Title of Invention

A DEVICE FOR ONE OF EPICARDIAL SUPPORT AND ASSUMING OF CARDIAC ACTIVITY

Abstract The invention relates to a device for epicardial support and/or resumption of cardiac activity. Said device comprises a double membrane (1) consisting of an elastic internal membrane (2), a non-expandable outer membrane (3), and a closed cavity (4) which is formed thereinbetween and can be inflated and deflated by means of a fluid. The aim of the invention is to improve one such device such that, in the critical post-operative phase, the heart can be stimulated in a simple manner. To this end, at least one probe/electrode unit (7, 8) for the epicardial derivation of the ECG and/or the signal transmission and conversion of an external pacemaker is arranged on the inner side (6) of the inner membrane (2) facing the heart (5).
Full Text

Description
The present invention relates to a device for epicardial support and/or the assuming
of cardiac activity having a double membrane consisting of an elastic inner membrane
and a non-expandable outer membrane as well as a closed cavity formed
therebetween which can be inflated and deflated by means of a fluid.
Such a device - although one which works pericardially - is known for example from
the document DE 199 5 1 220 A!. The device is a minimally-invasive, i.e.
percutaneously implantable system for the mechanical support and temporary
substitution of the heart's pumping function. After probing the pericardial sac, the
device is inserted into the pericardial sac percutaneously in collapsed state or
surgically positioned in the pericardia! sac at the end of an operation with the
double membrane surrounding the right and left ventricles. Thereby the device in
its deflated state is so thin that a compression of the adjacent organs will be
avoided. Subsequent implantation, the cavity of the double membrane is
rhythmically supplied through a connecting tube with a fluid which can either be a
gas (helium 01-CO2). or a suitable liquid. Due to this rhythmic inflation and
deflation of the double membrane's cavity and because the outer membrane is not
expandable in contrast to the inner membrane, the double membrane surrounding
the heart effects pressure transmission and compression of the heart. In so doing,
blood is urged from the right ventricle into the pulmonary artery and
simultaneously from the left ventricle into the aorta or, with available pumping
function of the heart, aids in the systolic ejection of the cardiac muscle.
For patients who undergo heart surgery at the present time, however, a temporary
pace-maker probe is still being attached epicardially at the end of the operation. In
the case of asystolia (electrical cardiac standstill) or bradycardia (too slow of a
heart rate) during the critical post-operative phase, the two temporary probes can
stimulate the heart by means of an externally attached pacemaker. The probe
cables are extracted after five to seven days, which is possible without reopening

the chest. Yet regarded as a disadvantage is that those temporary pacemaker probe
must every time be sewn on.
Should ventricular arrhythmias occur during the post-operative phase (ventricular
tachycardia or ventricular fibrillation), a defibrillator must be used to restore the
heart's normal rhythm. An external defibrillator attachable to the body is hereby
used, although it is known on the one hand that only 10-20% of the energy in the
form of electric work generated by the defibrillator (200 to 360 joules) acts directly
on the heart, while most is absorbed by the surrounding tissue. On the other hand,
implantable defibrillators can be used, whereby the probes positioned in the
ventricle are usually left inside the patient for many years. Yet also known in this
case is that usually only 30-50% of the energy generated by an implanted
defibrillator (16 to 34 joules) has any effect on the heart.
Against the background of the disadvantages as described; i.e. the need to attach a
temporary pacemaker probe and the large losses of energy when using known
defibrillators, the object on which the present invention is based is that of further
developing a device ofthe type as indicated at the outset which provides a simpler
possibility of stimulating the heart in the critical post-operative phase.
This object is solved by a device for the epicardial support of cardiac activity of the
type as indicated at the outset according to the invention which has at least one
probe/electrode unit arranged on the inward heart-facing side of the inner
membrane for epicardial ECG leads and/or signal transmission/conversion of an
external pacemaker.
To be understood hereby by the term "probe" is a heart flow or cardiac pressure
sensor and by the term "electrodes," electrical connecting members for the
transmission of an electrical stimulus or pulse to the heart.
The advantages of the device according to the invention are in particular in that the
epicardial ECG is obtained from probe/electrode unit(s) and is used for triggering,
controlling the charge of the device in the pericardial sac and as a function control.
The function control thereby includes the triggering of an alarm upon cardiac
arrhythmia through to automatically activating the cardiac pacemaker, a
defibrillating activity of the probe/electrode unit(s) respectively. Thus, with an

externally-obtained ECG, the device represents an excellent alternative to
conventional triggering. The epicardial sensors of the device according to the
invention moreover self-transmit data on cardiac activity itself through the signals
of the probe/electrode unit(s). The patient's recovery ("weaning") in the post-
operative phase can thus be monitored, an indication of augmentation signaled,
and the point in time to remove the device displayed. Furthermore, an automatic
switching from "standby" (no supporting of the heart) to triggered augmentation
(partial self-pumping of heart) all the way through to fully assuming cardiac
activity (heart standstill) is, of course, possible.
Advantageous embodiments of the invention are specified in subclaims 2 to 9.
At least one probe/electrode unit is preferably allocated to each of the two
ventricles, which also makes the device according to the invention applicable to
bilateral heart failures.
In order to enable the probe/electrode unit(s) to be connected to devices external
the patient, signal lines are preferably provided which are guided along the inward
facing side of the inner membrane of the double membrane.
Pressure sensors are preferably arranged on the inner membrane to measure the
systolic and diastolic blood pressure for allowing the device according to the
invention for example with available pumping function of the heart, to be
synchronizable with the heart action.
Also of advantage with respect to the pressure sensors is for the signal
transmission of the pressure sensors to be to an external device via signal lines
which are guided along on the inner side of the inner membrane.
The signal lines of the probe/electrode unit(s) and the pressure sensors preferably
run into a common connector plug which can be connected to a corresponding
terminal on an external control or drive unit.
It is provided for the double membrane to be collapsible and the probe/electrode
unit(s) as well as the pressure sensors to be configured such that both their
implantation as well as their explantation can ensue via percutaneous cannulation.

Insofar there is no need to open the chest either during the operation nor post-
operative.
Since external compression of the epicardial vessels is undesirable after coronary
bypass surgery, the double membrane near the large coronary artery preferably
comprises variable recesses. Such a double membrane can either be custom-made
for a patient or, however, as a further advantageous embodiment provides,
customized to the particular requirements of a patient's heart by means of
displaceable supports. The variable recesses can thereby be brought into their
desired position by the surgeon mechanically manipulating collapsible flexible bars
or half-tubes. These collapsible flexible bars or half-tubes can be held in the
desired position during pumping either by their own self-adhering properties, the
use of a tissue adhesive, by a support rail or by grooves within the double
membrane which force specific positions.
The following will make reference to a figure in describing an embodiment of the
invention in greater detail.
Shown are:
Fig. 1: a schematic representation of the device according to the invention;
Fig. 2: a schematic representation of a patient with an implanted device
according to the invention and an external control unit;
Fig. 3: a patient's opened chest with the implanted inventive device; and
Fig. 4: a representation of the human heart with the inserted device and recesses.
Figure 1 shows a schematic representation of a device for epicardial support and/or
the assuming or resuming of cardiac activity having a double membrane 1 consisting of
an elastic inner membrane 2 and a non-expandable outer membrane 3 as well as a
closed cavity 4 formed therebetween which can be inflated and deflated by means of
a fluid. Probe/electrode units 7, 8 are allocated to each ventricle 9, 10 at the inward facing side 6 of the inner membrane 2 to the heart 5 for the epicardial ECG
lead and/or signal transmission/conversion for an external pacemaker. These
probe/electrode units 7, 8 are connected to an external control or drive device

which is not shown in this figure by means of signal lines 11,12 guided along the
inward facing side 6 of the inner membrane 2.
Pressure sensors 13, 14 are moreover arranged on the inward facing side 6 of the,
inner membrane 2 for measuring the systolic and diastolic blood pressure, which are
likewise connected to the not shown external control unit by signal lines 15, 16
guided along the inward facing side 6 of inner membrane 2. In the implanted state,
these signal lines 11,12 and 15, 16 as well as a fluid tube 22 for inflating/deflating
the cavity 4 run through an insertion catheter 21 in the skin beside the patient's
sternum.
Figure 2 shows a schematic representation of the location of an implanted double
membrane 1 in a stylized patient torso as well as an external control and drive unit
23 supplied by the signal lines 11,12 and 15, 16 and the fluid tube 22 by means of
insertion catheter 21.
Figure 3 shows the opened torso of a patient with a schematically-depicted double
membrane 1 of the present invention projected thereon. The functional elements
7, 8 and 13, 14 as well as the cavity 4 are connected via fluid tube 22
(schematically depicted here by just a line) and via signal lines 11, 12 and 15, 16 to
a common connector plug 17 by means of which the signal lines and the fluid tube
can in turn be readily connected to the external control and drive unit 23 (not
shown in this figure).
Figure 4 shows the heart of a patient with a schematically-depicted surrounding
double membrane 1, the cavity 4 of which is in turn inflatable.and deflatable by
means of the fluid tube 22. This embodiment of double membrane 1 comprises
variable recesses 18, 19, 20 in the area of the large coronary artery in order to
avoid external compression of the epicardial vessels. These recesses 18, 19, 20 are
customizable to the specific requirements of a patient's heart by means of
displaceable supports which are not shown here.

WE CLAIM
1. A device for one of epicardial support and assuming of cardiac activity,
comprising:
a double membrane formed of an elastic inner membrane and a non-
expandable outer membrane with a closed cavity being formed
therebetween which can be inflated and deflated by means of a fluid;
wherein at least one probe/electrode unit is arranged on an inward facing
side of the inner membrane for at least one of epicardial ECG leads and
signal transmission/conversion of an external pacemaker
wherein variable recesses are provided in the double membrane in an
area which, in use, is located in an area of the large coronary artery, the
variable recesses being configured to be placed in their desired position
between the membranes by displaceable supports confined within the
closed cavity formed between the membranes.
2. The device as claimed in claim 1, wherein at least one said
probe/electrode unit is provided for allocation to each of two ventricles.
3. The device as claimed in claim 1, wherein signal lines to the
probe/electrode units are guided along the inward facing side of the inner
membrane.
4. The device as claimed in claim 1, wherein pressure sensors are arranged
on the inner membrane to measure systolic and diastolic blood pressure.

5. The device as claimed in claim 4, wherein signal lines to the pressure
sensors are guided along the inward facing side of the inner membrane.
6. The device as claimed in claim 3, wherein a common connector plug is
provided for the signal lines.
7. The device as claimed in claim 4, wherein the double membrane is
collapsible and the probe/electrode units as well as the pressure sensors
are configured for enabling implantation as well as their explantation
thereof via percutaneous cannulation.
8. The device as claimed in claim 1, wherein the displaceable supports
comprise mechanically manipulatable collapsible flexible bars or half-
tubes.
9. The device as claimed in claim 8, wherein the collapsible flexible bars or
half-tubes are fixable in the desired position by one of self-adhering
properties of the flexible bars or half-tubes, a tissue adhesive, and a
support rail or grooves within the double membrane.


The invention relates to a device for epicardial support and/or resumption of
cardiac activity. Said device comprises a double membrane (1) consisting of an
elastic internal membrane (2), a non-expandable outer membrane (3), and a
closed cavity (4) which is formed thereinbetween and can be inflated and
deflated by means of a fluid. The aim of the invention is to improve one such
device such that, in the critical post-operative phase, the heart can be stimulated
in a simple manner. To this end, at least one probe/electrode unit (7, 8) for the
epicardial derivation of the ECG and/or the signal transmission and conversion of
an external pacemaker is arranged on the inner side (6) of the inner membrane
(2) facing the heart (5).

Documents:

03303-kolnp-2006 abstract.pdf

03303-kolnp-2006 claims.pdf

03303-kolnp-2006 correspondence others.pdf

03303-kolnp-2006 description(complete).pdf

03303-kolnp-2006 drawings.pdf

03303-kolnp-2006 form-1.pdf

03303-kolnp-2006 form-2.pdf

03303-kolnp-2006 form-3.pdf

03303-kolnp-2006 form-5.pdf

03303-kolnp-2006 international publication.pdf

03303-kolnp-2006 international search authority report.pdf

03303-kolnp-2006 priority document.pdf

03303-kolnp-2006-correspondence-1.1.pdf

03303-kolnp-2006-correspondence-1.2.pdf

03303-kolnp-2006-form-18.pdf

03303-kolnp-2006-form-26.pdf

3303-KOLNP-2006-(03-01-2013)-FORM-27.pdf

3303-KOLNP-2006-(08-02-2012)-ABSTRACT.pdf

3303-KOLNP-2006-(08-02-2012)-AMANDED CLAIMS.pdf

3303-KOLNP-2006-(08-02-2012)-DESCRIPTION (COMPLETE).pdf

3303-KOLNP-2006-(08-02-2012)-DRAWINGS.pdf

3303-KOLNP-2006-(08-02-2012)-EXAMINATION REPORT REPLY RECIEVED.pdf

3303-KOLNP-2006-(08-02-2012)-FORM 1.pdf

3303-KOLNP-2006-(08-02-2012)-FORM 2.pdf

3303-KOLNP-2006-(08-02-2012)-FORM 3.pdf

3303-KOLNP-2006-(08-02-2012)-OTHERS.pdf

3303-KOLNP-2006-(08-02-2012)-PETITION UNDER RULE 137.pdf

3303-KOLNP-2006-CORRESPONDENCE 1.2.pdf

3303-KOLNP-2006-CORRESPONDENCE-1.1.pdf

3303-KOLNP-2006-CORRESPONDENCE.pdf

3303-KOLNP-2006-ENGLISH TRANSLATION.pdf

3303-KOLNP-2006-EXAMINATION REPORT.pdf

3303-KOLNP-2006-FORM 18.pdf

3303-KOLNP-2006-FORM 26.pdf

3303-KOLNP-2006-FORM 3.pdf

3303-KOLNP-2006-FORM 5.pdf

3303-KOLNP-2006-GRANTED-ABSTRACT.pdf

3303-KOLNP-2006-GRANTED-CLAIMS.pdf

3303-KOLNP-2006-GRANTED-DESCRIPTION (COMPLETE).pdf

3303-KOLNP-2006-GRANTED-DRAWINGS.pdf

3303-KOLNP-2006-GRANTED-FORM 1.pdf

3303-KOLNP-2006-GRANTED-FORM 2.pdf

3303-KOLNP-2006-GRANTED-SPECIFICATION.pdf

3303-KOLNP-2006-OTHERS.pdf

3303-KOLNP-2006-REPLY TO EXAMINATION REPORT.pdf

abstract-03303-kolnp-2006.jpg


Patent Number 252474
Indian Patent Application Number 3303/KOLNP/2006
PG Journal Number 20/2012
Publication Date 18-May-2012
Grant Date 17-May-2012
Date of Filing 10-Nov-2006
Name of Patentee PPA TECHNOLOGIES AG
Applicant Address SCHILLERSTRASSE 1, 07745 JENA. GERMANY
Inventors:
# Inventor's Name Inventor's Address
1 FERRARI, MARKUS BARENGASSE 13, 07745 JENA GERMANY
PCT International Classification Number A61M1/10; A61N1/362
PCT International Application Number PCT/EP2005/005051
PCT International Filing date 2005-05-10
PCT Conventions:
# PCT Application Number Date of Convention Priority Country
1 102004023190.7 2004-05-11 Germany