ASSEMBLY FOR A CLOSURE DEVICE WHICH IS IMPLANTABLE IN THE SUPERIOR OR INFERIOR VENA CAVA OF A HUMAN BODY IN A MINIMALLY INVASIVE MANNER, AND TRICUSPID VALVE PROSTHESIS WHICH IS IMPLANTABLE IN A MINIMALLY INVASIVE MANNER

20230181315 · 2023-06-15

Assignee

Inventors

Cpc classification

International classification

Abstract

A minimally-invasive implantable closing device (1) in the superior or inferior vena cava of a human body, with a valve device (6) and an anchoring device (7). The valve device (6) has closing elements and a support structure. The closing elements extend flat over a respective joint surface and in each case can be moved between a closed position, in which the closing elements together close a valve opening, and an open position, in which a flow is released through the valve opening. Further, a minimally-invasive implantable tricuspid valve prosthesis is provided.

Claims

1. Arrangement of a minimally-invasive implantable closing device (1) in the superior or inferior vena cava of a human body, with: a valve device (6), having closing elements (10), which extend flat over a respective joint surface and in each case can be moved between a closed position, in which the closing elements (10) together close a valve opening, and an opening position, in which a flow is released through the valve opening; and a support structure (12), which is arranged in the area of the valve opening and is formed with support elements (11) and at least one indentation (20), wherein the closing elements (10) in the closed position  rest at least partially on the support elements (11), and in the open position, they are separated at least partially from the support elements (11) and thus release the indentation (20) to allow flow; and an anchoring device (7), which has an anchor and is set up to anchor the valve device (6) in the area of the superior or inferior vena cava adjacent to the vein opening in the right chamber of the heart.

2. Arrangement according to claim 1, characterized in that adjacent closing elements (10) overlap in edge-side sections (13a) at least in the closed position, and the support elements (11) extend at least along the overlapping edge-side sections (13a).

3. Arrangement according to claim 1, characterized in that the valve device (6) is formed as a one-way valve.

4. Arrangement according to claim 1, characterized in that the closing elements (10) in each case comprise a sector surface, wherein adjacent closing elements overlap along the radii (10b, 10c) laterally bounding the sector surface.

5. Arrangement according to claim 4, characterized in that the closing elements (10) in each case comprise a sector of at least approximately 90 degrees.

6. Arrangement according to claim 1, characterized in that the closing elements (10) are fastened at least in sections along an outside circumferential edge in such a way that a section of the closing element (10) that is radially inside relative to the circumferential edge can swing open into the open position and can thus release the flow.

7. Arrangement according to claim 1, characterized in that the indentation (22) of the support structure (12) is formed with a flow nozzle (50).

8. Arrangement according to claim 1, characterized in that the support structure (12) has support elements (11), which extend in a star shape.

9. Arrangement according to claim 1, characterized in that the support structure (12) supports the closing elements (10) in the closed position in an essentially two-dimensional flat plane.

10. Arrangement according to claim 1, characterized in that the support structure (12) supports the closing elements (10) in the closed position in a curved three-dimensional plane.

11. Arrangement according to claim 1, characterized by a flexible packing collar (8).

12. Arrangement according to claim 1, characterized in that the anchoring device (7) has at least one of the following anchoring sections: a first anchoring section, which is covered with pericardium or a synthetic membranous plastic material, and a second anchoring section, which is free of pericardium and the synthetic membranous plastic material.

13. Arrangement according to claim 1, characterized in that the anchor is formed with a self-expanding anchor.

14. Arrangement according to claim 1, characterized in that some or all of the closing elements (10) consist of a biological material.

15. Minimally-invasive implantable tricuspid valve prosthesis, with an arrangement according to claim 1.

Description

DESCRIPTION OF EMBODIMENTS

[0027] Below, additional embodiments are explained in greater detail with reference to the figures of a drawing. In this case:

[0028] FIG. 1 shows a diagrammatic perspective depiction of a closing device that is implanted in the area of a vein;

[0029] FIG. 2 shows a diagrammatic depiction of a valve device in a closed position from above, in which the closing elements rest on a support surface;

[0030] FIG. 3 shows a diagrammatic perspective depiction of a support structure for closing elements with a support designed in three dimensions;

[0031] FIG. 4 shows a diagrammatic perspective depiction of a support structure with a support designed in two dimensions;

[0032] FIG. 5 shows a diagrammatic depiction of the valve device of FIG. 2 in an open position, in which the closing elements are arranged at least partially raised from the support structure;

[0033] FIG. 6 shows a diagrammatic depiction of a closing element, which is attached along a part of the outer circular arc; and

[0034] FIG. 7 shows a diagrammatic depiction of a section of the support structure with a flow nozzle and support elements starting therefrom in a star shape.

[0035] FIG. 1 shows a diagrammatic perspective depiction of a minimally-invasive implantable closing device 1 in the area of a vein 2. By means of the closing device 1, the flow into the vein can be opened and closed, wherein flow can take place only in the flow or stream direction that is shown in FIG. 1 by means of arrow A. In the opposite direction, the closing device 1 closes and thus prevents any backflow.

[0036] A section of a vena cava 3, a section of a hepatic vein 4, as well as a section of the right chamber of the heart 5 are shown.

[0037] The closing device 1 has a valve device 6, an anchoring device 7, as well as a flexible sealing ring 8, which is formed in a circumferential manner. In the embodiment that is shown, the anchoring device 7 is formed as a self-expanding anchor that has a spiral 9.

[0038] FIG. 2 shows a diagrammatic depiction of the valve device 6 in a closed position, in which no flow takes place, from above. In the closed position that is shown, closing elements 10 rest on support elements 11 of a support structure 12, for which FIGS. 3 and 4 show different embodiments. In this case, the closing elements 10 come to rest in overlapping areas 13 on the support elements 11, in which edge-side sections 13a of the closing elements 10 overlap. In the embodiment shown, the closing elements 10 are formed as sectors that are bounded in each case by a circular arc 10a and two radii 10b, 10c. In the area of the radii 10b, 10c, the overlapping areas 13 are made between adjacent closing elements 10. In the embodiment shown, the sectors of the closing elements 10 in each case comprise an area of somewhat more than 120 degrees in order to form the overlapping areas 13.

[0039] The support elements 11 of the support structure 12 extend in a star shape starting from a central area 14 and are arranged in a circumferential manner at equal intervals. The support structure has a circumferential edge 15 (cf. in particular FIGS. 3 and 4).

[0040] FIGS. 3 and 4 show diagrammatic perspective depictions of various embodiments for the support structure 12. For the same features, the same reference numbers are used in FIGS. 3 and 4. In a first embodiment of the support structure 12 according to FIG. 3, a support 20 designed in three dimensions is formed for the closing elements 10. An opening surface 21 of an indentation 22 in the central area 14 in the stream or flow direction is arranged offset relative to the valve opening surface, which is surrounded by the circumferential edge 15. FIG. 4, however, shows an alternative embodiment of the support structure 12, in which a flat support 30 designed in two dimensions is provided for the closing elements 10.

[0041] FIG. 5 shows a diagrammatic perspective depiction of the valve device 6 in an open position, in which the closing elements 10 are raised (swung open) at least in the central area 14 by the support elements 11 of the support structure 12, so that the indentation 22 as well as additional indentation areas 17 of the support structure 12 are released, and flow can take place.

[0042] According to the exemplary embodiment in FIG. 5, a sieve insert 18 is provided in the area of the valve opening, which can be connected detachably or non-detachably to the support structure 12.

[0043] In the embodiment that is shown, the closing elements 10 are designed as non-surface-rigid closing elements that bend upward in order to release the flow. To this end, the closing elements 10 consist of, for example, a plastic material.

[0044] The closing elements 10 can be arranged on the support structure 12 by means of a joint connection, for example by means of gluing or welding. FIG. 6 shows diagrammatically a closing element 10, which is designed as a sector. The closing element 10 is fastened to the support structure 12 along a connecting area 40, which extends along the circular arc 10a. Outside of the connecting area 40, the closing element 10 is free of a connection with the support structure 12, in particular even in corner areas 41, 42, in which the radii 10b, 10c as well as the circular arc 10a of the sector meet.

[0045] FIG. 7 shows a cutaway of the support structure 12 in the central area 14 with the indentation 22, which in the embodiment that is shown is formed with a flow nozzle 50. Starting from the flow nozzle 50, support elements 11 extend in a star shape. In the depicted configuration, the support elements 11 are tapered, which elements are designed as, e.g., a carrier that operates the support 20.

[0046] The features disclosed in the description above, the claims, as well as the drawing can be important both individually and in any combination for the implementation of the various embodiments.