possibly causing irreversible damage to the heart or the vessels. Moreover, the rigid container wall lastingly impairs the natural expansion behavior of the heart.
Generic pump systems which are able to support cardiac function and are positioned at the heart with the aid of flexible bands are also known. A device of this type is disclosed, for example, in U.S. Pat. No. 5,131,905. However, devices of this type have the disadvantage that the limited width of the attachment bands permits only insufficient fixation effects. Moreover, the edges of the bands rub on the surface of the heart and can lead to irreversible local damage to tissue. Furthermore, attachment of the bands about the beating heart for surgery is very difficult and complicated.
In order to avoid the aforementioned disadvantages, International patent document WO 94/27552 describes a device for supporting cardiac function. The device is provided with two approximately opposite filling chambers that are connected via a U-shaped, rigid rod between which the left ventricle region of the heart is located. A special advantage of this device is that upon compression of the left ventricle region by corresponding filling of the filling chambers, the other cardiac regions can expand without hindrance. Corresponding damage to the surface of the heart due to bruising occurring by way of illustration when hard shells are employed is prevented in this manner.
However, the above described device for supporting cardiac function has the disadvantage that some mobility remains between the filling chambers and the surface of the heart so that slipping of the device on the heart surface cannot be ruled out.
DESCRIPTION OF THE INVENTION
The object of the present invention is to provide an improved device for supporting cardiac function, with elastic filling chambers which are filled with a medium and evacuated via connection lines and which exert mechanical pressure selectively on the left ventricle region. The device according to the invention can be attached over a large surface to the heart so that, on the one hand, the heart's freedom of movement is not restricted and, on the other hand, the device is attached to the surface of the heart in such a way that it cannot slip.
This and other objects and advantages are achieved by the device for supporting cardiac function according to the invention, which includes an elastic cover that can be placed at least partially around the heart. The left wall of the device is provided with filling chambers in the region of the left ventricle, which chambers can also be detachably joined via suited connecting elements integrated in the wall of the elastic cover.
In a preferred embodiment of the invention, the filling chambers are located on the external side of the elastic cover, and possess expansion behavior directed predominantly toward the elastic cover. In this manner selective pressure can be exerted on the interior side of the elastic cover. For this purpose, for example, the side of the filling chamber facing the elastic cover is designed more elastic than the side facing in the opposite direction.
The invented elastic cover is provided at suitable sites, corresponding to the region of the left ventricle of the heart, with filling chambers (also composed of elastic material) which are integrated in the wall or joined thereto. The filling chambers preferably are integrated in pairs opposite each other in the wall of the elastic cover, and are provided with connecting valves, to which corresponding connecting lines can be applied. Alternatively, connecting elements, via which the filling chambers can subsequently be attached to the wall of the elastic cover, are integrated in the wall. Velcro connections, for example, are suitable for this purpose.
The material and size of the elastic cover must be selected so that, on the one hand, the heart can be covered snugly and, on the other hand, the expansion behavior of the heart remains unimpeded. That is, the cover must be so easily expandable that it imposes little or no impediment to expansion of the heart in a diastolic state, but remains sufficiently elastic in the diastolic state to present the cover from slipping on the surface of the heart.
An essential advantage of the intended embodiment of the cover is, in particular, that first the elastic cover is placed together with the elastic filling chambers attached to its wall, using suited auxiliary means, about the heart. After the elastic cover has been positioned at the heart in a suited manner and has fixed itself by means of its intrinsic elasticity to the heart, the connecting lines can be joined to the filling chambers. Abutment elements, described in the previously cited International patent document WO 94/27552, may also be attached at the sites of the filling chambers. Joining individual components which together yield a whole device for supporting cardiac function simplifies surgery substantially so that the actual surgical measures applied to the patient can be reduced considerably.
Other objects, advantages and novel features of the present invention will become apparent from the following detailed description of the invention when considered in conjunction with the accompanying drawings.
REFERENCES:
patent: 3376863 (1968-04-01), Kolobow et al.
patent: 5119804 (1992-06-01), Anstadt
patent: 5131905 (1992-07-01), Grooters
patent: 5749839 (1998-05-01), Kovacs
patent: 5848962 (1998-12-01), Feindt et al.
patent: 33 07 211 A1 (1982-03-01), None
patent: 94/02101 (1994-02-01), None
patent: 94/27552 (1994-12-01), None
Feindt Peter
Kazi Arif
Volker Paul
Evanisko George R.
Evenson, McKeown, Edwards & Lenahan P.L.L.C.
Fraunhofer Gesellschaft zur Foerderung der angewandten Forschung
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