EP4153093A1

EP4153093A1 - 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

Info

Publication number: EP4153093A1
Application number: EP21731899.7A
Authority: EP
Inventors: Christian Butter
Original assignee: Immanuel Albertinen Diakonie GmbH
Current assignee: Immanuel Albertinen Diakonie GmbH
Priority date: 2020-05-19
Filing date: 2021-05-18
Publication date: 2023-03-29
Also published as: CN115666448A; DE102020113585A1; CA3178779A1; WO2021233502A1; JP2023526079A; US20230181315A1

Abstract

The invention relates to an assembly for a closure device (1) which is implantable in the superior or inferior vena cava of a human body in a minimally invasive manner, with a valve device (6) and an anchoring device (7). The valve device (6) has closure elements and a support structure. The closure elements extend two-dimensionally over a respective element surface and are each transferable between a closed position, in which the closure elements together close a valve opening, and an open position, in which a flow through the valve opening is enabled. The support structure is arranged in the region of the valve opening and is formed with support elements and with at least one passage, wherein the closure elements, in the closed position, bear at least partially on the support elements and, in the open position, are at least partially spaced apart from the support elements and thus enable the flow through the passage. The anchoring device (7) has an anchor and is designed to anchor the valve device (6) in the region of the superior or inferior vena cava, adjacent to the vein aperture into the right atrium of the heart. The invention further relates to a tricuspid valve prosthesis which can be implanted in a minimally invasive maner.

Description

Arrangement for a closure device which can be implanted minimally invasively in the upper or lower vena cava of a human body and a minimally invasively implantable tricuspid valve prosthesis

The invention relates to an arrangement for a closure device that can be implanted minimally invasively in the upper or lower vena cava of a human body, and a tricuspid valve prosthesis that can be implanted minimally invasively.

background

A minimally invasively implantable mitral or tricuspid valve prosthesis is known from document EP 3 231 393 A1. The valve prosthesis is firmly connected to a self-expanding, wide-meshed stent for positioning and fixing, the shape of which is adapted to a three-dimensionally measured geometry of a patient's left or right atrium and, after implantation, rests against the inner wall of the forecourt.

summary

The object of the invention is to provide an arrangement for a closure device that can be implanted minimally invasively in the upper or lower vena cava of a human body, as well as a minimally invasively implantable tricuspid valve prosthesis that can be reliably localized at the site of implantation and that opens and closes reliably enable.

To solve this, an arrangement is created for a closure device that can be implanted minimally invasively in the upper or lower vena cava of a human body. The independent claim 15 relates to a minimally invasive implantable tricuspid plate prosthesis. Further refinements are the subject of the dependent subclaims.

According to one aspect, an arrangement is created for a closure device that can be implanted minimally invasively in the upper or the inferior vena cava of a human body, which has the following: a valve device, having closure elements which extend flat over a respective element surface and each between a closed position in which the closure elements jointly close a valve opening, and an opening position can be displaced in which a flow through the valve opening is exposed. ben is, and a support structure which is arranged in the region of the valve opening and is formed with support elements and at least one opening. In the closed position, the closure elements rest at least partially on the support elements and, in the open position, are at least partially spaced from the support elements and thus open the opening for the flow. The arrangement also has an anchoring device which is formed with an anchorage and is designed to anchor the valve device in the region of the upper or lower vena cava adjacent to the vein opening to the right atrium of the heart.

According to a further aspect, a minimally invasively implantable tricuspid valve prosthesis with such an arrangement is created.

The proposed closure device can be securely fixed at the implantation site with the aid of the anchoring device. The valve device with the closure elements ensures reliable opening and closing in order to prevent or allow the flow.

In one possible embodiment, the valve opening is designed as a round or circular Ventilöff voltage.

The support structure can be designed to extend over part of the surface of the valve opening or over the entire surface thereof.

The closure elements can be designed as non-rigid closure elements which (optionally additionally) bend in order to pivot open into the open position so that the flow is released. In an alternative embodiment, one or more of the closure elements are essentially rigid in area. In this embodiment, the rigid closure element pivots between the closed and the geöff Neten position, essentially maintaining the surface shape of the closure element in the closed position. To develop the displaceability, in particular special pivotability, a hinge device can be provided, for example.

The opening can be designed with an opening in the area of the center of the valve opening. In addition to the opening, one or more further openings can be provided in the support structure. In one or more of the openings a Sieve insert can be provided, which is detachably or non-detachably arranged in the area of the associated opening on the support structure.

Adjacent closure elements can overlap at least in the closed position in edge-side sections, and the support elements can extend at least along the overlapping edge-side sections. The support elements can optionally run additionally outside the overlap areas in order to also support the closure elements outside the overlap areas.

The valve device can be designed as a one-way valve. This means that the valve device lets through in one flow direction and blocks in the opposite direction, which is achieved with the help of the closure elements resting on the support structure in the closed position, which can at least partially lift off the support structure in the flow direction in order to release the flow.

The closure elements can each be formed to encompass a circular cutout area, with adjacent closure elements overlapping along the radii laterally delimiting the circular cutout area. As a result, the closure elements are designed to be comparable in plan view to the shape of a piece of cake. In the area of a radially inner tip section in which the radii laterally delimiting the circular segment surface intersect, the circular segment surface can be rounded. It can also be provided that a radially inner end section of the circular segment surface is cut off in the region of the tip. The radially inner tip sections of the circular cutout surfaces of the closure elements can overlap in the area of the opening. An overlap area formed in this way can have a size (expansion) of approximately 1 mm to approximately 4 mm in at least one direction, alternatively of approximately 1 mm to approximately 2 mm.

The closure elements can each cover a section of a circle of at least approximately 90 degrees. In this embodiment, four closure elements can be provided in order to jointly close the valve opening in the closed position. This means that at least one or all of the closure elements cover a section of a circle of slightly more than 90 degrees in order to form overlap areas running along the radii. The respective segments of a circle can cover an angle of at most approximately 120 degrees to approximately 130 degrees. The closure elements can be fastened at least in sections along an outer circumferential edge, in such a way that a section of the closure element lying radially inward with respect to the circumferential edge can pivot open into the open position and thus release the flow. The fastening of the closure elements along the outer circumferential edge can be detachable or non-detachable. For the non-releasable connection, for example, a joint connection can be provided, for example by means of gluing or welding. In one embodiment, the closure elements can be molded in one piece onto the anchoring device and / or the support structure, for example by means of 2-component injection molding. Here, the anchoring device and / or on the support structure can be made of a hard plastic component, and the closure elements can be made of a soft plastic component. The fastening of the closure elements along the outer circumferential edge can encompass an arc of about 60 degrees to about 110 degrees, alternatively an arc of about 90 degrees to 110 degrees, for example about 105 degrees. If the closure elements are formed as circular sections, corner areas in which the outer circular arc meets the laterally delimiting radii can be designed so that they are not subject to attachment.

The opening in the support structure can have a throughflow nozzle. In this or other configurations, the opening can be arranged essentially centered in the valve opening. A nozzle surface extending transversely to the direction of flow or throughflow of the valve device can be arranged essentially parallel to the valve opening surface extending transversely to the direction of flow or throughflow. The nozzle surface can lie essentially in the same plane as the valve opening surface. Alternatively, the nozzle surface is arranged offset (at a distance) from the valve opening surface in the flow direction. The offset can be, for example, approximately 5 mm to approximately 12 mm, alternatively approximately 7 mm to approximately 10 mm, for example approximately 8 mm to approximately 9 mm. In this or other embodiments, the opening can be formed with a diameter of approximately 2 mm to approximately 6 mm, alternatively with a diameter of approximately 4 mm to approximately 5 mm. The throughflow nozzle can be designed in a comparable manner.

The support structure can have support elements which extend in a star shape, for example along circular radii of the valve opening. The star-shaped supporting elements, which are designed, for example, as supporting webs, can extend from the opening or the flow-through nozzle to an edge of the supporting structure. The support elements arranged in a star shape can be essentially the same radially circumferentially be spaced apart, for example at a distance of about 90 degrees to about 120 degrees.

The support elements, for example designed as webs, can have a shape tapering towards a support surface in cross-section, the closure elements coming to rest in the closed position in the region of the support surface.

In a plan view of the valve opening, the support elements can have a width of approximately 1 mm to approximately 5 mm, alternatively from approximately 1 mm to approximately 3 mm, for example from approximately 1.5 mm to approximately 2.5 mm. If the support elements are designed as webs, this gives a web width in plan view of the valve opening.

The support structure can support the closure elements in the closed position in a substantially two-dimensional flat plane. In this embodiment, the opening area of the aperture can be located transversely to the direction of flow or flow essentially in the plane of the valve opening area. A flat support surface is provided for the closure elements by means of the support structure.

The support structure can support the closure elements in the closed position in a curved three-dimensional plane. A three-dimensionally shaped support surface is provided for the closure elements by means of the support structure. In this configuration, the support structure can be formed with a bell shape, so that a bell-shaped support surface is provided. It can be provided that the opening surface of the opening or the throughflow nozzle is arranged offset in the throughflow or flow direction relative to the valve opening surface.

A flexible sealing collar can be provided. The flexible sealing collar can be formed circumferentially around the valve device.

The anchoring device can have 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. The anchorage can be formed with a self-expanding anchorage. The self-expanding anchorage can have at least one anchorage from the following group: self-expanding spiral element and self-expanding stent.

Some or all of the closure elements can consist of a biological material. Some of the closure elements can consist of a non-biological material. Alternatively, all closure elements can be made from a non-biological material.

Description of exemplary embodiments

In the following, further exemplary embodiments are explained in more detail with reference to figures of a drawing. Here show:

1 shows a schematic perspective illustration of a closure device implanted in the region of a vein;

2 shows a schematic representation of a valve device in a closed position from above, in which the closure elements rest on a support structure;

3 shows a schematic perspective illustration of a support structure for locking elements with a three-dimensional support;

4 shows a schematic perspective illustration of a support structure with a two-dimensional support;

5 shows a schematic representation of the valve device from FIG. 2 in an open position, in which the closure elements are arranged at least partially lifted from the support structure;

6 shows a schematic illustration of a closure element which is fixed along part of the outer circular arc; and

7 shows a schematic representation of a section of the support structure with a flow nozzle and support elements extending therefrom in a star shape.

1 shows a schematic perspective illustration of a minimally invasively implanted closure device 1 in the region of a vein 2. With the aid of the closure device 1, the flow in the vein can be opened and closed, with a flow only in the area shown in FIG shown flow or flow direction is enabled. The closure device 1 closes in the opposite direction and thus prevents backflow. A section of a vena cava 3, a section of a hepatic vein 4 and a section of the right atrium of the heart 5 are shown.

The closure device 1 has a valve device 6, an anchoring device 7 and a flexible sealing ring 8 which is formed circumferentially. In the embodiment shown, the anchoring device 7 is formed as a self-expanding anchoring with a spiral 9.

Fig. 2 shows a schematic representation of the valve device 6 in a closed position, in which no flow takes place, from above. In the closed position shown, closure elements 10 rest on support elements 11 of a support structure 12, for which FIGS. 3 and 4 show different designs. The closure elements 10 come to rest in overlap regions 13 on the support elements 11, in which edge-side sections 13a of the closure elements 10 overlap. In the embodiment shown, the closure elements 10 are formed as circular sections which are each delimited by a circular arc 10a and two radii 10b, 10c. In the area of the radii 10b, 10c, the overlap areas 13 are formed between adjacent closure elements 10. In the embodiment shown, the circular sections of the locking elements 10 each cover an area of slightly more than 120 degrees in order to form the overlap areas 13.

The support elements 11 of the support structure 12 extend in a star shape starting from a central region 14 and are arranged equally spaced around the circumference. The support structure has a circumferential edge 15 (cf. in particular FIGS. 3 and 4).

3 and 4 show schematic perspective representations of different embodiments for the support structure 12. The same reference numerals are used in FIGS. 3 and 4 for the same features. In a first embodiment of the support structure 12 according to FIG. 3, a three-dimensional support 20 is formed for the closure elements 10. An opening surface 21 of an opening 22 in the central region 14 is arranged offset in the direction of flow or throughflow relative to the valve opening surface, which is surrounded by the circumferential edge 15. On the other hand, FIG. 4 shows an alternative embodiment of the support structure 12, in which a two-dimensional, flat support 30 is provided for the closure elements 10. 5 shows a schematic perspective illustration of the valve device 6 in an open position, in which the closure elements 10 are lifted (pivoted open) from the support elements 11 of the support structure 12 at least in the central region 14, so that the opening 22 and further opening areas 17 of the support structure 12 are released and a flow is enabled.

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

In the embodiment shown, the closure elements 10 are designed as non-rigid closure elements which bend upwards in order to release the flow. For this purpose, the closure elements 10 can be made of a plastic material, for example.

The closure 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 schematically a closure element 10 which is designed as a section of a circle. The closure element 10 is fastened to the support structure 12 along a connection area 40 which extends along the circular arc 10 a. Outside the connection area 40, the closure element 10 is free from a connection with the support structure 12, in particular also in corner areas 41, 42 in which the radii 10b, 10c and the circular arc 10a of the circular segment meet.

7 shows a section of the support structure 12 in the central region 14 with the opening 22 which, in the embodiment shown, is formed with a flow nozzle 50. Starting from the throughflow nozzle 50, support elements 11 extend in a star shape. In the embodiment shown, the support elements 11, which are designed, for example, as webs, taper towards the support 20.

The features disclosed in the above description, the claims and the drawing can be important both individually and in any combination for the implementation of the various designs.

Claims

Expectations

1. Arrangement for a closure device (1) that can be implanted minimally invasively in the upper or lower vena cava of a human body, with:

- A valve device (6), having

- Closing elements (10), which extend flat over a respective element surface and can each be displaced between a closed position in which the closure elements (10) jointly close a valve opening and an open position in which a flow through the valve opening is released is; and

- A support structure (12) which is arranged in the region of the valve opening and is formed with support elements (11) and at least one opening (20), the closure elements (10) resting at least partially on the support elements (11) in the closed position and in the open position are at least partially spaced from the support elements (11) and thus clear the opening (20) for the flow; and

- An anchoring device (7) which has an anchoring and is set up to anchor the valve device (6) in the region of the upper or lower vena cava be adjacent to the vein opening to the right atrium of the heart.

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

3. Arrangement according to claim 1 or 2, characterized in that the Ventilein direction (6) is formed as a one-way valve.

4. Arrangement according to at least one of the preceding claims, characterized in that the closure elements (10) each cover a circular section area, adjacent closure elements overlap along the radii (10b, 10c) laterally delimiting the circular section area.

5. Arrangement according to claim 4, characterized in that the closure elements (10) each cover a section of a circle of at least approximately 90 degrees.

6. Arrangement according to at least one of the preceding claims, characterized in that the closure elements (10) are fastened along an outer circumferential edge at least in sections, such that a portion of the closure element (10) located radially inward with respect to the circumferential edge in Swing open the open position and thus release the flow.

7. Arrangement according to at least one of the preceding claims, characterized in that the opening (22) of the support structure (12) is formed with a through-flow nozzle (50).

8. Arrangement according to at least one of the preceding claims, characterized in that the support structure (12) has support elements (11) which extend in a star shape.

9. The arrangement according to at least one of the preceding claims, characterized in that the support structure (12) supports the closure elements (10) in the closed position in a substantially two-dimensional flat plane.

10. The arrangement according to at least one of claims 1 to 8, characterized in that the support structure (12) supports the closure elements (10) in the closed position in a curved three-dimensional plane.

11. Arrangement according to at least one of the preceding claims, marked e t by a flexible sealing collar (8).

12. The arrangement according to at least one of the preceding claims, 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 the pericardium and the synthetic membranous plastic material.

13. Arrangement according to at least one of the preceding claims, characterized in that the anchorage is formed with a self-expanding anchorage.

14. Arrangement according to at least one of the preceding claims, characterized in that some or all of the closure elements (10) consist of a biological rule material.

15. Minimally invasive implantable tricuspid valve prosthesis, with an arrangement according to at least one of the preceding claims.