EP3294217A1

EP3294217A1 - Implantable device for improving or treating a heart valve insufficiency

Info

Publication number: EP3294217A1
Application number: EP16726277.3A
Authority: EP
Inventors: Till Neumann; Torsten Scheuermann; Niklas Maximilian Nathe
Original assignee: Coramaze Technologies GmbH; Universitaet Duisburg Essen
Current assignee: Coramaze Technologies GmbH; Universitaet Duisburg Essen
Priority date: 2015-05-12
Filing date: 2016-05-10
Publication date: 2018-03-21
Also published as: WO2016180530A1; CN107809982A; DE102015005934A1; JP2018519878A; US20180133012A1; CA2984978A1

Abstract

The invention relates to an implantable device for improving or treating a heart valve insufficiency, comprising a closure body (1) and at least one anchoring element fastened thereto, by way of which the closure body (1) can be fastened in the heart, preferably in the atrium of the heart. The anchoring element comprises a plurality of contact strips (2) extending between the closure body (1) and a shared connecting element (3) that is spaced from the closure body (1). The connecting element (3) can be brought into a first and a second position each spaced from the closure body, whereby the contact strips (2) undergo a change in shape, wherein in the first position, the connecting element (3) is spaced further apart from the closure body (1) than in the second position, and in the second position, the connecting element (3) is arranged between the contact strips (2).

Description

Implantable device for improving or eliminating a

Heart valve insufficiency

The invention relates to an implantable device for improving or eliminating heart valve insufficiency comprising a closure body and at least one anchoring element attached thereto, with which the

Closure body in the heart, preferably the atrium of the heart is attachable.

Implantable devices of this kind are known in the art, e.g. from the application DE 10 2012 010 798 A1 of the same inventor and are used when in a patient during the usual

Heart activity does not close the heart valves sufficiently and thereby

Misdirections occur between the ventricle and the atrium of the heart.

An implantable device of the type mentioned is then implanted in the heart of the patient, so that the closure body in

Passage region of the heart valve is arranged and thus the

When closing, the sails of the heart valve are applied externally to the closure body, therefore the closure body used closes an otherwise remaining gap area.

By the closure body of such an implantable device thus improved closing of the heart valve is restored and prevents the aforementioned false currents.

CONFIRMATION COPY The attachment of such a device by means of the attached thereto

Anchoring element can be made so that the anchoring element on the closure body allows atraumatic attachment in the heart, in particular by the fact that the anchoring element for the purpose of attachment to the inner wall of the heart creates without penetrating the heart wall.

For example, an anchoring element for this purpose can be formed by a band or a plurality of bands or band sections, wherein a respective band or band portion of the closure body, if necessary. With

Branches extending away. In this way, a basket-like structure can be formed, which can be applied from the inside to the heart wall, in particular of the atrium, especially when bands are returned in a loop to the closure body.

Since it is desired in this attachment method that an application from the inside to the heart wall, preferably in the atrium, an anchoring element of this type in the implanted state after attachment to a size that at least substantially corresponds to the volume of the atrium, preferably slightly larger is to achieve a resulting system pressure.

It is therefore problematic in such devices, a

Insert anchoring element with such a large cross-section in the heart, which is currently essentially done surgically by opening the heart, with a correspondingly complex and risky operation.

Against this background, it is an object of the invention to provide a device of the aforementioned generic type, which can be implanted minimally invasive, preferably transfemoral in the body of a patient. Preferably, a self-expanding device should be created. This object is achieved according to the invention in that the anchoring element comprises a plurality of investment bands extending between the closure body and a common, spaced from the closure body connecting member, wherein the connecting element below

Change in shape of the conveyor belts in a first and a second of

Locking body each spaced position can be brought, wherein in the first position, the connecting element has a greater distance from the closure body than in the second position and in the second position the

Connecting element is arranged between the bands.

In this case, the invention preferably provides that the device has exactly one single anchoring element formed by the bearing bands and lying on only one side of the closure body, in particular on the atrium side

Anchoring element having.

In this case, a band is understood to mean preferably any band-shaped or wire-shaped element that extends from the closure body to form the band

Anchoring element at least partially wegerstreckt and opens into the connecting element, if necessary, with the inclusion of branches or cross connections.

The two positions should preferably be chosen so that the

Connecting element in both positions lies on an imaginary line which coincides with the longitudinal direction of the closure body, preferably of a closure body whose cross-section can be changed perpendicular to the longitudinal extent, for example by having at least one cavity which can be filled with a fluid, wherein the at least one cavity after filling remains constant in volume, that is to say the volume of which does not subsequently change automatically, in particular during the cardiac phase a volume constancy is given, despite changing pressure conditions. Although the invention is preferably used in conjunction with such a closure body, it can in principle be used with any closure body which is known in the art or will be developed in the future.

Also, this type of anchoring element can be used not only with closure bodies to remedy heart valve insufficiency, but in principle with any implant that is to be anchored in the heart.

The essential core idea of the invention is based on the fact that the

Anchoring element take two forms can be achieved by changing the shape of the investment bands, wherein the position of the two forms

Connecting element is different.

As a connecting element while the element is understood that the from

Closure body wegerstreckten ends of the investment bands connects. In one possible embodiment, these ends of the abutment bands may be originally open, free ends, which are connected by the connecting element.

Since the contact strips have a fixed length, the assumption of the first position in which the connecting element is farther away from the

Closure body than in the second position, that the contact strips are stretched, preferably maximally stretched and are closer to each other, as is the case in the second position. In particular, in this position the

Investment belts touch each other. The extension can in particular be such that the contact strips have, at least in sections, a respective linear extent between the closure body and the connecting element.

For example, in this first position, the entire device may be inserted into a catheter to pass therethrough, eg, transfemoral into the heart to be brought. In the first position, the maximum cross section of the entire device is smaller than the inner cross section of the catheter.

In the second position, the connecting element is moved closer to the closure body not only relative to the first position, whereby the abutment belts move away from one another in a direction perpendicular to the longitudinal extent of the device, but positioned so close that it enters an area between the abutment belts is preferably on the imaginary line mentioned above, which coincides with the longitudinal direction.

The arrangement of the connecting element between the abutment bands preferably means that in a view of a cross-section perpendicular to the direction of connection between ventricle and atrium, i. perpendicular to

Longitudinal direction of the device, which positioned between the closure body and the atrium-side end portion of the anchoring element

Connecting element preferably located centrally between the bands, the investment bands this connecting element thus surrounded.

Preferably, an arrangement of the connecting element between the contact strips in the second position further or understood in other words that in a direction perpendicular to the aforementioned line, in particular a central axis line that passes through the closure body and the connecting element, laterally adjacent to the connecting elements areas consist of several bands, in particular those areas of several bands are arranged around this line / central axis line around.

Preferably, however, in the first position, the arrangement is such that in the aforementioned direction perpendicular to the line / central axis line laterally adjacent to the connecting element, in particular over its entire axial length, no areas of one or more bands are. The

Tiebacks connected to the connector are preferred at the axial end face of the closure body facing the

Connecting element connected to this.

In a preferred manner, in the second position thereby forms the from

Closing body wegweisende end of the connecting element is no longer the extremal end of the entire device, but lies before this, i. closer to the closure body. Thus, it can be achieved that the connecting element itself does not come to rest on the inner heart wall, but preferably only the abutment belts, in particular with their outer sides.

Preferably, in the second position, the abutment belts are pushed apart so far, preferably maximally, that they together form a basket structure which delimits a cross section which at least equals or is greater than the cross section of the atrium used for attachment.

In the second position, the said cage structure forms an inverted towards the interior of the basket structure invagination. This indentation is preferably arranged symmetrically about the said central axis line and further preferably forms an at least partially annular space which is formed around the connecting element and is more preferably open to the outside. "Outwards" means seen from the connecting element in the direction away from the closure body The outwardly facing opening of the indentation has an opening plane, in particular, which is intended to be tangential to the basket structure and intended to lie perpendicular to the central axis line, the connecting element being arranged between this plane and the closure element in the second position.

The design of the device can be chosen so that in the second position, the investment bands each area a to

Have closure body directed back extension and / or on the maximum distance from the closure body end of the anchoring element convex are formed and / or have a region-wise S-shaped extension, in particular adjacent to the connecting element. especially the

Vertex areas of the S-shaped extension can be used for

Form closure body back areas.

To form a stabilized anchoring element, it can be provided that the bearing strips are interconnected by braces or have branches.

Also, the device may have an embodiment in which an equal number is provided extending from the closure body away

Anlagebandabschnitten and merging into the connecting element

Conditioning belt sections.

In particular, in this case, the group of the closure body-side

Investment band sections to the group of connector-side

Investment band sections at an angle to the extension direction (initially mentioned imaginary line) to be offset.

It can be provided that each plant band section of the one group is shown in at least two plant band branches and is connected via these with two plant band sections of the other group.

Here, the plant band branches of adjacent branches

Crossing plant tape sections, in particular be connected at the intersection points.

It may preferably be provided in all possible embodiments that the investment bands are each connected at the end facing the closure body with an inner body of the closure element, around which are arranged with the heart valves interacting surfaces of the closure element. These interacting surfaces are preferably the wall or regions of at least one fluid-fillable cavity arranged around a base body. Here are under the investment bands in the sense of the aforementioned

Embodiments also subsumes the Anlagebandabschnitte, in particular the closure body-side.

The main body may be an e. G. act tubular element around which at least one fillable cavity is arranged, as mentioned above.

A base body may be formed in a simple embodiment by a rigid tube, in particular which is surrounded by the at least one cavity. A preferred embodiment may also provide that the

Base body is designed as a bendable out of its linear extension element, in particular by internal spring forces in the linear

Extension back is relaxable.

Such a body is therefore preferably self-restoring flexible.

In one embodiment, in particular as a metallic tubular body, the base body may be wound at least in sections into a spring, e.g. from a wire with a round or a band with an angular cross-section.

A flexible base body may also be made of an originally rigid tube, by introducing a plurality of incisions in the lateral surface of the tubular body. Notches may preferably be perpendicular to the longitudinal extent and are preferably spaced equidistantly in the longitudinal direction.

Longitudinally successive incisions may also be made alternately in different directions, by which it is preferably understood that cuts are made with respect to an angle viewed in the circumferential direction at different angular positions. The angular positions can be equidistant, for example, cuts are preferably at 0 degrees, 90 degrees, 180 degrees and 270 degrees.

At a respective longitudinal direction position can also be two

Opposite incisions each terminating in front of the center of the tube, e.g. a pair of opposing cuts at 0 and 180 degrees and a pair at 90 and 270 degrees. The pairs are then spaced longitudinally, preferably equidistant.

A self-restoring flexibility of a tubular base body can also be realized by one or more meander-shaped cuts in the lateral surface of the base body. In case of several cuts they can be interlocked. Such a meander cut may alternately have longitudinal and transverse, preferably perpendicular cutting sections.

The invention can provide in a preferred development that at least the connecting element, the contact strips and an inner body of the closure body, e.g. the one described above, integral with each other

are formed, in particular cut from a piece of pipe, preferably are laser cut.

Preferably also here belong to the bands again the

Closure body-side and connector-side conditioning tape sections and all these connecting or branching plant band branches.

Thus, in this one-piece embodiment, most of the device can be made from a semi-finished product, e.g. a tube, in particular of a shape memory material.

The invention can provide in all embodiments that the

Connecting element by a force away from the closure body of the second can be converted into the first position, in particular against a spring applied to the belt tension. This force can eg by means of a

Sliding catheter are exerted on the connecting element, which pushes the connecting element of the closure body. The push catheter may e.g. be guided by the closure body and on

Abut connection element.

An embodiment may also provide that the connecting element can be transferred from the first to the second position by means of temperature changes from a first temperature to a second temperature forces in the formed of a shape memory material investment bands, in particular wherein at the first and second temperature corresponding to the first or the second position forms a stable position of the investment bands.

For example, For example, the shape of the abutment bands taken in the first position can form a stable position at a first lower temperature and the shape of the second position form a stable position at a temperature higher than the first temperature. For example, For example, the device may be implanted in a cooled manner, for example, with continuous cooling during delivery in a catheter, e.g. which is acted upon by a cooling fluid.

After implantation, the device heats up and goes over into the mold in which the connecting element occupies the second position. By the

Taking the second position then exerts the anchoring element its anchoring function.

For the purpose of implantation, the connecting element may have an inner open cross-section, in particular be designed as a ring or tubular sleeve. By the connecting element, a guide wire can be pushed through, for example, after it has been passed through the closure body, in particular by its body. The above-mentioned sliding catheter can be guided on the guide wire until, for example, sleeve-shaped connecting element are advanced and abuts this, since he can not penetrate the connecting element. Sliding the sliding catheter causes the pushed, in particular sleeve-shaped connecting element pulls the rest of the device, in particular the closure body on the bands behind it.

An embodiment of the invention will be explained with reference to the following figures.

1 shows a lateral view of a device according to the invention with a closure body 1, here a fillable of the type described above with at least one cavity 4, which around a main body 1 a around

is arranged. The cavity 4 is bounded outwardly by the wall 4a. The closure body 1 is shown on the left side.

The right side of the closure body 1 wegerstreckenden investment bands 2 form a total basket or cage-like structure and with this structure, the anchoring element according to the invention, here in the expanded state after implantation.

The investment bands 2, are divided into closure body-side

Anlagebandabschnitte 2 a, the emanating from the closure body 1, and the main body 1 a and in each two plant band branches 2b1 (to the right) and 2b2 (to the left) branch. Two plant tape branches 2b1, 2b2 of different

Abutment tape sections 2a are reunited in a joint body side conditioning tape section 2c.

FIG. 1 shows that here the connecting element 3 has assumed a position close to the closure body, in which it is arranged between the contact bands 2. According to the previous general description, it is the second position. The adjacent to the connecting element 3 areas of the contact strips 2 and the Anlagebandabschnitte 2c are bent in an S-shape. In the areas 2d marked here, in particular, the vertices of the S form a bend, the investment belts 2, and the plant tape sections 2c to the closure body 1 back towards.

The investment bands 2, here the connecting element-side

Anlagebandabschnitte 2c, form a convex to the heart wall area 2e, which comes to rest on the inner heart wall of the atrium. In this case, the connecting element 3 is closer to the closure body 1 than the convex end portions 2e.

To the connecting element 3 results with this construction of the hatched here shown annular space 5, which is in the direction pioneering the closure body 1 open. This annular space 5 forms the

Basic area of an invagination of the basket or cage-shaped by the

Investment belts 2 formed anchoring element. The opening of the indentation pointing away from the closure body 1 has an opening plane 6, visualized by the dashed line. This opening plane 6 is perpendicular to

Central axis line 7, which through the closure body 1 and the

Connecting element 3 extends and is tangent to the contact strips 2. The connecting element 3 is in the second position shown here, ie the fully expanded state of the anchoring element between the

Closure body 1 and said opening plane 6. This is

it can be seen that the connecting element 3 can not come into contact with the myocardial tissue when anchoring is done.

FIG. 2 shows the device in a state in which the

Connecting element 3 is in a position in which it further from

Closure body 1 is removed than in the second position. The distance here is maximum, so that the contact strips 2 or the respective contact strip sections are maximally stretched and have a substantially linear extension. Here, as well as in the figure 1 it can be seen that the investment bands 2 on the closure body facing the axial end face / face of the

Connecting element 3 open into this, or are connected to it. Due to the extension of the abutment bands 2, these are located close to one another, so that the device as a whole has a cross section perpendicular to the direction of extent which is smaller than the inner diameter of a catheter 8, in which the device can be brought to the implantation site.

Claims

claims

1. Implantable device for improving or eliminating a

Heart valve insufficiency comprising a closure body (1) and at least one anchoring element attached thereto, with which the closure body (1) in the heart, preferably the atrium of the heart is fastened, characterized in that the anchoring element comprises a plurality of investment bands (2) extending between the closure body (1) and one

common, spaced from the closure body (1) connecting element (3), wherein the connecting element (3) under change of shape of the contact strips (2) in a first and a second spaced from the closure body position can be brought, wherein in the first position

Connecting element (3) has a greater distance from the closure body (1) than in the second position and in the second position

Connecting element (3) between the bands (2) is arranged.

2. Device according to claim 1, characterized in that in the second position, the contact strips (2) each a. partially directed towards the closure body (1) back

Extension (2d) and / or b. at the end of the closure body (1) maximum distance (2e) of the

Anchoring element are convex and / or c. have a region-wise S-shaped extension, in particular adjacent to the connecting element (3).

3. Device according to one of the preceding claims, characterized

characterized in that the investment bands (2) with each other by

Struts are connected.

4. Device according to one of the preceding claims, characterized

characterized in that it is exactly one formed by the bands on only one side of the closure body (1) lying anchoring element, in particular atriumseitig arranged anchoring element has.

5. Device according to one of the preceding claims, characterized

characterized in that the abutment bands (2) each at the end facing the closure body (1) with an inner base body (1 a) of the

Closure body (1) are connected, around which are arranged with the heart valves interacting surfaces (4a) of the closure body (1).

6. Device according to one of the preceding claims, characterized

characterized in that at least the connecting element (3), the

Investment belts (2) and an inner base body (1a) of the closure body (1) are integrally formed, in particular cut from a piece of pipe, preferably laser-cut.

7. Device according to one of the preceding claims, characterized

characterized in that the connecting element (3) is replaced by one of

Closure body (1) Wegweisende force from the second to the first position can be transferred, in particular against a the tension bands (2) impressed spring tension.

8. Device according to one of the preceding claims, characterized

characterized in that the connecting element (3) can be transferred from the first to the second position by forces caused by temperature change in the formed of a shape memory material

Anlagebändern (2), in particular wherein at the respective temperatures, both the first and the second position a stable position of the

Investment belts forms.

9. Device according to one of the preceding claims, characterized

characterized in that the connecting element (3) has an inner open cross-section, in particular as a ring or tube sleeve is formed.