Title of Invention	DEVICE FOR EPICARDIAL SUPPORT AND/OR THE ASSUMING OF CARDIAC ACTIVITY
Abstract	A device for epicardial support and/or the assuming 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 exhibiting a first chamber (6) allocated to the right ventricle (5) and a second chamber (8) allocated to the left ventricle (7). With the objective of further developing a device of the type as indicated at the outset so that same provides for simple device operability while maintaining the advantage of being able to augment only one ventricle, it is provided for the first chamber (6) and the second chamber (8) to be connected to one another by means of at least one valve (9) in a dividing wall (10) separating the two chambers (6, 8).

Title of Invention

DEVICE FOR EPICARDIAL SUPPORT AND/OR THE ASSUMING OF CARDIAC ACTIVITY

Abstract

A device for epicardial support and/or the assuming 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 exhibiting a first chamber (6) allocated to the right ventricle (5) and a second chamber (8) allocated to the left ventricle (7). With the objective of further developing a device of the type as indicated at the outset so that same provides for simple device operability while maintaining the advantage of being able to augment only one ventricle, it is provided for the first chamber (6) and the second chamber (8) to be connected to one another by means of at least one valve (9) in a dividing wall (10) separating the two chambers (6, 8).

Full Text	WO 2005/110513 PCTEP2005/005052 "Device for cpicardial support and/or the assuming of cardiac activity" 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 exhibiting a first chamber allocated to the right ventricle and a second chamber allocated to the left ventricle. Such a device - although one which works pericardially - is known for example from the document DE 199 51 220 Al. 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 pericardial sac at the end of an operation with the double membrane surrounding the right and left ventricles. 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 or 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, when the heart is pumping, aids in the systolic ejection of the cardiac muscle. A device for supporting cardiac activity is known from US-PS 5,169,381 A which has a double membrane comprising an inner and an outer membrane as well as a closed cavity formed therebetween which can be inflated and deflated by means of a fluid. This double membrane has an axially-extending wedge-shaped slot spanning ##VA of the vertical extension of the double membrane and is furthermore provided with a first chamber allocated to the right ventricle and a second chamber allocated -2- to the left ventricle. Each of these two chambers are supplied with fluid separately, which entails a double expenditure of fluid tubes and valves and results in the device as a whole being relatively complicated in its operation. Against the background of the disadvantages of the latter device for supporting cardiac activity as described, the task on which the present invention is based is that of providing simple operabilily of the device while maintaining the advantage of being able to augment only one ventricle. This object is solved by a device for the epicardial support of cardiac activity of the type as indicated at the outset according lo the invention in that the first chamber and the second chamber are connected to one another by means of at least one valve in a dividing wall separating the two chambers. The advantage of the device according to the invention is in particular in that only one fluid tube is required to inflate and deflate the cavity of the double membrane and yet one ventricle can still be augmented by regional inflation/deflation. The device thus formulated is simple to operate and depending on need, double membranes can be produced which allow the exclusive augmentation of the right ventricle or - in another embodiment - only the left ventricle, both while maintaining the potential to simultaneously support both ventricles. The inventive type of chambering and mechanical modification of the double membrane by at least one internal valve thus enables an isolated augmentation of a single ventricle, whereby the double membrane surrounds the other ventricle for purposes of mechanical stabilization and hence contributes stabilization in the sense of a-support. Thus, in the event of isolated right ventricular failure, a primary augmentation of the right ventricle can follow, while the double membrane only passively wraps the left ventricle. Opening or closing the valve enables switching between the two operating modes thus given; i.e. "full augmentation" or "regional augmentation." Advantageous embodiments of the invention are specified in subclaims 2 to 4. The valve which connects the two chambers together and which is arranged in the dividing wall separating the two chambers is preferably externally opened and closed in a controlled manner. That means that the valve can be operated for -3- example by means of an IR signal or by means of a radio signal. The advantage to this further development is that there is then no need for an additional control line for the valve, hence avoiding a further risk for the patient. 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 of 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 with augmentation of only the right ventricle in the systolic phase; Fig. 2: a comparable representation to Fig. 1 in the diastolic phase; and Fig. 3: 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 through fluid tube 15. Cavity 4 is divided into a first chamber 6 allocated to the right ventricle 5 and a second chamber 8 allocated to the left ventricle 7 by a dividing wall 10. Both chambers 6, 8 are connected together by means of at least one valve 9 arranged in the dividing wall 10. Valve 9 or all the valves arranged in the dividing wall respectively (only one is depicted here) can thereby be externally opened and closed in a controlled manner, for example by IR or radio signal. -4- The three arrows within the inflated chamber 6 of the right ventricle 5 pointing inward toward the heart 14 indicate that the representation reflects a snapshot ofthe systolic phase with" augmentation of only the right ventricle 5 by regional inflation of double membrane 1. Figure 2 shows a representation comparable to that of Fig. 1 in the diastolic phase. Here the filling of the right ventricle 5 is augmented by the deflation of the right chamber 6 of double membrane I. In cases where only an augmentation of the right ventricle 5 is desired, the valve 9 in dividing wall 10 remains closed. Only when an augmentation of both ventricles 5, 7 is desired is both the first chamber 6 as well as also the second chamber 8 then inflated/deflated. Figure 3 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 exhibits variable recesses 11, 12, 13 in the area ofthe large coronary artery in order to avoid external compression ofthe epicardial vessels. These recesses 11, 12, 13 are customizable to the specific requirements of a patient's heart by means of displaceablc supports which are not shown here. -5- "Device for epicardial support and/or the assuming of cardiac activity" Claims 1. A device for epicardial support and/or the assuming of cardiac activity having a double membrane (I) 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 exhibiting a first chamber (6) allocated to the right ventricle (5) and a second chamber (8) allocated to the left ventricle (7), characterized in that the first chamber (6) and the second chamber (8) are connected to one another by means of at least one valve (9) in a dividing wall (10) separating the two chambers (6, 8). 2. The device according to claim 1, characterized in that the valve (9) is externally opened and closed in a controlled manner. 3. The device according to claim 1 or 2, characterized in that recesses (11, 12, 13) are provided in the double membrane (1) in the area of the large-coronary artery. 4. The device according to claim 3, characterized in that displaceable supports are provided by means of which the recesses (11, 12, 13) can be adapted to the requirements of a patient's heart. A device for epicardial support and/or the assuming 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 exhibiting a first chamber (6) allocated to the right ventricle (5) and a second chamber (8) allocated to the left ventricle (7). With the objective of further developing a device of the type as indicated at the outset so that same provides for simple device operability while maintaining the advantage of being able to augment only one ventricle, it is provided for the first chamber (6) and the second chamber (8) to be connected to one another by means of at least one valve (9) in a dividing wall (10) separating the two chambers (6, 8).

Full Text

WO 2005/110513 PCTEP2005/005052
"Device for cpicardial support and/or the assuming of cardiac activity"
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 exhibiting a first chamber allocated to the right ventricle and a second chamber allocated to the left ventricle.
Such a device - although one which works pericardially - is known for example from the document DE 199 51 220 Al. 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 pericardial sac at the end of an operation with the double membrane surrounding the right and left ventricles. 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 or 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, when the heart is pumping, aids in the systolic ejection of the cardiac muscle.
A device for supporting cardiac activity is known from US-PS 5,169,381 A which has a double membrane comprising an inner and an outer membrane as well as a closed cavity formed therebetween which can be inflated and deflated by means of a fluid. This double membrane has an axially-extending wedge-shaped slot spanning ##VA of the vertical extension of the double membrane and is furthermore provided with a first chamber allocated to the right ventricle and a second chamber allocated

-2-
to the left ventricle. Each of these two chambers are supplied with fluid separately, which entails a double expenditure of fluid tubes and valves and results in the device as a whole being relatively complicated in its operation.
Against the background of the disadvantages of the latter device for supporting cardiac activity as described, the task on which the present invention is based is that of providing simple operabilily of the device while maintaining the advantage of being able to augment only one ventricle.
This object is solved by a device for the epicardial support of cardiac activity of the type as indicated at the outset according lo the invention in that the first chamber and the second chamber are connected to one another by means of at least one valve in a dividing wall separating the two chambers.
The advantage of the device according to the invention is in particular in that only one fluid tube is required to inflate and deflate the cavity of the double membrane and yet one ventricle can still be augmented by regional inflation/deflation. The device thus formulated is simple to operate and depending on need, double membranes can be produced which allow the exclusive augmentation of the right ventricle or - in another embodiment - only the left ventricle, both while maintaining the potential to simultaneously support both ventricles.
The inventive type of chambering and mechanical modification of the double membrane by at least one internal valve thus enables an isolated augmentation of a single ventricle, whereby the double membrane surrounds the other ventricle for purposes of mechanical stabilization and hence contributes stabilization in the sense of a-support. Thus, in the event of isolated right ventricular failure, a primary augmentation of the right ventricle can follow, while the double membrane only passively wraps the left ventricle. Opening or closing the valve enables switching between the two operating modes thus given; i.e. "full augmentation" or "regional augmentation."
Advantageous embodiments of the invention are specified in subclaims 2 to 4.
The valve which connects the two chambers together and which is arranged in the dividing wall separating the two chambers is preferably externally opened and closed in a controlled manner. That means that the valve can be operated for

-3-
example by means of an IR signal or by means of a radio signal. The advantage to this further development is that there is then no need for an additional control line for the valve, hence avoiding a further risk for the patient.
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 of 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 with
augmentation of only the right ventricle in the systolic phase;
Fig. 2: a comparable representation to Fig. 1 in the diastolic phase; and
Fig. 3: 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 through fluid tube 15. Cavity 4 is divided into a first chamber 6 allocated to the right ventricle 5 and a second chamber 8 allocated to the left ventricle 7 by a dividing wall 10. Both chambers 6, 8 are connected together by means of at least one valve 9 arranged in the dividing wall 10. Valve 9 or all the valves arranged in the dividing wall respectively (only one is depicted here) can thereby be externally opened and closed in a controlled manner, for example by IR or radio signal.

-4-

The three arrows within the inflated chamber 6 of the right ventricle 5 pointing
inward toward the heart 14 indicate that the representation reflects a snapshot ofthe systolic phase with" augmentation of only the right ventricle 5 by regional inflation of double membrane 1.
Figure 2 shows a representation comparable to that of Fig. 1 in the diastolic phase. Here the filling of the right ventricle 5 is augmented by the deflation of the right chamber 6 of double membrane I. In cases where only an augmentation of the right ventricle 5 is desired, the valve 9 in dividing wall 10 remains closed. Only when an augmentation of both ventricles 5, 7 is desired is both the first chamber 6 as well as also the second chamber 8 then inflated/deflated.
Figure 3 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 exhibits variable recesses 11, 12, 13 in the area ofthe large coronary artery in order to avoid external compression ofthe epicardial vessels. These recesses 11, 12, 13 are customizable to the specific requirements of a patient's heart by means of displaceablc supports which are not shown here.

-5-
"Device for epicardial support and/or the assuming of cardiac activity"
Claims
1. A device for epicardial support and/or the assuming of cardiac activity having a double membrane (I) 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 exhibiting a first chamber (6) allocated to the right ventricle (5) and a second chamber (8) allocated to the left ventricle (7),
characterized in that
the first chamber (6) and the second chamber (8) are connected to one another by means of at least one valve (9) in a dividing wall (10) separating the two chambers (6, 8).
2. The device according to claim 1,
characterized in that
the valve (9) is externally opened and closed in a controlled manner.
3. The device according to claim 1 or 2,
characterized in that
recesses (11, 12, 13) are provided in the double membrane (1) in the area of the large-coronary artery.
4. The device according to claim 3,
characterized in that
displaceable supports are provided by means of which the recesses (11, 12, 13) can be adapted to the requirements of a patient's heart.
A device for epicardial support and/or the assuming 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 exhibiting a first chamber (6) allocated to the right ventricle (5) and a second chamber (8) allocated to the left ventricle (7). With the objective of further developing a device of the type as indicated at the outset so that same provides for simple device operability while maintaining the advantage of being able to augment only one ventricle, it is provided for the first chamber (6) and the second chamber (8) to be connected to one another by means of at least one valve (9) in a dividing wall (10) separating the two chambers (6, 8).

Documents:

03304-kolnp-2006-abstract.pdf

03304-kolnp-2006-claims.pdf

03304-kolnp-2006-correspondence others-1.1.pdf

03304-kolnp-2006-correspondence others.pdf

03304-kolnp-2006-correspondence-1.1.pdf

03304-kolnp-2006-description(complete).pdf

03304-kolnp-2006-drawings.pdf

03304-kolnp-2006-form-1.pdf

03304-kolnp-2006-form-18.pdf

03304-kolnp-2006-form-2.pdf

03304-kolnp-2006-form-26.pdf

03304-kolnp-2006-form-3.pdf

03304-kolnp-2006-form-5.pdf

03304-kolnp-2006-international publication.pdf

03304-kolnp-2006-international search authority report.pdf

03304-kolnp-2006-others document.pdf

3304-KOLNP-2006-(03-01-2013)-FORM-27.pdf

3304-KOLNP-2006-(08-02-2012)-ABSTRACT.pdf

3304-KOLNP-2006-(08-02-2012)-AMANDED CLAIMS.pdf

3304-KOLNP-2006-(08-02-2012)-DESCRIPTION (COMPLETE).pdf

3304-KOLNP-2006-(08-02-2012)-EXAMINATION REPORT REPLY RECIEVED.pdf

3304-KOLNP-2006-(08-02-2012)-FORM 1.pdf

3304-KOLNP-2006-(08-02-2012)-FORM 2.pdf

3304-KOLNP-2006-(08-02-2012)-FORM 3.pdf

3304-KOLNP-2006-(08-02-2012)-OTHERS.pdf

3304-KOLNP-2006-(08-02-2012)-PETITION UNDER RULE 137.pdf

3304-KOLNP-2006-CORRESPONDENCE.pdf

3304-KOLNP-2006-EXAMINATION REPORT.pdf

3304-KOLNP-2006-FORM 18.pdf

3304-KOLNP-2006-FORM 26.pdf

3304-KOLNP-2006-FORM 3.pdf

3304-KOLNP-2006-FORM 5.pdf

3304-KOLNP-2006-GRANTED-ABSTRACT.pdf

3304-KOLNP-2006-GRANTED-CLAIMS.pdf

3304-KOLNP-2006-GRANTED-DESCRIPTION (COMPLETE).pdf

3304-KOLNP-2006-GRANTED-DRAWINGS.pdf

3304-KOLNP-2006-GRANTED-FORM 1.pdf

3304-KOLNP-2006-GRANTED-FORM 2.pdf

3304-KOLNP-2006-GRANTED-LETTER PATENT.pdf

3304-KOLNP-2006-GRANTED-SPECIFICATION.pdf

3304-KOLNP-2006-OTHERS.pdf

3304-KOLNP-2006-REPLY TO EXAMINATION REPORT.pdf

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Patent Number

252090

Indian Patent Application Number

3304/KOLNP/2006

PG Journal Number

17/2012

Publication Date

27-Apr-2012

Grant Date

25-Apr-2012

Date of Filing

10-Nov-2006

Name of Patentee

PPA TECHNOLOGIES AG.

Applicant Address

Schillerstrasse 1, 07745 Jena

Inventors:

#	Inventor's Name	Inventor's Address
1	FERRARI, MARKUS	Barengasse 13, 07747 Jena

PCT International Classification Number

A61M1/10

PCT International Application Number

PCT/EP2005/005052

PCT International Filing date

2005-05-10

PCT Conventions:

#	PCT Application Number	Date of Convention	Priority Country
1	102004023192.3	2004-05-11	Germany