Implantable device for the locationally accurate delivery and administration of substances into the pericardium or onto the surface of the heart

Abstract

The present invention relates to a device for the administration of substances onto the epicardial surface of the heart. The device comprises a frame structure which is able to assume shaping, positioning, guiding and stabilizing functions. The frame structure may contain at least one sleeve. The device comprises a substance carrier which is able to accommodate the substance to be administered.

Description

PRIORITY CLAIM[0001]The present application claims priority to German patent application serial no. DE 102015212699.4, filed Jul. 7, 2015, the entire contents of which is incorporated herein by reference and relied upon.BACKGROUND[0002]The invention is for use in the treatment of cardiac insufficiency, for example following previous myocardial infarction. It is intended to support the pumping function of the heart, increase it or regenerate damaged heart tissue and hence to reduce insufficiency over the medium and long term or prevent the terminal stage being reached.[0003]Cardiovascular diseases such as terminal cardiac insufficiency or myocardial infarction are the main cause of death worldwide (Behfar, A. and A. Terzic. Nature clinical practice Cardiovascular medicine 3 Suppl 1, pp. 78-82, 2006). 32% of worldwide deaths are the result of cardiovascular diseases (World Health Statistics, http: / / apps.who.int / iris / bitstream / 10665 / 81965 / 1 / 9789241564588_eng.pdf (2013)2013). 40% of all...

AI Technical Summary

Benefits of technology

[0018]The substance carrier may have a delivery line for filling and emptying the substance carrier with a substance to be administered. The substance carrier may have a spongy or porous structure. This increases the surface area and storage capacity of the substance carrier. Such a structure is also advantageous when administering cells because cells adhere and / or proliferate better in such structures.

[0025]The device for the administration of a substance onto a surface of the heart may comprise further components. For example, lines may be provided for delivering and discharging the substance to be administered. Mechanical forces may also be exerted on the administered substances or the epicardial heart surface of the myocardium. The forces may be built up by the expandable units. Alternatively or in addition, forces may be built up on the substance carrier which improve administration.

[0028]A further aspect of the device according to the invention is the fact that it may have devices which minimize the risk of damage to the surrounding tissue caused by pointed or sharp-edged components of the frame structure produced in the manufacturing process.

Problems solved by technology

The primary symptom is reduced pumping performance of the heart.

As a result, the thickness of the wall of the heart decreases, contractility falls and pumping performance therefore declines further.

This downward spiral culminates in heart failure or the failure of other organs owing to a lack of oxygen and nutrients.

However, there is a large demand for donor hearts and only insufficient supply (Sasaki, D. and T. Okano, Embryonic Stem Cells—Recent Advances in Pluripotent Stem Cell-Based Regenerative Medicine, 65-80, 2011).

However, the above methods only delay the development of insufficiency, they do not stop it or cure the disease (Christoforou et al., 2013).

In a heart attack, the sudden closure of at least one coronary artery leads to the death of heart muscle cells.

The limited ability of the damaged heart muscle tissue to regenerate prevents full and independent recovery.

They disclose devices which have the disadvantage that their implantation requires an open-chest operation.

They are also complex and can only be implanted by means of a complicated surgical operation.

Contact between the blood and the exogenous surfaces of the systems is a considerable technical and medical challenge.

Common complications of these systems are strokes, internal bleeding and infections.

They often result in long-term hospitalization and frequent readmission of patients who have just been released from hospital.

Other known cardiac support devices, such as the devices disclosed in US 2008 / 0021266 A1, DE 10 2009 043 795 A1, US 2004 / 0267329 A1, US 2005 / 0107661 A1, US 2006 / 0217774 A1, US 2007 / 0197859 A1, US 2009 / 0036730 A1, US 2011 / 0021864 A1, U.S. Pat. No. 8,944,987 B2 and EP 2482865 B1, have the disadvantage that no embodiments exist which prevent the spatial impairment of the inferior vena cava by the implanted device.

Spatial impairment of the inferior vena cava by the device would lead to inferior cava syndrome (obstruction of the filling of the right atrium).

A further disadvantage of known cardiac support systems is that no precautions are taken against dislocation of the device in relation to the heart.

Dislocation leads to a poorer fit of the device to the heart and to a loss of support.

Nor are any of these devices self-expanding, that is to say they can only be put into their target position, in which they surround the heart, with the aid of further devices.

Other known cardiac support systems, such as the devices disclosed in EP 2752208 A1, are self-expanding and have a recess which prevents the inferior vena cava or other anatomical features near the heart from being spatially impaired, but they lack the ability to administer substances, such as pharmaceutical active agents, locationally accurately and in a targeted manner onto the epicardium.

Injecting cells into the coronary artery can lead to the artery becoming blocked.

Because of the movement of the heart, these methods carry a high risk of tissue or vascular damage and of wrongly administered injections without resulting in more successful treatment (Jawad, H., A. R. Lyon, S. E. Harding, N. N. Ali and A. R. Boccaccini, 2008, Myocardial tissue engineering.

None of the disclosed devices can administer substances via an implantable device into the pericardial cavity or onto the surface of the heart.

Nor can any of the disclosed devices deliver or remove substances already administered to the pericardial cavity after implantation.

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